Misoprostol with balloon vs oxytocin with balloon in high-risk pregnancy induction: a randomized controlled trial

What Was Tested

The paper reports a study of Oxytocin, published as a randomized controlled trial.

This study aimed to compare the combination of oxytocin plus a Cook balloon vs misoprostol plus a Cook balloon for induction of labor in high-risk pregnancies.

A subgroup analysis was planned for the primary outcome to assess the different indications for cesarean delivery.

Why It Was Studied

Pregnancies at high risk for maternal, fetal, or placental complications often necessitate induction of labor in the late preterm or early term period for delivery.

Limited data exist on the safest method of induction to use in this specific patient population.

Who Took Part

PubMed tags the participants as women only.

Individuals with a high-risk pregnancy, at least ≥22 weeks' gestation, with a singleton in cephalic presentation, Bishop score ≤6, and intact membranes were offered enrollment.

How the Study Was Run

The design is described as randomized and open-label.

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

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.

The researchers conducted an open-label, randomized controlled trial at a single institution from July 2020 to May 2022.

The study was approved by the institutional review board and registered with ClinicalTrials.gov (NCT04492072).

A high-risk pregnancy was defined as a pregnancy with any of the following complications: hypertensive disease of pregnancy, fetal growth restriction, oligohydramnios, suspected placental abruption requiring delivery, uncontrolled pregestational diabetes, or abnormal biophysical profile or nonstress test requiring delivery.

The primary outcome was the rate of cesarean delivery.

Secondary maternal outcomes included induction to delivery interval, number of vaginal deliveries within 24 hours, rates of uterine tachysystole, intraamniotic infection, operative vaginal delivery, and postpartum hemorrhage.

What Was Measured

PubMed files the paper under topics including Misoprostol, Oxytocin, Oxytocics, Pregnancy, High-Risk, Labor, Induced, Placenta and Cervical Ripening.

Author keywords: abruption, cesarean, diabetes, fetal growth restriction, hypertension and induction.

What This Means in Plain Language

The paper is a randomized and open-label study of Oxytocin.

Results are reported in around 4 sentences of the abstract; we leave them to the paper itself rather than summarise them.

The publication is from 2023 (American journal of obstetrics & gynecology MFM), a journal based in United States.

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