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Category Archives: SMFM

Leaders in Women’s Health Convene to Save Mothers’ Lives

WASHINGTON, March 5, 2014—The Society for Maternal-Fetal Medicine (SMFM), the American Congress of Obstetricians and Gynecologists, the Association of Women’s Health, Obstetric and Neonatal Nurses, the Centers for Disease Control and Prevention, and other groups have created the Council on Patient Safety in Women’s Health Care.

“The Council on Patient Safety in Women’s Health Care is a collaborative effort with the goal of continually improving patient safety in women’s health care through multidisciplinary collaboration that drives culture change,” said SMFM board member and council chair Alfred Abuhamad.

Despite medical advances, mothers in the U.S. are more at risk of dying from pregnancy related problems today than they were in 1990. Women in the United States are twice as likely to have a life-threatening problem during pregnancy or childbirth than women in western Europe.

This week, the council launched a web site, Safe Health Care for Every Woman. To improve care, the site provides standardized tools for Severe Maternal Morbidity review. Hospitals can use these tools to identify problems with care delivery and reduce the chance of future life-threatening events.

“As high risk pregnancy experts, maternal-fetal medicine physicians lead patient safety programs throughout the country,” said Peter Bernstein, a SMFM board member and council member. “The first step is to identify the systems issues that put families at risk, and these Severe Maternal Mortality review forms facilitate that process.”

Excessive bleeding after childbirth is a leading cause of severe morbidity and mortality for pregnant women. In April, the council will release an Obstetric Hemorrhage Patient Safety Bundle with step-by-step, evidence-based tools to manage risk, prevent adverse events, and respond and debrief.

Later in the spring, the council will share Maternal Early Warning Criteria to identify mothers who require urgent bedside evaluation. Additional planned safety bundles will provide guidance on treatment of severe hypertension and prevention of venous thromboembolism in pregnancy.

“The council has brought together nurses, midwives, physicians, patient safety specialists and industry partners to realize our vision of safe healthcare for every woman,” Abuhamad said. “Together, we improve care.”

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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.

 

 

SMFM Physicians Recommend NIPT for High-Risk Patients

WASHINGTON, March 5, 2014—A paper published on Feb. 27, 2014 in the New England Journal of Medicine titled DNA Sequencing versus Standard Prenatal Aneuploidy Screening has garnered a great deal of media attention focused on the use of maternal serum cell-free DNA screening, or noninvasive prenatal testing (NIPT) for aneuploidy in average risk patients. The authors, supported by one of the commercial laboratories, compared NIPT with traditional screening for aneuploidy using serum analytes on a relatively small number of average risk patients. The study was too small to compare detection rates, but the authors report that the false positive rate of NIPT is lower and therefore the test “merits serious consideration as a primary screening method for fetal autosomal aneuploidy.

While this measured conclusion appears reasonable, the serious consideration that the authors propose requires further data, and the study by Bianchi et al has to be viewed in the context of its many limitations. Most importantly, the study is underpowered to compare the detection rates, and it is generally not valid to compare false-positive rates in isolation.

NIPT uses cell-free DNA from maternal serum to screen for common fetal aneuploidies with high sensitivity and specificity. It also uses next generation sequencing to directly measure fetal DNA in the maternal circulation, and clinical tests are now available using this technique. While there are differences in the methodologies employed by the commercial laboratories, overall the reported performance is similar, with detection rates for Down syndrome above 99 percent and false positive rates that are less than one percent. This makes this screening test an attractive alternative to traditional serum screening for aneuploidy for patients.

Currently, the Society for Maternal-Fetal Medicine (SMFM) recommends that NIPT is most appropriate for high-risk patients. The five high-risk criteria currently include maternal age 35 years or older at delivery, sonographic findings indicating an increased risk of aneuploidy, history of a prior pregnancy with a trisomy, positive screening results for aneuploidy, including first trimester, sequential, integrated, or quadruple screen, or parental balanced Robertsonian translocation with increased risk for trisomy 13 or 21.

