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

February 9, 2023 updated by: Centre Hospitalier Universitaire, Amiens

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.

Study Overview

Status

Recruiting

Conditions

Study Type

Observational

Enrollment (Anticipated)

700

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

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)

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Variation of vaginal deliveries within 24hours patient number in both groups
Time Frame: 24 hours
24 hours

Secondary Outcome Measures

Outcome Measure
Time Frame
Variation of Cesarean section patient number in both groups
Time Frame: 24 hours
24 hours
Variation of indications for cesarean section in both groups
Time Frame: 24 hours
24 hours
Variation of uterine contractility abnormalities in both groups
Time Frame: 24 hours
24 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Centre Hospitalier Universitaire, Amiens

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

July 5, 2021

Primary Completion (ANTICIPATED)

November 1, 2023

Study Completion (ANTICIPATED)

December 1, 2023

Study Registration Dates

First Submitted

July 5, 2021

First Submitted That Met QC Criteria

July 5, 2021

First Posted (ACTUAL)

July 9, 2021

Study Record Updates

Last Update Posted (ACTUAL)

February 10, 2023

Last Update Submitted That Met QC Criteria

February 9, 2023

Last Verified

February 1, 2023

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • PI2021_843_0070

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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