Mediolateral Episiotomy and Obstetric Anal Sphincter Injuries in Instrumental Delivery

Depression Clinical Trial

— INSTRUMODA  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04446780
• Other study ID #: INSTRUMODA
• Status: Recruiting
• Start date: April 1, 2021
• Est. completion date: April 2023

Study information

• Verified date: April 2021
• Source: Poitiers University Hospital
• Contact: Bertrand GACHON, MD
• Phone: +33549443945
• Email: bertrand.gachon[@]chu-poitiers.fr
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 15000
• Est. completion date: April 2023
• Est. primary completion date: April 1, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 55 Years

Eligibility

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

Related Conditions & MeSH terms

• Anal Incontinence
• Depression
• Episiotomy Wound
• Fecal Incontinence
• Obstetric Anal Sphincter Injury
• Pelvic Floor Disorders
• Wounds and Injuries

Intervention

Procedure:
• Mediolateral episiotomy
Cutting of the perineum during vaginal delivery in order to avoid obstetric anal sphincter injury

Locations

Country	Name	City	State
France	Poitiers University Hospital	Poitiers

Sponsors (1)

Lead Sponsor	Collaborator
Poitiers University Hospital

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	One year maternal morbidity (mediolateral episiotomy versus no episiotomy)	Anal incontinence, urinary incontinence, perineal pain, postnatal depression, sexual function, self rated health	1 year
Secondary	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
Secondary	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