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Category Archives: Maternal-fetal medicine

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

Study Finds Noninvasive Prenatal Testing Detects More Than Eighty Percent of Chromosomal Abnormalities

In a study to be presented on Feb. 6 at 9 a.m. CST, at the Society for Maternal-Fetal Medicine’s annual meeting, The Pregnancy Meeting ™, in New Orleans, researchers will report that noninvasive prenatal testing detected 83.2 percent of chromosomal abnormalities normally picked up by invasive diagnostic testing strategies, such as chorionic villus sampling (CVS) or amniocentesis. Noninvasive prenatal testing (NIPT) using cell free DNA provides accurate screening for the common trisomies, including trisomy 13 (Patau syndrome), 18 (Edwards syndrome), and 21 (Down syndrome).

In this study, titled Rare Chromosome Abnormalities Detected by Current Prenatal Screening Compared to Expected Performance using Non-Invasive Prenatal Testing (NIPT), 68,990 of 1,324,607 women tested positive for trisomy 18 or 21 when they underwent prenatal screening as part of the California Prenatal Screening Program between March 2009 and December 2012. Invasive diagnostic testing with CVS or amniocentesis was performed on 26,059 women who tested positive, and 2993 were found to have abnormal results. Of those chromosomal abnormalities, 2489 (83.2 percent) were abnormalities that would be detectable with NIPT, while 16.8 percent were less common aneuploidies that would not be detected.

One of the study’s authors Mary Norton, M.D., said that more of the abnormal results were detectable in the women over 40, who are at higher risk for trisomy 13, 18 or 21. Conversely, fewer of the abnormalities in younger women would be detected by NIPT, as the risk for common trisomies is lower in this group, while the rare aneuploidies are not typically associated with maternal age.

“While noninvasive prenatal testing with cell free DNA presents some real advantages in accuracy of screening for Down syndrome, as with everything there is a trade-off.  Traditional aneuploidy screening with serum and ultrasound markers has higher false positive rates, but in these false positive cases are some fetuses with significant abnormalities that would not be found with NIPT. It is very important that patients and providers understand this trade-off,” said Norton, professor and vice chair for Clinical and Translational Genetics, Department of Obstetrics, Gynecology and Reproductive Sciences at the University of California, San Francisco.

“In prenatal genetic testing, patient preferences are really the most important driver,” Norton continued. “With this test, the patient makes a tradeoff between NIPT, which is noninvasive and detects most, but not all chromosome abnormalities—and is somewhat better in older women—and amniocentesis or CVS, which detect more chromosome abnormalities [8 to 25 percent more, depending on age] but with a small risk of miscarriage due to the procedure.

For an older woman, detecting 83 percent with the noninvasive test may be good enough, while for a 25-year-old, failing to detect 25 percent [which may include rare aneuploidies not usually associated with age] may be of concern.”

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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 5: Rare Chromosome Abnormalities Detected by Current Prenatal Screening Compared to Expected Performance using Non-Invasive Prenatal Testing (NIPT)

Authors: Mary Norton1, Robert Currier2, Laura Jelliffe-Pawlowski2

1University of California, San Francisco, Division of Maternal Fetal Medicine, Department of Obstetrics, Gynecology and Reproductive Sciences, San Francisco, CA, 2California Department of Public Health, Genetic Disease Screening Program, Richmond, CA

Objective: To determine the range and number of chromosome abnormalities detected in a large statewide prenatal screening program and to assess how many of these would be identified if current screening and invasive diagnostic testing strategies were replaced by noninvasive prenatal testing (NIPT).

Study Design: All karyotype results of invasive prenatal testing in singleton pregnancies performed in response to a positive prenatal screen through the California Prenatal Screening Program (PNS) from March 2009 through December 2012 were examined (n = 26,059). Karyotypes were flagged as normal or abnormal; abnormal results were categorized by type of abnormality and whether the abnormality is detectable by current NIPT methods (e.g. non-mosaic trisomy 13, 18, or 21, or sex-chromosomal aneuploidy) or unlikely to be detected by NIPT due to testing limitations (e.g. other rare trisomies, unbalanced structural rearrangements, or mosaicism).

Results: Over 1.3 million women had screening during the study period (n = 1,324,607), and 68,990 (5.2%) were screen positive for trisomy 18 or 21. Of screen positive women, 26,059 (37.8%) underwent invasive diagnostic testing and 2993 had an abnormal result (11.5%). Of these, 2489 (83.2%) were predicted to be detectable with current NIPT methods, and 504 (16.8%) were considered not currently detectable (Table 1). Trisomy 21 comprised 53.2% of the abnormal results (n=1592).

Conclusion: For women with a positive aneuploidy screening test, over 80% of chromosome abnormalities will be detected by NIPT, while approximately 17% will be missed. Undetected aneuploidies range from relatively mild to those associated with significant disability. This is important information to be considered by patients, providers, and screening programs in evaluating the utility of traditional screening and invasive prenatal diagnosis compared to NIPT.

Table 1

Study Finds Increasing Trend in Home Birth Neonatal Mortality Rates

In a study to be presented on Feb. 7 at 2:15 p.m. CST, at the Society for Maternal-Fetal Medicine’s annual meeting, The Pregnancy Meeting ™, in New Orleans, researchers will report that patients delivered at home by midwives had a roughly four times higher risk of neonatal deaths than babies delivered in the hospital by midwives. The increased neonatal mortality risk is associated with the location of a planned birth, rather than the credentials of the person delivering the baby.

