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

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

Status
Not yet recruiting
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07606846
Enrollment
60
Registered
2026-05-26
Start date
2026-06-01
Completion date
2029-06-01
Last updated
2026-05-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cesarean Section, Postpartum Hemorrhage, Uterine Atony, Uterine Atony With Hemorrhage

Keywords

Postpartum Hemorrhage, Uterine Atony, Uterine Atony with Hemorrhage, Cesarean Section, Cesarean Delivery, Uterine Tone

Brief summary

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.

Detailed description

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.

Interventions

PROCEDURETest Intervention: In Situ Repair

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

PROCEDUREComparator Intervention: Exteriorization

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.

Sponsors

Stanford University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
SINGLE (Subject)

Intervention model description

Blinded, randomized clinical trial with 1:1 allocation of two commonly utilized surgical techniques for hysterotomy closure during cesarean section, with primary purpose of feasibility.

Eligibility

Sex/Gender
FEMALE
Age
18 Years to 55 Years
Healthy volunteers
No

Inclusion criteria

* Age 18-55 * Undergoing cesarean section

Exclusion criteria

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

Design outcomes

Primary

MeasureTime frameDescription
Compliance/FeasibilityDuration of the study, approximately 2 yearsPercentage of consented cesarean participants who were successfully treated as randomly allocated in each arm
Efficacy SignalDuration of the study, approximately 2 yearsMean quantitative blood loss, analyzed after log transformation in a regression model that adjusts for cesarean group (scheduled, 1st stage, and 2nd stage)

Secondary

MeasureTime frameDescription
Feasibility: EnrollmentDuration of the study, approximately 2 yearsNumber of consented participants who underwent cesarean section and Obstetrician agreed to randomization at huddle
10 Minute Uterine Tone Score between groupsDuration of the study, approximately 2 yearsUterine 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.
Incidence of Intraoperative Breakthrough Pain between groupsDuration of the study, approximately 2 years
Incidence of Intraoperative Vomiting between groupsDuration of the study, approximately 2 years
Total operative time between groupsDuration of the study, approximately 2 yearsMeasured in minutes from skin incision to closure
Time from fetal delivery to hysterotomy closure between groupsDuration of the study, approximately 2 yearsIn minutes

Contacts

CONTACTHannah Kyllo M. Resident Physician, MD
hkyllo@stanford.edu650-723-5403
STUDY_DIRECTORJess Ansari, MD, MS

Stanford University

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: May 28, 2026