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

Sponsor

Brigham and Women's Hospital (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05750394

Collaborator

(none)

120

Enrollment

Arms

Anticipated Duration (Months)

Study Details

Study Description

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:

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.
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.
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.

Condition or Disease	Intervention/Treatment	Phase
Pregnancy Related	Procedure: Uterine layers closed Device: Suture Type Procedure: Endometrium	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

120 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Single (Outcomes Assessor)

Masking Description:

Radiologist blinded to closure method

Primary Purpose:

Treatment

Official Title:

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

Anticipated Study Start Date :

Jul 1, 2023

Anticipated Primary Completion Date :

Jul 1, 2025

Anticipated Study Completion Date :

Jul 1, 2025

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Single Layer Closure 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.	Procedure: Uterine layers closed Uterus closed with 1, 2 or 3 layers Device: Suture Type Barbed or smooth Procedure: Endometrium Included or excluded
Active Comparator: Double Layer Closure Double layer closure using the following technique: 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. Imbrication of the first layer with one (1) Monocryl suture on a CT needle using a running un-locked technique	Procedure: Uterine layers closed Uterus closed with 1, 2 or 3 layers Device: Suture Type Barbed or smooth Procedure: Endometrium Included or excluded
Active Comparator: Triple Layer Closure 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 (1) 2-0 V-Loc 90 suture on a GS-21 needle using an unlocked technique 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 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 Closure of the remaining myometrium with one (1) 0 V-Loc 90 suture on a GS-24 needle using an unlocked technique Closure of the serosa with one (1) 2-0 V-Loc 90 suture on a GS-21 needle using an unlocked technique	Procedure: Uterine layers closed Uterus closed with 1, 2 or 3 layers Device: Suture Type Barbed or smooth Procedure: Endometrium Included or excluded

Arm

Intervention/Treatment

Active Comparator: Single Layer Closure

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.

Procedure: Uterine layers closed

Uterus closed with 1, 2 or 3 layers

Device: Suture Type

Barbed or smooth

Procedure: Endometrium

Included or excluded

Active Comparator: Double Layer Closure

Double layer closure using the following technique: 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. Imbrication of the first layer with one (1) Monocryl suture on a CT needle using a running un-locked technique

Procedure: Uterine layers closed

Uterus closed with 1, 2 or 3 layers

Device: Suture Type

Barbed or smooth

Procedure: Endometrium

Included or excluded

Active Comparator: Triple Layer Closure

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 (1) 2-0 V-Loc 90 suture on a GS-21 needle using an unlocked technique 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 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 Closure of the remaining myometrium with one (1) 0 V-Loc 90 suture on a GS-24 needle using an unlocked technique Closure of the serosa with one (1) 2-0 V-Loc 90 suture on a GS-21 needle using an unlocked technique

Procedure: Uterine layers closed

Uterus closed with 1, 2 or 3 layers

Device: Suture Type

Barbed or smooth

Procedure: Endometrium

Included or excluded

Outcome Measures

Primary Outcome Measures

Myometrial thickness [4 months]
Residual myometrial thickness at the scar site assessed by MRI performed

Secondary Outcome Measures

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
Time for closure [Immediate]
Time required for hysterotomy closure
Extra sutures [Immediate]
The number of extra sutures required to achieve surgeon-acceptable hemostasis

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 50 Years

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

Yes

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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

Brigham and Women's Hospital

Investigators

Principal Investigator: James A. Greenberg, MD, Brigham and Women's Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

James Greenberg, MD, Vice Chair OB/GYN, Brigham and Women's Hospital

ClinicalTrials.gov Identifier:

NCT05750394

Other Study ID Numbers:

2023P000041

First Posted:

Mar 1, 2023

Last Update Posted:

Mar 2, 2023

Last Verified:

Feb 1, 2023

Individual Participant Data (IPD) Sharing Statement:

Yes

Plan to Share IPD:

Yes

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Yes

Product Manufactured in and Exported from the U.S.:

Keywords provided by James Greenberg, MD, Vice Chair OB/GYN, Brigham and Women's Hospital

Study Results

No Results Posted as of Mar 2, 2023