NCT05750394

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.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
120

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jul 2023

Typical duration for not_applicable

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 20, 2023

Completed
9 days until next milestone

First Posted

Study publicly available on registry

March 1, 2023

Completed
4 months until next milestone

Study Start

First participant enrolled

July 1, 2023

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2025

Completed
Last Updated

March 2, 2023

Status Verified

February 1, 2023

Enrollment Period

2 years

First QC Date

February 20, 2023

Last Update Submit

February 28, 2023

Conditions

Pregnancy Related

Keywords

CesareanMyometriumscar thicknessniche

Outcome Measures

Primary Outcomes (1)

  • Myometrial thickness

    Residual myometrial thickness at the scar site assessed by MRI performed

    4 months

Secondary Outcomes (5)

  • Niche

    4 months

  • Scar ratio

    4 month

  • Blood loss

    1 day

  • Time for closure

    Immediate

  • Extra sutures

    Immediate

Study Arms (3)

Single Layer Closure

ACTIVE COMPARATOR

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 closedDevice: Suture TypeProcedure: Endometrium

Double Layer Closure

ACTIVE COMPARATOR

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

Procedure: Uterine layers closedDevice: Suture TypeProcedure: Endometrium

Triple Layer Closure

ACTIVE COMPARATOR

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

Procedure: Uterine layers closedDevice: Suture TypeProcedure: Endometrium

Interventions

Uterine layers closedPROCEDURE

Uterus closed with 1, 2 or 3 layers

Double Layer ClosureSingle Layer ClosureTriple Layer Closure
Suture TypeDEVICE

Barbed or smooth

Double Layer ClosureSingle Layer ClosureTriple Layer Closure
EndometriumPROCEDURE

Included or excluded

Double Layer ClosureSingle Layer ClosureTriple Layer Closure

Eligibility Criteria

Age18 Years - 50 Years
Sexfemale(Gender-based eligibility)
Gender Eligibility DetailsPregnant people having cesarean delivery
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (2)

  • 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.

    PMID: 26522861RESULT

  • 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.

    PMID: 34146146RESULT

MeSH Terms

Interventions

Endomet

Study Officials

  • James A. Greenberg, MD

    Brigham and Women's Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

James A. Greenberg, MD

CONTACT

7819101968jagreenberg@bwh.harvard.edu

Pamela A. Richtmyer

CONTACT

857-282-5170prichtmyer@mgh.harvard.edu

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Masking Details
Radiologist blinded to closure method
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Vice Chair OB/GYN

Study Record Dates

First Submitted

February 20, 2023

First Posted

March 1, 2023

Study Start

July 1, 2023

Primary Completion

July 1, 2025

Study Completion

July 1, 2025

Last Updated

March 2, 2023

Record last verified: 2023-02

Data Sharing

IPD Sharing
Will share
Shared Documents
STUDY PROTOCOL, SAP, ICF
Time Frame
1 year after completion