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Study in the American Journal of Obstetrics & Gynecology finds Maternal Safety Toolkits and Health Care Collaboration Reduced the Most Common Cause of Maternal Death Worldwide

WASHINGTON (March 6, 2017)— In a study in the American Journal of Obstetrics & Gynecology researchers with the California Maternal Quality Care Collaborative, based at Stanford University, Palo Alto, California, found that using a series of maternal safety toolkits and collaborating across multiple professional health care organizations could effectively reduce obstetric hemorrhage—the most common cause More »

Study in the American Journal of Obstetrics & Gynecology finds Glucose Supplementation Significantly Reduces Length of Induced Labor in Childbirth

WASHINGTON (Feb. 13, 2017)—A study in the American Journal of Obstetrics & Gynecology finds that simple glucose supplementation reduces length of induced labor. The study (currently available online as an Article in Press, in advance of the May issue of the Journal), was initially presented two weeks ago at the Society for Maternal-Fetal Medicine’s annual More »

Charles J. Lockwood, M.D. Recognized with Lifetime Achievement Award from the Society for Maternal-Fetal Medicine

WASHINGTON, Feb. 7, 2017—The Society for Maternal-Fetal Medicine surprised Charles (Charly) J. Lockwood, M.D., MHCM, last week when they gave him the SMFM Lifetime Achievement Award at the SMFM annual meeting in Las Vegas. “Dr. Lockwood was selected because he really has had a remarkable career,” said SMFM President Mary Norton, M.D., who presented Lockwood More »

Study Found Brain Abnormalities in Fetuses Exposed to Zika

LAS VEGAS (Jan. 23, 2017)—In a study to be presented Friday, Jan. 27, in the oral concurrent session at 1:15 p.m. PST, at the Society for Maternal-Fetal Medicine’s annual meeting, The Pregnancy Meeting™, researchers with the Baylor College of Medicine Department of Obstetrics and Gynecology, Houston, Texas partnered with the Maternal-Fetal Unit, CEDIFETAL, Centro de More »

Improving Birthing Deliveries with Less Physical Trauma to Mom and Baby

LAS VEGAS (Jan. 23, 2017)—In a study to be presented Friday, Jan. 27, in the oral concurrent session at 1:15 p.m. PST, at the Society for Maternal-Fetal Medicine’s annual meeting, The Pregnancy Meeting™, researchers with Community Medical Center in Missoula, Montana; Uniformed Services University of the Health Sciences, Bethesda, Md.; and Wilford Hall Ambulatory Surgery More »

New Health Care Model Cut Costs and Reduced Need for Medical Services for Pregnant Women and Newborns

LAS VEGAS (Jan. 23, 2017)—In a study to be presented Friday, Jan. 27, in the oral concurrent session at 1:15 p.m. PST, at the Society for Maternal-Fetal Medicine’s annual meeting, The Pregnancy Meeting™, researchers will present their findings for a study titled, Pregnancy medical home: Outcomes and cost-savings. The study set out to evaluate the More »

Study Finds that Limiting Gestational Weight Gain in Overweight and Obese Women Did Not Improve Pregnancy Complications

LAS VEGAS (Jan. 23, 2017)—In a study to be presented Thursday, Jan. 26, in the oral plenary session at 8 a.m. PST, at the Society for Maternal-Fetal Medicine’s annual meeting, The Pregnancy Meeting™, researchers with Northwestern University in Chicago, Illinois, will present their findings for a study titled,  MOMFIT: A randomized clinical trial of an intervention to prevent excess gestational weight gain in overweight and obese women.

 It is now recognized that excess maternal weight gain during pregnancy is very common in the United States, and is associated with an increased risk of a number of pregnancy complications, especially in women who start pregnancy overweight or obese. These complications include gestational diabetes, maternal hypertension, excessive newborn size and cesarean delivery. Excess maternal weight gain has also been associated with higher rates of obesity in the child later in life. Some previous trials have had success with interventions to help women limit weight gain during pregnancy, but with mixed results as to whether subsequent complications were reduced.

This study performed a randomized trial with an intervention including intensive interaction with a dietician, recommendations for physical activity and internet-based self-monitoring of dietary adherence in overweight and obese women, and compared their outcomes to a similar group of women without this intervention. The intervention was successful in that average weight gain was reduced significantly, but no improvements in pregnancy outcomes were detected.

“While pregnant women should still be counseled against excess weight gain, additional measures may be required to reduce the associated complications,” stated Alan Peaceman, M.D. chief of maternal-fetal medicine in the department of obstetrics and gynecology at Northwestern Medicine in Chicago.  Peaceman will present the findings at the SMFM annual meeting.

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Study Finds Use of Fetal Genetic Sequencing Increases the Detection Rate of Genetic Findings by 10 to 30 Percent

LAS VEGAS (Jan. 23, 2017)—In a study to be presented Thursday, Jan. 26, in the oral plenary session at 8 a.m. PST, at the Society for Maternal-Fetal Medicine’s annual meeting, The Pregnancy Meeting™, researchers with the Columbia University Medical Center in New York found that, in preliminary data, fetal genomic (whole exome) sequencing (WES) as a diagnostic test for women with pregnancies complicated by major fetal congenital anomalies increased the detection rate of genetic findings by between 10 to 30 percent.

The study, titled Whole exome sequencing in the evaluation of fetal structural anomalies: A prospective study of sequential patients used selected patients that were felt to have a high likelihood of having a fetal genetic anomaly.

In recent years, prenatal detection of fetal congenital anomalies has become increasingly more frequent, due to the adoption of routine ultrasound imaging.  Simultaneously, advanced genetic testing has evolved demonstrating that an increasing proportion of these anomalies have a genetic cause. Approximately 10 years ago, chromosomal microarray analysis (CMA) was added to standard karyotyping as a prenatal diagnostic test increasing the detection rate of clinically significant cytogenetic abnormalities by 6% in cases with a single anomaly (abnormality) and 13% when multiple anomalies were present.  In other words, CMA looked at cell and chromosomal disorders.  These prior studies, including a multi center Eunice Kennedy Shriver National Institutes Child Health and Human Development (NICHD)-funded trial presented at a prior Society of Maternal-Fetal Medicine annual meeting, has changed national guidelines so that CMA is now the recommended test for evaluating fetal anomalies.

While CMA has been a significant improvement, an estimated 60-70% of cases with identified fetal abnormalities still remain without a genetic diagnosis.  With this current study, fetal genomic (whole exome) sequencing was evaluated as a diagnostic test for women with pregnancies complicated by major fetal congenital anomalies.

“Our preliminary data and published literature indicate that sequencing will increase the detection rate of genetic findings and this information will significantly improve patient counseling and neonatal treatment,” explained Ronald Wapner, M.D., professor of obstetrics and gynecology for the maternal fetal medicine department at Columbia University Medical Center, who is presenting the study. “New associations with genes with very specific fetal phenotypes are also beginning to be uncovered,” he added.

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House, Senate Agree on Key SMFM-backed Language Assessing Research in Pregnancy and Breastfeeding

WASHINGTON, Nov. 28, 2016– In 2014, the Society for Maternal-Fetal Medicine began working with the March of Dimes, the American Congress of Obstetricians and Gynecologists, and the American Academy of Pediatrics to form the Coalition to Advance Maternal Therapeutics. The Coalition has been working to educate and inform Congress and other policymakers on the issues related to lack of data and information on medications in pregnancy and breastfeeding, recently hosting a congressional briefing on the topic.

In February 2015, SMFM hosted a workshop on the issue of medications in pregnancy and breastfeeding at its annual meeting, which was co-sponsored by the National Institute of Child Health and Human Development, American Academy of Pediatrics, and American Congress of Obstetricians and Gynecologists. The workshop explored the issue of medications used during pregnancy and breastfeeding, with participants agreeing that more research was necessary to ensure that safe and effective drugs are being prescribed to women who need them during pregnancy and lactation.

SMFM, with the CAMT, advocated for the creation of a task force housed within the U.S. Department of Health and Human Services that will improve federal interagency and key stakeholder communication, coordination and collaboration to advance research and information sharing on medications in pregnancy and breastfeeding.  This Task Force has been included in the bipartisan, negotiated 21st Century Cures Act. The task force will include federal agencies such as National Institutes of Health, U.S. Food & Drug Administration, and Centers for Disease Control and Prevention as well as public stakeholders from professional societies, consumer representation and industry representation to prioritize and identify gaps in research and recommend a path forward on greater inclusion of pregnant and breastfeeding women in medication research.

Dr. Mary Norton, president of SMFM, released the following statement:

“We applaud Congress for making the right decision in creating a Task Force on Research in Pregnant Women and Lactating Women in the final 21st Century Cures Act, slated for a vote in the House this week, and hope for swift action by the Senate shortly following. SMFM has been dedicated to moving this important initiative for several years, founding the Coalition to Advance Maternal Therapeutics – whose steering committee includes the American Academy of Pediatrics, American Congress of Obstetricians & Gynecologists and March of Dimes, as well as SMFM.

“SMFM would like to especially acknowledge Senator Patty Murray and Representatives Jaime Herrera Beutler and Kathy Castor for continuing to lead the efforts to ensure that this language made it into the final legislative package, which has strong bipartisan support.

“More women with chronic diseases are becoming pregnant, yet safe and effective medications to manage these ongoing conditions throughout their pregnancy and beyond are needed. This legislation is a great first step toward greater collaboration and communication among federal agencies and public stakeholders.

“We look forward to ensuring that the work of this task force will inform our members and patients and strongly support this legislation’s passage and seeing President Obama sign it into law.”

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Nation’s Health Experts Look to Improve Maternal Care

Nation’s Health Experts Look to Improve Maternal Care

ACOG and SMFM issue new guidance on Severe Maternal Morbidity:

Screening and Review

 WASHINGTON, Aug. 23, 2016 Each year, more than 65,000 women in the United States suffer complications during pregnancy or childbirth that are near-fatal. In many cases, these outcomes may have been prevented. Like maternal mortality, defined as the death of a woman during pregnancy, at delivery or soon after delivery, maternal morbidity in the United States has been steadily increasing. A maternal morbidity is an unintended outcome in the process of labor and delivery that results in significant short-term or long-term consequences to a woman’s health.

Today, as part of a continued effort to reduce maternal morbidity and mortality across the country, organizations representing women’s health care providers released new guidance on the screening and review of maternal morbidity. Severe Maternal Morbidity: Screening and Review is the fifth in the joint American College of Obstetricians and Gynecologists (ACOG) and Society for Maternal-Fetal Medicine (SMFM) Obstetric Care Consensus Series.

Maternal morbidity can be considered a “near miss” for maternal mortality because, in some cases, without identification and treatment the conditions that define maternal morbidity would lead to maternal death. Therefore, the importance of identifying a potential maternal morbidity is paramount. Identification can also highlight opportunities to avoid such injuries in other women in the future.

“Obstetrician-gynecologists always want the best, healthiest outcomes for both mother and child. That is why our Obstetric Care Consensus Series aims to improve maternal safety across the country,” said Sarah J. Kilpatrick, M.D./Ph.D., chair of the Department of Obstetrics and Gynecology at Cedars-Sinai Medical Center in Los Angeles, California, and a lead author of the document. “Developing systems that help us identify severe maternal morbidity will ultimately help provide better care. The two-step approach discussed in the document involves a screen to identify potential cases of severe maternal morbidity, followed by a review to help better understand the event, including determining if the morbidity was potentially avoidable.”

