Evaluation of the Safety of Relaxin in Preeclampsia

Corthera, Inc.(formerly BAS Medical, Inc.), a member of the Novartis group of companies18 enrolled

Overview

The purpose of this study is to determine whether different doses of recombinant human relaxin is safe when given to women with severe preeclampsia

The effects of relaxin may be beneficial in the treatment of women with preeclampsia. 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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

Conditions

Pre-Eclampsia

Interventions

recombinant human relaxinDRUG

Eligibility

Sex: FEMALEMin age: 18 YearsMax age: 40 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Diagnosis of preeclampsia * Hospital admission for expectant management Exclusion Criteria: * Eclampsia or history of seizures * Vaginal bleeding * Multifetal gestation * Requirement for immediate delivery

Locations (2)

Central Baptist Hospital

Lexington, Kentucky, United States

University of Cincinnati

Cincinnati, Ohio, United States

Outcomes

Primary Outcomes

maternal adverse experiences

fetal adverse experiences

neonatal adverse experiences

Secondary Outcomes

preeclampsia assessments

vital signs

physical examinations

clinical laboratory assessments

Data from ClinicalTrials.gov

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