Clinical Trials Logo

Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT04446780
Other study ID # INSTRUMODA
Secondary ID
Status Recruiting
Phase
First received
Last updated
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
Health authority
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

Study Design


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
See also
  Status Clinical Trial Phase
Active, not recruiting NCT05777044 - The Effect of Hatha Yoga on Mental Health N/A
Recruiting NCT04680611 - Severe Asthma, MepolizumaB and Affect: SAMBA Study
Recruiting NCT04977232 - Adjunctive Game Intervention for Anhedonia in MDD Patients N/A
Recruiting NCT04043052 - Mobile Technologies and Post-stroke Depression N/A
Completed NCT04512768 - Treating Comorbid Insomnia in Transdiagnostic Internet-Delivered Cognitive Behaviour Therapy N/A
Recruiting NCT03207828 - Testing Interventions for Patients With Fibromyalgia and Depression N/A
Completed NCT04617015 - Defining and Treating Depression-related Asthma Early Phase 1
Recruiting NCT06011681 - The Rapid Diagnosis of MCI and Depression in Patients Ages 60 and Over
Completed NCT04476446 - An Expanded Access Protocol for Esketamine Treatment in Participants With Treatment Resistant Depression (TRD) Who do Not Have Other Treatment Alternatives Phase 3
Recruiting NCT02783430 - Evaluation of the Initial Prescription of Ketamine and Milnacipran in Depression in Patients With a Progressive Disease Phase 2/Phase 3
Recruiting NCT05563805 - Exploring Virtual Reality Adventure Training Exergaming N/A
Completed NCT04598165 - Mobile WACh NEO: Mobile Solutions for Neonatal Health and Maternal Support N/A
Completed NCT03457714 - Guided Internet Delivered Cognitive-Behaviour Therapy for Persons With Spinal Cord Injury: A Feasibility Trial
Recruiting NCT05956912 - Implementing Group Metacognitive Therapy in Cardiac Rehabilitation Services (PATHWAY-Beacons)
Completed NCT05588622 - Meru Health Program for Cancer Patients With Depression and Anxiety N/A
Recruiting NCT05234476 - Behavioral Activation Plus Savoring for University Students N/A
Active, not recruiting NCT05006976 - A Naturalistic Trial of Nudging Clinicians in the Norwegian Sickness Absence Clinic. The NSAC Nudge Study N/A
Enrolling by invitation NCT03276585 - Night in Japan Home Sleep Monitoring Study
Terminated NCT03275571 - HIV, Computerized Depression Therapy & Cognition N/A
Completed NCT03167372 - Pilot Comparison of N-of-1 Trials of Light Therapy N/A