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

Cesarean Section Clinical Trial

— MISODINO  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04955847
• Other study ID #: PI2021_843_0070
• Status: Recruiting
• Start date: July 5, 2021
• Est. completion date: December 2023

Study information

• Verified date: February 2023
• Source: Centre Hospitalier Universitaire, Amiens
• Contact: Fabrice Sergent, Pr
• Phone: 03 22 08 74 00.
• Email: sergent.fabrice[@]chu-amiens.fr
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 700
• Est. completion date: December 2023
• Est. primary completion date: November 2023
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Cesarean Section
• Induction of Labor
• Vaginal Delivery

Locations

Country	Name	City	State
France	CHU Amiens Picardie	Amiens

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier Universitaire, Amiens

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Variation of vaginal deliveries within 24hours patient number in both groups		24 hours
Secondary	Variation of Cesarean section patient number in both groups		24 hours
Secondary	Variation of indications for cesarean section in both groups		24 hours
Secondary	Variation of uterine contractility abnormalities in both groups		24 hours