Induction of labour in case of premature rupture of membranes at term with an unfavourable cervix: protocol for a randomised controlled trial comparing double balloon catheter (+oxytocin) and vaginal prostaglandin (RUBAPRO) treatments

What Was Tested

The paper reports a study of Oxytocin, published as a clinical study.

Written informed consent is required from participants.National Ethics Committee approval was obtained in August 2017.

The results will be published in a peer-reviewed journal and presented at relevant conferences.

Who Took Part

The study group was 40 patients.

PubMed tags the participants as women only.

The researchers are conducting a prospective, monocentric, randomised clinical trial on pregnant women with an unfavourable cervix showing PROM at term (RUBAPRO).After 12-24 hours of PROM, women are randomly assigned to one group treated with a double balloon catheter for 12 hours, with oxytocin administered after 6 hours or to the control group treated with 24 hours of vaginal prostaglandin followed by oxytocin infusion alone.

Patients (n=80) are randomised at a 1:1 ratio with stratification on parity.The inclusion criteria are a Bishop score of <6, cephalic presentation at term and confirmed PROM.

How the Study Was Run

In design terms this was a randomized study.

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

Women with suspected chorioamnionitis; group B streptococcus (GBS) carrier; a history of caesarean delivery or any contraindication for vaginal delivery are excluded.The time from induction to delivery is the primary outcome.

What Was Measured

The subject headings attached to it are Administration, Intravaginal, Catheters, Cervical Ripening, Cervix Uteri, Delivery, Obstetric, Premature Rupture of Fetal Membranes and France.

Author keywords: cervical ripening balloon, labor induction, premature rupture of membranes and unfavorable cervix.

What This Means in Plain Language

The paper is a randomized study of Oxytocin in 40 patients.

The publication is from 2019 (BMJ open), a journal based in England.

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