Multidisciplinary expert groups have called for all obstetric hospitals to review their cases of severe maternal morbidity in order to recognize opportunities for improvement in care. Building off this recommendation, ACOG and SMFM recommend using a two-step screen and review process to identify severe maternal morbidity.

First, they recommend facilities have a screening process in place to detect potential cases. ACOG and SMFM recommend using the following two criteria as a screen, although institutions may choose to incorporate additional criteria:

  • Transfusion of four or more units of blood
  • Admission of a pregnant or postpartum woman to an ICU

Second, facilities should then review all cases that meet at least one of these screening criteria to efficiently detect severe maternal morbidity and determine whether there were opportunities for improvement in care. Institutions may also elect to define additional screening criteria if deemed useful in their setting.

ACOG and SMFM are careful to highlight that not all cases of severe maternal morbidity are preventable. Some cases of morbidity reflect the underlying health of a woman or her pregnancy and are thus unavoidable. Therefore, simply screening positive for one of the two recommended screening criteria does not constitute a sentinel event and rates of occurrence of either criterion should not be used as a quality metric.

While the document provides an example list of conditions that could constitute severe maternal morbidity, there is no consensus on a comprehensive list of conditions. This underscores the importance of institutions and systems either adopting an existing screening criteria or creating their own list of outcomes that merit review.

“The intent of this document is to provide a standard, evidence-based approach to help obstetric providers and their facilities more easily recognize cases of severe maternal morbidity which deserve more detailed review, “Dr. Kilpatrick continued. “These criteria and the examples listed in the document are not categorical definitions and should not be misconstrued as quality measures. Rather, we understand that as women’s health care physicians we need to be at the forefront of developing a reference to identify severe maternal morbidity and that’s what this document is intended to do.”

“Quality improvement is something all obstetrician-gynecologists should be actively involved in—regardless of hospital size, location, or low- or high-risk pregnancy status. There is almost always something to learn about our systems following these types of complex cases. We owe it to our future patients to continuously improve the care we provide and this document will help these efforts,” stated Dr. Sean Blackwell, chair of the publications committee for the SMFM and chair of the Department of Obstetrics, Gynecology and Reproductive Sciences at McGovern Medical School at The University of Texas Health Science Center at Houston.

In addition to this newly-released guidance, ACOG and SMFM have been long-standing lead partners in the Alliance for Innovation on Maternal Health (AIM), a national alliance to promote consistent and safe maternity care to reduce maternal mortality and severe maternal morbidity.

Other recommendations issued in the September Obstetrics & Gynecology:

Committee Opinion #671, Perinatal Risks Associated With Assisted Reproductive Technology

Over the past decades, the use of assisted reproductive technology (ART) has increased dramatically worldwide and has made pregnancy possible for many infertile couples. Although the perinatal risks that may be associated with ART and ovulation induction are much higher in multifetal gestations, even singletons achieved with ART and ovulation induction may be at higher risk than singletons from naturally occurring pregnancies. However, it remains unclear to what extent these associations might be related to the underlying cause(s) of infertility. Before initiating ART or ovulation induction procedures, obstetrician–gynecologists and other health

care providers should complete a thorough medical evaluation to ensure that patients are in good health and should counsel these women about the risks associated with treatment. Any maternal health problems or inherited conditions should be addressed. Couples at risk of passing genetic conditions on to their offspring, including those due to infertility-associated conditions, should be counseled appropriately. When a higher-order (triplet or more) multifetal pregnancy is encountered, the option of multifetal reduction should be discussed. In the case of

a continuing higher-order multifetal pregnancy, ongoing obstetric care should be with an obstetrician–gynecologist or other obstetric care provider and at a facility capable of managing anticipated risks and outcomes.

Committee Opinion #672, Clinical Challenges of Long-Acting Reversible Contraceptive Methods

Long-acting reversible contraceptive methods are the most effective reversible contraceptives and have an excellent safety record. Although uncommon, possible long-acting reversible contraceptive complications should be included in the informed consent process. Obstetrician–gynecologists and other gynecologic care providers should understand the diagnosis and management of common clinical challenges. The American College of Obstetricians and Gynecologists recommends the algorithms included in this document for management of the most common clinical challenges.

Committee Opinion #673, Persistent Vulvar Pain

Persistent vulvar pain is a complex disorder that frequently is frustrating to the patient and the clinician. It can be difficult to treat and rapid resolution is unusual, even with appropriate therapy. Vulvar pain can be caused by a specific disorder or it can be idiopathic. Idiopathic vulvar pain is classified as vulvodynia. Although optimal treatment remains unclear, consider an individualized, multidisciplinary approach to address all physical and emotional aspects possibly attributable to vulvodynia. Specialists who may need to be involved include sexual counselors, clinical psychologists, physical therapists, and pain specialists. Patients may perceive this approach to mean the practitioner does not believe their pain is “real”; thus, it is important to begin any treatment approach with a detailed discussion, including an explanation of the diagnosis and determination of realistic treatment goals. Future research should aim at evaluating a multimodal approach in the treatment of vulvodynia, along with more research on the etiologies of vulvodynia.

Committee Opinion #674, Guiding Principles for Privileging of Innovative Procedures in Gynecologic Surgery

New or emerging surgical procedures and technologies continue to be developed at a rapid rate and must be implemented safely into clinical practice. Additional privileging may be required if substantively new technical or cognitive skills are required to implement an innovative procedure or technology. Guiding principles for privileging should include cognitive and technical assessment to ensure appropriate patient selection and performance of the new procedure. Implementation also should include pertinent institutional and staff support as needed. A dynamic process for assessment and maintenance of current competency will enhance the safety of implementation and continued application of emerging procedures and technologies. The number of cases needed to demonstrate cognitive and technical proficiency will vary depending on many factors, including the health care provider’s baseline expertise and technical acumen.

Practice Bulletin #166, Thrombocytopenia in Pregnancy

Thrombocytopenia in pregnant women is diagnosed frequently by obstetricians because platelet counts are included with automated complete blood cell counts (CBCs) obtained during routine prenatal screening (1). Although most U.S. health care providers are trained using U.S. Conventional Units, most scientists, journals, and countries use Système International (SI) units. The laboratory results reported in U.S. Conventional Units can be converted to SI Units or vice versa by using a conversion factor. The conversion factor for platelet count results is 1.0 (ie, to convert from x 103/μL, multiply by 1.0, to get x 109/L). Thrombocytopenia, defined as a platelet count of less than 150 x 109/L, is common and occurs in 7–12% of pregnancies (2, 3). Thrombocytopenia can result from a variety of physiologic or pathologic conditions, several of which are unique to pregnancy. Some causes of thrombocytopenia are serious medical disorders that have the potential for maternal and fetal morbidity. In contrast, other conditions, such as gestational thrombocytopenia, are benign and pose no maternal or fetal risks. Because of the increased recognition of maternal and fetal thrombocytopenia, there are numerous controversies about obstetric management of this condition. Clinicians must weigh the risks of maternal and fetal bleeding complications against the costs and morbidity of diagnostic tests and invasive interventions.

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Key Committee Votes to Create Task Force on Pregnant and Lactating Women to Ensure Safer Medications, Collaboration on Research and Wider Dissemination of Information

WASHINGTON, April 18, 2016—The Society for Maternal-Fetal Medicine announced today that the Senate Health Education Labor & Pensions (HELP) Committee has approved bill S. 2745 by voice vote, a bill intended to promote the inclusion of minorities in clinical research. This legislation includes a key provision that would create a Task Force on Pregnant Women and Lactating Women.

SMFM held a workshop on the issue of medications in pregnancy and breastfeeding at its annual meeting in February 2015, which was co-sponsored by the National Institute of Child Health and Human Development, American Academy of Pediatrics and American Congress of Obstetricians and Gynecologists.

“We are thrilled to see this initiative move to the next step in the legislative process,” stated Mary Norton, M.D., president of SMFM. “As more women with chronic diseases, such as diabetes, hypertension, depression and asthma are becoming pregnant, safe and effective medications to manage these ongoing conditions throughout their pregnancy and beyond are needed. This legislation is a great first step toward greater collaboration and communication among federal agencies and public stakeholders on this important issue.”

In her opening statement, HELP Committee Ranking Member Senator Patty Murray (D-WA), noted her thanks to the legislation’s cosponsors, including Senators Susan Collins (R-ME), Kirk (R-IL), Baldwin (D-WI), Warren (D-MA) and Chairman Alexander (R-TN) and herself. She noted specifically the inclusion of this task force to ensure safer medications and greater information for pregnant women and new mothers.

In 2014, SMFM began working with the March of Dimes, the American Congress of Obstetricians and Gynecologists, and the American Academy of Pediatrics to form the Coalition to Advance Maternal Therapeutics. The Coalition has been working to educate and inform Congress and other policymakers on the issues related to lack of data and information on medications in pregnancy and breastfeeding.

The provision included in S. 2745 will created a task force housed within the U.S. Department of Health and Human Services that will improve federal interagency and key stakeholder communication, coordination and collaboration to advance research and information sharing on medications in pregnancy and breastfeeding.  It will include federal agencies such as National Institutes of Health, U.S. Food & Drug Administration and Centers for Disease Control and Prevention as well as public stakeholders from professional societies, consumer representation and industry representation to prioritize and identify gaps in research and recommend a path forward on greater inclusion of pregnant and breastfeeding women in research.

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SMFM Releases Statement on Ultrasound Screening for Fetal Microcephaly following Zika Virus Exposure

WASHINGTON (April 13, 2016)— The Society for Maternal-Fetal Medicine released a statement on the use of ultrasound screening for fetal microcephaly following Zika virus exposure.

Microcephaly is a condition in which the size of the head is smaller than expected for age. This condition in fetuses and infants has been associated with the recent outbreak of Zika virus.  Due to this association, the Centers for Disease Control and Prevention, American Congress of Obstetricians and Gynecologists and the Society for Maternal-Fetal Medicine have suggested ultrasound evaluation to measure the baby’s head in pregnant women who have been infected or potentially exposed.  Diagnosis of microcephaly by ultrasound is not always straightforward and can be complex. The Society for Maternal-Fetal Medicine provided recommendations on how to interpret the findings, including when to perform follow up ultrasound, as well as a table of values at each week of pregnancy that would define the lower limit of normal. The goal is to provide the tools to health care providers to counsel women who may have been exposed to the Zika virus. The Society for Maternal-Fetal will continue to assist clinicians in tackling this new health threat.

For more information on the Society of Maternal-Fetal Medicine’s recommendations and the Zika virus, go to www.smfm.org/education/zika or visit SMFM’s publications www.smfm.org/publications.

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Society for Maternal-Fetal Medicine Releases Statement on use of Antenatal Corticosteroids in the Late Preterm Birth Period in Women at Risk for Preterm Birth

WASHINGTON (April 6, 2016)— The Society for Maternal-Fetal Medicine released a statement on the use of antenatal corticosteroids during the late preterm birth period for women at risk of preterm birth. The statement, is currently available online and will be published in the July issue of the American Journal of Obstetrics and Gynecology. It comes on the heels of a study and a presentation at SMFM’s annual meeting in Atlanta in February where researchers with the Eunice Kennedy Shriver National Institute of Child Health and Human Development and Maternal-Fetal Medicine Units Network (MFMU) presented findings that the administration of antenatal steroids in pregnancies at risk for late preterm delivery prevents respiratory and other neonatal complications.