This recommendation has been based primarily on the more limited evidence regarding the utility of NIPT in low- or average-risk pregnant women, and validation studies that have generally been limited to high-risk populations. Understandably, there is a keen interest in performing the same type of validation studies in a low-risk population.

The study compared only false positive rates for trisomies 18 and 21, although all commercially available products also include testing for trisomy 13 and the sex chromosomes, which have higher false positive rates. A high percentage of the samples for NIPT were collected in the third trimester – at gestational ages when clinical aneuploidy screening is not performed and is not clinically relevant, yet when fetal DNA amounts are far higher allowing better test performance. The authors compared NIPT with standard prenatal screening with a variety of first and second trimester tests that have a broad range of performance characteristics. Fewer than three percent of patients had integrated screening, which is the prenatal screening method with the best performance, including the lowest false positive rate. In addition, traditional screening can detect risk for a broad array of structural, chromosomal and perinatal abnormalities.

“The importance of these in a low-risk population may be far greater than the impact of trisomy 18 and 21, which are relatively rare in a younger maternal cohort.  It is important to note that this study included only five Down syndrome. Five cases of trisomy 21 in the population of 1909 patients represents a rate of 1 out of 381, which is substantially higher than the population risk of 1 out of 700 that would be expected in a truly “average” or “low-risk” cohort,” said Dr. Vincenzo Berghella, president of SMFM. “Finally and importantly, when considering population screening, some patients who choose NIPT will fail to obtain a result. While that number was just under 1 percent in this study, rates as high as 12 percent have been published, especially in overweight and obese women.”

SMFM has reviewed the evidence, including this recent paper, and feels that while NIPT is a promising new technology, and this new report is important and excellent news, it is not enough to change current ACOG and SMFM recommendations. Given that just eight aneuploidies were present in the entire cohort of patients, the true test performance is difficult to determine.

“Further evidence comparing costs, false positive rates for all included analyses, ability to obtain a result, and overall test performance for all detectable abnormalities in larger numbers of truly average risk patients are required to justify changing recommendations regarding population based prenatal screening from just high-risk pregnancies, to all pregnancies. We eagerly await the results of ongoing research studies which will address these issues,” said Berghella.

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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.

 

SMFM Physicians Urge Caution when Interpreting Recent Study on Tylenol and Childhood ADHD

WASHINGTON, March 3, 2014—In response to a recent study of Tylenol exposure during pregnancy and childhood ADHD, high-risk pregnancy experts are urging caution when interpreting results.

“These results are interesting, but it’s premature to change the advice we give to patients,” said Dr. Vincenzo Berghella, president of the Society for Maternal-Fetal Medicine.

In the recent study of acetaminophen and childhood development, the authors found higher rates of ADHD-like behavioral problems among children whose mothers had taken acetaminophen during pregnancy. In the US, acetaminophen is mostly found in Tylenol as well as other pain medications. More than half of the women included in the study had taken acetaminophen at some point during their pregnancy.

Using a standardized score for ADHD-like behavior, the authors found that 3.4 percent of children whose mothers had taken acetaminophen had an elevated score, compared with 2.5 percent of never-users. This 1.36-fold difference diminished to 1.13-fold when the authors accounted for factors such muscle or joint pain, mental health problems, and fever or illness during pregnancy that differed between mothers who did and did not take acetaminophen.

“The study has a number of limitations and its results need to be considered in context,” Berghella said. “The authors found a less-than-one-percent difference in risk.”

Berghella also noted that an association found in an observational study does not necessarily equate with causation. Unmeasured differences between mothers who did and did not take acetaminophen, such as differences in susceptibility to pain, might be behind the use of acetaminophen as well as explain their child’s risk of ADHD-like behavioral problems. In other words, the reason the acetaminophen was taken could have been the real culprit, and not the acetaminophen itself.

