Prostaglandin E2 gel for cervical ripening and labour induction: a multicentre placebo-controlled trial.

What Was Tested

This randomized controlled trial looks at Oxytocin.

Who Took Part

According to the abstract, 397 women were involved.

PubMed tags the participants as women only.

A total of 397 women met the inclusion criteria: gestational age of at least 36 weeks, parity of 3 or less, a Bishop score of 4 or less, intact membranes, an indication for induction, no contraindication to vaginal delivery, no history of cesarean section or major uterine surgery, no hypersensitivity to prostaglandins, no previous attempt at cervical ripening or induction, no vaginal bleeding and no fetal abnormalities.

How the Study Was Run

In design terms this was a randomized, double-blind, placebo-controlled and multicenter study.

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

As a double-blind Oxytocin study, the assignments were hidden from both participants and investigators until the end.

Some women received a placebo instead of Oxytocin, giving a reference point.

Running at several centres spread the Oxytocin study over different clinics and patient groups.

Multicentre randomized, double-blind, placebo-controlled study.

The observation period was 12 hours before further induction (with oxytocin) was attempted.

What Was Measured

Topics PubMed links to this paper include Cervix Uteri, Dinoprostone, Gels, Heart Rate, Fetal, Labor, Induced, Oxytocin and Pregnancy Outcome.

What This Means in Plain Language

The paper is a randomized, double-blind and placebo-controlled study of Oxytocin in 397 women.

With several hundred people or more, it is a fairly large study for this kind of research.

Results are reported in around 7 sentences of the abstract; we leave them to the paper itself rather than summarise them.

The publication is from 1991 (CMAJ : Canadian Medical Association journal = journal de l'Association medicale canadienne), a journal based in Canada.

More context: the related Oxytocin library page, all human trials.