Obstetric Anal Sphincter InjuryINSTRUMODANCT04446780
Mediolateral Episiotomy and Obstetric Anal Sphincter Injuries in Instrumental Delivery
An observational study of Obstetric Anal Sphincter Injury and Episiotomy Wound, run by Poitiers University Hospital at 1 site in France.
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. Read more about this study
- Who is it for?
- Ages 18 to 55 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Obstetric Anal Sphincter Injury, Episiotomy Wound, Anal Incontinence
- What is being tested?
- Mediolateral episiotomy
- Type of treatment
- Surgery or procedure
- How many people
- 15,000 participants
- Where
- 1 siteFrance
- Study dates
- 1 Apr 2021to Apr 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 55 years
- Women only
- Healthy volunteers accepted
- Adult
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
Who may be able to join
- 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
Who cannot join
- 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
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- inability to understand French
- under judicial protection
- without access to a numeric terminal with internet connexion
Trial locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
Poitiers University Hospital
Poitiers, 86000
Bertrand GACHON, +33549443945, bertrand.gachon@chu-poitiers.fr
About this study
Official title: 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.
- Conditions
- Obstetric Anal Sphincter Injury, Episiotomy Wound, Anal Incontinence, Pelvic Floor Disorders, Depression
- Being tested
- Mediolateral episiotomy
- Medical subject headings
- Encopresis, Pelvic Floor Disorders, Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mediolateral episiotomyProcedure or surgery
Cutting of the perineum during vaginal delivery in order to avoid obstetric anal sphincter injury
| Study group | Role | What they receive |
|---|---|---|
| Women who underwent an episiotomy | Nulliparous women who underwent an instrumental vaginal delivery with mediolateral episiotomy Receives: Procedure: Mediolateral episiotomy | |
| Women who did not underwent an episiotomy | Nulliparous women who underwent an instrumental vaginal delivery without mediolateral episiotomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: Immediately after the delivery
Secondary outcomes (5)
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
Measured: 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
Measured: 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
Measured: 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
Measured: 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.
Measured: through mother's hospitalization, an average of 4 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jun 2020
- Study start1 Apr 2021
- Primary completion1 Apr 2022 (estimated)
- Study completionApr 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Obstetric Anal Sphincter InjuryStudies of the same condition, open and under way.
- More trials run by Poitiers University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 15,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Poitiers University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04446780
- Sponsor's protocol ID
- INSTRUMODA
- Acronym
- INSTRUMODA
- Status last verified
- Apr 2021
- First submitted
- 15 Jun 2020
- Last updated
- 30 Jun 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 39889841Gachon 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.
PubMed 33765964
Study at a glance
From the registry record, last updated by the sponsor on 30 Jun 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Mediolateral Episiotomy and Prevention of Obstetric Anal Sphincter Injuries in Instrumental Delivery: a Prospective Population-based Propensity Score Study
- ClinicalTrials.gov ID
- NCT04446780
- Acronym / sponsor ID
- INSTRUMODA / INSTRUMODA
- Conditions
- Obstetric Anal Sphincter Injury, Episiotomy Wound, Anal Incontinence, Pelvic Floor Disorders, Depression
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 15,000 participants (estimated)
- Lead sponsor
- Poitiers University HospitalUniversity, hospital or other
- Study start
- 1 Apr 2021 (actual)
- Primary completion
- 1 Apr 2022 (estimated)
- Study completion
- Apr 2023 (estimated)
- First posted
- 25 Jun 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Women who underwent an episiotomy | – | Procedure: Mediolateral episiotomyNulliparous women who underwent an instrumental vaginal delivery with mediolateral episiotomy |
| Women who did not underwent an episiotomy | – | –Nulliparous women who underwent an instrumental vaginal delivery without mediolateral episiotomy |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- 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
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Mediolateral episiotomyCutting of the perineum during vaginal delivery in order to avoid obstetric anal sphincter injury | Procedure or surgery | Women who underwent an episiotomy |
Primary outcome
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)
5 secondary outcomes
Immediate maternal morbidity (mediolateral episiotomy vs no episiotomy)
Time frame: 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
One year maternal morbidity (mediolateral episiotomy versus no episiotomy)
Time frame: 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
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jun 2021.
- Derived from this study: PubMed 39889841Gachon 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.
- Derived from this study: PubMed 33765964Gachon 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Obstetric Anal Sphincter Injury and Episiotomy Wound, run by Poitiers University Hospital at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 30 Jun 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Bertrand GACHON, MD (+33549443945, bertrand.gachon@chu-poitiers.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Obstetric Anal Sphincter Injury (mediolateral episiotomy vs no episiotomy for each type of instrument) (time frame: Immediately after the delivery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04446780, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Jun 2021.