Mediolateral Episiotomy and Obstetric Anal Sphincter Injuries in Instrumental Delivery

NCT04446780 | Unknown DMC

• 1 other identifier: INSTRUMODA
• Study Type: observational
• Target: 15,000
• Locations: 1 country
• Sites: 1

Brief 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

Outcome Measures

Primary Outcomes (1)

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

  Perineal tears involving the anal sphincter complex (3rd and 4th degree according RCOG OMS classification)

  Immediately after the delivery

Secondary Outcomes (5)

• Immediate maternal morbidity (mediolateral episiotomy vs no episiotomy)

  through mother's hospitalization, an average of 4 days

• Immediate neonatal morbidity (mediolateral episiotomy versus no episiotomy)

  through mother's hospitalization, an average of 4 days

• One year maternal morbidity (mediolateral episiotomy versus no episiotomy)

  1 year

• Association between fetal presentation assessment before the delivery and the issue of delivery (ultrasound assessment versus no ultrasound assessment)

  through mother's hospitalization, an average of 4 days

• Development of a clinical score to assess the absolute risk of obstetric anal sphincter injury during instrumental delivery (with or without mediolateral episiotomy)

  through mother's hospitalization, an average of 4 days

Study Arms (2)

Women who underwent an episiotomy

Nulliparous women who underwent an instrumental vaginal delivery with mediolateral episiotomy

Procedure: Mediolateral episiotomy

Women who did not underwent an episiotomy

Nulliparous women who underwent an instrumental vaginal delivery without mediolateral episiotomy

Interventions

Mediolateral episiotomy PROCEDURE

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

Women who underwent an episiotomy

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• Sampling Method: Probability Sample

Study Population

We will include in 121 centers in France during women year women who gave birth to their first child with requirement of an operative delivery. We will compare those who underwent a mediolateral episiotomy to those wo have not for the occurrence of obstetric anal sphincter injury according to the type of instrument used

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Poitiers University Hospital: lead

Study Sites (1)

Poitiers University Hospital

Poitiers, 86000, France

RECRUITING

Related Publications (2)

• Gachon B, Durocher L, Garabedian C, Guerby P, Chauleur C, Bertholdt C, Desplanches T, Sentilhes L, Sibiude J, Mottet N, Le Ray C, Estzo ML, Lassel L, Bel S, Devouge P, Dochez V, Riethmuller D, Schmitz T, Vincent-Rohfritsch A, Harvey T, Delaunay F, Ducarme G, Checchi-Guichard C, Foucher Y, de Tayrac R, Pizzoferrato AC, Pierre F, Berveiller P, Fritel X; INSTRUMODA Study Group; GROG (Groupe de Recherche en Obstetrique et Gynecologie). Episiotomy to prevent obstetric anal sphincter injuries during instrumental delivery in nulliparous women: a national prospective comparative cohort study. Am J Obstet Gynecol. 2025 Aug;233(2):123.e1-123.e24. doi: 10.1016/j.ajog.2025.01.029. Epub 2025 Jan 30.

  PMID: 39889841 DERIVED

• Gachon B, Schmitz T, Artzner F, Parant O, De Tayrac R, Ducarme G, Le Ray C, Pizzoferrato AC, Garabedian C, Riethmuller D, Pierre F, Ragot S, Fritel X; GROG (Groupe de Recherche en Gynecologie Obstetrique). A core outcome set development for a French national prospective study about the effect of mediolateral episiotomy on obstetric anal sphincter injury during operative vaginal delivery (INSTRUMODA). BMC Pregnancy Childbirth. 2021 Mar 25;21(1):251. doi: 10.1186/s12884-021-03603-0.

  PMID: 33765964 DERIVED

MeSH Terms

Conditions

Encopresis; Pelvic Floor Disorders; Depression

Condition Hierarchy (Ancestors)

Signs and Symptoms, Digestive; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Behavioral Symptoms; Behavior; Elimination Disorders; Mental Disorders; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Pregnancy Complications; Male Urogenital Diseases

Central Study Contacts

Bertrand GACHON, MD

CONTACT

+33549443945; bertrand.gachon@chu-poitiers.fr

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 15, 2020
• First Posted: June 25, 2020
• Study Start: April 1, 2021
• Primary Completion: April 1, 2022
• Study Completion: April 1, 2023
• Last Updated: June 30, 2021

Record last verified: 2021-04

Locations

FR (1)