Postpartum HemorrhageNCT07606846
Exteriorization Versus In Situ Hysterotomy Repair During Cesarean: Effects on Uterine Tone
A study testing Test Intervention: In Situ Repair and Comparator Intervention: Exteriorization in people with Postpartum Hemorrhage and Uterine Atony, run by Stanford University.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 to 55 years, women only
- Conditions the study is for
- Postpartum Hemorrhage, Uterine Atony, Uterine Atony With Hemorrhage
- What is being tested?
- Test Intervention: In Situ Repair and Comparator Intervention: Exteriorization
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- No sites listed yet
- Study dates
- 1 Jun 2026to 1 Jun 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 55 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Age 18-55
- Undergoing cesarean section
Who cannot join
- Patient age <18 or >55
- Case urgency deemed too great for consent
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: 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.
Read the 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.
- Being tested
- Test Intervention: In Situ Repair, Comparator Intervention: Exteriorization
- Keywords
- Postpartum Hemorrhage, Uterine Atony, Uterine Atony with Hemorrhage, Cesarean Section, Cesarean Delivery, Uterine Tone
- Medical subject headings
- Postpartum Hemorrhage, Uterine Inertia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Test Intervention: In Situ RepairProcedure or surgery
Repair of the hysterotomy (uterine incision) within the abdomen (in situ) after delivery of the infant during a cesarean section.
Comparator Intervention: ExteriorizationProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Procedure: Test Intervention: In Situ Repair |
What is being measured
The primary outcome is the main question the study is designed to answer.
Compliance/Feasibility
Percentage of consented cesarean participants who were successfully treated as randomly allocated in each arm
Measured: 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)
Measured: Duration of the study, approximately 2 years
Secondary outcomes (6)
Feasibility: Enrollment
Number of consented participants who underwent cesarean section and Obstetrician agreed to randomization at huddle
Measured: Duration of the study, approximately 2 years
10 Minute Uterine Tone Score between groups
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.
Measured: Duration of the study, approximately 2 years
Incidence of Intraoperative Breakthrough Pain between groups
Measured: Duration of the study, approximately 2 years
Incidence of Intraoperative Vomiting between groups
Measured: Duration of the study, approximately 2 years
Total operative time between groups
Measured in minutes from skin incision to closure
Measured: Duration of the study, approximately 2 years
Time from fetal delivery to hysterotomy closure between groups
In minutes
Measured: Duration of the study, approximately 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 May 2026
- Study start1 Jun 2026 (estimated)
- Primary completion1 Jun 2029 (estimated)
- Study completion1 Jun 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Postpartum HemorrhageStudies of the same condition, open and under way.
- More trials run by Stanford UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Stanford University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hannah Marie Kyllo, Stanford University
- Investigators
- Jess Ansari, MD, MS, Study director, Stanford University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07606846
- Sponsor's protocol ID
- 84585
- Status last verified
- Apr 2026
- First submitted
- 19 May 2026
- Last updated
- 27 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: No patient level data is anticipated to be shared with other researchers for future use after this study.
Study at a glance
From the registry record, last updated by the sponsor on 27 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Uterine Exteriorization Versus In Situ Hysterectomy Repair During Cesarean Delivery: A Pilot Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07606846
- Acronym / sponsor ID
- 84585
- Keywords
- Postpartum Hemorrhage, Uterine Atony, Uterine Atony with Hemorrhage, Cesarean Section, Cesarean Delivery, Uterine Tone
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Stanford UniversityUniversity, hospital or other
- Study start
- 1 Jun 2026 (estimated)
- Primary completion
- 1 Jun 2029 (estimated)
- Study completion
- 1 Jun 2029 (estimated)
- First posted
- 26 May 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Uterine Exteriorization | Active comparator | Procedure: Comparator Intervention: ExteriorizationFor 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. |
| In Situ Repair | Experimental | Procedure: Test Intervention: In Situ RepairFor 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. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Age 18-55
- Undergoing cesarean section
Key exclusion criteria (2 listed)
- Patient age <18 or >55
- Case urgency deemed too great for consent
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Test Intervention: In Situ RepairRepair of the hysterotomy (uterine incision) within the abdomen (in situ) after delivery of the infant during a cesarean section. | Procedure or surgery | In Situ Repair |
| Comparator Intervention: ExteriorizationThe uterus will be temporarily exteriorized from the abdomen for repair of the hysterotomy (uterine incision) after delivery of the infant in a cesarean section. | Procedure or surgery | Uterine Exteriorization |
Primary outcome
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
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)
6 secondary outcomes
Feasibility: Enrollment
Time frame: Duration of the study, approximately 2 years
10 Minute Uterine Tone Score between groups
Time frame: Duration of the study, approximately 2 years
Incidence of Intraoperative Breakthrough Pain between groups
Time frame: Duration of the study, approximately 2 years
Incidence of Intraoperative Vomiting between groups
Time frame: Duration of the study, approximately 2 years
Total operative time between groups
Time frame: Duration of the study, approximately 2 years
Time from fetal delivery to hysterotomy closure between groups
Time frame: Duration of the study, approximately 2 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 May 2026.
- Individual participant dataSharing planned: No. No patient level data is anticipated to be shared with other researchers for future use after this study.
Related trials for Postpartum Hemorrhage
Not yet recruiting
Comparison of Effect of Two Different Doses of Intravenous Oxytocin on Patients Undergoing Elective Cesarean Section
Postpartum Hemorrhage, Uterine Atony
RecruitingPhase 3
Tranexamic Acid to Prevent Heavy Bleeding After Childbirth in Women at Higher Risk
Postpartum Hemorrhage
Not yet recruitingObservational study
Measured Versus Hemoglobin-Calculated Postpartum Blood Loss in Waterbirth
Postpartum Hemorrhage, Waterbirth
RecruitingObservational study
Long Term Outcome After Use of Vacuum-induced Tamponade for Postpartum Hemorrhage
Postpartum Hemorrhage, Treatment Outcome
RecruitingPhase 2
Prevention of Postpartum Hemorrhage With Tranexamic Acid
Post Partum Hemorrhage
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Jess Ansari, MD, MS study director
Stanford University
Questions about this trial
What is this clinical trial studying?
A study testing Test Intervention: In Situ Repair and Comparator Intervention: Exteriorization in people with Postpartum Hemorrhage and Uterine Atony, run by Stanford University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 27 May 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Hannah Kyllo M. Resident Physician, MD (650-723-5403, hkyllo@stanford.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Compliance/Feasibility (time frame: Duration of the study, approximately 2 years). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 May 2026.