A Randomized Trial of Induction Versus Expectant Management


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Trial ID: NCT01990612


A randomized clinical trial to assess whether elective induction of labor at 39 weeks of gestation compared with expectant management will improve outcomes.

Official Title

Induction in Nulliparous Women at 39 Weeks to Prevent Adverse Outcomes: A Randomized Controlled Trial

Stanford Investigator(s)

Yasser El-Sayed, Professor
Yasser El-Sayed, Professor

Charles B. and Ann L. Johnson Professor in the School of Medicine and Professor, by courtesy, of Pediatrics (Neonatology) and of Surgery


Inclusion Criteria:

   1. Nulliparous - no previous pregnancy beyond 20 weeks

   2. Singleton gestation. Twin gestation reduced to singleton, either spontaneously or
   therapeutically, is not eligible unless the reduction occurred before 14 weeks project
   gestational age.

   3. Gestational age at randomization between 38 weeks 0 days and 38 weeks 6 days inclusive
   based on clinical information and evaluation of the earliest ultrasound.

Exclusion Criteria:

   1. Project gestational age at date of first ultrasound is > 20 weeks 6 days

   2. Plan for induction of labor prior to 40 weeks 5 days

   3. Plan for cesarean delivery or contraindication to labor

   4. Breech presentation

   5. Signs of labor (regular painful contractions with cervical change)

   6. Fetal demise or known major fetal anomaly

   7. Heparin or low-molecular weight heparin during the current pregnancy

   8. Placenta previa, accreta, vasa previa

   9. Active vaginal bleeding greater than bloody show

10. Ruptured membranes

11. Cerclage in current pregnancy

12. Known oligohydramnios, defined as AFI < 5 or MVP < 2

13. Fetal growth restriction, defined as EFW < 10th percentile

14. Known HIV positivity because of modified delivery plan

15. Major maternal medical illness associated with increased risk for adverse pregnancy
   outcome (for example, any diabetes mellitus, lupus, any hypertensive disorder, cardiac
   disease, renal insufficiency)

16. Refusal of blood products

17. Participation in another interventional study that influences management of labor at
   delivery or perinatal morbidity or mortality

18. Delivery planned elsewhere at a non-Network site


procedure: Elective Induction of Labor


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Contact Information

Stanford University
School of Medicine
300 Pasteur Drive
Stanford, CA 94305
Cynthia Willson, RN, BSN