A Randomized Trial of Induction Versus Expectant Management
Trial ID or NCT#
NCT01990612
Status
RECRUITING
Purpose
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
Eligibility Criteria
Sexes Eligible for Study: Female
Accepts Healthy Volunteers: No
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
Investigator(s)
Yasser El-Sayed, Professor
Obstetrician and Gynecologist (OB-GYN)
Charles B. and Ann L. Johnson Professor in the School of Medicine and Professor, by courtesy, of Pediatrics (Neonatology) and of Surgery
Contact us to find out if this trial is right for you.
Contact
Cynthia Willson, RN, BSN
650-724-6372
View on ClinicalTrials.gov
