Misoprostol Versus Oxytocin for Induction of Labour in Parturients With Spontaneous Rupture of Fetal Membranes at Term

What Was Tested

This registered not phased trial tested Oxytocin.

It had two arms (groups): first arm - Oxytocin titration (active comparator) and second arm - Misoprostol give sublingual (active comparator).

The registry classes the interventions as drug.

More on the Plan

The ideal method of induction of labour for term PROM is a subject of controversy.

The primary outcome measure was the mean induction delivery interval.

The secondary outcome measures were Caesarean section rate, the incidence of uterine hyper-stimulation, tachysystole or hypertonus, APGAR scores at the first and fifth minute and NICU admission.

Data analysis was done using statistical Package for Social Science (IBM SPSS) software (version 20, Chicago IL, USA).

Who Took Part

Enrollment: 120 actual participants took part.

It was open to women only aged from 15 years up to 44 years.

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

Examples of who could join: Signed informed consent. Singleton pregnancy at term. Prelabour rupture of membranes. Not having contraction. Bishop scoe 5 or less.

The full record lists 5 inclusion and 10 exclusion criteria; among the exclusions: prelabour rupture of membranes at less than term; declined consent; contraindication for vaginal delivery.

How the Study Was Run

It was run as a randomized, parallel-group and triple-blind study.

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

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

As a double-blind Oxytocin study, the assignments were hidden from both participants and investigators until the end.

Those kept unaware of assignments: participant, care provider and investigator.

It started in 2020-09-01 with completion listed for 2021-08-31.

It ran at 2 sites in Nigeria (2).

Its stated primary purpose is treatment.

What Was Measured

Researchers chose this as the main measure: Mean induction delivery interval (time frame: During the delivery).

What This Means in Plain Language

Put simply, this is a not phased, randomized trial of Oxytocin in 120 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.