“In fact, as the authors state, maternal infections or immunologic factors have been linked to childhood ADHD. These are the conditions for which acetaminophen is often used, so this is what is called ‘confounding,’ a finding which seems due to a factor, but is in fact due to another issue (e.g. infection) linked to both the exposure (e.g. acetaminophen) and outcome (e.g. ADHD).”

It is also important to note that the association with ADHD was mostly seen with prolonged use, sometimes weeks or months, a practice that is not typical of how acetaminophen is prescribed in most pregnancies. Tylenol is one of the few medications we can use in pregnancy to treat pain and control the temperature during a fever.

“Publicity about the study results might actually lead to worse outcomes for mothers and infants,” Berghella said. “For example, high fever during pregnancy is associated with increased risk of complications. Women with febrile illnesses who don’t treat their fever in order to avoid Tylenol might increase the risk of serious complications.”

Other medications to control pain or fever, such as ibuprofen and other non-steroidal anti-inflammatory drugs, have well-described risks for the fetus, including damage to the developing kidneys and changes in blood flow to the fetal heart. Substituting these pain medications to Tylenol may lead to more harm.

Additional studies are needed in order to determine whether acetaminophen causes ADHD. “We need prospective studies of all drugs used in pregnancy and lactation, not just acetaminophen, so that pregnant women or women considering pregnancy can make informed decisions about treatment,” Berghella said. “These results underscore the need for well-designed studies of medication safety in pregnancy and lactation.”

“Most drug trials do not include pregnant women, leaving mothers and their providers with limited information to weigh the risks and benefits of treatment,” Berghella continued. “This gap in understanding has become increasingly problematic as more women delay childbearing and rates of chronic disease rise, because more mothers than ever before are requiring medications to manage conditions such as diabetes, hypertension, depression, and asthma.”

Women should not take any medications, even over the counter medications, without consulting their care provider. As mentioned above, acetaminophen containing medications are still safer than other medications to control pain or fever. If needed, it should be taken for a limited time. If the symptoms persist after few days on acetaminophen, then follow up with the care provider is needed in order to consider other treatments.

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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.

Study Reveals Correlation between Neonatal and Early Childhood Outcomes among Children Delivered Preterm

In a study to be presented on Feb. 6 at 3:15 p.m. CST, at the Society for Maternal-Fetal Medicine’s annual meeting, The Pregnancy Meeting ™, in New Orleans, researchers will report on a correlation between initial neonatal and early childhood outcomes among children delivered less than 34 weeks gestation.

Preterm babies are at high risk for death and other serious medical complications, and some premature infants continue to experience side effects from prematurity even during later childhood. It’s uncertain whether preterm babies diagnosed with intestinal problems, severe respiratory problems, bleeding in their brains, and other complications during their stay in the newborn intensive care unit (NICU) after birth will continue to have complications when examined later in childhood.

This study examined more than 1,700 babies who were born prematurely at less than 34 weeks gestation. It then followed babies after they were discharged from the NICU and re-evaluated them as 2-year-olds for evidence of cerebral palsy and neurologic impairment.

Results revealed that about one in five babies who appeared healthy at the time of hospital discharge had cerebral palsy or neurologic impairment at 2 years of age. Further, one in three babies who had one or more serious complications during their NICU stay also had these complications.

“Babies delivered preterm are at high risk for complications as newborns and also later in childhood,” said Tracy Manuck, M.D., one of the researchers and co-director of the University of Utah Prematurity Prevention Clinic. “We found that babies who had serious complications in the newborn intensive care unit were more likely to have cerebral palsy or neurologic impairment in early childhood, but not necessarily. The converse is also true, as about one in five babies who appeared healthy at the time of hospital discharge had complications in early childhood. Early childhood evaluation and interventions should not be withheld from seemingly healthy previous preterm children.”

