Recombinant human relaxin versus placebo for cervical ripening: a double-blind randomised trial in pregnant women scheduled for induction of labour

What Was Tested

The paper reports a study of Relaxin (Serelaxin), published as a randomized controlled trial.

Clinicaltrials.gov identifier NCT00259103 (15 November 2005).

Who Took Part

The abstract describes 22 subjects taking part.

The age groups tagged for this paper are adults, women only.

This Phase II study (conducted November 2, 2005-October 20, 2006) was a randomised, double blind, placebo controlled trial testing 24-h intravenous infusion of serelaxin (recombinant human relaxin) or placebo for cervical ripening in 72 healthy, primiparous women.

Eligible subjects had a singleton pregnancy ≥40 weeks, were planned for elective induction, had vertex presentation of the fetus, intact membranes and a Bishop score at screening ≤4.

How the Study Was Run

The researchers set it up as a randomized, double-blind and placebo-controlled study.

Random assignment meant chance, not the researchers, decided who got Relaxin (Serelaxin) and who got the comparison, which limits bias.

Neither the subjects nor the staff measuring them knew who was on Relaxin (Serelaxin), so expectations could not easily colour the readings.

The comparison arm used a placebo, so changes seen with Relaxin (Serelaxin) could be set against what happens without it.

Maternal safety evaluations included adverse events and vital signs through 4 weeks.

Fetal assessments included serial heart rate monitoring and nonstress testing.

Neonatal assessments included Apgar scores, NICU admissions, and adverse events through 4 weeks.

What Was Measured

PubMed files the paper under topics including Cervical Ripening, Labor, Induced, Recombinant Proteins and Relaxin.

The authors tagged it with the keywords Serelaxin.

What This Means in Plain Language

The paper is a randomized, double-blind and placebo-controlled study of Relaxin (Serelaxin) in 22 subjects.

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.

Results are reported in around 5 sentences of the abstract; we leave them to the paper itself rather than summarise them.

The publication is from 2016 (BMC pregnancy and childbirth), a journal based in England.

More context: the Relaxin (Serelaxin) compound page, all human trials.