NCT05750394

Cesarean 123 Trial: Randomized Trial Comparing Single, Double and Triple Layer Uterine Closures During Cesarean Delivery

Cesarean 123 Trial: Prospective Randomized Trial Comparing Single, Double and Triple Layer Uterine Closures During Cesarean Delivery

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 120 (estimated)
• Sponsor: Brigham and Women's Hospital · Academic / Other
• Sex: Female
• Age: 18 Years – 50 Years
• Healthy volunteers: Accepted

Summary

The goal of this clinical trial is to compare post-operative uterine scar thickness in people who have had the uterus closed during cesarean sections by one of three different methods. The main questions it aims to answer are: * Residual myometrial thickness at the scar site assessed by MRI performed 4 months after the procedure * Myometrial niche formation assessed by MRI performed 4 months after the procedure * Scar healing ratio (HR) difference as defined by HR= residual myometrial thickness/total myometrial thickness * Post-operative change in hemoglobin * Time required for hysterotomy closure * The number of extra sutures required to achieve surgeon-acceptable hemostasis Participants undergoing scheduled cesarean sections will be randomized to one of three different uterine closure methods. The methods are: 1. Single layer closure using the following technique: Closure of the myometrium and serosa with one barbed suture using a running unlocked technique. The endometrium should be excluded. 2. Double layer closure using the following technique: Closure of the full thickness of the myometrium with one smooth suture using a running locked technique. The endometrium should be excluded. Followed by imbrication of the second layer with one smooth suture using a running unlocked technique. 3. Triple layer closure of Endometrium, Myometrium and Serosa (EMS) using one of the the following two techniques: Closure of the endometrium and 2-4 mm of internal myometrium with one barbed suture using a running unlocked technique followed by closure of the remaining myometrium and serosa with one barbed suture using a running unlocked technique. Or, Closure of the endometrium and 2-4 mm of internal myometrium with one barbed suture on using a running unlocked technique followed by closure of the remaining myometrium with one barbed suture a running unlocked technique followed by closure of the serosa with one barbed suture using a running unlocked technique. Four months after the surgery, participants will have a MRI of the pelvis to assess the scar on the uterus.

Conditions

• Pregnancy Related

Interventions

Type	Name	Description
PROCEDURE	Uterine layers closed	Uterus closed with 1, 2 or 3 layers
DEVICE	Suture Type	Barbed or smooth
PROCEDURE	Endometrium	Included or excluded

Timeline

• Start date: 2023-07-01
• Primary completion: 2025-07-01
• Completion: 2025-07-01
• First posted: 2023-03-01
• Last updated: 2023-03-02

Regulatory

• FDA-regulated device study