However, Manuck noted that the relationship between serious NICU complications and serious neurologic impairment in early childhood was not perfect, as the NICU complications were only moderately predictive of prognosis later in childhood.

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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), or Meghan Blackburn at Meghan@bendurepr.com, 540-687-5099 (office) or 859-492-6303 (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 35: Correlation Between Initial Neonatal and Early Childhood Outcomes Among Children Delivered <34 Weeks Gestation

Authors: Tracy Manuck1, Xiaoming Sheng2, Bradley Yoder2, Michael Varner1

1University of Utah, Obstetrics and Gynecology, Salt Lake City, UT, 2University of Utah, Pediatrics, Salt Lake City, UT

Objective: Obstetric researchers commonly use neonatal morbidities as surrogate endpoints for longer-term outcomes. We sought to correlate neonatal diagnoses prior to hospital discharge with early childhood cognitive and motor function.

Study Design: Secondary analysis of a multicenter RCT of antenatal magnesium sulfate (Mg) vs. placebo administered to women at imminent risk for early PTB to prevent death and cerebral palsy (CP) in their offspring. All women were at high risk for PTB <32.0 wks. Singletons delivered 24.0-33.9 wks who survived to hospital discharge post-birth and had 2-year-old outcome data were included. Those surviving to age 2 were assessed by trained physicians and Bayley Scales of Infant Development Mental Development and Psychomotor Development Indices (MDI, PDI). Neonatal diagnoses at each baby’s initial hospital discharge were examined singly and in combination to determine those most predictive of severe composite childhood morbidity, defined as a childhood diagnosis of moderate/severe CP and/or Bayley MDI and/or PDI scores >2 SD below the mean. Data were analyzed by multiple logistic regression and area under ROC curves (AUC).

Results: 1400 children met criteria. Children were delivered at a mean of 29.9 (range: 24.0-33.9) wks gestation. 58 (4.1%) had moderate/severe CP. On Bayley testing, 245 (19.2%) had a MDI Score >2 SD and 229 (17.8%) a PDI Score >2SD below the mean. A total of 349 (24.9%) had severe composite childhood morbidity. Multivariable regression results demonstrating the relationship between neonatal diagnoses and severe childhood morbidity are shown in the Table.

Conclusion: Approximately 1 in 4 children born <34 weeks had severe childhood morbidity at age 2. Individual neonatal morbidities (BPD, NEC, sepsis, severe IVH, and PVL) had modest predictive value for subsequent adverse early childhood outcomes; combinations of multiple morbidities were only marginally more prognostic. Prediction of childhood outcomes from neonatal diagnoses remains imperfect.

Multivariable regression results. Relationship between neonatal diagnoses and the probability of severe composite childhood morbidity are shown. All models are shown for individual predictors; the best model is shown for the combination of 2, 3, and 4 neonatal morbidities. * brain injury = severe intraventricular hemorrhage and/or periventricular leukomalacia  Other co-variables in regression models included delivery gestational age, maternal education, randomization to magnesium, and chorioamnionitis.

Multivariable regression results. Relationship between neonatal diagnoses and the probability of severe composite childhood morbidity are shown. All models are shown for individual predictors; the best model is shown for the combination of 2, 3, and 4 neonatal morbidities.
* brain injury = severe intraventricular hemorrhage and/or periventricular leukomalacia
Other co-variables in regression models included delivery gestational age, maternal education, randomization to magnesium, and chorioamnionitis.

Study Associates Gene with Cerebral Palsy and Death in Very Preterm Babies

In a study to be presented on Feb. 6 at 2:45 p.m. CST, at the Society for Maternal-Fetal Medicine’s annual meeting, The Pregnancy Meeting ™, in New Orleans, researchers will report that a variant in SERPINE1, a gene involved in inflammation and blood clotting, is associated with cerebral palsy and death in very preterm babies. This gene has been associated with increased risk of cerebral palsy in one previous study of preterm babies.

