Labor, Induced
Conditions
Keywords
relaxin, pregnancy, cervical ripening, normal pregnancy at least at 40 weeks of gestation
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.
Interventions
DRUGSerelaxin
DRUGPlacebo
Sponsors
Corthera, Inc.(formerly BAS Medical, Inc.), a member of the Novartis group of companies
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 40 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Cervical ripening | Through 24 hours |
Secondary
| Measure | Time frame |
|---|---|
| Progression to active labor and delivery | Within 7 Days of Drug Infusion |
Countries
Russia
Outcome results
None listed