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Induction of Labor After Cesarean Using Foley Alone vs. Concurrent Foley and Oxytocin

Plain-language guide to NCT07006896: not phased randomized trial of Oxytocin, 100 participants. Who took part, design and what was measured.

Key Facts

Registry ID
NCT07006896
Phase
not phased
Status
active, not recruiting
Start
2025-07-10
Completion (planned or actual)
2026-07-25
Participants
100 (estimated)
Design
randomized, open label (everyone knows who gets what), treatment
Conditions studied
Labor Induction; Cesarean Delivery
Results posted
not yet

What This Study Did, in Plain Language

What Was Tested

In this not phased trial, researchers set out to test Oxytocin.

A randomized trial of patients undergoing a term (≥37 weeks) induction of labor with a history of one prior Cesarean delivery, wherein the provider intends to use a Foley catheter for cervical ripening.

The investigators will be comparing Foley alone with concurrent Foley and Oxytocin use at the start of the induction.

It had two arms (groups): Concurrent Foley balloon and Oxytocin (experimental) and Foley balloon alone (active comparator).

Cervical ripening will begin with a Foley balloon and concurrent oxytocin, started within 2 hour of balloon placement.

Cervical ripening will begin with a Foley balloon alone. Oxytocin will not be started until the balloon is removed or expelled, though can be considered if the balloon remains in place for \>8 hours.

The registry classes the interventions as device and drug.

Who Took Part

The registry lists 100 planned participants were the target.

It was open to women only aged from 18 years with no upper age limit.

Healthy volunteers were not accepted; participants needed the condition being studied.

Examples of who could join: Eligible for induction of labor. Live singleton gestation ≥37 weeks. History of 1 cesarean delivery. ≥18 years of age. English or Spanish speaking (Able to read/understand consent and instructions).

The full record lists 8 inclusion and 3 exclusion criteria; among the exclusions: \>1 prior cesarean delivery; known chorioamnionitis; major fetal anomaly.

How the Study Was Run

The set-up was randomized, parallel-group and open-label.

Because people in this Oxytocin study were split into groups at random, differences between the groups are less likely to reflect who happened to join each one.

Groups ran in parallel: each of the participants stayed in one arm throughout.

Being open-label, the Oxytocin study did not mask who received what.

It started in 2025-07-10 with completion listed for 2026-07-25.

It ran at 1 site in United States.

Its stated primary purpose is treatment.

What Was Measured

The main thing measured (primary outcome): Time to delivery (time frame: At delivery).

It also tracked 11 secondary outcomes, for example Estimated postpartum blood loss, Postpartum hemorrhage, Number of Participants with Chorioamnionitis, Mode of delivery, Number of Participants with Uterine Rupture and Maternal morbidity.

What This Means in Plain Language

Put simply, this is a not phased, randomized trial of Oxytocin in 100 people.

Its status is active not recruiting; no results are posted to the registry yet, so nothing here describes outcomes.

More context: the Oxytocin compound page, all human trials.

Our Notes on the Compound

Oxytocin: A peptide hormone with established obstetric medical uses and a less settled role in research on behavior, sexual function and appetite.

Related Pages

Source: ClinicalTrials.gov record. This explanation is written by PeptideWhiz from the public record. For research and education only. Not medical advice; no dosing information is given.