Last reviewed · How we verify

NCT03039036

Early Amniotomy Versus Delayed Amniotomy Following Foley Catheter Ripening in Nulliparous Labor Induction

Completed NA Last updated 3 April 2023
What this trial tests

NA trial testing Amniotomy in Labor Induction in 69 participants. Completed in 1 December 2022.

Timeline
12 September 2017
Primary endpoint
1 December 2022
1 December 2022

Quick facts

Lead sponsorNorthwestern University
PhaseNA
StatusCompleted
Study typeINTERVENTIONAL
Allocationrandomized
Designparallel
Maskingnone
Primary purposetreatment
Enrollment69
Start date12 September 2017
Primary completion1 December 2022
Estimated completion1 December 2022
Sites1 location across United States

Drugs / interventions tested

Conditions studied

Sponsor

Northwestern University

Who can join

18 and older, female only, with Labor Induction. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

Amniotomy (breaking the bag of water) is commonly used in the induction of labor. However, the timing is highly variable. The purpose of this study is to determine if first time mothers undergoing induction of labor with a Foley catheter experience a decrease in their labor time when undergoing early amniotomy (breaking the bag of water within 1 hour of Foley catheter removal) than when undergoing delayed amniotomy (breaking the bag of water at least 4 hours after Foley catheter removal). Other aims include the relationship between timing of amniotomy and cesarean section, postpartum hemorrhage, intrauterine infection, neonatal Apgar score \<7 at 5 minutes, neonatal need for intensive care. The investigators hypothesize that induction of labor with Foley catheters followed by early amniotomy will result in a decreased duration of labor compared to those who undergo delayed amniotomy.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.

Verify or expand the search:

Other trials of Amniotomy

Trials testing the same drug.

Other recruiting trials for Labor Induction

Currently open trials in the same condition.

Other Northwestern University trials

Trials by the same sponsor.

Verify against primary sources

Data sources for this page

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03039036.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing