Suture of UTerus and Ultrasound Repair Evaluation

Not Applicable

Completed

• Conditions: Uterine Scar Defect

• Registration Number: NCT01860859
• Lead Sponsor: CHU de Quebec-Universite Laval

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2013-03
• Study First Submitted: 2013-05-09
• Study First Submitted QC: 2013-05-21
• Study First Posted: 2013-05-23
• Primary Completion: 2015-03
• Study Completion: 2015-03
• Status Verified: 2015-05
• Last Update Submitted: 2015-05-14
• Last Update Posted: 2015-05-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 81

Inclusion Criteria

• Planned cesarean
• Primary cesarean
• ≥ 38 gestational weeks

Exclusion Criteria

• Previous cesarean
• Women < 18 years old
• Multiple gestation
• Mullerian anomalies
• Active labor
• Diabetes
• BMI >35 kg/m2
• Placenta praevia
• Chronic systemic disease

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Mean myometrium thickness	6 months after intervention	Using transvaginal ultrasound the residual myometrium thickness at the site of the uterine scar will be measure.

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

CHU de Québec; 🇨🇦 Québec, Quebec, Canada