Misoprostol With Mechanical Dilation Versus Oxytocin With Mechanical Dilation for High-risk Pregnancy Inductions

What Was Tested

This registered not phased trial tested Oxytocin.

It had two arms (groups): Oxytocin with Mechanical Dilation (experimental) and Misoprostol with Mechanical Dilation (active comparator).

The registry classes the interventions as drug.

More on the Plan

This is a single center randomized control trial of two arms.

Singleton, cephalic, high risk pregnancies will be randomized to either oxytocin with mechanical dilation versus misoprostol with mechanical dilation.

In group A, receiving misoprostol with mechanical dilation, will serve as the control group.

Group B, oxytocin with mechanical dilation, will serve as the experimental group.

Who Took Part

The registry lists 150 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: • Age \> 18 years old. Singleton, or twins with demise of one. Hypertension (chronic hypertension, gestational hypertension, pre-eclampsia with/without severe features, superimposed preeclampsia with/without severe features, eclampsia, HELLP). Oligohydramnios (AFI\< 5cm and/or MVP \<2cm). Fetal growth restriction (EFW or AC \<10th percentile) with normal or abnormal (elevated, absent, or reversed) Umbilical Artery Dopplers.

The full record lists 12 inclusion and 5 exclusion criteria; among the exclusions: • prior cesarean delivery; allergy to misoprostol; allergy to oxytocin.

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.

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 2020-08-17 with completion listed for 2022-05-26.

It ran at 1 site in United States.

Its stated primary purpose is treatment.

What Was Measured

The main thing measured (primary outcome): Rate of Cesarean Delivery (time frame: 48 hours).

It also tracked 17 secondary outcomes, for example The time interval from induction-to-delivey for vaginal deliveries, The number of vaginal births within 24 hours, The incidence of uterine tachysystole, The rate of each indication for the cesarean delivery, The rate of operative vaginal delivery and The rate of intra-amniotic infection.

What This Means in Plain Language

Put simply, this is a not phased, randomized trial of Oxytocin in 150 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.