The study, titled Antenatal Late Preterm Steroids (ALPS): a Randomized Trial to Reduce Neonatal Respiratory Morbidity was a randomized, double-blind, placebo-controlled trial at 17 tertiary medical centers around the United States from Oct. 2010 to Feb. 2015.  The study enrolled 2,831 women with singleton pregnancies at high risk for late preterm delivery (34 0/7 to 36 6/7 weeks) who were randomized to receive antenatal betamethasone intramuscularly or a matching placebo.  This study found a significant decrease in neonatal respiratory complications in the group given the steroid treatment.  Investigators also found that these babies were less likely to have prolonged intensive care nursery stays, less likely to need postnatal treatment for respiratory complications, and less likely to develop bronchopulmonary dysplasia, which is a sign of chronic lung disease. Prior to this report, such treatment was only recommended with risk of preterm delivery before 34 weeks of gestation, as infants in the late preterm period were thought to be at little, if any, increased risk of complications.

Lead investigator, Cynthia Gyamfi-Bannerman, M.D., MSc, the Ellen Jacobson Levine and Eugene Jacobson Associate Professor of Women’s Health (in Obstetrics and Gynecology) from Columbia University Medical Center, put the findings in context: “The majority of preterm deliveries occur in the late preterm period.  We now have a treatment that can significantly improve outcomes for these at risk babies.”  The study was co-funded by the NHLBI, with the aid of program officer Carol Blaisdell, M.D. and the NICHD under the guidance of Uma Reddy, M.D.

In their statement, the Society for Maternal-Fetal Medicine recommends:

  • In women with a singleton pregnancy between 34 weeks to 36 6/7 weeks of gestation who are at high risk for preterm birth within the next seven days (but before 37 weeks of gestation), SMFM recommends treatment with betamethasone, a corticosteroid demonstrated to decrease neonatal complications in preterm infants.
  • In women with preterm labor symptoms in the late preterm period, SMFM recommends waiting for evidence of true preterm labor, such as a cervical dilatation of at least three centimeters or effacement of at least 75% before treatment with betamethasone.
  • In women with late preterm pregnancies receiving betamethasone, SMFM recommends against the use of tocolysis in an attempt to delay delivery to complete the steroid course since it is unclear if the benefits are outweighed by the risks of attempts to delay delivery.
  • In women with late preterm pregnancies with a potential medical indication for delivery, SMFM recommends betamethasone not be given unless there is a definitive plan for late preterm delivery.
  • SMFM also recommends against the implementation of antenatal late preterm steroids protocol for conditions not studied in the randomized controlled trials.

Given that more than 300,000 pregnancies deliver in the late preterm period each year in the U.S., the study along with recommendations for adoption by the Society for Maternal-Fetal Medicine will have a significant impact on the health of newborns and infants.

For more information on SMFM publications, go to https://www.smfm.org/publications.

Study Finds Maternal Intake of High Fructose Leads to Fetal Programming of Adult Obesity, Hypertension and Metabolic Dysfunction Especially in Female Offspring

ATLANTA (Feb. 4, 2016)—In a study to be presented on Feb. 5 in the oral session at 1:15 p.m. EST, at the Society for Maternal-Fetal Medicine’s annual meeting, The Pregnancy Meeting™, in Atlanta, researchers will present findings on the effects of antenatal exposure to a high fructose diet on the offspring’s development of metabolic syndrome-like phenotype and cardiovascular disease later in life.

The study, titled High fructose diet in pregnancy leads to fetal programming of hypertension, insulin resistance and obesity in adult offspring, randomly allocated either a fructose solution or water as the only drinking fluid for pregnant mice from first day of pregnancy through delivery. Offspring were then started on regular chow and evaluated after one year of life.  Percent of visceral adipose tissue was measured along with liver fat infiltrates using computed tomography, and blood pressure using a non-invasive monitor. Glucose tolerance testing was also performed and serum concentrations of glucose, insulin, triglycerides, total cholesterol, leptin and adiponectin were measured.

Maternal weight, pup number and average weight at birth were similar between the two groups. Male and female offspring born to mothers who received the fructose solution group had higher peak glucose compared with controls. Female offspring from the fructose group were heavier and had a higher percent of visceral adipose tissue, liver fat infiltrates, fasting homeostatic model assessment scores, higher serum concentrations of leptin and lower concentrations of adiponectin.

No significant differences in these parameters were noted in male offspring. Serum concentrations of triglycerides and total cholesterol were not different between the two groups or either gender.

“While this study was done in a mouse model, it is an important indicator of the effect of the mothers’ diet during pregnancy on the health of their children later in life,” explained Antonio Saad, M.D. with UTMB Galveston and the lead researcher of the study. “Through this study, we know that consuming high fructose during pregnancy putts the child at future risk for a variety of health conditions including obesity and the many complications it causes.”

The study concluded that, while maternal intake of high fructose leads to fetal programming of adult obesity, hypertension, and metabolic dysfunction—all of which risk factors for cardiovascular disease; limiting high fructose enriched diets in pregnancy may have a significant impact on long term health.

 

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A copy of the abstract is available at http://www.smfmnewsroom.org and below. For interviews please contact Vicki Bendure at Vicki@bendurepr.com 202-374-9259 (cell).

 

The Society for Maternal-Fetal Medicine (est. 1977) is the premiere membership organization for obstetricians/gynecologists who have additional formal education and training in maternal-fetal medicine. The society is devoted to reducing high-risk pregnancy complications by sharing expertise through continuing education to its 2,000 members on the latest pregnancy assessment and treatment methods. It also serves as an advocate for improving public policy, and expanding research funding and opportunities for maternal-fetal medicine. The group hosts an annual meeting in which groundbreaking new ideas and research in the area of maternal-fetal medicine are shared and discussed.  For more information visit www.smfm.org.

 

Abstract 67    High Fructose Diet in Pregnancy Leads to Fetal Programming of Hypertension, Insulin Resistance and Obesity in Adult Offspring

 

Authors: Antonio Saad1, Joshua Disckerson1, Phyllis Gamble1, Huaizhi Yin1, Talar Kechichian1, Ashley Salazar1, Igor Patrikeev2, Massoud Motamedi2, George Saade1, Maged Costantine1

1UTMB Galveston, Galveston, TX, 2UTMB Center of Biomedical Engineering, Galveston, TX

 

Objective: Consumption of fructose rich diets in the U.S is on the rise and thought to be associated with obesity and cardio-metabolic diseases. Our objective was to determine the effects of antenatal exposure to high fructose diet on offspring’s development of metabolic syndrome-like phenotype and other cardiovascular disease (CVD) risk factors later in life.
Study Design: Pregnant C57BL/6J dams were randomly allocated to fructose solution (FRC, 10% W/V, n=10) as only drinking fluid or water (CTR, n=10) from day 1 of pregnancy until delivery. Pups were then started on regular chow, and evaluated at 1 year of life. We measured % visceral adipose tissue (VAT) and liver fat infiltrates using computed tomography (CT), and blood pressure using CODA/ non-invasive monitor. Intraperitoneal glucose tolerance testing (IPGTT), with corresponding insulin concentrations were obtained. Serum concentrations of glucose, insulin, triglycerides (TG), total cholesterol (TC), leptin, and adiponectin were measured in duplicate using standardized assays. Fasting homeostatic model assessment (HOMA- IR) was also calculated to assess insulin resistance.
Results: Maternal weight, pup number and average weight at birth were similar between the two groups. Male and female FRC offspring had higher peak glucose and area under the IPGTT curve, compared with CTR (Figures 1A&B), and higher mean arterial pressure compared to CTR (Figure 1C). Female FRC offspring were heavier and had higher % VAT (Figure 1D), liver fat infiltrates, HOMA-IR scores, insulin area under the IPGTT curve, serum concentrations of leptin, and lower concentrations of adiponectin compared to female CTR offspring (Table). No significant differences in these parameters were noted in male offspring. Serum concentrations of TG or TC were not different between the 2 groups for either gender.
Conclusion: Maternal intake of high fructose leads to fetal programming of adult obesity, hypertension and metabolic dysfunction, all risk factors for CVD. This fetal programming is more pronounced in female offspring. Limiting intake of high fructose enriched diets in pregnancy may have significant impact on long term health.

 

Abstract 67a

Abstract 67b

Study Shows Maternal Diet Alters the Breast Milk Microbiome and Microbial Gene Content

ATLANTA (Feb. 1, 2016)—In a study to be presented on Feb. 5 at 2:30 p.m. EST, at the Society for Maternal-Fetal Medicine’s annual meeting, The Pregnancy Meeting™, in Atlanta, researchers will present findings from a study titled, Maternal Diet Alters the Breast Milk Microbiome and Microbial Gene Content.

Breast milk contains a diverse microbiome that is presumed to colonize the infant gastrointestinal tract and contribute to the establishment of the infant gut microbiome. The composition of the breast milk microbiome varies over time and among individuals, though the factors driving the variation are largely unknown. Since maternal diet during gestation and lactation has been previously shown to independently alter the offspring microbiome and offspring disease susceptibility, researchers speculated that the breast milk microbiome may be a mediator of this dietary impact. Two groups of lactating women participated in highly-controlled single-blinded cross-over dietary intervention studies to evaluate if maternal diet plays a significant role in structuring the taxonomic and metagenomic composition of the breast milk microbiome.

“We saw considerable differences based on maternal diet,” explained Kristen Meyer, with the Baylor College of Medicine, one of the researchers of the study and the presenter at the SMFM annual meeting. “Based on this, we speculate that the maternal diet serves as a significant driver of the early infant microbiome, reinforcing the gestational dietary impact,” added Meyer.

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A copy of the abstract is available at http://www.smfmnewsroom.org and below. For interviews please contact Vicki Bendure at Vicki@bendurepr.com 202-374-9259 (cell).

 

The Society for Maternal-Fetal Medicine (est. 1977) is the premiere membership organization for obstetricians/gynecologists who have additional formal education and training in maternal-fetal medicine. The society is devoted to reducing high-risk pregnancy complications by sharing expertise through continuing education to its 2,000 members on the latest pregnancy assessment and treatment methods. It also serves as an advocate for improving public policy, and expanding research funding and opportunities for maternal-fetal medicine. The group hosts an annual meeting in which groundbreaking new ideas and research in the area of maternal-fetal medicine are shared and discussed.  For more information visit www.smfm.org.

 

abstract 66

New Research Uses Nanotechnology to Prevent Preterm Birth, March of Dimes honors abstract on prematurity at SMFM Annual Meeting

ATLANTA, FEB. 4, 2016 ­­– Using nanoparticles to engineer a special drug, a team of researchers has demonstrated in mice a new way to both reduce preterm birth and avoid the risks of medication in pregnancy to unborn babies.

Jerrie S. Refuerzo, M.D., of the McGovern Medical School at The University of Texas Health Science Center at Houston (UTHealth) was frustrated with the limitations of existing tocolytic (anti-contraction or labor-repressant) medications such as indomethacin in treating women experiencing preterm labor. These drugs can cross the placental barrier and cause a heart defect or other problems in the fetus. Dr. Refuerzo and Monica Longo, M.D., Ph.D. (UT Health), in collaboration with colleagues from Houston Methodist Research Institute, Biana Godin, PharmD, Ph.D., bioengineered an innovative microscopic nanoparticle of indomethacin aimed at reaching the pregnant uterus but not crossing the placenta to the fetus. This targeted liposomal indomethacin, called LIPINDORA, was coated with an oxytocin receptor antagonist to make it bind to uterine tissue.

