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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)

23 août 2026 mis à jour par: 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.

Aperçu de l'étude

Statut

Recrutement

Les conditions

Intervention / Traitement

Description détaillée

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.

Type d'étude

Interventionnel

Inscription (Estimé)

374

Phase

  • N'est pas applicable

Contacts et emplacements

Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.

Coordonnées de l'étude

  • Nom: Amr S. Hamza, Assoc. Prof.
  • Numéro de téléphone: +41564863513
  • E-mail: amr.hamza@ksb.ch

Sauvegarde des contacts de l'étude

Lieux d'étude

  • Suisse
    • Canton of Aargau
      • Baden, Canton of Aargau, Suisse, 5400
        • Recrutement
        • Kantonsspital Baden
        • Contact:
          • Amr S. Hamza, Assoc. Prof.
          • Numéro de téléphone: +41564863513
          • E-mail: amr.hamza@ksb.ch
        • Contact:

Critères de participation

Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.

Critère d'éligibilité

Âges éligibles pour étudier

  • Adulte
  • Adulte plus âgé

Accepte les volontaires sains

Non

La description

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

Plan d'étude

Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.

Comment l'étude est-elle conçue ?

Détails de conception

  • Objectif principal: La prévention
  • Répartition: Randomisé
  • Modèle interventionnel: Affectation parallèle
  • Masquage: Double

Armes et Interventions

Groupe de participants / Bras
Intervention / Traitement
Expérimental: 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.
Procédure: 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.
Expérimental: 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.
Procédure: 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.

Que mesure l'étude ?

Principaux critères de jugement

Mesure des résultats
Description de la mesure
Délai
Proportion of participants with a cesarean scar niche measured by ultrasound
Délai: 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

Mesures de résultats secondaires

Mesure des résultats
Description de la mesure
Délai
Residual-to-adjacent myometrial thickness ratio
Délai: 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
Délai: Periprocedural
Operative time in minutes
Periprocedural
Need for additional sutures for hemostasis
Délai: Periprocedural
Need for additional hemostatic sutures, yes (how many: __ Number) /no
Periprocedural
Length of hospital stay
Délai: Postoperative day 2
Length of postoperative hospital stay in days
Postoperative day 2
Postoperative pain intensity on the 11-point Numeric Rating Scale
Délai: 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
Délai: Postoperative day 2
Clinically relevant postoperative bleeding, yes/no
Postoperative day 2
Wound infection
Délai: Postoperative day 2
Postoperative wound infection, yes/no
Postoperative day 2
Postoperative fever
Délai: Postoperative day 2
Postoperative fever, yes/no
Postoperative day 2
Abnormal uterine bleeding
Délai: 6 to 9 months post-operation
Abnormal uterine bleeding reported at follow-up, yes/no
6 to 9 months post-operation
Dysmenorrhea
Délai: 6 to 9 months post-operation
Dysmenorrhea reported at follow-up, yes/no
6 to 9 months post-operation
Chronic pelvic pain
Délai: 6 to 9 months post-operation
Chronic pelvic pain reported at follow-up, yes/no
6 to 9 months post-operation
Dyspareunia
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 6 to 9 months post-operation
Presence or absence of intrauterine fluid on ultrasound.
6 to 9 months post-operation

Collaborateurs et enquêteurs

C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.

Parrainer

Kantonsspital Baden

Les enquêteurs

  • Chercheur principal: Amr S. Hamza, Assoc. Prof., Kantonsspital Baden

Dates d'enregistrement des études

Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.

Dates principales de l'étude

Début de l'étude (Réel)

17 juin 2026

Achèvement primaire (Estimé)

1 mai 2029

Achèvement de l'étude (Estimé)

30 mai 2029

Dates d'inscription aux études

Première soumission

27 août 2025

Première soumission répondant aux critères de contrôle qualité

19 mai 2026

Première publication (Réel)

27 mai 2026

Mises à jour des dossiers d'étude

Dernière mise à jour publiée (Réel)

25 août 2026

Dernière mise à jour soumise répondant aux critères de contrôle qualité

23 août 2026

Dernière vérification

1 août 2026

Plus d'information

Termes liés à cette étude

Mots clés

Termes MeSH pertinents supplémentaires

Autres numéros d'identification d'étude

  • StudyKSBHAM001

Plan pour les données individuelles des participants (IPD)

Prévoyez-vous de partager les données individuelles des participants (DPI) ?

NON

Description du régime IPD

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.

Informations sur les médicaments et les dispositifs, documents d'étude

Étudie un produit pharmaceutique réglementé par la FDA américaine

Non

Étudie un produit d'appareil réglementé par la FDA américaine

Non

Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .

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