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Comparing Decidual Inclusion vs. Exclusion in Uterine Suture Techniques During Cesarean Section to Improve Scar Thickness and Reduce Isthmocele Risk in Primiparous Women (DISSUC)

28. maj 2026 opdateret af: Amr Sherif Hamza, Kantonsspital Baden

The Impact of Decidual Inclusion or Sparing in a Single Unlocked Closure of a Cesarean Uterine Incision: Randomized Controlled Trial

This study compares two ways of closing the uterus during cesarean delivery. In one group, the decidual layer near the uterine cavity is included in the suture. In the other group, this layer is left out. The study will examine whether these two methods differ in how well the uterine scar heals 6 to 9 months after surgery.

Women having an elective cesarean delivery will be randomly assigned to one of the two closure methods. Scar healing will be assessed by ultrasound after delivery. The goal is to determine whether one method is associated with better cesarean scar healing and fewer scar defects.

Studieoversigt

Status

Ikke rekrutterer endnu

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

Cesarean scar defects, also referred to as niches or isthmoceles, are associated with gynecologic symptoms and adverse outcomes in subsequent pregnancies. The effect of uterine closure technique on scar healing remains uncertain, particularly with regard to whether the cavum-near decidual layer should be included in or excluded from the suture during cesarean closure.

This study is a prospective, randomized, controlled trial comparing two approaches to single-layer, non-locked uterine closure during elective cesarean delivery: decidual inclusion and decidual sparing. In both study groups, all operative steps are standardized except for the handling of the cavum-near decidual layer at the uterotomy margin.

Participants will be followed 6 to 9 months after cesarean delivery, including blinded ultrasound assessment of cesarean scar healing. The objective is to determine whether decidual inclusion or decidual sparing is associated with differences in postoperative uterine scar healing and cesarean scar defect formation.

Undersøgelsestype

Interventionel

Tilmelding (Anslået)

374

Fase

  • Ikke anvendelig

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiekontakt

  • Navn: Amr S. Hamza, Assoc. Prof.
  • Telefonnummer: +41564863513
  • E-mail: amr.hamza@ksb.ch

Undersøgelse Kontakt Backup

Studiesteder

  • Schweiz
    • Canton of Aargau
      • Baden, Canton of Aargau, Schweiz, 5400
        • Kantonsspital Baden
        • Kontakt:
          • Amr S. Hamza, Assoc. Prof.
          • Telefonnummer: +41564863513
          • E-mail: amr.hamza@ksb.ch
        • Kontakt:

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

  • Voksen
  • Ældre voksen

Tager imod sunde frivillige

Ingen

Beskrivelse

Inclusion Criteria:

  • Singleton, term pregnancy
  • Elective cesarean section before labor onset or membrane rupture
  • Maternal age >18 years
  • Ability to provide informed consent

Exclusion Criteria:

  • Placenta previa
  • Maternal substance abuse or infection
  • Suspected placenta accreta
  • Diabetes
  • one or more prior cesarean section
  • Vulnerable participants (e.g., mental health conditions)
  • Emergency cesarean sections

Studieplan

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

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Forebyggelse
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Dobbelt

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: Decidual Inclusion Closure
Participants randomized to this arm will undergo elective cesarean delivery with single-layer, non-locked uterine closure in which the cavum-near decidual layer at the uterotomy margin is included in the suture. All other operative steps will be performed according to the standardized study protocol.
Procedure: Single-Layered Non-Locked Closure with Decidual Inclusion

During the cesarean section, the uterine incision is closed with a single-layered, non-locked suture. In this technique, the decidua (the uterine lining) is included in the closure. This means that the endometrial cells are part of the suture, potentially influencing the healing process of the uterine scar.

Goal: The idea is that including the decidua may promote better healing and scar formation, reducing the risk of complications such as isthmocele and improving long-term uterine health.
Eksperimentel: Decidual Sparing Closure
Participants randomized to this arm will undergo elective cesarean delivery with single-layer, non-locked uterine closure in which the cavum-near decidual layer at the uterotomy margin is excluded from the suture. All other operative steps will be performed according to the standardized study protocol.
Procedure: Single-Layered Non-Locked Closure with Decidual Sparing

Procedure: In this technique, the uterine incision is also closed using a single-layered non-locked suture, but the decidua is excluded from the closure. The suture is placed only through the myometrium (muscle layer) of the uterus, leaving the decidua out of the scar tissue.

