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

Study ID
STU 092013-050

Cancer Related
No

Healthy Volunteers
No

Study Sites

  • Parkland Health & Hospital System

Contact
Lisa Moseley
214/648-2591
LISA.MOSELEY@UTSouthwestern.edu

Principal Investigator
Brian Casey, M.D.

Summary

The study is a randomized controlled multi-center clinical trial of 6000 women at 38 weeks 0 days to 38 weeks 6 days randomized to one of two arms at participating MFMu network clinical centers.
* elective induction of labor between 39 weeks 0 days and 39 weeks 4 days
* expectant management (unless a medical indication arises) until at least 40 weeks 5 days.

Participant Eligibility

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