A Randomized Trial of Induction Versus Expectant Management

Completed · Not applicable

Conditions studied: Labor and Delivery

In brief

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

Key facts

Study ID

NCT01990612

Run by

The George Washington University Biostatistics Center

People needed

6106

Starts

2014-03-01

Expected to finish

2018-01-01

Last updated by the study team

2019-02-21

Who can join

Age: any. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• Nulliparous - no previous pregnancy beyond 20 weeks
• Singleton gestation. Twin gestation reduced to singleton, either spontaneously or therapeutically, is not eligible unless the reduction occurred before 14 weeks project gestational age.
• 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.

You may not qualify if…

• Project gestational age at date of first ultrasound is > 20 weeks 6 days
• Plan for induction of labor prior to 40 weeks 5 days
• Plan for cesarean delivery or contraindication to labor
• Breech presentation
• Signs of labor (regular painful contractions with cervical change)
• Fetal demise or known major fetal anomaly
• Heparin or low-molecular weight heparin during the current pregnancy
• Placenta previa, accreta, vasa previa
• Active vaginal bleeding greater than bloody show
• Ruptured membranes
• Cerclage in current pregnancy
• Known oligohydramnios, defined as AFI < 5 or MVP < 2
• Fetal growth restriction, defined as EFW < 10th percentile
• Known HIV positivity because of modified delivery plan
• 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)
• Refusal of blood products
• Participation in another interventional study that influences management of labor at delivery or perinatal morbidity or mortality
• Delivery planned elsewhere at a non-Network site

Where it is running

• University of Alabama - Birmingham — Birmingham, Alabama, United States
• Stanford University — Stanford, California, United States
• University of Colorado — Denver, Colorado, United States
• Northwestern University-Prentice Hospital — Chicago, Illinois, United States
• Columbia University-St. Luke's Hospital — New York, New York, United States
• University of North Carolina - Chapel Hill — Chapel Hill, North Carolina, United States
• Duke University — Durham, North Carolina, United States
• Case Western Reserve University — Cleveland, Ohio, United States
• Ohio State University Hospital — Columbus, Ohio, United States
• Hospital of the University of Pennsylvania — Philadelphia, Pennsylvania, United States
• Magee Womens Hospital of UPMC — Pittsburgh, Pennsylvania, United States
• Brown University — Providence, Rhode Island, United States
• Dept of OB/GYN, Southwestern Medical Center, University of Texas — Dallas, Texas, United States
• University of Texas - Galveston — Galveston, Texas, United States
• University of Texas - Houston — Houston, Texas, United States
• University of Utah — Salt Lake City, Utah, United States

Full record on ClinicalTrials.gov

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