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

Not Applicable

Not yet recruiting

• Conditions: Pregnancy Related

• Registration Number: NCT05750394
• Lead Sponsor: Brigham and Women's Hospital

Brief 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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2023-02
• Study First Submitted: 2023-02-20
• Study First Submitted QC: 2023-02-20
• Last Update Submitted: 2023-02-28
• Study First Posted: 2023-03-01
• Last Update Posted: 2023-03-02
• Study Start: 2023-07
• Primary Completion: 2025-07
• Study Completion: 2025-07

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: Female
• Target Recruitment: 120

Inclusion Criteria

• 18 years or older
• Singleton gestation
• Nonurgent primary or secondary cesarean delivery at greater than 35w6d
• Body Mass Index (BMI) <35 kg/m^2

Exclusion Criteria

• More than 1 prior cesarean delivery
• Multiple gestation
• Known coagulation disorder or current use of anti-coagulants
• Mullerian anomalies
• Placenta previa

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Myometrial thickness	4 months	Residual myometrial thickness at the scar site assessed by MRI performed

Secondary Outcome Measures

Name	Time	Method
Niche	4 months	Myometrial niche formation assessed by MRI performed
Scar ratio	4 month	Scar healing ratio (HR) difference as defined by HR= residual myometrial thickness/total myometrial thickness by MRI
Blood loss	1 day	Post-operative change in hemoglobin
Extra sutures	Immediate	The number of extra sutures required to achieve surgeon-acceptable hemostasis
Time for closure	Immediate	Time required for hysterotomy closure