Reducing Neonatal Morbidity by Discontinuing Oxytocin During the Active Phase of 1st Stage of Labor

What Was Tested

This registered phase 4 trial tested Oxytocin.

The purpose of this study is to measure the impact of a discontinuous administration of oxytocin during the active phase of the 1st stage of labor on the neonatal morbidity rate.

It had two arms (groups): discontinuation of oxytocin administration (experimental) and continuation of oxytocin administration (active comparator).

Discontinuation of oxytocin administration at the beginning of the active phase of the 1st stage of labor, i.e. oxytocin infusion will be stopped beyond a cervical dilatation of 6cm.

The registry classes the interventions as drug.

More on the Plan

By causing uterine hyper-stimulation, oxytocin infusion may lead to or aggravate abnormal fetal heart rate, contributing to neonatal acidosis.

The first stage of labor is divided into two phases, a latent phase where cervical dilation is relatively slow until 5-6 cm and an active phase until full dilatation, where cervical dilation accelerates.

One assumption is that, once women requiring oxytocin during the latent phase enter the active phase, natural oxytocin takes over from synthetic oxytocin.

Several small trials attempting to evaluate this practice have been published, but their design and small population did not allow evaluating the impact of discontinuation of oxytocin on neonatal morbidity.

Who Took Part

Enrollment: 2459 actual participants took part.

It was open to women only aged from 18 years with no upper age limit.

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

Examples of who could join: With a term (≥37 WG) pregnancy. Fetus in cephalic presentation. Speaking and reading French language. Affiliated to social security. Who have signed the consent form.

The full record lists 7 inclusion and 6 exclusion criteria; among the exclusions: women with a scarred uterus; fetus with a congenital anomaly; fetal growth retardation \<3rd percentile.

How the Study Was Run

It was run as a randomized, parallel-group and open-label study.

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.

Being open-label, the Oxytocin study did not mask who received what.

It started in 2020-01-17 with completion listed for 2022-04-25.

It ran at 1 site in France.

Its stated primary purpose is treatment.

What Was Measured

The main thing measured (primary outcome): neonatal morbidity composite measure (time frame: At birth).

It also tracked 23 secondary outcomes, for example umbilical cord pH<7.20, umbilical cord pH<7.10, umbilical cord pH<7.00, Need for hypothermia, other neonatal complications: and neonatal admission.

What This Means in Plain Language

Put simply, this is a phase 4, randomized trial of Oxytocin in 2459 people.

With 2459 participants it is a large trial for this field.

The trial is marked completed; no results are posted to the registry yet, so nothing here describes outcomes.

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