NCT06794385

Comparison of the Effectiveness, Safety, and Satisfaction of Different Methods for Labor Induction

• Status: Not Yet Recruiting
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 200 (estimated)
• Sponsor: University Medical Centre Ljubljana · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The objective of this interventional study is to compare the effectiveness, safety, and patient satisfaction associated with two commonly used methods of labor induction: low-dose oral misoprostol and the vaginal delivery system with dinoprostone. The study aims to identify the most suitable induction method for specific subgroups of patients based on parity, body mass index (BMI), age, and cervical ripeness, as well as assess patient preferences for these induction methods.

Conditions

• Induction of Labour

Interventions

Type	Name	Description
DRUG	dinoprostone vaginal delivery system	Pregnant women in this group will receive a vaginal delivery system containing 10 mg of dinoprostone for labor induction.
DRUG	low dose peroral misoprostol	Participants will be induced with a low-dose oral formulation of misoprostol, administered per protocol at 25 mcg every 2 hours

Timeline

• Start date: 2025-01-22
• Primary completion: 2025-09-01
• Completion: 2025-12-01
• First posted: 2025-01-27
• Last updated: 2025-01-27

Locations

1 site across 1 country: Slovenia