Evaluation of the Safety of Relaxin in Preeclampsia

Corthera

Status and phase: Suspended; Phase 1

Conditions: Pre-Eclampsia

Treatments: Drug: recombinant human relaxin

Study type: Interventional

Funder types: Industry

Identifiers

NCT00333307

RLX.PE.001

Details and patient eligibility

About

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

Full description

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.

Enrollment: 18 estimated patients

Sex: Female

Ages: 18 to 40 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind