Informations générales (source: ClinicalTrials.gov)

NCT04955847 Statut inconnu
Efficacy and Safety of Oral Misoprostol 25 μg vs. Vaginal Dinoprostone in Induction of Labor at Term
Observational
Centre Hospitalier Universitaire, Amiens (Voir sur ClinicalTrials)
juillet 2021
décembre 2023
08 septembre 2025
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.

Etablissements

Les établissements sans correspondance certaine dans le répertoire FINESS dont les données sont issues de ClinicalTrials.gov Origine et niveau de fiabilité des données
CHU Amiens Picardie - Amiens - France Fabrice Sergent, Pr En recrutement Contact (sur clinicalTrials)

Critères

Femme
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).



- intrauterine fetal death,

- preterm pregnancy,

- scarred uterus

- contraindications to vaginal delivery.