Evaluation of the Safety of Relaxin in Preeclampsia

What Was Tested

This registered phase 1 trial tested Relaxin (Serelaxin).

The registry classes the interventions as drug.

More on the Plan

This study will preliminarily evaluate the maternal, fetal and neonatal safety and tolerability of an IV infusion of relaxin compared with placebo given to women with severe preeclampsia.

Who Took Part

18 planned participants were the target.

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: Diagnosis of preeclampsia. Hospital admission for expectant management.

The full record lists 2 inclusion and 4 exclusion criteria; among the exclusions: eclampsia or history of seizures; vaginal bleeding; multifetal gestation.

How the Study Was Run

The set-up was 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.

Blinding on both sides kept the participants and researchers unaware of who received Relaxin (Serelaxin).

It started in 2006-10.

It ran at 2 sites in United States (2).

Its stated primary purpose is treatment.

What Was Measured

Researchers chose this as the main measure: maternal adverse experiences. fetal adverse experiences. neonatal adverse experiences.

It also tracked 4 secondary outcomes, for example preeclampsia assessments, vital signs, physical examinations and clinical laboratory assessments.

What This Means in Plain Language

Put simply, this is a phase 1, randomized trial of Relaxin (Serelaxin) in 18 people.

Its size is small, so on its own it can only give an early look.

Its status is suspended; no results are posted to the registry yet, so nothing here describes outcomes.

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