Comparing Cervical Foley Catheter, Dinoprostone and a Combination of the Two for Labor Induction

What Was Tested

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

The investigators intend to conduct a randomized clinical trial comparing 3 methods of induction of labor in term primiparous women with singleton.

First group will be women induced with Foley catheter and pitocin, second group Foley catheter and vaginal dinoprostone and third group will be induced with vaginal dinoprostone alone.

The investigators compare time for induction to delivery and way of delivery.

It had three arms (groups): Foley catheter and pitocin (active comparator), Foley catheter and dinoprostone (active comparator) and Dinoprostone (active comparator).

The registry classes the interventions as device and drug.

More on the Plan

Introduction: Labor induction, an iatrogenic initiation of labor is one of the most common obstetric procedures performed nowadays.

Out of the vast options for cervical ripening, the Foley catheter and vaginal prostaglandins are frequently used.

Two randomized controlled trials compared the Foley catheter method with the vaginal dinoprostone method.

In an additional trial, Foley bulb with vaginal Misoprostol was compared to Misoprostol alone.

Who Took Part

360 planned participants were the target.

It was open to women only aged from 18 years up to 35 years.

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

Examples of who could join: 37 weeks pregnant or more. Cephalic live singleton,. Unfavorable cervix (bishop's score 6 or less).

The full record lists 5 inclusion and 15 exclusion criteria; among the exclusions: previous cesarean section or other uterine surgery; severe iugr; severe preeclampsia.

How the Study Was Run

The set-up was randomized, parallel-group and triple-blind.

Random assignment meant chance, not the researchers, decided who got Oxytocin and who got the comparison, which limits bias.

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

Neither the participants nor the staff measuring them knew who was on Oxytocin, so expectations could not easily colour the readings.

Those kept unaware of assignments: care provider, investigator and outcomes assessor.

It started in 2016-08 with completion listed for 2018-02.

Its stated primary purpose is treatment.

What Was Measured

The main thing measured (primary outcome): Time from induction to delivery (in hours) (time frame: up to 24 hours). Mode of delivery (time frame: up to 24 hours).

It also tracked 5 secondary outcomes, for example Time form induction to active labor (in hours), Rate of deliveries within 24 hours, Tachysystole, Neonatal Apgar scores (in a 1-10 scale) and Neonatal intensive care unit admission.

What This Means in Plain Language

Put simply, this is a not phased, randomized trial of Oxytocin in 360 people.

Its status is unknown; no results are posted to the registry yet, so nothing here describes outcomes.

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