Previous genetic studies of very preterm babies have suggested several genetic variations that might predispose to brain injury and developmental problems. However, different studies have had different results.

This study, titled Genetic Predisposition to Adverse Neurodevelopmental Outcome After Early Preterm Birth: A Validation Analysis, was a collaborative effort between the Eunice Kennedy Shriver NICHD Maternal-Fetal Medicine Units and Neonatal Research Networks.

Researchers evaluated two different populations of very early preterm births (earlier than 32 weeks) with the goal of confirming the same genetic risk factors in both groups. The first population of preterm births was enrolled in a large Neonatal Research Network study, and the other group was of births that were enrolled in a Maternal Fetal Medicine Units Network study of magnesium sulfate before preterm birth for prevention of cerebral palsy.

Results revealed a variant in the gene SERPINE1, a gene involved in inflammation and blood clotting, was associated with cerebral palsy and death after early preterm birth in both populations of preterm babies.

“Preterm birth is the leading cause of childhood brain injury in otherwise normal children. The earlier a baby is born, the higher the risk of brain injury. However, even among the tiniest preemies, some babies develop quite normally, while others have devastating brain injury and life-long disability,” said Erin Clark, M.D., the study’s author. “The reason for this difference in outcomes is not well understood. Genetics may allow identification of babies at increased risk so that we can target those babies for prevention and treatment strategies. These results add to the evidence that genes may play a role in risk of brain injury and death in preterm babies.”

Clark, assistant professor of Maternal Fetal Medicine, University of Utah School of Medicine’s Department of Obstetrics and Gynecology, also noted that additional research is necessary to further evaluate genes that may influence risk and to determine how to apply these results to clinical care.

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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), or Meghan Blackburn at Meghan@bendurepr.com, 540-687-5099 (office) or 859-492-6303 (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.

Financial Disclosure:  The authors did not report any potential conflicts of interest.

 

Abstract 15: Genetic Predisposition to Adverse Neurodevelopmental Outcome After Early Preterm Birth: A Validation Analysis

Author: Erin A. S. Clark, The Eunice Kennedy Shriver NICHD Maternal-Fetal Medicine Units and Neonatal Research Networks, Bethesda, MD  

Objective: Validate genetic risk loci associated with adverse neurodevelopment after early preterm birth.

Study Design: We previously conducted a large candidate gene association study in a cohort of 1013 extremely low birth weight infants (<1000 gms). The case-control analysis utilized samples in the NICHD Neonatal Research Network’s DNA Bank and evaluated 1634 SNPs in 145 genes in hypothesized causal pathways, with emphasis on inflammation, angiogenesis, and brain development. Cases were children who died by age 1 or who were diagnosed with CP or neurodevelopmental delay (Bayley II MDI or PDI <70) by 18-22 months. Controls were survivors with normal neurodevelopment. The outcomes of CP, combined CP or death, mental delay (MDI<70), and motor delay (PDI<70) were evaluated. Twenty-five SNPs with P<0.01 for one or more outcomes in the previous analysis were selected for validation in this analysis. Validation samples were derived from an RCT of magnesium sulfate before anticipated early preterm birth (<32 weeks) for prevention of cerebral palsy (CP). Case/control definitions were equivalent to the primary cohort, with the exception that neurodevelopmental outcomes were evaluated at 24 months. As in the primary analysis, four outcomes were evaluated. Cases and controls were matched for race and infant sex; covariates included gestational age at birth, small for gestational age, maternal education level, treatment group, and antenatal corticosteroids. Significance in the validation cohort was defined as P<0.05.

Results: The validation cohort included 364 infants, 170 cases and 192 controls. Three genetic loci from the primary analysis were significantly associated with the outcomes CP, CP/death and mental delay after early preterm birth in the validation analysis (Table).

Conclusion: Genetic loci involved in inflammation and brain development are associated with CP, CP/death, and mental delay after early preterm birth in primary and validation genetic analyses.

Table

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