Suture of UTerus and Ultrasound Repair Evaluation (SUTURE)

Laval University

Status: Completed

Conditions: Uterine Scar Defect

Treatments: Procedure: Closure of the hysterotomy at the time of primary cesarean

Study type: Interventional

Funder types: Other

Identifiers

NCT01860859

C12-03-204

Details and patient eligibility

About

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.

Enrollment: 81 patients

Sex: Female

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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81 participants in 3 patient groups

Unlocked double layer

Other group

Description:

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.

Treatment:

Procedure: Closure of the hysterotomy at the time of primary cesarean

Locked single layer closure

Other group

Description:

As reported in Williams Obstetrics textbook

Treatment:

Procedure: Closure of the hysterotomy at the time of primary cesarean

Locked double layer

Other group

Description:

Double layer closure with a first continuous locked suture and a second imbricating continuous suture.

Treatment:

Procedure: Closure of the hysterotomy at the time of primary cesarean