Safety and Efficacy Study of Vaginal Misoprostol for Cervical Ripening and Induction of Labor
NCT01428037 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 225
Last updated 2013-11-25
Summary
The purpose of this study is to estimate the efficacy and safety of the 25mcg vaginal misoprostol for cervical ripening and induction of labour.
Conditions
- Cervical Ripening
- Induction of Labor
Interventions
- DRUG
-
One tablet vaginal inserted at 4 hrly interval with maximum of three doses
- DRUG
-
Misoprostol vaginal Tablet 25 mcg
One tablet vaginal insert at 4 hrly interval with maximum of three doses
Sponsors & Collaborators
-
Regenex Pharmaceutical, China
lead OTHER
Principal Investigators
-
Wen Di, MD · RenJi Hospital
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- QUADRUPLE
- Model
- PARALLEL
Eligibility
- Min Age
- 20 Years
- Sex
- FEMALE
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2012-03-31
- Primary Completion
- 2013-01-31
- Completion
- 2013-01-31
Countries
- China
Study Locations
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