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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 More »

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 More »

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 More »

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 More »

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 More »

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 More »

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.

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