LIPINDORA was given to near-term pregnant mice and the researchers found that the treated mice were significantly less likely than controls to have preterm uterine contractions or to deliver prematurely.

“These findings are exciting because we don’t currently have any medication that can reliably stop contractions or prevent preterm birth without also crossing the mom’s placenta and causing risks to babies,” explained Edward R. B. McCabe, M.D., Ph.D,, senior vice president and chief medical officer of the March of Dimes.

Preterm birth (birth before 37 weeks of pregnancy) is the number one killer of babies in the United States.

About 380,000 babies are born too soon each year in this country, and those who survive an early birth often face an increased risk of a lifetime of health challenges, such as breathing problems, cerebral palsy, intellectual disabilities and others. Even babies born just a few weeks early have higher rates of hospitalization and illness than full-term infants.

Dr. McCabe said nanoparticles are a leading-edge technology also being studied for delivery of drugs for other conditions, such as cancer, heart disease, and bacterial infections, in order to target specific cells to reduce toxicity and side effects of those medications and to make them more effective. Nanoparticles range 100-200 nanometers in diameter and a nanometer is one billionth of a meter. To demonstrate scale: a nanometer is to a tennis ball as a tennis ball is to the earth.

Dr. Refuerzo and her team, F. Leonard, A. E. Ontiveros, N. Buleyeva, Biana Godin, and Monica Longo, are being honored by the March of Dimes at the annual Society for Maternal-Fetal Medicine. Joe Leigh Simpson, M.D., senior vice president for Research and Global Programs, will present Dr. Refuerzo with the March of Dimes award for Best Abstract in Prematurity at the SMFM’s Annual Meeting. 2016 marks the 13th year that the March of Dimes award has been presented.

Dr. Refuerzo said the team currently is conducting tests of LIPINDORA’s effectiveness in human uterine tissue donated from C-sections. They’re looking for biomarkers to indicate that the tissue has an anti-contraction response to the drug. If successful, they hope to begin a Phase I human clinical trial of the drug within the next few years.

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The Society for Maternal-Fetal Medicine (est. 1977) is the premiere membership organization for obstetricians/gynecologists who have additional formal education and training in maternal-fetal medicine. The society is devoted to reducing high-risk pregnancy complications by sharing expertise through continuing education to its 2,000 members on the latest pregnancy assessment and treatment methods. It also serves as an advocate for improving public policy, and expanding research funding and opportunities for maternal-fetal medicine. The group hosts an annual meeting in which groundbreaking new ideas and research in the area of maternal-fetal medicine are shared and discussed. For more information visit www.smfm.org.

The March of Dimes is the leading nonprofit organization for pregnancy and baby health. For more than 75 years, moms and babies have benefited from March of Dimes research, education, vaccines, and breakthroughs. Find out how you can help prevent premature birth and birth defects by joining March for Babies at marchforbabies.org. For the latest resources and information, visit marchofdimes.org or nacersano.org. Find us on Facebook and Twitter.

Study Develops New Equation for Estimating Gestational Age

ATLANTA (Feb. 1, 2016)—In a study to be presented on Feb. 6 at 8:45 a.m. EST, at the Society for Maternal-Fetal Medicine’s annual meeting, The Pregnancy Meeting™, in Atlanta, researchers will present findings from a study titled, The NICHD Fetal Growth Studies: Development of a contemporary formula for estimating gestational age from ultrasound fetal biometrics.

Accurate assessment of gestational age is an important variable affecting perinatal morbidity and mortality. The most commonly used formula for estimating gestational age has been Hadlock’s formula which uses biparietal diameter, head circumference, femur length and abdominal circumference. If gestational age is not accurately estimated, induction of labor may be performed inappropriately. A smaller premature fetus may be thought to have fetal growth restriction and undergo induction of labor, which can produce prematurity. A fetus wrongly thought to be post term may also undergo induction of labor, which is an unnecessary intervention. It is important to accurately estimate gestational age.

Researchers used fetal biometric data from the National Institute of Child Health and Human Development Fetal Growth Studies. They sought to develop and validate a new gestational age estimation equation and compare its accuracy to Hadlock formula created in 1984.

Healthy women from four racial/ethnic groups comprised of 614 (26%) non-Hispanic whites, 611 (26%) non-Hispanic blacks, 649 (28%) Hispanics and 460 (20%) Asians. All were low-risk for altered fetal growth and reported a sure last menstrual period, underwent serial ultrasound every four weeks starting at an average of 19.7 weeks.

Biparietal diameter (BPD) which is one of the basic biometric parameters to assess fetal size, abdominal circumference (AC), femur length (FL) and head circumference (HC) were used to develop a formula for estimating gestational age.  The formula was validated using 50% training and test set paradigm; a 50% random sample was used to develop the predictor and the remaining 50% was used to evaluate predictive accuracy. This procedure was run one thousand times and the predictive accuracy measures averaged. Comparative formula accuracies were assessed using the standard deviation of prediction derived from the predicted versus actual population gestational ages.

Daniel W. Skupski, M.D., one of the researchers of the study who is with New York Presbyterian Queens in Flushing, N.Y. and will present the findings said, “We have developed and validated a new equation for estimating gestational age from fetal biometrics measured between 14 and 22 weeks gestational age using a multi-racial/ethnic population, certified sonographers and modern ultrasound units.”  The study shows a slight improvement in this newly developed formula over the traditional Hadlock with accuracy of less than nine days versus less than 10 days for Hadlock.  It also validates the establishment of this new formula in a large, high-quality multi-center study.

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A copy of the abstract is available at http://www.smfmnewsroom.org and below.  For interviews please contact Vicki Bendure at Vicki@bendurepr.com 202-374-9259 (cell).

The Society for Maternal-Fetal Medicine (est. 1977) is the premiere membership organization for obstetricians/gynecologists who have additional formal education and training in maternal-fetal medicine.  The society is devoted to reducing high-risk pregnancy complications by sharing expertise through continuing education to its 2,000 members on the latest pregnancy assessment and treatment methods. It also serves as an advocate for improving public policy, and expanding research funding and opportunities for maternal-fetal medicine. The group hosts an annual meeting in which groundbreaking new ideas and research in the area of maternal-fetal medicine are shared and discussed.  For more information visit www.smfm.org.

Abstract 105  The NICHD Fetal Growth Studies: Development of a contemporary formula for estimating gestational age from ultrasound fetal biometrics

Authors: Daniel W. Skupski1, John Owen2, Sungduk Kim3, Paul Albert3, Katherine Laughon Grantz3

1New York Presbyterian Queens, Flushing, NY, 2University of Alabama at Birmingham, Birmingham, AL, 3Division of Intramural Population Health Research Eunice Kennedy Shriver National Institute of Child Health and Human Development, Bethesda, MD

Objective: Using fetal biometric data from the NICHD Fetal Growth Studies, we sought to develop and validate a new gestational age (GA) estimation equation and compare its accuracy to a commonly used formula (Hadlock 1984).

Study Design: Healthy women from 4 racial/ethnic groups who were low-risk for altered fetal growth and reported a sure LMP confirmed by CRL at <14+0 weeks, underwent serial ultrasound every 4 weeks, starting at an average of 19.7 weeks, using study-certified sonographers. Project EDC was based on the LMP date+280 days. Linear regression with BPD, AC, FL and HC and product terms were used to develop a formula for estimating GA. The formula was validated using 50% training and test set paradigm; a 50% random sample was used to develop the predictor and the remaining 50% was used to evaluate predictive accuracy. This procedure was run 1,000 times and the predictive accuracy measures averaged. Comparative formula accuracies were assessed using the standard deviation (SD) of prediction derived from the predicted versus actual population GA’s.

Results: The study population comprised: 614 (26%) non-Hispanic Whites, 611 (26%) non-Hispanic Blacks, 649 (28%) Hispanics, and 460 (20%) Asians. The best-fit formula was: GA=7.85-0.127*BPD+0.07304*HC+0.00638*AC+0.122*FL+0.000685*BPD*AC-0.00015*HC*AC; validation confirmed a SD of 4.57 days (2SDs=9.14 days). The SD of the Hadlock 1984 formula was 5.06 days (2 SDs=10.12 days). Figure 1 shows the observed versus the predicted GA for the best-fit formula.

Conclusion: We have developed and validated a new equation for estimating GA from fetal biometrics measured between 14 and 22 weeks’ gestational age using a multi-racial/ethnic population, certified sonographers and modern ultrasound units. Sonography confirms the best GA with accuracy of ≤ 9 days. Our study shows a slight improvement in our newly developed formula over the traditional Hadlock formula (accuracy ≤ 10 days) and validates this established formula in a large high-quality multi-center study.

Abstract 105

Study Shows Time of Hospital Rounds for Postpartum Women Impacts Patient Satisfaction

ATLANTA (Feb. 1, 2016)—In a study to be presented on Feb. 6 at 8:45 a.m. EST, at the Society for Maternal-Fetal Medicine’s annual meeting, The Pregnancy Meeting™, in Atlanta, researchers will present findings from a study titled, Routine versus delayed timing of morning hospital rounds for postpartum women on patient satisfaction: A randomized quality improvement trial.

While it is convenient for physicians to have early morning hospital rounds so that they can handle other clinical duties including seeing patients in-office, it is not always convenient for postpartum hospital patients who often face sleep disruption and inadequate communication.

The study looked at 152 women with similar maternal demographics and clinical characteristics, except that delivery mode differed. More women had cesarean delivery in the routine.  The women were all under the care of a university-based obstetrics/gynecology faculty practice and delivered at a tertiary care medical center. They were randomly allocated to either routine rounding (4-7 a.m.) or delayed physician rounding (after 8 a.m.) from postpartum day one until discharge. Women with medical conditions or delivery complications that precluded the ability to delay rounding were excluded. On day of discharge, research staff blinded to rounding group distributed a standardized survey that included questions regarding physician communication and hospital experience.

The result was that postpartum women who received delayed physician rounding were more satisfied with physician communication and overall hospital experience without prolonging their hospital stay or time of discharge.

“This simple study indicates that physicians should be more cognizant of the hours they perform their rounds with healthy postpartum patients,” stated Robyn P. Roberts, M.D.  Roberts, with the University of Texas Medical School at Houston was researcher on the study and will present the study this week at the SMFM annual meeting.  “By just moving rounds later in the morning, patient satisfaction can be significantly improved,” added Roberts.

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A copy of the abstract is available at http://www.smfmnewsroom.org and below.  For interviews please contact Vicki Bendure at Vicki@bendurepr.com 202-374-9259 (cell).

The Society for Maternal-Fetal Medicine (est. 1977) is the premiere membership organization for obstetricians/gynecologists who have additional formal education and training in maternal-fetal medicine.  The society is devoted to reducing high-risk pregnancy complications by sharing expertise through continuing education to its 2,000 members on the latest pregnancy assessment and treatment methods. It also serves as an advocate for improving public policy, and expanding research funding and opportunities for maternal-fetal medicine. The group hosts an annual meeting in which groundbreaking new ideas and research in the area of maternal-fetal medicine are shared and discussed.  For more information visit www.smfm.org.

