Double-layer Versus Purse Uterine Closure Techniques : Impact on Residual Myometrial Thickness After Cesarean

University Tunis El Manar

Status: Completed

Conditions: Uterine Scar Defect

Treatments: Procedure: Double layer closure of the hysterotomy; Procedure: Purse closure of the hysterotomy

Study type: Interventional

Funder types: Other

Identifiers

NCT04871022

UTuniselmanar3

Details and patient eligibility

About

There are different surgical techniques of uterine closure during cesarean. Currently data suggest that the double layer unlocked closure technique is associated with better uterine scar healing, and this technique is considered the gold standard.

This study compares two techniques of uterine closure on myometrium thickness:

1. Double layer unlocked suture;
2. Purse suture of the uterus with a first continuous purse suture of the deep portion of the myometrium and a second unlocked continuous suture including the remaining part of the myometrium.

The primary outcome is the mean residual myometrium thickness at the site of the uterine scar evaluated by transvaginal ultrasound at six months after cesarean.

Enrollment: 126 patients

Sex: Female

Ages: 18 to 48 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
• Covid-19 infection

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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126 participants in 2 patient groups

Double layer unlocked uterine closer

Active Comparator group

Description:

Double layer closure with a first continuous unlocked suture of the deep portion of the myometrium and a second unlocked continuous suture that approximate the upper portion of the myometrium.

Treatment:

Procedure: Double layer closure of the hysterotomy

Purse uterine closer

Experimental group

Description:

Purse suture of the uterus with a first continuous purse suture of the deep portion of the myometrium and a second unlocked continuous suture including the remaining part of the myometrium

Treatment:

Procedure: Purse closure of the hysterotomy