Cesarean 123 Trial: Randomized Trial Comparing Single, Double and Triple Layer Uterine Closures During Cesarean Delivery (C123T)

Mass General Brigham

Status: Not yet enrolling

Conditions: Pregnancy Related

Treatments: Device: Suture Type; Procedure: Endometrium; Procedure: Uterine layers closed

Study type: Interventional

Funder types: Other

Identifiers

NCT05750394

2023P000041

Details and patient eligibility

About

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.

Enrollment: 120 estimated patients

Sex: Female

Ages: 18 to 50 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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120 participants in 3 patient groups

Single Layer Closure

Active Comparator group

Description:

Single layer closure using the following technique: a. Closure of the myometrium and serosa with one (1) 0 V-Loc 90 suture on a GS-24 needle using an unlocked technique. The endometrium should be excluded.

Treatment:

Procedure: Endometrium

Device: Suture Type

Procedure: Uterine layers closed

Double Layer Closure

Active Comparator group

Description:

Double layer closure using the following technique: 1. Closure of the full thickness of the myometrium with one (1) Monocryl suture on a CT needle using a running locked technique. The endometrium should be excluded. 2. Imbrication of the first layer with one (1) Monocryl suture on a CT needle using a running un-locked technique

Treatment:

Procedure: Endometrium

Device: Suture Type

Procedure: Uterine layers closed

Triple Layer Closure

Active Comparator group

Description:

Triple layer closure of Endometrium, Myometrium and Serosa (EMS) using one of the the following two techniques: 1. Closure of the endometrium and 2-4 mm of internal myometrium with one (1) 2-0 V-Loc 90 suture on a GS-21 needle using an unlocked technique 2. Closure of the remaining myometrium and serosa with one (1) 0 V-Loc 90 suture on a GS-24 needle using an unlocked technique or 1. Closure of the endometrium and 2-4 mm of internal myometrium with one (1) 2-0 V-Loc 90 suture on a GS-21 needle using an unlocked technique 2. Closure of the remaining myometrium with one (1) 0 V-Loc 90 suture on a GS-24 needle using an unlocked technique 3. Closure of the serosa with one (1) 2-0 V-Loc 90 suture on a GS-21 needle using an unlocked technique

Treatment:

Procedure: Endometrium

Device: Suture Type

Procedure: Uterine layers closed