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Completed

NCT Number: NCT01860859

Suture of UTerus and Ultrasound Repair Evaluation

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.

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Key information

Conditions

Uterine Scar Defect

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

CHU de Québec

Québec, Quebec, G1V 4G2, Canada

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Closure of the hysterotomy at the time of primary cesarean

Procedure

Primary outcomes

  1. 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

  1. Estimated blood loss

    Time frame: Same day of intervention: day 1

  2. Operative time

    Time frame: Same day of intervention: day 1

  3. Mean number of haemostatic sutures

    Time frame: Same day of intervention: day 1

Sponsors and collaborators

Lead sponsor

CHU de Quebec-Universite Laval

Other

Collaborators

  • Laval University
  • Université de Montréal

Registry information

Official study title

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

Acronym: SUTURE

Important dates

Study start
2013
Primary completion
2015
Study completion
2015
First posted
May 23, 2013
Registry last updated
May 18, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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