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Clinical Trials/NCT05750394
NCT05750394Not yet recruitingNot Applicable

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

Brigham and Women's Hospital0 sites120 target enrollmentStarted: July 2023Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Status
Not yet recruiting
Enrollment
120
Primary Endpoint
Myometrial thickness

Study Overview

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.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
Single (Outcomes Assessor)

Masking Description

Radiologist blinded to closure method

Eligibility Criteria

Ages
18 Years to 50 Years (Adult)
Sex
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

Outcomes

Primary Outcomes

Myometrial thickness

Time Frame: 4 months

Residual myometrial thickness at the scar site assessed by MRI performed

Secondary Outcomes

  • Niche(4 months)
  • Scar ratio(4 month)
  • Blood loss(1 day)
  • Extra sutures(Immediate)
  • Time for closure(Immediate)

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

James Greenberg, MD

Vice Chair OB/GYN

Brigham and Women's Hospital

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