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

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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Pregnancy Related
• Intervention / Treatment: Procedure: Uterine layers closed; Device: Suture Type; Procedure: Endometrium

• Study Type: Interventional
• Enrollment (Anticipated): 120
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: James A. Greenberg, MD; Phone Number: 7819101968; Email: jagreenberg@bwh.harvard.edu
• Study Contact Backup: Name: Pamela A. Richtmyer; Phone Number: 857-282-5170; Email: prichtmyer@mgh.harvard.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 50 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Female

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

3

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Myometrial thickness	Residual myometrial thickness at the scar site assessed by MRI performed	4 months

Secondary Outcome Measures

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

Collaborators and Investigators

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

Publications and helpful links

General Publications

• Roberge S, Demers S, Girard M, Vikhareva O, Markey S, Chaillet N, Moore L, Paris G, Bujold E. Impact of uterine closure on residual myometrial thickness after cesarean: a randomized controlled trial. Am J Obstet Gynecol. 2016 Apr;214(4):507.e1-507.e6. doi: 10.1016/j.ajog.2015.10.916. Epub 2015 Nov 11.
• Alessandri F, Evangelisti G, Centurioni MG, Gustavino C, Ferrero S, Barra F. Fishbone double-layer barbed suture in cesarean section: a help in preventing long-term obstetric sequelae? Arch Gynecol Obstet. 2021 Sep;304(3):573-576. doi: 10.1007/s00404-021-06121-8.

Study record dates

Study Major Dates

• Study Start (Anticipated): July 1, 2023
• Primary Completion (Anticipated): July 1, 2025
• Study Completion (Anticipated): July 1, 2025

Study Registration Dates

• First Submitted: February 20, 2023
• First Submitted That Met QC Criteria: February 20, 2023
• First Posted (Actual): March 1, 2023

Study Record Updates

• Last Update Posted (Actual): March 2, 2023
• Last Update Submitted That Met QC Criteria: February 28, 2023
• Last Verified: February 1, 2023

More Information

Terms related to this study

• Keywords: Cesarean; niche; Myometrium; scar thickness
• Other Study ID Numbers: 2023P000041

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Sharing Time Frame: 1 year after completion
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No