Recombinant Human Relaxin (rhRlx) in Pregnant Women Scheduled for Induction of Labor

What Was Tested

In this phase 2 trial, researchers set out to test Relaxin (Serelaxin).

It had four arms (groups): one (experimental), one (experimental), one (experimental) and Placebo (experimental).

The registry classes the interventions as drug.

More on the Plan

The endpoints include cervical ripening, as well as progression to labor and delivery.

Who Took Part

Enrollment: 72 actual participants took part.

It was open to women only aged from 18 years up to 40 years.

Healthy volunteers were not accepted; participants needed the condition being studied.

Examples of who could join: Age between 18 and 40 years. At least 40 weeks of gestation.

The full record lists 4 inclusion and 6 exclusion criteria; among the exclusions: anemia or hypertension; presence of chronic disease; known fetal anomaly.

How the Study Was Run

Design: randomized, parallel-group and double-blind.

The participants were allocated by chance, so the Relaxin (Serelaxin) group and the comparison group should start out alike.

The Relaxin (Serelaxin) group and the comparison group ran side by side rather than switching.

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

Those kept unaware of assignments: participant and investigator.

It started in 2005-11 with completion listed for 2006-10.

It ran at 3 sites in Russia (3).

Its stated primary purpose is treatment.

What Was Measured

Primary outcome: Cervical ripening (time frame: Through 24 hours).

It also tracked 1 secondary outcome, for example Progression to active labor and delivery.

What This Means in Plain Language

Put simply, this is a phase 2, randomized trial of Relaxin (Serelaxin) in 72 people.

The trial is marked completed; no results are posted to the registry yet, so nothing here describes outcomes.

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