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

Corthera, Inc.(formerly BAS Medical, Inc.), a member of the Novartis group of companies72 enrolled

Overview

The purpose of this study is to assess the safety and efficacy of rhRlx for cervical ripening, when compared to a placebo.

A multicenter, randomized, double-blind, placebo-controlled, dose escalation study of healthy female subjects at ≥ 40 weeks gestation and who are scheduled for induction. A dose-escalation portion of the study is followed by a randomized, double-blind, placebo-controlled portion of the study. The endpoints include cervical ripening, as well as progression to labor and delivery.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

Conditions

Labor, Induced

Interventions

SerelaxinDRUG

PlaceboDRUG

Eligibility

Sex: FEMALEMin age: 18 YearsMax age: 40 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Age between 18 and 40 years * Normal pregnancy * At least 40 weeks of gestation * Otherwise healthy Exclusion Criteria: * Anemia or hypertension * Presence of chronic disease * Endometriosis * Known fetal anomaly * Substance abuse * History of cancer

Locations (3)

Novosibirsk State Medical Academy

Novosibirsk, Russia

Evidence CPR

Saint Petersburg, Russia

D.O. Ott Research Institute of Obstetrics and Gynecology

Saint Petersburg, Russia

Outcomes

Primary Outcomes

Cervical ripening

Time frame: Through 24 hours

Secondary Outcomes

Progression to active labor and delivery

Time frame: Within 7 Days of Drug Infusion

Data from ClinicalTrials.gov

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