NCT01990612

A Randomized Trial of Induction Versus Expectant Management

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 6,106 (actual)
• Sponsor: The George Washington University Biostatistics Center · Academic / Other
• Sex: Female
• Age: —
• Healthy volunteers: Not accepted

Summary

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

Detailed description

Given the reported increased risks of adverse events in pregnancies extending beyond 39 weeks it has been hypothesized that a policy of planned elective induction at 39 weeks could improve outcomes for the infant and the mother. For multiparous patients, especially those with a favorable cervix, it is perhaps easy to justify an elective induction at 39 weeks given the low risk of cesarean section. However, for nulliparous patients the current evidence, derived mainly from retrospective observational studies, does not allow a clear recommendation. Nevertheless, a trend towards an increased rate of elective labor induction in pregnancies at 39 weeks has been reported, indicating that practitioners are more commonly using elective induction at this gestational age,even as others caution against routine elective induction prior to 41 weeks given the reported increased risk of cesarean delivery. Ultimately, a randomized controlled trial is necessary to satisfactorily understand whether elective induction of labor of nulliparas at 39 weeks improves neonatal and maternal outcomes.

Conditions

• Labor and Delivery

Interventions

Type	Name	Description
PROCEDURE	Elective Induction of Labor	Women randomized to induction of labor will undergo induction via oxytocin at 39 weeks 0 days to 39 weeks 4 days. Those with an unfavorable cervix (modified Bishop score \< 5) will first undergo cervical ripening (method left to the discretion of the patient's physician) in conjunction with or followed by oxytocin stimulation unless a contraindication arises.

Timeline

• Start date: 2014-03-01
• Primary completion: 2017-11-01
• Completion: 2018-01-01
• First posted: 2013-11-21
• Last updated: 2019-02-21
• Results posted: 2019-01-25

Locations

16 sites across 1 country: United States