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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Women who underwent an episiotomy | Nulliparous 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 |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Mediolateral episiotomy | Procedure | Cutting of the perineum during vaginal delivery in order to avoid obstetric anal sphincter injury |
|
| 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 |
| 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) |
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Inclusion Criteria:
Exclusion Criteria:
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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
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Bertrand GACHON, MD | Contact | +33549443945 | bertrand.gachon@chu-poitiers.fr |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Poitiers University Hospital | Recruiting | Poitiers | 86000 | France |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39889841 | Derived | 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. | |
| 33765964 |
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| ID | Term |
|---|---|
| D004688 | Encopresis |
| D059952 | Pelvic Floor Disorders |
| D003863 | Depression |
| ID | Term |
|---|---|
| D012817 | Signs and Symptoms, Digestive |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D001526 | Behavioral Symptoms |
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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 |
| Derived |
| Gachon 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. |
| D001519 | Behavior |
| D019960 | Elimination Disorders |
| D001523 | Mental Disorders |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D011248 | Pregnancy Complications |
| D052801 | Male Urogenital Diseases |