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

Not Applicable

Completed

• Conditions: Uterine Scar Defect
• Interventions: Procedure: Double layer closure of the hysterotomy; Procedure: Purse closure of the hysterotomy

• Registration Number: NCT04871022
• Lead Sponsor: University Tunis El Manar

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2021-04-28
• Study First Submitted QC: 2021-04-28
• Study First Posted: 2021-05-04
• Study Start: 2021-05-15
• Primary Completion: 2022-03-31
• Study Completion: 2022-07-01
• Status Verified: 2022-09
• Last Update Submitted: 2022-09-24
• Last Update Posted: 2022-09-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 126

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Double layer unlocked uterine closer	Double layer closure of the hysterotomy	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.
Purse uterine closer	Purse closure of the hysterotomy	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

Primary Outcome Measures

Name	Time	Method
Residual myometrium thickness	6 months after intervention

Secondary Outcome Measures

Name	Time	Method
scar width	Same day of intervention: day 1
Operative time	Same day of intervention: day 1
Estimated blood loss	Same day of intervention: day 1
Mean number of haemostatic sutures	Same day of intervention: day 1

Trial Locations

Locations (1)

University hospital Mongi Slim la Marsa; 🇹🇳 Tunis, La Marsa, Tunisia