UnknownNot Applicable

Mediolateral Episiotomy and Obstetric Anal Sphincter Injuries in Instrumental Delivery

France15,000 participantsStarted 2021-04-01

Plain-language summary

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.

Who can participate

Age range

18 Years – 55 Years

Sex

FEMALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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 Exclusion Criteria: * 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

Questions worth asking your doctor

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1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

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Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Obstetric Anal Sphincter Injury (mediolateral episiotomy vs no episiotomy for each type of instrument)

Timeframe: Immediately after the delivery

Trial details

NCT IDNCT04446780

SponsorPoitiers University Hospital

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2022-04-01

Contact for this trial

Bertrand GACHON, MD

+33549443945 bertrand.gachon@chu-poitiers.fr

View on ClinicalTrials.gov More Obstetric Anal Sphincter Injury trials