Recombinant Human Relaxin (rhRlx) in Pregnant Women Scheduled for Induction of Labor
Information source: BAS Medical
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Labor, Induced
Intervention: recombinant human relaxin (Drug)
Phase: Phase 2
Status: Completed
Sponsored by: BAS Medical Official(s) and/or principal investigator(s):
Sam Teichman, MD, Study Director, Affiliation: Chief Medical Officer of BAS Medical, Inc.
Summary
The purpose of this study is to assess the safety and efficacy of rhRlx for cervical
ripening, when compared to a placebo.
Clinical Details
Official title: A Phase II Randomized, Double-Blind, Placebo-Controlled, Parallel Group Study of the Safety, Pharmacokinetics and Efficacy of Intravenous Recombinant Human Relaxin (rhRlx) in Pregnant Women Scheduled for Induction of Labor
Study design: Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study
Primary outcome: Cervical ripening
Secondary outcome: Progression to active labor and delivery
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.
Eligibility
Minimum age: 18 Years.
Maximum age: 40 Years.
Gender(s): Female.
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
Locations and Contacts
D.O. Ott Research Institute of Obstetrics and Gynecology, Saint Petersburg, Russian Federation
Novosibirsk State Medical Academy, Novosibirsk, Russian Federation
Evidence CPR, Saint Petersburg 199034, Russian Federation
Additional Information
Starting date: November 2005
Last updated: April 21, 2008
|
