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Mediolateral Episiotomy and Obstetric Anal Sphincter Injuries in Instrumental Delivery

NCT04446780 · Status: UNKNOWN · Type: OBSERVATIONAL · Enrollment: 15000

Last updated 2021-06-30

No results posted yet for this study

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.

Conditions

  • Obstetric Anal Sphincter Injury
  • Episiotomy Wound
  • Anal Incontinence
  • Pelvic Floor Disorders
  • Depression

Interventions

PROCEDURE

Mediolateral episiotomy

Cutting of the perineum during vaginal delivery in order to avoid obstetric anal sphincter injury

Sponsors & Collaborators

  • Poitiers University Hospital

    lead OTHER

Eligibility

Min Age
18 Years
Max Age
55 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2021-04-01
Primary Completion
2022-04-01
Completion
2023-04-30

Countries

  • France

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04446780 on ClinicalTrials.gov