An interventional study of Test Intervention: In Situ Repair and Comparator Intervention: Exteriorization in Postpartum Hemorrhage, Uterine Atony and Uterine Atony With Hemorrhage, sponsored by Stanford University. Not yet recruiting. Open to female participants aged 18 Years to 55 Years. Per ClinicalTrials.gov, last updated 2026-05-27.
Sponsored by Stanford University · Not applicable, Interventional, and Other
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.
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.
469 studies on the registry are indexed under Postpartum Hemorrhage; 76 are open to participants now.
This study's planned enrollment of 60 is below the median of 148 across 360 interventional studies indexed under Postpartum Hemorrhage.
Browse Postpartum Hemorrhage studies →Stanford University is the lead sponsor of 2,168 studies on the registry; 431 are open to participants now.
Of its 267 completed or terminated interventional studies of FDA-regulated products, 207 (78%) have results posted.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
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
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
Repair of the hysterotomy (uterine incision) within the abdomen (in situ) after delivery of the infant during a cesarean section.
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.
Compliance/Feasibility
Percentage of consented cesarean participants who were successfully treated as randomly allocated in each arm
Time frame: 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)
Time frame: Duration of the study, approximately 2 years
Feasibility: Enrollment
Number of consented participants who underwent cesarean section and Obstetrician agreed to randomization at huddle
Time frame: 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.
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
Measured in minutes from skin incision to closure
Time frame: Duration of the study, approximately 2 years
Time from fetal delivery to hysterotomy closure between groups
In minutes
Time frame: Duration of the study, approximately 2 years
No study locations are listed for this record.
Plan to share: No — No patient level data is anticipated to be shared with other researchers for future use after this study.
No publications or documents are linked to this record.
Start is estimated for Jun 2026; primary completion for Jun 2029, 36 months later.
Of 112 non-industry interventional studies with no phase under Postpartum Hemorrhage, half reached primary completion within 16 months of starting (the median), counting those still running; a quarter within 7 and three quarters within 26. This study's planned 36 months is above that.
Counting every sponsor, half of 119 studies reached it within 16 months; a quarter within 7 and three quarters within 26.
How these figures are worked out, and which studies are left out of them.
This study is not yet recruiting, as verified in Apr 2026. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.