Oral Misoprostol alone versus oral misoprostol followed by oxytocin for labour induction in women with hypertension in pregnancy (MOLI): protocol for a randomised controlled trial

What Was Tested

This clinical study looks at Oxytocin.

Every year approximately 30,000 women die from hypertensive disease in pregnancy.

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

Who Took Part

According to the abstract, 30,000 women were involved.

PubMed tags the participants as women only.

The study will recruit 520 pregnant women being induced for hypertensive disease in pregnancy and requiring augmentation after membrane rupture.

How the Study Was Run

The design is described as randomized and open-label.

Because people in this Oxytocin study were split into groups at random, differences between the groups are less likely to reflect who happened to join each one.

Nothing was hidden in this open-label Oxytocin study: the women and staff both knew the treatment.

This pragmatic, open-label, randomised trial will compare a misoprostol alone labour induction protocol with the standard misoprostol plus oxytocin protocol in three Indian hospitals.

The primary outcome will be caesarean birth.

This protocol (version 1.04) adheres to the SPIRIT checklist.

What Was Measured

The subject headings attached to it are Administration, Intravenous, Hospitals, Hypertension, Pregnancy-Induced, India, Labor, Induced, Misoprostol and Oxytocics.

Author keywords: Augmentation of labour, Induction of labour, Oxytocin, Pre-eclampsia, Randomized controlled trial and Study protocol.

What This Means in Plain Language

The paper is a randomized and open-label study of Oxytocin in 30,000 women.

With several hundred people or more, it is a fairly large study for this kind of research.

The abstract goes on to report its results in about 6 sentences; this page does not restate them, so read the paper for the findings and their limits.

The publication is from 2021 (BMC pregnancy and childbirth), a journal based in England.

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