The Association Between Fluid Administration, Oxytocin Administration, and Fetal Heart Rate Changes

What Was Tested

This registered not phased trial tested Oxytocin.

Fetal heart rate patterns are an important parameter in the diagnosis of non-reassuring fetal status.

Optimizing the variables which could affect fetal heart rate patterns at the time of initiation of analgesia, such as fluid administration and oxytocin management, could help them provide better care for their patients and their fetuses.

It had four arms (groups): Group A (active comparator), Group B (experimental), Group C (active comparator) and Group D (experimental).

The registry classes the interventions as drug.

More on the Plan

After obtaining informed, written consent, candidates were randomized to one of four groups at the time of request for labor analgesia.

All subjects received a maintenance infusion of Lactated Ringers(LR).

Candidates in Groups C and D did not receive any additional fluid.

If randomized to group A or C, the oxytocin management was continued as per the normal active management of labor protocal (AMOL).

Who Took Part

Enrollment: 251 actual participants took part.

It was open to women only aged from 18 years up to 60 years.

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

Examples of who could join: Healthy nulliparous or multiparous women. Term (\>36 week gestation). Spontaneous labor or with spontaneous rupture of membranes. Request neuraxial analgesia.

The full record lists 7 inclusion and 7 exclusion criteria; among the exclusions: under 18 years of age; presence of any systemic disease (e.g., diabetes mellitus, hypertension, preeclampsia); use of chronic analgesic medications.

How the Study Was Run

It was run as a randomized, parallel-group and double-blind study.

Random assignment meant chance, not the researchers, decided who got Oxytocin and who got the comparison, which limits bias.

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

Neither the participants nor the staff measuring them knew who was on Oxytocin, so expectations could not easily colour the readings.

Those kept unaware of assignments: participant and investigator.

It started in 2007-09 with completion listed for 2012-07.

It ran at 2 sites in United States (2).

Its stated primary purpose is prevention.

What Was Measured

Researchers chose this as the main measure: Number of Participants With Non-reassuring Fetal Heart Rate Tracings During the First 30 Minutes After the Placement of Epidural Analgesia (time frame: Request for labor analgesia up to the first 30 minutes after the placement of epidural).

What This Means in Plain Language

Put simply, this is a not phased, randomized trial of Oxytocin in 251 people.

It ended early (terminated); results are posted on the registry, and this page does not restate them.

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