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

NCT04955847 | Completed

• 1 other identifier: PI2021_843_0070
• Study Type: observational
• Target: 706
• Locations: 1 country
• Sites: 1

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.

Conditions

Induction of Labor; Vaginal Delivery; Cesarean Section

Keywords

Induction of Labor; PGE1; PGE2; vaginal delivery; cesarean section

Outcome Measures

Primary Outcomes (1)

• Variation of vaginal deliveries within 24hours patient number in both groups

  24 hours

Secondary Outcomes (3)

• 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

Study Arms (2)

PGE2

In period 1, the service protocol for induction at term on an unfavorable cervix indicated the use of a PGE2. In nulliparous women, Propess® was introduced intra-vaginally for 24 hours or until regular painful uterine contractions occurred. In the case of a multiparous woman, Prostine® gel, one or two mg depending on the cervical conditions at the time of induction, was introduced intravaginally and the cervix was reassessed after six hours. If the cervix remained unfavorable and the kinetics of the contractions were not optimal, a new dose of Prostine® one or two mg was administered to the patient.

misoprostol

In period 2, patients who were induced with an unfavorable cervix at term were induced with misoprostol. Regardless of parity, the patient received oral misoprostol 25 μg, one tablet orally every two hours until a maximum of eight tablets per day, or 200 µg, was reached, with cessation of the tablets when painful, regular contractions were obtained.

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: pregnant women
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

all 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)

You may qualify if:

• 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).

You may not qualify if:

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

Sponsors & Collaborators

• Centre Hospitalier Universitaire, Amiens: lead

Study Sites (1)

CHU Amiens Picardie

Amiens, France

Location

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 5, 2021
• First Posted: July 9, 2021
• Study Start: January 15, 2021
• Primary Completion: May 8, 2021
• Study Completion: May 8, 2021
• Last Updated: June 12, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)