Comparison of Low-dose and High-dose Oxytocin Regimens for Labor Augmentation

What Was Tested

This registered phase 4 trial tested Oxytocin.

Oxytocin is a medication that is often used to strengthen contractions to overcome delayed labor progress.

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

The registry classes the interventions as drug and other.

More on the Plan

This project will include 1002 women recruited from the obstetrical service at Prentice Women's Hospital.

Women will be included if they are at least 36 weeks gestation, have a singleton pregnancy, and have been diagnosed with spontaneous labor or spontaneous rupture of membranes.

Women will be exposed to oxytocin for the indication of labor augmentation at the discretion of their obstetric provider.

Women will be randomized with equal probability to intervention group using a fixed allocation procedure.

Who Took Part

1003 actual participants took part.

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: Able to give informed written consent. Age 18-45 years. Pregnant with a live singleton gestation that is equal to or greater than 36 weeks.

The full record lists 6 inclusion and 5 exclusion criteria; among the exclusions: women not meeting the above criteria; history of prior cesarean section or uterine surgery; fetus in non-cephalic presentation.

How the Study Was Run

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

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.

Blinding on both sides kept the participants and researchers unaware of who received Oxytocin.

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

It started in 2015-09-28 with completion listed for 2020-09-01.

It ran at 1 site in United States.

Its stated primary purpose is treatment.

What Was Measured

Primary outcome: Number of Participants Delivered by Cesarean (time frame: At time of delivery).

It also tracked 9 secondary outcomes, for example Labor Augmentation Duration, Number of Participants With Postpartum Hemorrhage, Number of Participants With Intrapartum Chorioamnionitis, Number of Participants With Postpartum Endometritis, Number of Participants With Umbilical Cord Acidemia and Neonatal Apgar Score of Less Than 3 at 5 Minutes of Life.

What This Means in Plain Language

Put simply, this is a phase 4, randomized trial of Oxytocin in 1003 people.

With 1003 participants it is a large trial for this field.

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.