Labor Induction With Misoprostol Versus Oxytocin in Women With Premature Rupture of Membranes

What Was Tested

In this not phased trial, researchers set out to test Oxytocin.

This study compares the rate of vaginal delivery after induction of labor with misoprostol versus oxytocin in women with prelabor rupture of membranes.

It had two arms (groups): misoprostol (active comparator) and oxytocin (active comparator).

The registry classes the interventions as drug.

More on the Plan

Misoprostol is a synthetic prostaglandin analogue commonly used for labor induction.

It causes uterine contractions and ripening of the cervix.

Oxytocin sold under the brand name Pitocin among others, is a medication made from the peptide oxytocin and is used to cause contraction of the uterus to start labor.

This randomized controlled trial will compare induction of labor in women with term premature rupture of the membranes and unripe cervix using misoprostol versus oxytocin.

Who Took Part

The registry lists 200 planned participants were the target.

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

Healthy volunteers could join, not only people with the condition.

Examples of who could join: Women in their 1st - 4th delivery. Term prelabor rupture of membranes (37+0 to 42+0 gestational age).

The full record lists 4 inclusion and 6 exclusion criteria; among the exclusions: multiple pregnancy; previous cesarean section; chorioamnionitis on admission.

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.

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

It started in 2019-12-01 with completion listed for 2021-08-01.

It ran at 1 site in Israel.

Its stated primary purpose is treatment.

What Was Measured

Primary outcome: Vaginal delivery rate (time frame: During delivery).

It also tracked 7 secondary outcomes, for example Operative delivery rate, Cesarean section rate, time interval from induction of labor to delivery, chorioamnionitis rate, Uterine tachysystole, Neonatal morbidity, Neonatal morbidity and Neonatal morbidity.

What This Means in Plain Language

Put simply, this is a not phased, randomized trial of Oxytocin in 200 people.

Its status is unknown; no results are posted to the registry yet, so nothing here describes outcomes.

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