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- Klinische proef NCT07606846
Exteriorization Versus In Situ Hysterotomy Repair During Cesarean: Effects on Uterine Tone
22 mei 2026 bijgewerkt door: Hannah Marie Kyllo, Stanford University
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.
Studie Overzicht
Toestand
Nog niet aan het werven
Interventie / Behandeling
Gedetailleerde beschrijving
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.
Studietype
Ingrijpend
Inschrijving (Geschat)
60
Fase
- Niet toepasbaar
Contacten en locaties
In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.
Studiecontact
- Naam: Hannah Kyllo M. Resident Physician, MD
- Telefoonnummer: 650-723-5403
- E-mail: hkyllo@stanford.edu
Deelname Criteria
Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
- Volwassen
Accepteert gezonde vrijwilligers
Nee
Beschrijving
Inclusion Criteria:
- Age 18-55
- Undergoing cesarean section
Exclusion Criteria:
- Patient age <18 or >55
- Case urgency deemed too great for consent
Studie plan
Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.
Hoe is de studie opgezet?
Ontwerpdetails
- Primair doel: Ander
- Toewijzing: Gerandomiseerd
- Interventioneel model: Parallelle opdracht
- Masker: Enkel
Wapens en interventies
Deelnemersgroep / Arm |
Interventie / Behandeling |
|---|---|
|
Actieve vergelijker: Uterine Exteriorization
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.
|
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.
|
|
Experimenteel: In Situ Repair
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.
|
Repair of the hysterotomy (uterine incision) within the abdomen (in situ) after delivery of the infant during a cesarean section.
|
Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
|
Compliance/Feasibility
Tijdsspanne: Duration of the study, approximately 2 years
|
Percentage of consented cesarean participants who were successfully treated as randomly allocated in each arm
|
Duration of the study, approximately 2 years
|
|
Efficacy Signal
Tijdsspanne: 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)
|
Duration of the study, approximately 2 years
|
Secundaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
|
Feasibility: Enrollment
Tijdsspanne: Duration of the study, approximately 2 years
|
Number of consented participants who underwent cesarean section and Obstetrician agreed to randomization at huddle
|
Duration of the study, approximately 2 years
|
|
Incidence of Intraoperative Breakthrough Pain between groups
Tijdsspanne: Duration of the study, approximately 2 years
|
Duration of the study, approximately 2 years
|
|
|
Incidence of Intraoperative Vomiting between groups
Tijdsspanne: Duration of the study, approximately 2 years
|
Duration of the study, approximately 2 years
|
|
|
Total operative time between groups
Tijdsspanne: Duration of the study, approximately 2 years
|
Measured in minutes from skin incision to closure
|
Duration of the study, approximately 2 years
|
|
Time from fetal delivery to hysterotomy closure between groups
Tijdsspanne: Duration of the study, approximately 2 years
|
In minutes
|
Duration of the study, approximately 2 years
|
|
10 Minute Uterine Tone Score between groups
Tijdsspanne: 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.
|
Duration of the study, approximately 2 years
|
Medewerkers en onderzoekers
Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.
Sponsor
Onderzoekers
- Studie directeur: Jess Ansari, MD, MS, Stanford University
Studie record data
Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.
Bestudeer belangrijke data
Studie start (Geschat)
1 juni 2026
Primaire voltooiing (Geschat)
1 juni 2029
Studie voltooiing (Geschat)
1 juni 2029
Studieregistratiedata
Eerst ingediend
19 mei 2026
Eerst ingediend dat voldeed aan de QC-criteria
19 mei 2026
Eerst geplaatst (Werkelijk)
26 mei 2026
Updates van studierecords
Laatste update geplaatst (Werkelijk)
27 mei 2026
Laatste update ingediend die voldeed aan QC-criteria
22 mei 2026
Laatst geverifieerd
1 april 2026
Meer informatie
Termen gerelateerd aan deze studie
Trefwoorden
Aanvullende relevante MeSH-voorwaarden
- Urogenitale ziekten
- Pathologische processen
- Vrouwelijke urogenitale ziekten en zwangerschapscomplicaties
- Verloskundige arbeidscomplicaties
- Zwangerschap Complicaties
- Bloeding
- Puerperale aandoeningen
- Bloeding van de baarmoeder
- Dystocie
- Pathologische aandoeningen, tekenen en symptomen
- Post-partumbloeding
- Baarmoeder traagheid
Andere studie-ID-nummers
- 84585
Plan Individuele Deelnemersgegevens (IPD)
Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?
NEE
Beschrijving IPD-plan
No patient level data is anticipated to be shared with other researchers for future use after this study.
Informatie over medicijnen en apparaten, studiedocumenten
Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel
Nee
Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct
Nee
Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .