Foley With Oxytocin Versus Foley no Oxytocin for Induction of Labor

What Was Tested

In this phase 4 trial, researchers set out to test Oxytocin.

It had four arms (groups): Nulliparous - Foley only (active comparator), Nulliparous - Foley and oxytocin (active comparator), Multi(primi)parous - Foley only (active comparator) and Multi(primi)parous - Foley and oxytocin (active comparator).

The registry classes the interventions as device and drug.

More on the Plan

This is a multi-center, open-label, randomized study.

Women with a singleton, vertex gestation between 24-42 weeks gestations presenting for labor induction will be offered participation in this study.

All indications for induction will be included except those specifically mentioned as exclusion criteria.

Any contraindication for vaginal delivery would exclude the subject.

Who Took Part

Enrollment: 323 actual participants took part.

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

Healthy volunteers could join, not only people with the condition.

Examples of who could join: Age greater than 18 years. Pregnant, singleton gestation, vertex presentation. Admitted for induction of labor between gestational ages 24 - 42 weeks. Bishop score \<6.

The full record lists 4 inclusion and 15 exclusion criteria; among the exclusions: multiple gestation; non-vertex presentation; latex allergy or latex-free foley catheter to be placed.

How the Study Was Run

It was run as a randomized, parallel-group and open-label study.

The participants were allocated by chance, so the Oxytocin group and the comparison group should start out alike.

The Oxytocin group and the comparison group ran side by side rather than switching.

Everyone knew when Oxytocin was being given (open label), which is simpler to run but leaves more room for expectations to affect what is reported.

It started in 2014-10 with completion listed for 2016-09-11.

It ran at 2 sites in United States (2).

Its stated primary purpose is treatment.

What Was Measured

Primary outcome: Delivery Rate (time frame: Within 24 hours).

It also tracked 8 secondary outcomes, for example Number of Participants With Time to Delivery Achieved Within 12 Hours, Total Time to Delivery, Time to Foley Expulsion, Number of Vaginal Deliveries, Regional Analgesia and Obstetric Complications.

What This Means in Plain Language

Put simply, this is a phase 4, randomized trial of Oxytocin in 323 people.

The trial is marked completed; results are posted on the registry, and this page does not restate them.

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