Abstract 84:   Routine versus delayed timing of morning hospital rounds for postpartum women on patient satisfaction: A randomized quality improvement trial

Authors: Robyn P. Roberts1, Sean C. Blackwell1, Kelly M. Brown1, Baha M. Sibai1, Jon E. Tyson1

1UT Health-University of Texas Medical School at Houston, Houston, TX

Objective: Early morning physician rounding is a part of traditional hospital culture. Benefits include early patient discharge as well as physician convenience to begin other clinical duties. Potential disadvantages include inadequate communication and sleep disruption. The objective of this study was to determine whether timing of physician rounding of postpartum women impacts patient satisfaction.

Study Design: Women under the care of a university-based OB/GYN faculty practice who delivered at a tertiary care medical center were randomly allocated to either routine rounding (4 – 7am) or delayed physician rounding (after 8 am) from postpartum day 1 until discharge. Women with medical conditions or delivery complications that precluded the ability to delay rounding were excluded. On day of discharge, research staff blinded to rounding group distributed a standardized survey that included questions regarding physician communication and hospital experience. Based on delivery volumes, we planned to conduct the study over a pre-defined two month period. We estimated that the study would require 74 total subjects (N=37 per group) to detect a 20% difference in overall rating of the hospital (0-10 score) between groups (assumption P=0.05 and power 90%).

Results: 152 women participated in the study (N= 76 routine rounding; N= 76 delayed rounding). Maternal demographics and clinical characteristics were similar between groups except for delivery mode. More women had cesarean delivery in the routine compared to delayed rounding group (47.4% vs. 22.4%). Patient satisfaction scores were improved not only for quality of physician communication, but also for hospital experience and overall hospital rating (see Table). Adjustment for delivery mode with linear regression did not alter the findings (p < 0.001). There were no differences between groups in timing of maternal discharge occurring after 10 am (25% routine vs. 30.3% delayed; p=0.47) or timing of neonatal discharge after 10 am, 94.7% vs. 90.8% (p=0.35).

Conclusion: Postpartum women who received delayed physician rounding were more satisfied with physician communication and overall hospital experience without prolonging their hospital stay or time of discharge.

 Abstract 84

Effectiveness of Influenza Vaccine for Pregnant Women May Differ by Trimester

ATLANTA (Feb. 1, 2016)—In a study to be presented on Feb. 5 in an oral concurrent session at 1:15 p.m. EST, at the Society for Maternal-Fetal Medicine’s annual meeting, The Pregnancy Meeting™, in Atlanta, researchers will present findings from a study titled, T-follicular helper (Thf) cell expansion varies by trimester after influenza vaccination in pregnancy.

The Centers for Disease Control recommends that all pregnant women get a flu shot, unless they have already been vaccinated over the past year.  Cautioning that “Flu is more likely to cause severe illness in pregnant women than in healthy women who are not pregnant,” the CDC website recommends that pregnant women may safely get the shot during any trimester.

In the study to be presented, researchers found that the T-follicular helper cell response to vaccination is greatest during the first trimester of pregnancy.  Vaccine immunology is poorly understood in pregnancy and Tfh cell expansion has been shown to be a predictor of response to influenza vaccination outside of pregnancy.

The researchers studied 36 pregnant women during flu season in 2012 to 2014.  They administered inactivated influenza vaccine and blood samples were collected pre-vaccination and 14 days later.  The influenza specific T-follicular helper cell response varied based on trimester of pregnancy in which the vaccine was given.

“The study results suggest that immunological changes during pregnancy may affect the response to the vaccination,” stated Emily Patel, M.D. with Duke University.  Dr. Patel is one of the researchers and the presenter of the study. “Future studies will lead to a better understanding of vaccine immunology and how pregnant women respond to antigen exposure through the course of their pregnancy,” added Patel.

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A copy of the abstract is available at http://www.smfmnewsroom.org and below.  For interviews please contact Vicki Bendure at Vicki@bendurepr.com 202-374-9259 (cell).

The Society for Maternal-Fetal Medicine (est. 1977) is the premiere membership organization for obstetricians/gynecologists who have additional formal education and training in maternal-fetal medicine.  The society is devoted to reducing high-risk pregnancy complications by sharing expertise through continuing education to its 2,000 members on the latest pregnancy assessment and treatment methods. It also serves as an advocate for improving public policy, and expanding research funding and opportunities for maternal-fetal medicine. The group hosts an annual meeting in which groundbreaking new ideas and research in the area of maternal-fetal medicine are shared and discussed.  For more information visit www.smfm.org.

Abstract 80:   T-follicular helper (Tfh) cell expansion varies by trimester after influenza vaccination in pregnancy

Authors: Emily Patel1, Chad Grotegut1, R. Phillips Heine1, Janet Staats1, Brian Antczak1, Kristin Weaver1, Kent Weinhold1, Geeta Swamy1

1Duke University, Durham, NC

Objective: Vaccine immunology is poorly understood in pregnancy. Tfh cell expansion has been shown to be a predictor of response to influenza vaccination outside of pregnancy. Our objective was to determine if Tfh cell expansion after vaccination changes based on trimester of pregnancy.

Study Design: Inactivated Influenza Vaccine (IIV) was administered during the 2012-2014 influenza seasons to 36 pregnant women. Blood samples were collected pre-vaccination and 14 days later. Peripheral blood mononuclear cells (PBMC) were isolated at each time point. Frequency and phenotype of influenza specific T-follicular helper cells (CD4+, CXCR5+, IL21+) was measured using polychromatic flow cytometry. Frequencies were compared using Wilcoxon signed rank test.

Results: The influenza specific T-follicular helper cell response varied based on trimester of pregnancy in which the vaccine was given. There was a significant expansion of Tfh cells after vaccination among women in the first trimester (p=0.036) but there was not a significant expansion after vaccination in either the second or third trimesters (p=0.091 and 0.347 respectively).

Conclusion: The Tfh cell response to vaccination is greatest during the first trimester of pregnancy. These results suggest that immunologic changes that occur during pregnancy may affect response to vaccination. Future work in this area will lead to a better understanding of vaccine immunology and how pregnant women respond to antigen exposure through the course of pregnancy.

Abstract 80

Study on Use of Umbilical Cord vs. Biocellulose Film for Antenatal Spina Bifida Repair, Regenerative patch may improve neurological outcomes

ATLANTA (Feb. 1, 2016)—In a study to be presented on Feb. 5 in an oral plenary session at 8 a.m. EST, at the Society for Maternal-Fetal Medicine’s annual meeting, The Pregnancy Meeting™, in Atlanta, researchers will present findings from a study titled, Cryopreserved Human Umbilical Cord (HUC) vs. Biocellulose Film (BCF) for Antenatal Spina Bifida Repair.

Spina Bifida is a birth defect where there is incomplete closing of the backbone and the coverings around the spinal cord. The birth defect is associated with lifelong disability and death due to complications. In-utero surgery has been recently shown to improve the ability to walk and to reduce the need for shunting of hydrocephalus. However, over half of these children do not benefit from the in-utero repair. Researchers are trying to find a regenerative patch material for repair that would further reduce morbidity after repair through decreased damage to the spinal cord from inflammation and scar formation. This study sought to compare two patches that can be used in utero to repair the closing of the backbone with material that will promote regeneration of different coverings of spine.

Although the study took place in a rat model of spina bifida, it provided promising results. The human umbilical cord patch was determined to promote cellular migration of epidermal, neuronal and endothelial cells with minimal inflammatory response compared to biocellulose film.

“By finding a patch that will regenerate coverings of the spinal cord, with minimal inflammation and scar formation, we hope to improve the outcomes of in-utero spina bifida repair. We have established more evidence in large animal models and human cases, which showed similar results. This is a initial step toward a safe minimally invasive in-utero repair.” stated Ramesha Papanna, M.D., M.P.H., the principal investigator of the project at The Fetal Center, Children’s Memorial Hermann Hospital Dept. OB/GYN McGovern Medical School at The University of Texas Health Science Center at Houston (UTHealth).  Saul Snowise, M.D. is a fetal intervention fellow at The Fetal Center and has actively worked and participated under the guidance of his mentor Dr. Papanna in the development of this project.  Dr. Snowise is the primary author of the study and will present the findings.

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A copy of the abstract is available at http://www.smfmnewsroom.org and below.  For interviews please contact Vicki Bendure at Vicki@bendurepr.com 202-374-9259 (cell).

The Society for Maternal-Fetal Medicine (est. 1977) is the premiere membership organization for obstetricians/gynecologists who have additional formal education and training in maternal-fetal medicine.  The society is devoted to reducing high-risk pregnancy complications by sharing expertise through continuing education to its 2,000 members on the latest pregnancy assessment and treatment methods. It also serves as an advocate for improving public policy, and expanding research funding and opportunities for maternal-fetal medicine. The group hosts an annual meeting in which groundbreaking new ideas and research in the area of maternal-fetal medicine are shared and discussed.  For more information visit www.smfm.org.

 Abstract 47:   Cryopreserved Human Umbilical Cord (HUC) vs. Biocellulose Film (BCF) for Antenatal Spina Bifida Repair

Authors: Saul Snowise1, Lovepreet Mann1, Mi-Ae Lyu1, Yisel Morales1, Kenneth J. Moise Jr.1, Stephen Fletcher1, Ray Grill2, Schaeffer CG Tseng3, Anthony Johnson1, Ramesha Papanna1

1The Fetal Center, Children’s Memorial Hermann Hospital Dept. OB/GYN UT Health- University of Texas Medical School at Houston, Houston, TX, 2Department of Neurobiology and Anatomical Sciences, University of Mississippi Medical Center, Jackson, MS, 3Ocular Surface Center, Miami, FL

Objective: Antenatal fetoscopic spina bifida (SB) repair with a regenerative patch may improve neurological outcomes by allowing earlier intervention and decreasing inflammatory scarring. Our objective was to compare two patches, HUC and BCF sutured over SB lesions in a retinoic acid (RA) rat model, for regenerative ingrowth of native cells and associated inflammatory response.

Study Design: Pregnant time-dated Sprague-Dawley rats were gavaged with RA (40mg/kg) on gestational day 10 (GD10) to induce SB in pups. Laparotomy and hysterotomy were performed on GD20 and HUC (n=11) or BCF (n=10) sutured over the spinal defect. Patches placed into the amniotic cavity without suturing over the lesion were controls. 30-34 hours after grafting pups were harvested and formalin fixed. H&E and Trichrome staining assessed cellular migration into the patches. Immunohistochemistry was performed to demonstrate the nature of the cellular migration. Native cell markers evaluated were CK 5/6 (epidermal), GFAP (astrocytes) and vWF (endothelial). Inflammatory markers were CD3 (lymphocytes), MPO (neutrophils), and F4-80 (macrophages). Four high power fields (hpf) of all patches and surrounding exudates were evaluated and Image-J software was used to quantify cells.

