A Randomized Trial of Oral Misoprostol Alone Versus Oral Misoprostol Followed by Oxytocin for Labour Induction

What Was Tested

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

It had two arms (groups): Oxytocin infusion (other) and Oral misoprostol (other).

The registry classes the interventions as drug.

More on the Plan

Usually, once active labour has commenced, the misoprostol is replaced with an intravenous oxytocin infusion.

However, these two protocols have never been directly compared.

The researchers propose a pragmatic, open-label, randomised trial to compare an M/M labour induction protocol with the standard M/Ox protocol.

Who Took Part

Enrollment: 520 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: Signed informed consent form. Undergone cervical ripening with misoprostol if cervix initially unfavourable. Decision to augment labour for inadequate uterine contractions despite ruptured membranes (either artificial or spontaneous as part of the induction process)s.

The full record lists 5 inclusion and 8 exclusion criteria; among the exclusions: those unable to give informed consent; cervical ripening with agents other than misoprostol (e.g. foley catheter, prostaglandins); multiple pregnancy.

How the Study Was Run

Design: randomized, parallel-group and open-label.

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

Groups ran in parallel: each of the participants stayed in one arm throughout.

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 2020-01-06 with completion listed for 2022-07-30.

It ran at 3 sites in India (3).

Its stated primary purpose is treatment.

What Was Measured

Researchers chose this as the main measure: Caesarean birth (time frame: At delivery).

What This Means in Plain Language

Put simply, this is a phase 4, randomized trial of Oxytocin in 520 people.

With 520 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.