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Clinical Trials/NCT01860859
NCT01860859
Completed
Not Applicable

Randomized Controlled Trial Comparing Three Techniques of Uterine Closure on the Myometrium Thickness Evaluated With Ultrasound Six Months After a Primary Cesarean

CHU de Quebec-Universite Laval1 site in 1 country81 target enrollmentMarch 2013

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.

Registry
clinicaltrials.gov
Start Date
March 2013
End Date
March 2015
Last Updated
10 years ago
Study Type
Interventional
Study Design
Parallel
Sex
Female

Investigators

Sponsor
CHU de Quebec-Universite Laval
Responsible Party
Principal Investigator
Principal Investigator

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)

Study Sites (1)

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