Results: Pup survival was equal: HUC 8/11, BCF 7/10, (p=0.9). Histology showed cellular migration in all HUC patches applied over lesions (median:38[range;13-102] cells/hpf) compared to none in BCF patches (Figure; p<0.001). CK 5/6 positive cells were noted migrating over the HUC patch surface (4-7cells/hpf): GFAP positive cells were noted on the HUC patch surface adjacent to the lesion (3-11 cells/hpf); vWF positive cells were noted in the HUC patch (5-15cells/hpf). No CK 5/6, GFAP or vWF positive cells were noted in BCF patches (p=0.03). HUC patches showed minimal MPO (2%[0-7%]), CD3 (7%[3-12%]) and F4-80 (0%) positive cells. Exudates in HUC treated pups had fewer MPO (0%[0-9%] vs 17%[0-39%]; p<0.01) and CD3 (7%[0-13%] vs 15%[0-22%]; p<0.01) positive cells compared to BCF and demonstrated no difference in F4-80. Both HUC and BCF control patches demonstrated no infiltrate.

Conclusion: HUC promotes cellular migration of epidermal, neuronal and endothelial cells with minimal inflammatory response compared to BCF. HUC may be the ideal patch material for use in antenatal SB repair.

Study Shows Increased Risk of Early Mortality in Women with Hypertensive Disease During Pregnancy

ATLANTA (Feb. 1, 2016)—In a study to be presented on Feb. 5 at 8 a.m. EST, at the Society for Maternal-Fetal Medicine’s annual meeting, The Pregnancy Meeting™, in Atlanta, researchers will present findings from a study titled, Long-term mortality risk following hypertensive disease of pregnancy (HDP).

It has long been recognized that pregnancy puts considerable stress on the body and that there are specific conditions during pregnancy that will indicate lifelong health issues. The objective of this study was to assess whether women with a history of any hypertensive disease during pregnancy have increased risk for early mortality and to determine the timing and most common cause of their deaths.

The study looked at births from 1939 to 2012 using the Utah Population Database. Based on birth certificate data, researchers assigned a diagnosis of HDP and, when possible, the category of disease (gestational hypertension, preeclampsia, HELLP syndrome—a serious complication of high blood pressure during pregnancy, and eclampsia).  Exposed women had a singleton pregnancy complicated by HDP and lived in Utah for more than a year following delivery. Primary cause of death was ascertained from death certificates.

Of 2,083,331 birth certificates evaluated, 61,727 (3%) had HDP.  Of these, all-cause mortality was significantly increased for women with a history of HDP. They also had the greatest risk of mortality due to Alzheimer’s disease, diabetes, ischemic heart disease, and stroke.

“We now know that women with a history of any category of HDP are at increased risk for mortality from a variety of causes,” stated Lauren Theilen, M.D. one of the researchers on the study who will present the findings at the SMFM annual meeting. Dr. Theilen is with the University of Utah Health Sciences Center in Salt Lake City.  “It’s important for physicians who care for these women beyond their childbearing years to recognize the significance of a history of HDP so that these women may receive appropriate screening and intervention,” Theilen added.

The study concluded that women with a history of HDP have increased risk of early mortality with the highest hazard ratios for neurologic, endocrine and circulatory causes.  Increased mortality risk for these women begins approximately 20 years after pregnancy.

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A copy of the abstract is available at http://www.smfmnewsroom.org and below.  For interviews please contact Vicki Bendure at Vicki@bendurepr.com 202-374-9259 (cell).

The Society for Maternal-Fetal Medicine (est. 1977) is the premiere membership organization for obstetricians/gynecologists who have additional formal education and training in maternal-fetal medicine.  The society is devoted to reducing high-risk pregnancy complications by sharing expertise through continuing education to its 2,000 members on the latest pregnancy assessment and treatment methods. It also serves as an advocate for improving public policy, and expanding research funding and opportunities for maternal-fetal medicine. The group hosts an annual meeting in which groundbreaking new ideas and research in the area of maternal-fetal medicine are shared and discussed.  For more information visit www.smfm.org.

Abstract 45    Long-term mortality risk following hypertensive disease of pregnancy (HDP)

Authors: Lauren Theilen1,2, Alison Fraser3, Michael Hollingshaus4, Karen Schliep1, Michael Varner1,2, Ken Smith3, Sean Esplin1,2

1University of Utah Health Sciences Center, Salt Lake City, UT, 2Intermountain Healthcare, Salt Lake City, UT, 3Huntsman Cancer Institute, Salt Lake City, UT, 4University of Utah, Salt Lake City, UT

Objective: To assess whether women with a history of HDP have increased risk for early mortality, and to determine the timing and most common causes of their deaths.

Study Design: We defined a cohort of births from 1939-2012 using the Utah Population Database. Based on birth certificate data, we assigned a diagnosis of HDP and, when possible, the category of disease [gestational hypertension (GHTN), preeclampsia (PRE), HELLP syndrome, and eclampsia (ECL)]. Exposed women had a singleton pregnancy complicated by HDP and lived in Utah for ≥1 year after delivery. Women with >1 pregnancy with HDP were included only once, in the most severe group. Exposed women were matched (1:2) to women without HDP by age, year of childbirth, and parity at time of index pregnancy. Primary cause of death was ascertained from death certificates. Mortality risk by primary cause of death was compared between exposed women (stratified by category of disease) and unexposed women using Cox regression to adjust for infant sex, parental education, ethnicity, and marital status.

Results: Of 2,083,331 birth certificates evaluated, 61,727 (3.0%) unique women had HDP (GHTN 49,438, PRE 29,941, HELLP 921, ECL 1,137) in >1 pregnancy. These women were matched to 123,454 unexposed women. A total of 11,278 women had known death dates: 4,516 (7.3%) exposed and 6,762 (5.5%) unexposed. All-cause mortality was significantly increased among exposed women (HR 1.68, p<0.01) (Table 1). Exposed women had the greatest risk of mortality due to Alzheimer’s disease (HR 3.44, p<0.01), diabetes (HR 3.22, p<0.01), ischemic heart disease (HR 2.28, p<0.01), and stroke (HR 1.92, p<0.01). Hazard ratios for causes of mortality varied by category of HDP. Figure 1 illustrates the survival curve in years after the index pregnancy for women with each category of HDP.

Conclusion: Women with a history of HDP have increased risk of early mortality, with highest hazard ratios for neurologic, endocrine, and circulatory causes. Increased mortality risk begins 20 years after the exposed pregnancy.

Abstract 45-1 Abstract 45-2

Study Shows Impact of Sleep on Gestational Weight Gain During Pregnancy

ATLANTA (Feb. 1, 2016)—In a study to be presented on Feb. 4 at 1:15 p.m. EST, at the Society for Maternal-Fetal Medicine’s annual meeting, The Pregnancy Meeting™, in Atlanta, researchers will present findings from a study titled, Short and long sleep durations in pregnancy are associated with extremes of gestational weight gain.

Epidemiologic data from non-pregnant women has linked poor sleep with obesity and weight gain. The researchers in this study set out to determine the relationship between objectively measured sleep duration and weight gain during pregnancy.

Women studied were enrolled in the nuMoM2b study, a multi-center prospective cohort study of nulliparous women with a singleton gestation. They were recruited to wear an actigraph to record objective sleep activity for seven consecutive days. Women with pregestational diabetes and chronic hypertension were excluded from the study. Sleep duration was calculated as an average across study nights.  Actigraphy and weight gain data were reviewed for 751 women.  The majority of women (74.8%) had a sleep duration between seven and nine hours.

The data suggested that both short and long sleep duration in pregnancy are associated with gestational weight gain.  “We know that poor sleep in pregnancy has been linked to adverse pregnancy outcomes,” explained Francesca Facco, M.D., one of the researchers of the study who is with the Eunice Kennedy Shriver NICHD NuMoM2b Network in Bethesda, Md.  Dr. Facco will present the findings at the SMFM annual meeting. “Our findings provide a potential mechanism for poor sleep in pregnancy and adverse outcomes,” Facco added.

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A copy of the abstract is available at http://www.smfmnewsroom.org and below.  For interviews please contact Vicki Bendure at Vicki@bendurepr.com 202-374-9259 (cell).

The Society for Maternal-Fetal Medicine (est. 1977) is the premiere membership organization for obstetricians/gynecologists who have additional formal education and training in maternal-fetal medicine.  The society is devoted to reducing high-risk pregnancy complications by sharing expertise through continuing education to its 2,000 members on the latest pregnancy assessment and treatment methods. It also serves as an advocate for improving public policy, and expanding research funding and opportunities for maternal-fetal medicine. The group hosts an annual meeting in which groundbreaking new ideas and research in the area of maternal-fetal medicine are shared and discussed.  For more information visit www.smfm.org.

Abstract 33    Short and long sleep durations in pregnancy are associated with extremes of gestational weight gain

Authors: Francesca Facco1,2, Kathryn Reid3,1, William Grobman3,1, Corette Parker4,1, Shannon Hunter4,1, Matthew Koch4,1, Phyllis Zee3,1

1for the Eunice Kennedy Shriver NICHD NuMoM2b Network, Bethesda, MD, 2Magee-Womens Research Institute, University of Pittsburgh, Pittsburgh, PA, 3Northwestern University, Chicago, IL, 4RTI International, Triangle Park, NC

Objective: Epidemiologic data from non-pregnant cohorts have linked poor sleep with obesity and weight gain. Our objective was to determine the relationship between objectively measured sleep duration and weight gain in pregnancy.

Study Design: Women enrolled in the nuMoM2b study, a multi-center prospective cohort study of nulliparous women with a singleton gestation, were recruited at the 2nd study visit (16- 21 weeks’) to wear an actigraph to record objective sleep activity for 7 consecutive days. Women with pregestational diabetes and chronic hypertension were excluded. Sleep duration (SD) was calculated as an average across study nights and categorized as follows: <6, 6 to <7, 7 to <8, 8 to <9, and >9 hours/night. Gestational weight gain (GWG) was calculated relative to self-reported prepregnancy weight using measured weights at visit 2 and visit 3 (22-29 weeks’), and chart abstracted last weight prior to delivery. We examined GWG using gestational age-standardized z-scores, a measure of GWG that by design is uncorrelated with gestational age at measurement and BMI. Z scores of <-1 and >+1 were used to define groups with the smallest and largest normalized weight gains, respectively.

Results: Actigraphy and weight data were available for 751 women. The majority of women (74.8%) had a SD between 7 to <9 hours; 2.1% and 5.2% had a SD of <6 and >9 hours/night, respectively. Non-linear relationships were observed between SD and GWG (see Table). For all GWG assessments, large GWG (Z>+1) became less frequent as SD increased. Women with the shortest (<6) and the longest (> 9) SD had the highest rates of small GWG ( Z<-1). Differences were statistically significant for GWG at Visit 2 and Visit 3 (p<.0001, p=.04) and were similar in magnitude for the last weight prior to delivery (p=0.0504).

Conclusion: Our data suggests that both short and long SD in pregnancy are associated with GWG. Poor sleep in pregnancy has been linked to adverse pregnancy outcomes, and our findings provide one potential mechanism for this association.

Abstract 33

The Benefits of Chocolate During Pregnancy

ATLANTA (Feb. 1, 2016)—In a study to be presented on Feb. 4 at 1:15 p.m. EST, at the Society for Maternal-Fetal Medicine’s annual meeting, The Pregnancy Meeting™, in Atlanta, researchers will present findings from a study titled, High-flavanol chocolate to improve placental function and to decrease the risk of preeclampsia: a double blind randomized clinical trial.