The number of homebirths in the United States has grown over the last decade. In the largest study of its kind, using Centers for Disease Control data on nearly 14 million linked infant birth and neonatal death data, term singleton U.S. births, researchers at New York-Presbyterian/Weill Cornell Medical Center found the absolute risk of neonatal mortality was 3.2/10,000 births in midwife hospital births, and 12.6/10,000 births in midwife home births, and it further increased in first-time mothers to 21.9/10,000 births in midwife home deliveries. Neonatal mortality was defined as neonatal deaths up to 28 days after delivery.

“This risk further increased to about seven-fold if this was the mother’s first pregnancy, and to about ten-fold in pregnancies beyond 41 weeks,” said Amos Grunebaum, M.D.

The excess total neonatal mortality for deliveries performed by home midwives was 9.3/10,000 births or about 18-19 excess neonatal deaths a year from midwife homebirths. Based on the most recent 2012 births data, the authors concluded that if home births by midwives continue to grow at the present 10 percent yearly rate, then the excess total neonatal mortality of home births by midwives would nearly double  from about 16-17 in 2009 to about 32 in 2016.

Given the study’s findings, Amos Grunebaum, M.D. and Frank Chervenak, M.D., the main authors of the study, said that obstetric practitioners have an ethical obligation to disclose the increased absolute and relative risks associated with planned home birth to expectant parents who express an interest in this delivery setting, and to recommend strongly against it.

The authors also continued to say that hospitals should create a welcoming and comfortable birthing environment, as well as address unnecessary obstetric interventions, both of which are often a primary motivation for planned homebirth.

Study co-authors include Laurence B. McCullough, Ph.D., at Baylor College of Medicine and Weill Cornell Medical College, Katherine J. Sapra, MPH, at Columbia University, Robert L. Brent M.D., Ph.D., at Thomas Jefferson University and Weill Cornell Medical College, Malcolm I. Levene, M.D., FRCP, FRCPCH at the University of Leeds, and Birgit Arabin, M.D., at Philipps University and Clara Angela Foundation.

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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 57: Term neonatal deaths resulting from home births: An increasing trend

Authors: Amos Grunebaum1, Kate Sapra2, Frank Chervenak1

1New York Weill Cornell Medical College, New York, NY, 2Columbia University, New York, NY

Objective: Home births have increased over the last years. The objective of our study was to examine excess term neonatal mortality rates by birth location (hospital, birthing centers, and home births) and by providers (midwives, doctors, and “others” for home births) and to document the number of excess neonatal deaths resulting from the increase in home births.

Study Design: A retrospective cohort study using the CDC linked birth/infant death data set for term (>=37 weeks), >=2500 grams, singleton live births, excluding congenital anomalies from 2007 to 2009. Deliveries were categorized by setting: hospitals, birthing centers, and home as well as providers (midwives, doctors, and “others” for home births). Neonatal mortality (NNM) was defined as neonatal deaths up to 28 days after delivery. Hospital midwives served as reference.

Results: There were a total of 10,453,778 term deliveries between 2007 and 2009 which met study criteria: 9,526,450 (91.13%) were by hospital physicians, 826,543 (7.91%) by hospital midwives, 30,415 (0.29%) by midwives in freestanding birthing centers, 48,202 (0.46%) by midwives at home, and 22,168 (0.21%) by others at home. NNM for those delivered at home by others and by midwives, and those delivered in a freestanding birthing center was significantly higher than those delivered by midwives in the hospital: hospital midwives: 3.1/10,000 (RR:1); home others: 18.2/10,000 (RR: 5.87; 95%CI: 4.21-8.19), home midwives: 13.2/10,000; (RR: 4.32 95%CI: 3.29-5.68), freestanding birthing center: 6.3/10,000;(RR: 2.03; 95%CI: 1.28-3.24). The excess NNM for home births by midwives was 10.2/10,000 births (95% CI 6.9-13.2), and 15.0/10,000 births (95% CI 9.4-20.6) for home births by “others”.

Conclusion: Our study documents the number of excess term neonatal deaths resulting from home births. If home births continue to grow at a 6% per year rate, then excess yearly neonatal deaths from home births will increase by about 1/3 from about 31 in 2010 to about 42 in 2015.

 

Predicted Excess Neonatal Deaths From Home Births By Year

Predicted Excess Neonatal Deaths From Home Births By Year

Total and Excess Neonatal Mortality By Setting and Attendant

Total and Excess Neonatal Mortality By Setting and Attendant

 

 

Pregnancy as a Window to Future Health – SMFM White Paper

The development of complications in pregnancy provides a new window of opportunity for early heart disease risk screening and intervention for women.

How Pregnancy Provides a Window to Future Health and Eliminating Some Chronic Disease

Physicians with the Society for Maternal-Fetal Medicine released a paper today that provides significant insight into future health conditions that women are likely to experience, and that can be detected early based on information relating to the course of pregnancy.  The paper, Pregnancy as a Window to Future Health: The development of complications in pregnancy provides a new window of opportunity for early heart disease risk screening and intervention for women, acknowledges that, for most women, the demands of pregnancy on the cardiovascular and metabolic systems are some of the highest the body will endure.

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