Mediolateral Episiotomy and Obstetric Anal Sphincter Injuries in Instrumental Delivery

Study Overview
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Brief Summary
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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.

Official Title
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Mediolateral Episiotomy and Prevention of Obstetric Anal Sphincter Injuries in Instrumental Delivery: a Prospective Population-based Propensity Score Study

Conditions
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Obstetric Anal Sphincter Injury, Episiotomy Wound, Anal Incontinence, Pelvic Floor Disorders, Depression

Intervention / Treatment
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* Procedure: Mediolateral episiotomy


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 55 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Women who underwent an episiotomy<br>Nulliparous women who underwent an instrumental vaginal delivery with mediolateral episiotomy | Procedure: Mediolateral episiotomy<br>* Cutting of the perineum during vaginal delivery in order to avoid obstetric anal sphincter injury<br>|
| Women who did not underwent an episiotomy<br>Nulliparous women who underwent an instrumental vaginal delivery without mediolateral episiotomy | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

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