Breast Stimulation Versus Pitocin for Induction of Labor

What Was Tested

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

The purpose of the trial is to compare nipple stimulation with a breast pump to pitocin for induction of labor in term pregnancies.

It had two arms (groups): Oxytocin induction (active comparator) and Breast Stimultion (active comparator).

Nipple stimulation with a breast pump, calibrated at the lowest suction strength,operated alternately: 15 min one breast, 15 min second breast, 15 min rest, till appearance of regular uterine contractions (3 contractions in 10 min). the manipulation will continue for 3 hours of regular contractions.

The registry classes the interventions as drug and procedure.

Who Took Part

Enrollment: 150 planned participants were the target.

It was open to women only aged from 18 years up to 45 years.

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

Examples of who could join: 18 years and older. Completed 37 weeks gestation. Reassuring fetal heart rate at admission monitor.

The full record lists 4 inclusion and 10 exclusion criteria; among the exclusions: multiple pregnancies; known fetal malformations; non reassuring nst.

How the Study Was Run

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

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.

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 2009-11 with completion listed for 2010-10.

It ran at 1 site in Israel.

Its stated primary purpose is treatment.

What Was Measured

The main thing measured (primary outcome): time from induction to delivery (time frame: 24h).

It also tracked 2 secondary outcomes, for example fetal distress (monitor assessment, cord ph) and cesarean section rate.

What This Means in Plain Language

Put simply, this is a not phased, randomized trial of Oxytocin in 150 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.