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Clinical Trials/NCT01860859
NCT01860859CompletedNot 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 Laval2 sites in 1 country81 target enrollmentStarted: March 1, 2013Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Sponsor
Enrollment
81
Locations
2
Primary Endpoint
Mean myometrium thickness

Study 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.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Prevention
Masking
Triple (Participant, Investigator, Outcomes Assessor)

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
Female
Accepts Healthy Volunteers
Yes

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)

Investigators

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

Emmanuel Bujold

MD, MSc

CHU de Quebec-Universite Laval

Study Sites (2)

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