Comparison of Vaginal Misoprostol Plus Supracervical Balloon Versus Vaginal Misoprostol Alone for Induction of Labor
NCT02762942 · Status: UNKNOWN · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 80
Last updated 2016-05-12
Summary
Demonstrate that with concomitant and synchronous use of supracervical balloon and vaginal misoprostol for induction of labour, vaginal delivery is achieved in less time compared with vaginal misoprostol alone.
Conditions
- Induction of Labor
- Cervical Ripening
- Pregnancy
Interventions
- DRUG
-
Administration of 25 mcg of vaginal misoprostol every 4 hours up to 5 doses
- DEVICE
-
Foley catheter
Insertion of a Foley catheter (16French) through the internal os for a maximum of 12 hours
Sponsors & Collaborators
-
Consorci Sanitari de Terrassa
lead OTHER
Principal Investigators
-
Àngels Vives Argilagós, MD · Consorci Sanitari de Terrassa
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Sex
- FEMALE
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2016-05-31
- Primary Completion
- 2017-05-31
- Completion
- 2017-09-30
Countries
- Spain
Study Locations
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