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Kejsersnit 123-forsøg: Randomiseret forsøg, der sammenligner enkelt-, dobbelt- og trelags livmoderlukninger under kejsersnit (C123T)

29. september 2026 opdateret af: James Greenberg, MD, Brigham and Women's Hospital

Kejsersnit 123-forsøg: Prospektivt randomiseret forsøg, der sammenligner enkelt-, dobbelt- og trelags livmoderlukninger under kejsersnit

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.

Studieoversigt

Undersøgelsestype

Interventionel

Fase

  • Ikke anvendelig

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

18 år til 50 år (Voksen)

Tager imod sunde frivillige

Ja

Køn, der er berettiget til at studere

Kvinde

Beskrivelse

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

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Behandling
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Enkelt

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Aktiv komparator: 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.

Uterus closed with 1, 2 or 3 layers

Barbed or smooth

Included or excluded

Aktiv komparator: Double Layer Closure

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

Uterus closed with 1, 2 or 3 layers

Barbed or smooth

Included or excluded

Aktiv komparator: Triple Layer Closure

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

Uterus closed with 1, 2 or 3 layers

Barbed or smooth

Included or excluded

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Myometrial thickness
Tidsramme: 4 months

Residual myometrial thickness at the scar site assessed by MRI performed

4 months

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Niche
Tidsramme: 4 months

Myometrial niche formation assessed by MRI performed

4 months
Scar ratio
Tidsramme: 4 month

Scar healing ratio (HR) difference as defined by HR= residual myometrial thickness/total myometrial thickness by MRI

4 month
Blood loss
Tidsramme: 1 day

Post-operative change in hemoglobin

1 day
Time for closure
Tidsramme: Immediate

Time required for hysterotomy closure

Immediate
Extra sutures
Tidsramme: Immediate

The number of extra sutures required to achieve surgeon-acceptable hemostasis

Immediate

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Efterforskere

  • Ledende efterforsker: James A. Greenberg, MD, Brigham and Women's Hospital

Publikationer og nyttige links

Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Anslået)

1. juli 2023

Primær færdiggørelse (Anslået)

1. juli 2025

Studieafslutning (Anslået)

1. juli 2025

Datoer for studieregistrering

Først indsendt

20. februar 2023

Først indsendt, der opfyldte QC-kriterier

20. februar 2023

Først opslået (Faktiske)

1. marts 2023

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

2. oktober 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

29. september 2026

Sidst verificeret

1. september 2026

Mere information

Begreber relateret til denne undersøgelse

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • 2023P000041

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

JA

IPD-delingstidsramme

1 year after completion

IPD-deling Understøttende informationstype

  • STUDY_PROTOCOL
  • SAP
  • ICF

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

Studerer et amerikansk FDA-reguleret lægemiddelprodukt

Ingen

Studerer et amerikansk FDA-reguleret enhedsprodukt

Ingen

produkt fremstillet i og eksporteret fra U.S.A.

Ingen

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

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