Low-Dose Versus High-Dose Oxytocin Dosing for Induction and Augmentation of Labor

What Was Tested

This registered phase 4 trial tested Oxytocin.

The goal of this clinical trial is to compare oxytocin infusion rates for induction and augmentation of labor in nulliparous women.

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

The registry classes the interventions as drug.

Who Took Part

170 actual participants took part.

It was open to women only aged from 18 years up to 50 years.

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

Examples of who could join: Women aged 18-50 years old. Gestational age greater than or equal to 37 weeks. No prior uterine surgery. Need for augmentation of labor with oxytocin.

The full record lists 8 inclusion and 8 exclusion criteria; among the exclusions: previous cervical ripening using non-mechanical methods; patient unable or unwilling to provide verbal consent; contraindications to vaginal delivery.

How the Study Was Run

Design: randomized, parallel-group and single-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.

In this single-blind Oxytocin study one party knew the assignments and the other did not.

Those kept unaware of assignments: participant.

It started in 2023-04-17 with completion listed for 2024-12-31.

It ran at 1 site in United States.

Its stated primary purpose is treatment.

What Was Measured

Primary outcome: Time to Delivery (time frame: Through delivery, on average 24 hours).

It also tracked 12 secondary outcomes, for example Mode of Delivery, Rate of Primary Cesarean Delivery, Rate of Uterine Tachysystole, Number of Participants With Postpartum Hemorrhage, Rate of Placental Abruption and Number of Participants With Nausea/Vomiting Requiring Antiemetics and Diarrhea.

What This Means in Plain Language

Put simply, this is a phase 4, randomized trial of Oxytocin in 170 people.

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.