NCT02762942

Comparison of Vaginal Misoprostol Plus Supracervical Balloon Versus Vaginal Misoprostol Alone for Induction of Labor

Prospective Randomized Clinical Trial Comparing the Effect of Vaginal Misoprostol Synchronously With Supracervical Balloon Versus Vaginal Misoprostol Alone for Induction of Labor

• Status: Unknown
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 80 (estimated)
• Sponsor: Consorci Sanitari de Terrassa · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Type	Name	Description
DRUG	Misoprostol	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

Timeline

• Start date: 2016-05-01
• Primary completion: 2017-05-01
• Completion: 2017-09-01
• First posted: 2016-05-05
• Last updated: 2016-05-12

Locations

1 site across 1 country: Spain