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

NCT ID: NCT00259103

Last Updated: 2014-05-07

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 72 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2005-11-30
• Study Completion Date: 2006-10-31

Brief Summary

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

Detailed Description

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.

Conditions

Labor, Induced

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

7.5 µg/kg/d

Participants who received intravenous (IV) infusion of 7.5 µg/kg/d serelaxin, all during part A.

Group Type: EXPERIMENTAL

Serelaxin

Intervention Type: DRUG

25 µg/kg/d

Participants who received intravenous (IV) infusion of 25 µg/kg/d serelaxin, all during part A.

Group Type: EXPERIMENTAL

Serelaxin

Intervention Type: DRUG

75 µg/kg/d

Participants who received IV infusion of 75 µg/kg/d serelaxin, some during part A and others during part B.

Group Type: EXPERIMENTAL

Serelaxin

Intervention Type: DRUG

Placebo

Participants who received IV infusion of placebo, some during part A and others during part B.

Group Type: EXPERIMENTAL

Placebo

Intervention Type: DRUG

Interventions

Serelaxin

Intervention Type: DRUG

Placebo

Intervention Type: DRUG

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 40 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

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

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Sam Teichman, MD

Role: STUDY_DIRECTOR

Chief Medical Officer of BAS Medical, Inc.

Locations

Novosibirsk State Medical Academy

Novosibirsk, , Russia

Evidence CPR

Saint Petersburg, , Russia

D.O. Ott Research Institute of Obstetrics and Gynecology

Saint Petersburg, , Russia

Countries

Russia

References

Weiss G, Teichman S, Stewart D, Nader D, Wood S, Breining P, Unemori E. Recombinant human relaxin versus placebo for cervical ripening: a double-blind randomised trial in pregnant women scheduled for induction of labour. BMC Pregnancy Childbirth. 2016 Sep 5;16(1):260. doi: 10.1186/s12884-016-1046-1.

Reference Type: DERIVED

PMID: 27596360 (View on PubMed)

Other Identifiers

RLX.CR.001

Identifier Type: -

Identifier Source: org_study_id