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

2014-08-27 03:47:24 | BioPortfolio

Summary

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

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.

Study Design

Allocation: Randomized, Control: Placebo Control, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Conditions

Labor, Induced

Intervention

recombinant human relaxin

Location

Novosibirsk State Medical Academy
Novosibirsk
Russian Federation
199034

Status

Completed

Source

Corthera, Inc.

Results (where available)

View Results

Links

Published on BioPortfolio: 2014-08-27T03:47:24-0400

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Medical and Biotech [MESH] Definitions

Artificially induced UTERINE CONTRACTION. Generally, LABOR, OBSTETRIC is induced with the intent to cause delivery of the fetus and termination of pregnancy.

The repetitive uterine contraction during childbirth which is associated with the progressive dilation of the uterine cervix (CERVIX UTERI). Successful labor results in the expulsion of the FETUS and PLACENTA. Obstetric labor can be spontaneous or induced (LABOR, INDUCED).

A change in the CERVIX UTERI with respect to its readiness to relax. The cervix normally becomes softer, more flexible, more distensible, and shorter in the final weeks of PREGNANCY. These cervical changes can also be chemically induced (LABOR, INDUCED).

A water-soluble polypeptide (molecular weight approximately 8,000) extractable from the corpus luteum of pregnancy. It produces relaxation of the pubic symphysis and dilation of the uterine cervix in certain animal species. Its role in the human pregnant female is uncertain. (Dorland, 28th ed)

The beginning of true OBSTETRIC LABOR which is characterized by the cyclic uterine contractions of increasing frequency, duration, and strength causing CERVICAL DILATATION to begin (LABOR STAGE, FIRST ).

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