Breast Stimulation vs. Low Dose Oxytocin Augmentation for Labor Induction

What Was Tested

The trial (phase 1, phase 2) is built around Oxytocin.

It had two arms (groups): Breast stimulation (experimental) and one (active comparator).

Breast pump for breast stimulation: The suction cup will be placed on the breast, held by the patient or a strap, alternated between nipples every 15 minutes, with a pause of 15 minutes after each 30 minutes. Suction intensity will be adjusted to the maximum tolerated by the patient while avoiding causing pain or discomfort. Treatment will be continued for a maximum of 12 hours.

The registry classes the interventions as biological and procedure.

More on the Plan

Introduction The primary cause of uterine scars is a previous cesarean.

Maternal morbidity in women with previous cesareans is higher when TOLAC fails than when it leads to successful vaginal delivery\[2\].

The goal of labor induction is to ensure the best possible outcome for mother and newborn\[3\].

For women after cesarean delivery labor should be induced only for medical indications\[4\].

Who Took Part

The registry lists 200 planned participants were the target.

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

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

Examples of who could join: Singleton vertex gestations at or beyond 37 weeks of gestation. History of one prior cesarean section scar or grandmultipara (birth number 6 and above),. Spontaneous onset of labor or after labor induction by Foley balloon catheter, eligible for this trial. Determined by the obstetrics care team that augmentation was needed. Augmentation will be initiated at or beyond 2.5 cm dilation, with or without ruptured membranes and uterine activity less than 3 contractions in 10 minutes on tocodynamometry.

The full record lists 5 inclusion and 7 exclusion criteria; among the exclusions: history of two prior cesarean section scars,; younger than 18 years,; any contraindication for vaginal birth (placenta previa, vasa previa, cord presentation, inadequate pelvis, prior uterine rupture),.

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.

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

It started in 2022-10 with completion listed for 2024-10.

It ran at 1 site in Israel.

Its stated primary purpose is treatment.

What Was Measured

The main thing measured (primary outcome): Time interval from augmentation of labor to delivery (time frame: up to 48 hours).

It also tracked 5 secondary outcomes, for example Montevideo units in each group, rate of women who achieved vaginal delivery, Endometritis, Postpartum hemorrhage and Apgar score 3 or less at 5 minutes.

What This Means in Plain Language

Put simply, this is a phase 1, phase 2, randomized trial of Oxytocin in 200 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.