Informations générales (source: ClinicalTrials.gov)
Mediolateral Episiotomy and Prevention of Obstetric Anal Sphincter Injuries in Instrumental Delivery: a Prospective Population-based Propensity Score Study (INSTRUMODA)
Observational
Poitiers University Hospital (Voir sur ClinicalTrials)
avril 2021
avril 2023
29 juin 2024
Literature is contradictory about the impact of mediolateral episiotomy during operative
vaginal delivery in obstetric anal sphincter injuries prevention explaining the absence
of international guidelines. The investigators consider that a randomized trials does not
appears feasible for both ethical and practical reason and so we suggest a large national
observational study.
The investigators will include all nulliparous women that underwent an operative vaginal
delivery within the 72h following the delivery at more than 34 weeks of amenorrhea. The
investigators will collect data about the history of pregnancy, the course of labor, the
mode of delivery, maternal immediate and one-year morbidity, neonatal immediate
morbidity. The investigators expect a one-year study in 129 recruiting center with 15000
included women.
The primary objective is to assess the protective effect of mediolateral episiotomy
against obstetric anal sphincter injury during instrumental delivery in nulliparous women
according to the type of instrument used. The secondary endpoints are to investigate the
effect of mediolateral episiotomy on one-year maternal morbidity, immediate maternal
morbidity. The investigators also aim to develop a clinical score to assess the absolute
risk of obstetric anal sphincter injury during instrumental delivery. Finally, the
investigators will investigate the impact of fetal presentation ultrasound assessment
immediately before instrumental delivery on the mode of delivery.
Etablissements
| Les établissements d'Île-de-France ayant mis à jour leurs données Origine et niveau de fiabilité des données | |||||
|---|---|---|---|---|---|
| CHI DE CRETEIL | Edouard LECARPENTIER | 29/03/2024 01:29:22 | Contacter | ||
| Les établissements sans correspondance certaine dans le répertoire FINESS dont les données sont issues de ClinicalTrials.gov Origine et niveau de fiabilité des données | |||||
| Poitiers University Hospital - 86000 - Poitiers - France | Bertrand GACHON | Contact (sur clinicalTrials) | |||
Critères
Femme
Inclusion Criteria:
- age of 18 years or older
- nulliparity and instrumental delivery of a singleton in cephalic presentation in the
previous 72 hours including failure of vaginal instrumental delivery leading to
cesarean section
- age of 18 years or older
- nulliparity and instrumental delivery of a singleton in cephalic presentation in the
previous 72 hours including failure of vaginal instrumental delivery leading to
cesarean section
- expression of any opposition or objection to study participation
- previous delivery of a fetus at a gestational age greater than 20 weeks, regardless
of the mode of delivery
- preterm birth before 34 weeks of amenorrhea
- fetal presentation other than cephalic
- multiple pregnancy
- in utero death
- inability to understand French
- under judicial protection
- without access to a numeric terminal with internet connexion