Mediolateral Episiotomy and Obstetric Anal Sphincter Injuries in Instrumental Delivery

• Conditions: Episiotomy Wound; Depression; Obstetric Anal Sphincter Injury; Pelvic Floor Disorders; Anal Incontinence
• Interventions: Procedure: Mediolateral episiotomy

• Registration Number: NCT04446780
• Lead Sponsor: Poitiers University Hospital

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2020-06-15
• Study First Submitted QC: 2020-06-21
• Study First Posted: 2020-06-25
• Status Verified: 2021-04
• Study Start: 2021-04-01
• Last Update Submitted: 2021-06-29
• Last Update Posted: 2021-06-30
• Primary Completion: 2022-04-01
• Study Completion: 2023-04

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 15000

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Women who underwent an episiotomy	Mediolateral episiotomy	Nulliparous women who underwent an instrumental vaginal delivery with mediolateral episiotomy

Primary Outcome Measures

Name	Time	Method
Obstetric Anal Sphincter Injury (mediolateral episiotomy vs no episiotomy for each type of instrument)	Immediately after the delivery	Perineal tears involving the anal sphincter complex (3rd and 4th degree according RCOG OMS classification)

Secondary Outcome Measures

Name	Time	Method
Immediate neonatal morbidity (mediolateral episiotomy versus no episiotomy)	through mother's hospitalization, an average of 4 days	Clinical vitality status, neonatal cephalic marks , neonatal bone fractures, admission into intensive unit care, death
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	Failed instrumental delivery defined as a requirement of several instrument and/or requirement of cesarean section
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	We will report the sensitivity, specificity and area under the curve of this score.
Immediate maternal morbidity (mediolateral episiotomy vs no episiotomy)	through mother's hospitalization, an average of 4 days	post partum hemorrhage, perineal infection, perineal hematoma, perineal pain, difficulty for voiding, satisfaction about childbirth, intensive care admission, death
One year maternal morbidity (mediolateral episiotomy versus no episiotomy)	1 year	Anal incontinence, urinary incontinence, perineal pain, postnatal depression, sexual function, self rated health

Trial Locations

Locations (1)

Poitiers University Hospital; 🇫🇷 Poitiers, France