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

NCT07606846 | Not Yet Recruiting

• 1 other identifier: 84585
• Study Type: interventional
• Target: 60
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Postpartum Hemorrhage; Uterine Atony; Uterine Atony With Hemorrhage; Cesarean Section

Keywords

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

Outcome Measures

Primary Outcomes (2)

• Compliance/Feasibility

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

  Duration of the study, approximately 2 years

• Efficacy Signal

  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

Secondary Outcomes (6)

• Feasibility: Enrollment

  Duration of the study, approximately 2 years

• 10 Minute Uterine Tone Score between groups

  Duration of the study, approximately 2 years

• Incidence of Intraoperative Breakthrough Pain between groups

  Duration of the study, approximately 2 years

• Incidence of Intraoperative Vomiting between groups

  Duration of the study, approximately 2 years

• Total operative time between groups

  Duration of the study, approximately 2 years

Study Arms (2)

Uterine Exteriorization

ACTIVE COMPARATOR

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.

Procedure: Comparator Intervention: Exteriorization

In Situ Repair

EXPERIMENTAL

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.

Procedure: Test Intervention: In Situ Repair

Interventions

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.

In Situ Repair

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.

Uterine Exteriorization

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Age 18-55
• Undergoing cesarean section

You may not qualify if:

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

Sponsors & Collaborators

• Stanford University: lead

MeSH Terms

Conditions

Postpartum Hemorrhage; Uterine Inertia

Condition Hierarchy (Ancestors)

Obstetric Labor Complications; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Puerperal Disorders; Uterine Hemorrhage; Hemorrhage; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Dystocia

Study Officials

• Jess Ansari, MD, MS

  Stanford University

  STUDY DIRECTOR

Central Study Contacts

Hannah Kyllo M. Resident Physician, MD

CONTACT

650-723-5403; hkyllo@stanford.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Resident

Model Details: 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.

Study Record Dates

• First Submitted: May 19, 2026
• First Posted: May 26, 2026
• Study Start: June 1, 2026
• Primary Completion (Estimated): June 1, 2029
• Study Completion (Estimated): June 1, 2029
• Last Updated: May 27, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share