INSTRUMODA: Mediolateral Episiotomy and Obstetric Anal Sphincter Injuries in Instrumental Delivery
Study Details
Study Description
Brief 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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Study Design
Arms and Interventions
| Arm | 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 |
Outcome Measures
Primary Outcome Measures
- Obstetric Anal Sphincter Injury (mediolateral episiotomy vs no episiotomy for each type of instrument) [Immediately after the delivery]
Perineal tears involving the anal sphincter complex (3rd and 4th degree according RCOG OMS classification)
Secondary Outcome Measures
- Immediate maternal morbidity (mediolateral episiotomy vs no episiotomy) [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
- Immediate neonatal morbidity (mediolateral episiotomy versus no episiotomy) [through mother's hospitalization, an average of 4 days]
Clinical vitality status, neonatal cephalic marks , neonatal bone fractures, admission into intensive unit care, death
- One year maternal morbidity (mediolateral episiotomy versus no episiotomy) [1 year]
Anal incontinence, urinary incontinence, perineal pain, postnatal depression, sexual function, self rated health
- Association between fetal presentation assessment before the delivery and the issue of delivery (ultrasound assessment versus no ultrasound assessment) [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
- Development of a clinical score to assess the absolute risk of obstetric anal sphincter injury during instrumental delivery (with or without mediolateral episiotomy) [through mother's hospitalization, an average of 4 days]
We will report the sensitivity, specificity and area under the curve of this score.
Eligibility Criteria
Criteria
Inclusion Criteria:
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age of 18 years or older
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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:
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expression of any opposition or objection to study participation
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previous delivery of a fetus at a gestational age greater than 20 weeks, regardless of the mode of delivery
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preterm birth before 34 weeks of amenorrhea
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fetal presentation other than cephalic
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multiple pregnancy
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in utero death
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inability to understand French
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under judicial protection
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without access to a numeric terminal with internet connexion
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Poitiers University Hospital | Poitiers | France | 86000 |
Sponsors and Collaborators
- Poitiers University Hospital
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- INSTRUMODA