In light of previous studies showing conflicting results regarding the role of chocolate consumption during pregnancy and the risk of preeclampsia, this study set out to evaluate the impact of high-flavanol chocolate.  Researchers conducted a single-center randomized controlled trial of 129 women with singleton pregnancy between 11 and 14 weeks gestation who had double-notching on uterine artery Doppler.  The pregnant women selected were randomized to either high-flavanol or low-flavanol chocolate. A total of 30 grams of chocolate was consumed daily for 12 weeks and women were followed until delivery.  Uterine artery Doppler pulsatility index was at baseline and 12 weeks after randomization. Preeclampsia, gestational hypertension, placenta weight, and birthweight were also evaluated.

The result was that there was no difference in preeclampsia, gestational hypertension, placental weight or birthweight in the two groups; however, the uterine artery Doppler pulsatility index (a surrogate marker of blood velocity in the uterine, placental and fetal circulations) in both groups showed marked improvement that was much greater than expected in general population.

“This study indicates that chocolate could have a positive impact on placenta and fetal growth and development and that chocolate’s effects are not solely and directly due to flavanol content,” explained Emmanuel Bujold, M.D., one of the researchers on the study who will present the findings.  Dr. Bujold and Dr. Sylvie Dodin, principal investigator of the trial, are with the Université Laval Québec City, Canada.

# # #

A copy of the abstract is available at http://www.smfmnewsroom.org and below.  For interviews please contact Vicki Bendure at Vicki@bendurepr.com 202-374-9259 (cell).

The Society for Maternal-Fetal Medicine (est. 1977) is the premiere membership organization for obstetricians/gynecologists who have additional formal education and training in maternal-fetal medicine.  The society is devoted to reducing high-risk pregnancy complications by sharing expertise through continuing education to its 2,000 members on the latest pregnancy assessment and treatment methods. It also serves as an advocate for improving public policy, and expanding research funding and opportunities for maternal-fetal medicine. The group hosts an annual meeting in which groundbreaking new ideas and research in the area of maternal-fetal medicine are shared and discussed.  For more information visit www.smfm.org.

Abstract 32    High-flavanol chocolate to improve placental function and to decrease the risk of preeclampsia: a double blind randomized clinical trial

Authors: Emmanuel Bujold1, Asma Babar1, Elise Lavoie1, Mario Girard2, Vicky Leblanc1, Simone Lemieux1, Lionel-Ange Poungui1, Isabelle Marc1, Belkacem Abdous1, Sylvie Dodin1

1Université Laval, Québec City, QC, Canada, 2Centre de recherche du CHU de Québec, Québec City, QC, Canada

Objective: Previous studies showed conflicting results regarding the role of chocolate consumption during pregnancy and the risk of preeclampsia. We aimed to evaluate the impact of high-flavanol chocolate in a randomized clinical trial.

Study Design: We conducted a single-center randomized controlled trial including women with singleton pregnancy between 11 and 14 weeks gestation who had double-notching on uterine artery Doppler. The pregnant women selected were randomized to either high-flavanol (HFC) or low-flavanol chocolate (LFC). A total of 30 g of chocolate was consumed daily for 12 weeks and women were followed until delivery. Uterine artery Doppler pulsatility index (UtA PI), reported as multiple of medians (MoM) adjusted for gestational age, was assessed at baseline and 12 weeks after randomization. Preeclampsia, gestational hypertension, placenta weight, and birthweight were also evaluated.

Results: One hundred twenty nine women were randomized at a mean gestational age of 12.4 ± 0.6 weeks with a mean UtA PI of 1.4 ± 0.4 MoM. Although adjusted UtA PI significantly decreased from baseline to 12 weeks in the 2 groups (<0.0001), the difference between the 2 groups was not significant (p=0.16). At 12 weeks, we observed no significant difference between HFC and LFC groups in the rate of preeclampsia (4.7% vs 3.1%, p=0.49) and gestational hypertension (6.2% vs 12.5%, p=0.56). Placental weight (466 vs 464 grams), p=0.93) and birthweight (3348 vs 3215 grams, p=0.07) were comparable between the two groups.

Conclusion: Compared with low-flavanol chocolate, daily intake of 30g of high-flavanol chocolate did not improve placental function, placental weight and the risk of preeclampsia. Nevertheless, the marked improvement of the pulsatility index observed in the 2 chocolate groups might suggest that chocolate effects are not solely and directly due to flavanol content.

Effectively Predicting Cesarean Delivery in Nulliparous Women, Study determines a risk score to better inform women of their risk of Cesarean Delivery

ATLANTA (Feb. 1, 2016)—In a study to be presented on Feb. 4 in an oral concurrent session at 1:15 p.m. EST, at the Society for Maternal-Fetal Medicine’s annual meeting, The Pregnancy Meeting™, in Atlanta, researchers will present findings from a study titled, How to Predict Cesarean Delivery in the Nulliparous Patient: Results from the Prospective Multi-center Genesis Study. The objective of the Genesis study, was to assess the use of a range of demographic, clinical and ultrasound features to develop a predictive tool for cesarean delivery (CD) in nulliparous, singleton pregnancies.

In contemporary obstetric practice the majority of women now require medical intervention for safe childbirth. Despite all of this obstetric intervention we cannot predict which women will experience the greatest of difficulties during labor. In this study a detailed clinical evaluation and ultrasound assessment were performed after 39 weeks’ gestation. Women and their managing clinicians were blinded to the ultrasound derived fetal biometry. This study developed a risk scoring tool based on five easy to record parameters, which accurately predicts an individual woman’s risk of CD.

Of 2,336 women recruited to the Genesis Study, 491 (21%) had an unplanned cesarean delivery.  In a multivariate analysis, five parameters were determined to be the best combined predictors of CD. These were advancing maternal age, short maternal height, higher body mass index, a larger fetal abdominal circumference and increasing fetal head circumference.  The study’s conclusion was that, by using these five factors, overall risk of CD in nulliparous women at term can be better determined.

Naomi Burke, M.D. lead researcher on the Genesis Study stated “We developed a simple risk scoring system for cesarean delivery in first time mothers. We hope this will aid women and obstetricians with decisions about labor and delivery”.   Burke will present the findings at the SMFM annual meeting.

Fergal Malone, chairman of the Perinatal Ireland Research Consortium commented, “This risk assessment tool may be useful for planning service needs as well as for individual patient’s decisions on place and mode of delivery.”

# # #

A copy of the abstract is available at http://www.smfmnewsroom.org and below.  For interviews please contact Vicki Bendure at Vicki@bendurepr.com 202-374-9259 (cell).

The Society for Maternal-Fetal Medicine (est. 1977) is the premiere membership organization for obstetricians/gynecologists who have additional formal education and training in maternal-fetal medicine.  The society is devoted to reducing high-risk pregnancy complications by sharing expertise through continuing education to its 2,000 members on the latest pregnancy assessment and treatment methods. It also serves as an advocate for improving public policy, and expanding research funding and opportunities for maternal-fetal medicine. The group hosts an annual meeting in which groundbreaking new ideas and research in the area of maternal-fetal medicine are shared and discussed.  For more information visit www.smfm.org.

Abstract 20:   How to Predict Cesarean Delivery in the Nulliparous Patient: Results from the Prospective Multi-center Genesis Study

Authors: Naomi Burke1, Gerry Burke2, Fionnuala Breathnach1, Fionnuala McAuliffe3, John J. Morrison4, Michael Turner5, Samina Dornan6, John Higgins7, Amanda Cotter2, Michael Geary8, Fiona Cody9, Peter McParland10, Sean Daly11, Patrick Dicker12, Elizabeth Tully1, Fergal D. Malone1

1Obstetrics and Gynecology, Royal College of Surgeons in Ireland, Dublin, Ireland, 2Obstetrics and Gynecology, Graduate Entry Medical School, University of Limerick, Limerick, Ireland, 3Obstetrics and Gynecology, UCD School of Medicine and Medical Science, National Maternity Hospital, Dublin, Ireland, 4Obstetrics and Gynecology, National University of Ireland, Galway, Ireland, 5Obstetrics and Gynecology, UCD Centre for Human Reproduction Coombe Women and Infants University Hospital, Dublin, Ireland, 6Obstetrics and Gynecology, Royal Jubilee Maternity Hospital, Belfast, Ireland, 7Obstetrics and Gynecology, University College Cork, Cork University Maternity Hospital, Cork, Ireland, 8Obstetrics and Gynecology, St Michael’s Hospital, University of Toronto, Toronto, ON, Canada, 9Obstetrics and Gynecology, Rotunda Hospital, Dublin, Ireland, 10Obstetrics and Gynecology, National Maternity Hospital, Dublin, Ireland, 11Obstetrics and Gynecology, Coombe Women and Infants University Hospital, Dublin, Ireland, 12Epidemiology and Public Health, Royal College of Surgeons in Ireland, Dublin, Ireland

Objective: The rising cesarean delivery rate continues to generate concern. While many studies have tried to predict cesarean delivery (CD) by prenatal diagnosis of cephalopelvic disproportion or fetal macrosomia, neither strategy has proved particularly useful in the clinical setting. In this primary analysis of the Genesis Study we sought to prospectively assess the use of a range of demographic, clinical and ultrasound features to develop a predictive tool for CD in nulliparous, singleton pregnancies.

Study Design: The Genesis Study recruited 2,336 nulliparous patients with a vertex presentation between 39+0 and 40+6 weeks’ gestation in a prospective multi-center national study to examine predictors of CD. At recruitment a detailed clinical evaluation and ultrasound assessment were performed. Patients and their managing clinicians were blinded to the ultrasound details, to reduce bias from knowledge of this data potentially influencing mode of delivery. All hypothetical prenatal risk factors for unplanned CD were assessed individually and as a composite to eliminate confounding factors. Multiple logistic regression analysis was used to develop a risk evaluation tool for CD in nulliparous patients.

Results: From a cohort of 2,336 nulliparous patients, 491 (21%) had an unplanned CD. In a multivariate analysis, five parameters (maternal age, maternal height, BMI, fetal AC and fetal HC) were determined to be the best combined predictors of CD. These five parameters are listed in Table 1 along with their respective odds ratios when calculated at different time points during pregnancy. Individual Z scores were calculated for demographic and biometric data to determine these odds ratios and a risk score. Z scores can be calculated from Table 1. The totaled Z scores for the five parameters can then be applied to Figure 1 to give a personalized risk of CD.

Conclusion: Five parameters (maternal age, BMI, height, fetal AC and fetal HC) can be used to better determine the overall risk of cesarean delivery in nulliparous patients at term. A risk score can be used to better inform patients of their individualized risk of CD in early gestation and again from 39 weeks’ gestation. This risk tool may be useful for planning service needs as well as for individual patient’s decisions on place and mode of delivery.

Abstract 20-1 Abstract 20-2

Study Shows Racial and Ethnic Disparities in use of 17-hydroxyprogesterone for Prevention of Preterm Birth

ATLANTA (Feb. 1, 2016)—In a study to be presented on Feb. 4 at 1:15 p.m. EST, at the Society for Maternal-Fetal Medicine’s annual meeting, The Pregnancy Meeting™, in Atlanta, researchers will present findings from a study titled, Racial and ethnic disparities in use of 17-hydroxyprogesterone caproate for prevention of preterm birth.

The study looked at 472 women with a prior spontaneous preterm birth who were eligible for 17-hydroxyprogesterone caproate (also known as 17P) in evaluating whether racial and ethnic disparities exist in the use of and adherence to 17P. Associations between self-identified race/ethnicity (non-Hispanic black versus in all other racial/ethnic groups) and documented counseling about 17P, receipt of 17P, and adherence to 17P administration (no more than one missed dose, initiation at less than 20 weeks gestational age, and continuation until 37 weeks or delivery) were estimated by bivariable analysis and multivariable logistic regression.

