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NCT Number: NCT07606846

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

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.

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Key information

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Age 18-55
  • Undergoing cesarean section

Exclusion criteria

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

Treatment and study plan

Test Intervention: In Situ Repair

Procedure

Repair of the hysterotomy (uterine incision) within the abdomen (in situ) after delivery of the infant during a cesarean section.

Comparator Intervention: Exteriorization

Procedure

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.

Primary outcomes

  1. Compliance/Feasibility

    Time frame: Duration of the study, approximately 2 years

    Percentage of consented cesarean participants who were successfully treated as randomly allocated in each arm

  2. Efficacy Signal

    Time frame: 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)

Secondary outcomes

  1. Feasibility: Enrollment

    Time frame: Duration of the study, approximately 2 years

    Number of consented participants who underwent cesarean section and Obstetrician agreed to randomization at huddle

  2. 10 Minute Uterine Tone Score between groups

    Time frame: 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.

  3. Incidence of Intraoperative Breakthrough Pain between groups

    Time frame: Duration of the study, approximately 2 years

  4. Incidence of Intraoperative Vomiting between groups

    Time frame: Duration of the study, approximately 2 years

  5. Total operative time between groups

    Time frame: Duration of the study, approximately 2 years

    Measured in minutes from skin incision to closure

  6. Time from fetal delivery to hysterotomy closure between groups

    Time frame: Duration of the study, approximately 2 years

    In minutes

Study contacts

Contact information is provided by the study sponsor or research team.

Hannah Kyllo M. Resident Physician, MD

CONTACT

[email protected]

650-723-5403

Sponsors and collaborators

Lead sponsor

Stanford University

Other

Registry information

Official study title

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

Important dates

Study start
2026
Primary completion
2029
Study completion
2029
First posted
May 26, 2026
Registry last updated
May 27, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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