Efficacy and Safety of Oral Misoprostol 25 μg vs. Vaginal Dinoprostone in Induction of Labor at Term

Recruiting

• Conditions: Vaginal Delivery; Induction of Labor; Cesarean Section

• Registration Number: NCT04955847
• Lead Sponsor: Centre Hospitalier Universitaire, Amiens

Brief Summary

Labor induction is a common medical technique. There is no consensus on which technique is better than the others. Misoprostol is an analogue of Prostaglandin E1 previously used off-label in labor induction. Its low cost, room-temperature storage, and diverse route options have made it an alternative to PGE2 in labor induction. As of 2018, oral misoprostol 25 μg tablet was licensed for labor induction.

Very few studies have been performed on oral misoprostol 25 μg and none compared it with the PGE2s mostly used in induction on unfavorable cervix at term.

The investigators compared the safety and the efficacy between the oral misoprostol 25 μg Angusta® used since 20/02/2020 and the vaginal dinoprostone previously used in gel or diffuser over two consecutive periods from 01/01/2019 to 19/02/2020 for the dinoprostone and from 20/02/2020 to 07/04/2021 for the misoprostol.

Detailed Description

Not available

Study Timeline

• Study Start: 2021-07-05
• Study First Submitted: 2021-07-05
• Study First Submitted QC: 2021-07-05
• Study First Posted: 2021-07-09
• Status Verified: 2023-02
• Last Update Submitted: 2023-02-09
• Last Update Posted: 2023-02-10
• Primary Completion: 2023-11
• Study Completion: 2023-12

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 700

Inclusion Criteria

• age of patient> 18 years
• patients requiring induction of labor with a singleton pregnancy at term, a gestational age greater than 37 weeks of amenorrhea, with a fetus in cephalic presentation and an unfavorable cervix (Bishop score less than six).

Exclusion Criteria

• intrauterine fetal death,
• preterm pregnancy,
• scarred uterus
• contraindications to vaginal delivery.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Variation of vaginal deliveries within 24hours patient number in both groups	24 hours

Secondary Outcome Measures

Name	Time	Method
Variation of Cesarean section patient number in both groups	24 hours
Variation of indications for cesarean section in both groups	24 hours
Variation of uterine contractility abnormalities in both groups	24 hours

Trial Locations

Locations (1)

CHU Amiens Picardie; 🇫🇷 Amiens, France