Goal: The intent is to observe if sparing the decidua results in better scar healing and a lower risk of isthmocele formation, as well as fewer long-term complications.

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Proportion of participants with a cesarean scar niche measured by ultrasound
Tidsramme: 6 to 9 months post-operation
Presence of a cesarean scar niche, defined as a myometrial indentation at the cesarean scar site with a depth of at least 2 mm, assessed by postoperative ultrasound. The outcome will be reported as the proportion of participants with a niche in each treatment group.
6 to 9 months post-operation

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Residual-to-adjacent myometrial thickness ratio
Tidsramme: 6 to 9 months post-operation
Ratio of residual myometrial thickness to adjacent myometrial thickness measured by ultrasound.
6 to 9 months post-operation
Operative time
Tidsramme: Periprocedural
Operative time in minutes
Periprocedural
Need for additional sutures for hemostasis
Tidsramme: Periprocedural
Need for additional hemostatic sutures, yes (how many: __ Number) /no
Periprocedural
Length of hospital stay
Tidsramme: Postoperative day 2
Length of postoperative hospital stay in days
Postoperative day 2
Postoperative pain intensity on the 11-point Numeric Rating Scale
Tidsramme: Postoperative day 2
Pain intensity assessed using an 11-point Numeric Rating Scale ranging from 0 to 10, where 0 indicates no pain and 10 indicates the worst imaginable pain. Higher scores indicate worse pain.
Postoperative day 2
Postoperative bleeding
Tidsramme: Postoperative day 2
Clinically relevant postoperative bleeding, yes/no
Postoperative day 2
Wound infection
Tidsramme: Postoperative day 2
Postoperative wound infection, yes/no
Postoperative day 2
Postoperative fever
Tidsramme: Postoperative day 2
Postoperative fever, yes/no
Postoperative day 2
Abnormal uterine bleeding
Tidsramme: 6 to 9 months post-operation
Abnormal uterine bleeding reported at follow-up, yes/no
6 to 9 months post-operation
Dysmenorrhea
Tidsramme: 6 to 9 months post-operation
Dysmenorrhea reported at follow-up, yes/no
6 to 9 months post-operation
Chronic pelvic pain
Tidsramme: 6 to 9 months post-operation
Chronic pelvic pain reported at follow-up, yes/no
6 to 9 months post-operation
Dyspareunia
Tidsramme: 6 to 9 months post-operation
Dyspareunia reported at follow-up, yes/no
6 to 9 months post-operation
Cesarean scar niche length measured by ultrasound in mm
Tidsramme: 6 to 9 months post-operation
Length of cesarean scar niche in mm measured by ultrasound.
6 to 9 months post-operation
Cesarean scar niche depth measured by ultrasound in mm
Tidsramme: 6 to 9 months post-operation
Depth of cesarean scar niche in mm measured by ultrasound.
6 to 9 months post-operation
Cesarean scar niche width measured by ultrasound in mm
Tidsramme: 6 to 9 months post-operation
Width of cesarean scar niche in mm measured by ultrasound.
6 to 9 months post-operation
Residual myometrial thickness measured by ultrasound in mm
Tidsramme: 6 to 9 months post-operation
Residual myometrial thickness measured by ultrasound in mm
6 to 9 months post-operation
Presence of intrauterine fluid on ultrasound
Tidsramme: 6 to 9 months post-operation
Presence or absence of intrauterine fluid on ultrasound.
6 to 9 months post-operation

Samarbejdspartnere og efterforskere

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

Sponsor

Kantonsspital Baden

Efterforskere

  • Ledende efterforsker: Amr S. Hamza, Assoc. Prof., Kantonsspital Baden

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)

25. maj 2026

Primær færdiggørelse (Anslået)

1. maj 2029

Studieafslutning (Anslået)

30. maj 2029

Datoer for studieregistrering

Først indsendt

27. august 2025

Først indsendt, der opfyldte QC-kriterier

19. maj 2026

Først opslået (Faktiske)

27. maj 2026

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

1. juni 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

28. maj 2026

Sidst verificeret

1. maj 2026

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • StudyKSBHAM001

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

INGEN

IPD-planbeskrivelse

De-identified individual participant data will not be shared outside the research team because no external data-sharing process has been approved by the ethics committee or institution. Aggregate study results may be shared through publication or presentation.

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