Continuous Oxytocin Infusion Versus Pulsatile Intravenous Oxytocin for Augmentation of First Stage of Labor

What Was Tested

In this phase 4 trial, researchers set out to test Oxytocin.

Comparing continuous intravenous oxytocin infusion with pulsatile administration of intravenous oxytocin for augmentation of the first stage of labor.

It had two arms (groups): pulsatile oxytocin (active comparator) and continuous oxytocin (active comparator).

The registry classes the interventions as drug.

More on the Plan

The sample size for either regimen in that study was 240 patients or 241 patients, respectively.

From the study of Tribe et al.

(2012), it could be estimated that the standard deviation (SD) for the infusion to delivery time was 4.66 hours or 5.23 hours for the continuous or pulsatile oxytocin regimen, respectively.

Under the alternative hypothesis, the mean ± SD infusion to delivery time is assumed to equal 7.17 ± 4.66 hours in the continuous infusion group versus 9.61 ± 5.23 hours in the pulsatile group.

Who Took Part

The registry lists 120 planned participants were the target.

It was open to women only aged from 17 years up to 40 years.

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

Examples of who could join: Women in labor (cervical dilatation 3-4 centimeters) who require augmentation of first stage of labor. Single viable fetus. Rupture of membranes before augmentation of labor.

The full record lists 5 inclusion and 8 exclusion criteria; among the exclusions: induction of labor by prostaglandins; any uterine previous surgery; fetal anomalies.

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.

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

Only one side, usually the participants, was kept unaware of whether Oxytocin was given.

Those kept unaware of assignments: participant.

It started in 2016-03 with completion listed for 2017-01.

It ran at 1 site in Egypt.

Its stated primary purpose is treatment.

What Was Measured

Researchers chose this as the main measure: duration of active phase of first stage of labor (time frame: 24 hours).

What This Means in Plain Language

Put simply, this is a phase 4, randomized trial of Oxytocin in 120 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.