Stimulation Therapy for Inducing Mothers

What Was Tested

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

This is a pilot feasibility and acceptability study of a randomized clinical trial of pregnant women at 36 weeks of gestation and greater randomized to one of two arms at Yale New Haven Hospital: (1) Breast stimulation by hand or with an electronic breast pump (intervention) compared to (2) Exogenous oxytocin intravenous infusion (current standard of care, control).

The pilot study will be randomized since one of the goals is to evaluate whether the idea of randomization would be acceptable to patients.

It had two arms (groups): Breast stimulation (experimental) and Exogenous oxytocin intravenous infusion (active comparator).

Participants randomized to the breast stimulation will use breast stimulation by hand or with an electronic breast pump (intervention) to stimulate labor.

Participants randomized to the standard care arm will use exogenous oxytocin intravenous infusion to stimulate labor.

The registry classes the interventions as device and other.

More on the Plan

Breast stimulation was historically used successfully for inducing contractions for the purposes of contraction stress testing.

A Cochrane review was performed in 2010 that compared breast stimulation with either no intervention or oxytocin infusion for labor induction.

However, that study was conducted in India, women were not monitored during breast stimulation, there was no clearly reported method of randomization, and there were very few study details divulged.

First, most included studies compared breast stimulation to no intervention, which is not the appropriate alternative when it has been determined that a labor induction is indicated.

Who Took Part

24 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: Provision of signed and dated informed consent form. Stated willingness to comply with all study procedures and availability for the duration of the study. Age 18 years and older. Gestational age 36 weeks and greater at randomization. Vertex-presenting singleton gestation, or presenting gestation (a.k.a. Fetus A) is vertex-presenting in a multiple gestation.

The full record lists 8 inclusion and 11 exclusion criteria; among the exclusions: unable to understand english; fetal demise; major fetal anomaly suspected prenatally (defined as a fetal anomaly with anticipated neonatal intensive care unit admission).

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.

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

Nothing was hidden in this open-label Oxytocin study: the participants and staff both knew the treatment.

It started in 2021-03-13 with completion listed for 2021-06-23.

It ran at 1 site in United States.

Its stated primary purpose is other.

What Was Measured

Researchers chose this as the main measure: Recruitment (enrollment) rate (time frame: 3 months). Adherence rate (time frame: 3 months). Cross-over frequencies (time frame: 3 months).

What This Means in Plain Language

Put simply, this is a not phased, randomized trial of Oxytocin in 24 people.

Its size is small, so on its own it can only give an early look.

The trial is marked completed; no results are posted to the registry yet, so nothing here describes outcomes.

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