Mediolateral Episiotomy and Obstetric Anal Sphincter Injuries in Instrumental Delivery (INSTRUMODA)

June 29, 2021 updated by: Poitiers University Hospital

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Anticipated)

15000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years to 51 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

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

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Women who underwent an episiotomy
Nulliparous women who underwent an instrumental vaginal delivery with mediolateral episiotomy
Procedure: Mediolateral episiotomy
Cutting of the perineum during vaginal delivery in order to avoid obstetric anal sphincter injury
Women who did not underwent an episiotomy
Nulliparous women who underwent an instrumental vaginal delivery without mediolateral episiotomy

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Obstetric Anal Sphincter Injury (mediolateral episiotomy vs no episiotomy for each type of instrument)
Time Frame: Immediately after the delivery
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)
Time Frame: 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
through mother's hospitalization, an average of 4 days
Immediate neonatal morbidity (mediolateral episiotomy versus no episiotomy)
Time Frame: through mother's hospitalization, an average of 4 days
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)
Time Frame: 1 year
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)
Time Frame: 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
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)
Time Frame: through mother's hospitalization, an average of 4 days
We will report the sensitivity, specificity and area under the curve of this score.
through mother's hospitalization, an average of 4 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Poitiers University Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 1, 2021

Primary Completion (Anticipated)

April 1, 2022

Study Completion (Anticipated)

April 1, 2023

Study Registration Dates

First Submitted

June 15, 2020

First Submitted That Met QC Criteria

June 21, 2020

First Posted (Actual)

June 25, 2020

Study Record Updates

Last Update Posted (Actual)

June 30, 2021

Last Update Submitted That Met QC Criteria

June 29, 2021

Last Verified

April 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • INSTRUMODA

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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