Oxytocin and Fetal Heart Rate Changes

What Was Tested

This registered phase 4 trial tested Oxytocin.

This variability may be due to fluid and oxytocin management prior to and during the initiation of neuraxial analgesia.

It had two arms (groups): one (no intervention) and one (experimental).

The registry classes the interventions as drug.

More on the Plan

One of the limitations of these studies is that the labor analgesia was not standardized.

The primary outcome of this study is the incidence of non-reassuring fetal heart rate tracings within the first 60 minutes after the placement of combined spinal epidural analgesia.

Who Took Part

The registry lists 730 planned participants were the target.

It was open to women only aged from 18 years up to 55 years.

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

Examples of who could join: Healthy nulliparous or multiparous women at term (37 \> weeks' gestation). Request for neuraxial analgesia. Oxytocin used for induction of labor or augmentation of labor per institutional protocols.

The full record lists 4 inclusion and 5 exclusion criteria; among the exclusions: use of chronic analgesic medications; prior administration of systemic opioid labor analgesia; non-vertex presentation.

How the Study Was Run

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

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

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, investigator and outcomes assessor.

It started in 2019-02-20 with completion listed for 2025-12-31.

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

Its stated primary purpose is treatment.

What Was Measured

Primary outcome: Incidence of non-reassuring fetal heart rate tracings (time frame: 1.5 hours).

It also tracked 2 secondary outcomes, for example Mode of delivery.

What This Means in Plain Language

Put simply, this is a phase 4, randomized trial of Oxytocin in 730 people.

With 730 participants it is a large trial for this field.

It is still recruiting; no results are posted to the registry yet, so nothing here describes outcomes.

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