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OpenTrials
Completed

NCT Number: NCT04955847

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

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.

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Key information

Conditions

Induction of Labor Cesarean Section Vaginal Delivery

Age range

18 year and older

Sex eligibility

Female

Study type

Observational

Primary location

CHU Amiens Picardie

Amiens, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

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

    Time frame: 24 hours

Secondary outcomes

  1. Variation of Cesarean section patient number in both groups

    Time frame: 24 hours

  2. Variation of indications for cesarean section in both groups

    Time frame: 24 hours

  3. Variation of uterine contractility abnormalities in both groups

    Time frame: 24 hours

Sponsors and collaborators

Lead sponsor

Centre Hospitalier Universitaire, Amiens

Other

Registry information

Acronym: MISODINO

Important dates

Study start
2021
Primary completion
2021
Study completion
2021
First posted
Jul 9, 2021
Registry last updated
Jun 12, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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