Continuous Versus Intermittent Oxytocin Infusion for Induction of Labor

What Was Tested

The trial (not phased) is built around Oxytocin.

The study will compare 2 treatment modalities.

One group will receive the routine protocol of intermittent pitocin induction for 6 hours and the second group will receive continous pitocin infusion for 16 hours.

The primary aim is to observe which protocol leads to the fastest delivery and evaluate the time in each group from induction to delivery.

It had two arms (groups): Intermittent treatment (active comparator) and Continous treatment (active comparator).

Infusion of oxytocin for 6 hours at a time until patient delivers.

Infusion of oxytocin continuously from patient admission for 16 hours.

The registry classes the interventions as drug.

More on the Plan

After singing an informed consent, and prior to IOL initiation, study participants were randomly assigned (1:1) to receive either intermittent or continuous Oxytocin infusion.

During Oxytocin infusion, fetal heart rate was continuously monitored.

Artificial ROM was performed according to the accepted indications, local protocol and by the staff physician discretion who was in charge on the labor ward at that time, regardless of oxytocin initiation time.

In the intermittent Oxytocin infusion group, Oxytocin was discontinued after 8 h if the patient did not go into active labor during by that time, and renewed 4 h later.

Who Took Part

153 actual participants took part.

It was open to women only aged from 18 years up to 45 years.

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

Examples of who could join: Women with a singleton pregnancy that are admitted for induction or augmentation of labor. Women at gestational age 370/7 or more.

The full record lists 3 inclusion and 7 exclusion criteria; among the exclusions: age under 18 or over 45; high order gestation; women with contraindication for vaginal delivery.

How the Study Was Run

The set-up was randomized, parallel-group and open-label.

The participants were allocated by chance, so the Oxytocin group and the comparison group should start out alike.

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

Everyone knew when Oxytocin was being given (open label), which is simpler to run but leaves more room for expectations to affect what is reported.

It started in 2019-11-01 with completion listed for 2022-06-30.

It ran at 1 site in Israel.

Its stated primary purpose is treatment.

What Was Measured

Primary outcome: Delivery within 24 hours (time frame: from admission up to 24 hours postpartum).

It also tracked 4 secondary outcomes, for example latent phase of labor, active phase of labor, caesarian deliveries and instrumental deliveries.

What This Means in Plain Language

Put simply, this is a not phased, randomized trial of Oxytocin in 153 people.

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.