Cervical ripening balloon with and without oxytocin in multiparas: a randomized controlled trial

What Was Tested

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

The optimal method for induction of labor for multiparous women with an unfavorable cervix is unknown.

Who Took Part

The abstract describes 24 women taking part.

By PubMed's age tags, the people studied were young adults and adults, women only.

Eligible participants were multiparous women with a vertex presenting, nonanomalous singleton gestation ≥34 weeks undergoing induction of labor.

Women were excluded for admission cervical examination >2 cm, ruptured membranes, chorioamnionitis or evidence of systemic infection, placental abruption, low-lying placenta, >1 prior cesarean delivery, or contraindication to vaginal delivery.

How the Study Was Run

The researchers set it up as a randomized study.

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

The researchers performed a randomized controlled trial from November 2014 through June 2017.

Patients were randomly allocated to the following cervical ripening groups: simultaneous (oxytocin with cervical ripening balloon) or sequential (oxytocin following cervical ripening balloon expulsion).

The primary outcome was delivery within 24 hours of cervical ripening balloon placement.

Secondary outcomes included induction-to-delivery interval, time to cervical ripening balloon expulsion, mode of delivery, and adverse maternal or neonatal outcomes.

What Was Measured

The subject headings attached to it are Catheterization, Cervical Ripening, Cesarean Section, Chorioamnionitis, Delivery, Obstetric, Labor, Induced and Oxytocics.

The authors tagged it with the keywords Foley balloon, cervical ripening balloon, induction of labor, labor induction, multipara and oxytocin.

What This Means in Plain Language

The paper is a randomized study of Oxytocin in 24 women.

With fewer than 40 people, it is a small study, so it is better read as an early signal for further research than as a settled answer.

Its findings take up roughly 6 sentences of the abstract and are left out here on purpose; the source paper is the place to read them.

The publication is from 2018 (American journal of obstetrics and gynecology), a journal based in United States.

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