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

NCT ID: NCT04871022

Last Updated: 2022-09-27

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 126 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-05-15
• Study Completion Date: 2022-07-01

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.

Conditions

Uterine Scar Defect

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

Double layer unlocked uterine closer

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.

Group Type: ACTIVE_COMPARATOR

Double layer closure of the hysterotomy

Intervention Type: PROCEDURE

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 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

Group Type: EXPERIMENTAL

Purse closure of the hysterotomy

Intervention Type: PROCEDURE

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

Interventions

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.

Intervention Type: PROCEDURE

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

Intervention Type: PROCEDURE

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 48 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

University Tunis El Manar

OTHER

Sponsor Role: lead

Responsible Party

Ahmed Halouani

MD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

University hospital Mongi Slim la Marsa

Tunis, La Marsa, Tunisia

Countries

Tunisia

References

Halouani A, Dimassi K, Ben Mansour A, Triki A. Impact of purse-string uterine suture on scar healing after a cesarean delivery: a randomized controlled trial. Am J Obstet Gynecol MFM. 2023 Jul;5(7):100992. doi: 10.1016/j.ajogmf.2023.100992. Epub 2023 Apr 29.

Reference Type: DERIVED

PMID: 37127211 (View on PubMed)

Other Identifiers

UTuniselmanar3

Identifier Type: -

Identifier Source: org_study_id