The results were that non-Hispanic black women had more missed doses,  initiated care later, and were more likely to discontinue 17P for non-medical reasons than women in other racial/ethnic groups. A significant interaction between non-Hispanic black race/ethnicity and public insurance was also identified.

“17-hydroxyprogesterone caproate is a helpful medication for preventing recurrent preterm birth. This study  identifies racial/ethnic disparities in health care utilization required for successful 17P use,” explained Lynn M. Yee, M.D., MPH with the Northwestern University Feinberg School of Medicine in Chicago.  Dr. Yee is one of the researchers of the study and will present the findings at the SMFM annual meeting. “By identifying these disparities, we can develop systems to  facilitate timely 17P initiation in eligible patients, continued weekly dosing, and remaining on 17P until delivery or reaching term,” added Yee.

# # #

A copy of the abstract is available at http://www.smfmnewsroom.org and below.  For interviews please contact Vicki Bendure at Vicki@bendurepr.com 202-374-9259 (cell).

The Society for Maternal-Fetal Medicine (est. 1977) is the premiere membership organization for obstetricians/gynecologists who have additional formal education and training in maternal-fetal medicine.  The society is devoted to reducing high-risk pregnancy complications by sharing expertise through continuing education to its 2,000 members on the latest pregnancy assessment and treatment methods. It also serves as an advocate for improving public policy, and expanding research funding and opportunities for maternal-fetal medicine. The group hosts an annual meeting in which groundbreaking new ideas and research in the area of maternal-fetal medicine are shared and discussed.  For more information visit www.smfm.org.

Abstract 18:   Racial and ethnic disparities in use of 17-hydroxyprogesterone caproate for prevention of preterm birth

Authors: Lynn M. Yee1, Lilly Y. Liu1, Allie Sakowicz1, Janelle R. Bolden1, Emily S. Miller1

1Northwestern University Feinberg School of Medicine, Chicago, IL

 Objective: To evaluate whether racial and ethnic disparities exist in the use of and adherence to 17-hydroxyprogesterone caproate (17P) within a population of women eligible for preterm birth prevention.

Study Design: Retrospective cohort study of women with a prior spontaneous, singleton preterm birth who were eligible for 17P for preterm birth prevention and received care at a single institution from 2010-2014. Associations between self-identified race/ethnicity (non-Hispanic black versus women in all other racial/ethnic groups) and documented counseling about 17P, receipt of 17P, and adherence to 17P administration (no more than 1 missed dose, initiation <20 weeks’ gestational age, and continuation until 37 weeks or delivery) were estimated by bivariable analysis and multivariable logistic regression.

Results: Of 472 women who were clinically eligible for 17P, 72% (N=296) had documented 17P counseling and 48.9% (N=229) received 17P. There were no differences in likelihood of 17P counseling or receipt of 17P based on race/ethnicity. While overall 83% (N=176) of women were adherent to 17P, only 70% (N=58) of non-Hispanic black women were adherent, compared to 91% (N=118) of all other women (p<0.001). Non-Hispanic black women had more missed doses (2.4 vs 0.4 doses, p<0.001), were more likely to discontinue 17P injections prior to 37 weeks or delivery (21.1% vs 5.3%, p=0.001), and had later initiation of 17P counseling (12.0 vs 10.2 weeks, p<0.001) than women in other racial/ethnic groups. After adjustment for potential confounders, non-Hispanic black women were significantly less likely to be adherent to 17P (adjusted odds ratio [aOR] 0.16, 95% confidence interval [CI] 0.04-0.65) (Table). A significant interaction between non-Hispanic black race/ethnicity and public insurance was identified (aOR 0.16, 95% CI 0.05-0.52).

Conclusion: In a diverse cohort of women eligible for preterm birth prevention, non-Hispanic black women are at substantially increased risk of non-adherence to 17P. Non-Hispanic black women with public insurance are at a particularly increased risk of non-adherence.

Factors associated with adherence to 17-hydroxyprogesterone caproate
Adherent
N=176
Non-adherent
N=37
p-value Adjusted OR

(95% CI)*

Maternal age (y) 32.5 (5.2) 30.2 (4.7) 0.014 0.95 (0.84-1.07)
Non-Hispanic black 58 (33.0%) 25 (67.6%) <0.001 0.16 (0.04-0.65)
Public insurance 57 (32.4%) 25 (67.6%) <0.001 0.19 (0.04-0.87)
Intended pregnancy 60 (55.6%) 8 (30.8%) 0.023 0.72 (0.22-2.37)
Gestational age at first prenatal visit (w) 9.3 (2.4) 11.6 (4.6) 0.025 0.80 (0.67-0.97)
More than one prior preterm birth 35 (19.9%) 10 (27.0%) 0.333 0.29 (0.08-1.04)
Gestational age at earliest preterm birth (w) 28.8 (5.4) 29.9 (4.9) 0.227 0.93 (0.82-1.06)
Prior term birth 41 (23.3%) 12 (32.4%) 0.243 1.11 (0.34-3.69)
Data presented as mean (SD) or n (%)
* Adjusted for maternal age, race/ethnicity, insurance status, pregnancy intendedness, gestational age of first prenatal visit, more than one prior preterm birth, gestational age at earliest preterm birth, and prior term birth

Study Validates Two-Protein Test for Spontaneous Preterm Birth Prediction

ATLANTA (Feb. 1, 2016)—In a study to be presented on Feb. 4 at 1:15 p.m. EST, at the Society for Maternal-Fetal Medicine’s annual meeting, The Pregnancy Meeting™, in Atlanta, researchers will present findings from the Proteomic Assessment of Preterm Risk study (PAPPR study, #NCT01371019) with the title Clinical validation of a two-protein test for spontaneous preterm birth (sPTB) prediction in a large multicenter prospective study of asymptomatic women.

 Pre-term birth is a birth that takes place before 37 weeks of pregnancy. According to the Centers for Disease Control and Prevention, in 2014, preterm birth affected one out of every 10 infants.  In the U.S., preterm birth is the largest contributor to infant death with most preterm related deaths occurring among babies born very preterm (before 32 weeks).  It is also a leading cause of long-term neurological disabilities in children.  For these reasons, it is critical to identify key indicators of preterm birth.

This study performed a blind evaluation of the performance of a two-protein test for spontaneous preterm birth prediction.  The study was conducted at 11 sites between 2011 and 2013, with 5501 pregnant women (representative of the U.S. population) enrolled at 17-28 weeks of gestational age.  By examining specimens from PAPR, researchers identified an optimal gestational age window in pregnancy (19-21 weeks) and two highly performing proteins for predicting subsequent spontaneous preterm birth.

Following the discovery and verifications steps, the novel classifier (IBP4 and SHBG) was validated in an independent group of women, with excellent performance and an area under the ROC curve of 93% for preterm delivery before 35 weeks and 75% for delivery before 37 weeks.

“The performance of this proteomic classifier was excellent,” said George R. Saade, M.D. professor of Obstetrics and Gynecology at the University of Texas Medical Branch in Galveston and lead investigator.  “Having a classifier to help physicians risk-stratify patients for preterm birth in early pregnancy would be extremely valuable in guiding levels of care and employing preventive strategies for their patients,” added Saade.

The Proteomic Assessment of Preterm Birth study was supported by Sera Prognostics.

# # #

A copy of the abstract is available at http://www.smfmnewsroom.org and below.  For interviews please contact Vicki Bendure at Vicki@bendurepr.com 202-374-9259 (cell).

The Society for Maternal-Fetal Medicine (est. 1977) is the premiere membership organization for obstetricians/gynecologists who have additional formal education and training in maternal-fetal medicine.  The society is devoted to reducing high-risk pregnancy complications by sharing expertise through continuing education to its 2,000 members on the latest pregnancy assessment and treatment methods. It also serves as an advocate for improving public policy, and expanding research funding and opportunities for maternal-fetal medicine. The group hosts an annual meeting in which groundbreaking new ideas and research in the area of maternal-fetal medicine are shared and discussed.  For more information visit www.smfm.org.

 Abstract 17    Clinical validation of a two-protein test for spontaneous preterm birth (sPTB) prediction in a large multicenter prospective study of asymptomatic women

Authors: George Saade1, Kim Boggess2, Scott Sullivan3, Glenn Markenson4, Jay Iams5, Dean Coonrod6, Leonardo Pereira7, M. Sean Esplin8, Larry Cousins9, Garrett Lam10, Matthew K. Hoffman11, Angela Fox12, Chad Bradford12, Tracey Fleischer12, Ilia Ichetovkin12, Ashoka Polpitiya12, Paul Kearney13, Jay Boniface12, Durlin Hickok12

1University of Texas Medical Branch, Galveston, TX, 2Department of Obstetrics and Gynecology, Division of Maternal-Fetal Medicine, University of North Carolina, Chapel Hill, NC, 3Department of Obstetrics and Gynecology, Medical University of South Carolina, Charleston, SC, 4Maternal Fetal Medicine Baystate Medical Center, Obstetrics and Gynecology Tufts University School of Medicine, Springfield, MA, 5Department of Obstetrics and Gynecology, The Ohio State University, Columbus, OH, 6Department of Obstetrics and Gynecology, Maricopa Integrated Health System and University of Arizona College of Medicine, Phoenix, AZ, 7Division of Maternal-Fetal Medicine, Oregon Health and Science University, Portland, OR, 8Division of Maternal Fetal Medicine, Intermountain Healthcare and University of Utah Health Sciences Center, Salt Lake City, UT, 9Maternal Fetal Medicine Division, San Diego Perinatal Center, Childrens Specialists of San Diego, San Diego, CA, 10Regional Obstetrical Consultants and University of Tennessee College of Medicine, Chattanooga, TN, 11Department of Obstetrics and Gynecology, Christiana Care Health System, Newark, DE, 12Sera Prognostics, Inc., Salt Lake City, UT, 13Integrated Diagnostics, Inc., Seattle, WA

Objective: To perform a blinded evaluation of the performance of a two-protein test for spontaneous preterm birth (sPTB) prediction

Study Design: Pregnant women representative of the U.S. population were enrolled at 17-28 weeks of gestational age (GA) in the Proteomic Assessment of Preterm Risk (PAPR) study at 11 sites between 2011 and 2013. Biospecimens were collected at enrollment and outcomes ascertained following birth. Intensity values from a LC-MS (MRM) method were measured for 2 predictive analytes, insulin-like growth factor binding protein 4 (IBP4) and sex-hormone binding globulin (SHBG), that had been previously discovered and verified in separate studies with best performance in the 19-21 week GA interval. Strict blinding and double validation protocols were utilized consistent with the Institute of Medicine guidelines for classifier validation.

Results: All cases eligible for validation (those not used for classifier training, discovery or verification) and their respective independent matched controls drawn during the 19-21 week GA interval were analyzed (18 cases, 36 controls). The classifier performance was excellent (Table 1), with statistically significant AUC values and Odds Ratios. Addition of pregnancy and medical history variables did not improve the proteomic classifier performance.

Conclusion: We validated a novel maternal serum proteomic classifier consisting of IBP4 and SHBG for prediction of sPTB. This proteomic classifier can risk-stratify patients to test PTB preventive strategies or guide levels of care.

Abstract 17

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