IRB#: 529843-2, Wake: 529843
This study compares first time moms who are induced at 39 weeks to those who are managed until 41 weeks gestation. The study looks at whether induction at 39 weeks reduces the risk of severe neonatal morbidity and perinatal mortality.
You may be qualified if the following applies to you:
- Women who have had no previous pregnancies beyond the 20 weeks,
- Pregnant with one baby or twins that were reduced to one baby before 14 weeks gestation, and are between 38 weeks and 0 days to 38 weeks and 6 days.
You may not be able to participate if:
- Gestational age greater than 20 weeks and 6 days at first ultrasound
- planned induction prior to 40 weeks and 5 days
- planned cesarean section
- signs of labor as defined as regular uterine contractions with cervical change
- fetal demise or anomalies
- heparin use during pregnancy
- Previa/accreta/vasa Previa
- active vaginal bleeding
- ruptured membranes
- oligo defined as a AFI less than 5
- fetal growth restriction as defined by a EFW of less than the 10th percentile
- maternal medical illnesses
- refusal of blood products
- participation in another interventional study
- delivery planned at non-network site
If you're not sure if you qualify please contact us so we can help guide you.
Dates of Study
Projected start date of April 2014 until 6000 women have been randomized nationally.
This study is funded by the Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD). Conducted by the NICHD Maternal-Fetal Medicine Units (MFMU). All biostatistical information is the responsibility of the Biostatistical Coordinating Center (BCC) at George Washington University.
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American Academy of Pediatrics, American College of Obstetricians and Gynecologists. Guidelines for perinatal care. 7th ed. Elk Grove Village, IL; Washington, DC: American Academy of Pediatrics; American College of Obstetricians and Gynecologists; 2012.
Gulmezoglu AM, Crowther CA, Middleton P. Induction of labour for improving birth outcomes for women at or beyond term. Cochrane Database Syst Rev 2006:CD004945.
Caughey AB, Bishop JT. Maternal complications of pregnancy increase beyond 40 weeks of gestation in low-risk women. J Perinatol 2006;26:540-5.
Caughey AB, Musci TJ. Complications of term pregnancies beyond 37 weeks of gestation. Obstet Gynecol 2004;103:57-62.
Caughey AB, Stotland NE, Washington AE, Escobar GJ. Maternal and obstetric complications of pregnancy are associated with increasing gestational age at term. Am J Obstet Gynecol 2007;196:155 e1-6.
Caughey AB, Washington AE, Laros RK, Jr. Neonatal complications of term pregnancy: rates by gestational age increase in a continuous, not threshold, fashion. Am J Obstet Gynecol 2005;192:185-90.