Randomized Controlled Trial Comparing Three Techniques of Uterine Closure on the Myometrium Thickness Evaluated With Ultrasound Six Months After a Primary Cesarean
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Uterine Scar Defect
- Sponsor
- CHU de Quebec-Universite Laval
- Enrollment
- 81
- Locations
- 1
- Primary Endpoint
- Mean myometrium thickness
- Status
- Completed
- Last Updated
- 10 years ago
Overview
Brief Summary
This study compares three techniques of uterine closure on myometrium thickness evaluated by ultrasound six months after the primary cesarean. The three techniques include: 1) locked single layer closure; 2) double layer closure with a first continuous locked suture and a second imbricating continuous suture; 3) double layer closure with a first continuous unlocked suture of the deep portion of the myometrium avoiding the inclusion of the decidua and a second unlocked continuous suture that approximate the upper portion of the myometrium. The primary outcome is the mean myometrium thickness at the site of the uterine scar evaluated by transvaginal ultrasound at six months after cesarean.
Investigators
Emmanuel Bujold
MD, MSc
CHU de Quebec-Universite Laval
Eligibility Criteria
Inclusion Criteria
- •Planned cesarean
- •Primary cesarean
- •≥ 38 gestational weeks
Exclusion Criteria
- •Previous cesarean
- •Women \< 18 years old
- •Multiple gestation
- •Mullerian anomalies
- •Active labor
- •BMI \>35 kg/m2
- •Placenta praevia
- •Chronic systemic disease
Outcomes
Primary Outcomes
Mean myometrium thickness
Time Frame: 6 months after intervention
Using transvaginal ultrasound the residual myometrium thickness at the site of the uterine scar will be measure.
Secondary Outcomes
- Operative time(Same day of intervention: day 1)
- Mean number of haemostatic sutures(Same day of intervention: day 1)
- Estimated blood loss(Same day of intervention: day 1)