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Exteriorization Versus In Situ Hysterotomy Repair During Cesarean: Effects on Uterine Tone

22 mai 2026 mis à jour par: Hannah Marie Kyllo, Stanford University

Uterine Exteriorization Versus In Situ Hysterectomy Repair During Cesarean Delivery: A Pilot Randomized Controlled Trial

During standard cesarean deliveries, there are two ways that obstetricians repair the incision on the uterus (hysterotomy after delivery of the baby. One method involves lifting the uterus out of its regular place in the abdomen to repair the incision (uterine exteriorization for repair). The second method involves leaving the uterus inside the abdomen to repair the uterus (in situ repair). Both of these methods are regularly used by obstetricians during cesarean deliveries, and it is not currently known if one has benefits over the other. Currently, surgeons use both methods, but lifting the uterus out of its place is slightly more common. In this study, participants will be randomly assigned to have one of these techniques performed during their surgery. Researchers will be investigating whether one technique or the other leads to better contraction of the uterus after delivery, less bleeding, less intra-operative nausea/vomiting, or a better patient experience than another.

Aperçu de l'étude

Description détaillée

There are two methods of uterine incision (hysterotomy) repair that can be utilized intra-operatively during a cesarean section: repair of the uterus within the abdomen (in situ) or temporary exteriorization of the uterus from the abdomen to repair the hysterotomy. These two techniques have been previously compared in the literature, with outcomes that focus on intraoperative nausea/vomiting or blood loss measured as estimated blood loss or changes in hemoglobin. Postpartum hemorrhage is the leading source of maternal morbidity and mortality worldwide. Uterine atony, defined as inadequate uterine contraction to compress bleeding from the placental bed after delivery, is the leading cause of postpartum hemorrhage worldwide, accounting for upwards of 70% of cases. Early assessments of and communication about uterine tone intra-operatively during cesarean deliveries are important for predicting and managing hemorrhage. In a recent 2021 study, an 11-point (0 to 10) numeric rating scale for uterine tone, was shown to have strong interrater reliability and has since been implemented to assess uterine tone intra-operatively during cesarean sections at a number of institutions. Low uterine tone scores have been found to be tightly correlated with postpartum hemorrhage and need for blood transfusion during hospitalization. Uterine repair techniques have not yet been compared with regard to their impact on uterine tone intra-operatively, and this comparison may provide valuable information on how to optimize uterine tone through surgical technique, thereby decreasing the risk of hemorrhage and need for additional interventions. The investigators propose a pilot randomized controlled trial comparing uterine exteriorization for hysterotomy repair versus in situ repair during cesarean sections. The primary outcomes related to feasibility and acceptability will include: percent of patients approached who consented, percent of patients consented who obstetricians agreed to allow for randomization, and percent crossover from randomization arm. The primary efficacy-related outcome will be uterine tone, as reported by the surgeon intra-operatively at multiple time points following delivery of the infant. Secondary outcomes will include qualitative blood loss and use of medications to treat low uterine tone, intraoperative breakthrough pain, and nausea.

Type d'étude

Interventionnel

Inscription (Estimé)

60

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: Hannah Kyllo M. Resident Physician, MD
  • Numéro de téléphone: 650-723-5403
  • E-mail: hkyllo@stanford.edu

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

Accepte les volontaires sains

Non

La description

Inclusion Criteria:

  • Age 18-55
  • Undergoing cesarean section

Exclusion Criteria:

  • Patient age <18 or >55
  • Case urgency deemed too great for consent

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: Autre
  • Répartition: Randomisé
  • Modèle interventionnel: Affectation parallèle
  • Masquage: Seul

Armes et Interventions

Groupe de participants / Bras
Intervention / Traitement
Comparateur actif: Uterine Exteriorization
For participants randomized to the control group (uterine exteriorization for repair), standard technique for cesarean delivery will be performed intra-operatively. At the time of hysterotomy repair, the uterus will be exteriorized from the abdomen and will be sutured closed in typical fashion. Following closure of the hysterotomy, the uterus will be returned to the abdomen. The remainder of the surgery will be performed with standard technique.
The uterus will be temporarily exteriorized from the abdomen for repair of the hysterotomy (uterine incision) after delivery of the infant in a cesarean section.
Expérimental: In Situ Repair
For participants randomized to the experimental group (in situ repair), standard technique for cesarean delivery will be performed intra-operatively. At the time of hysterotomy repair, the uterus will be left in situ and will be sutured closed in typical fashion. The remainder of the surgery will be performed with standard technique.
Repair of the hysterotomy (uterine incision) within the abdomen (in situ) after delivery of the infant during a cesarean section.

Que mesure l'étude ?

Principaux critères de jugement

Mesure des résultats
Description de la mesure
Délai
Compliance/Feasibility
Délai: Duration of the study, approximately 2 years
Percentage of consented cesarean participants who were successfully treated as randomly allocated in each arm
Duration of the study, approximately 2 years
Efficacy Signal
Délai: Duration of the study, approximately 2 years
Mean quantitative blood loss, analyzed after log transformation in a regression model that adjusts for cesarean group (scheduled, 1st stage, and 2nd stage)
Duration of the study, approximately 2 years

Mesures de résultats secondaires

Mesure des résultats
Description de la mesure
Délai
Feasibility: Enrollment
Délai: Duration of the study, approximately 2 years
Number of consented participants who underwent cesarean section and Obstetrician agreed to randomization at huddle
Duration of the study, approximately 2 years
Incidence of Intraoperative Breakthrough Pain between groups
Délai: Duration of the study, approximately 2 years
Duration of the study, approximately 2 years
Incidence of Intraoperative Vomiting between groups
Délai: Duration of the study, approximately 2 years
Duration of the study, approximately 2 years
Total operative time between groups
Délai: Duration of the study, approximately 2 years
Measured in minutes from skin incision to closure
Duration of the study, approximately 2 years
Time from fetal delivery to hysterotomy closure between groups
Délai: Duration of the study, approximately 2 years
In minutes
Duration of the study, approximately 2 years
10 Minute Uterine Tone Score between groups
Délai: Duration of the study, approximately 2 years
Uterine tone score 10 minutes after delivery of the placenta between groups, measured on a scale of 0 to 10, with "0" representing "no tone" and "10" representing excellent tone.
Duration of the study, approximately 2 years

Collaborateurs et enquêteurs

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

Les enquêteurs

  • Directeur d'études: Jess Ansari, MD, MS, Stanford University

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 (Estimé)

1 juin 2026

Achèvement primaire (Estimé)

1 juin 2029

Achèvement de l'étude (Estimé)

1 juin 2029

Dates d'inscription aux études

Première soumission

19 mai 2026

Première soumission répondant aux critères de contrôle qualité

19 mai 2026

Première publication (Réel)

26 mai 2026

Mises à jour des dossiers d'étude

Dernière mise à jour publiée (Réel)

27 mai 2026

Dernière mise à jour soumise répondant aux critères de contrôle qualité

22 mai 2026

Dernière vérification

1 avril 2026

Plus d'information

Termes liés à cette étude

Plan pour les données individuelles des participants (IPD)

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

NON

Description du régime IPD

No patient level data is anticipated to be shared with other researchers for future use after this study.

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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