- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT07606846
Exteriorization Versus In Situ Hysterotomy Repair During Cesarean: Effects on Uterine Tone
22. maj 2026 opdateret af: 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.
Studieoversigt
Status
Ikke rekrutterer endnu
Intervention / Behandling
Detaljeret beskrivelse
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.
Undersøgelsestype
Interventionel
Tilmelding (Anslået)
60
Fase
- Ikke anvendelig
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiekontakt
- Navn: Hannah Kyllo M. Resident Physician, MD
- Telefonnummer: 650-723-5403
- E-mail: hkyllo@stanford.edu
Deltagelseskriterier
Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.
Berettigelseskriterier
Aldre berettiget til at studere
- Voksen
Tager imod sunde frivillige
Ingen
Beskrivelse
Inclusion Criteria:
- Age 18-55
- Undergoing cesarean section
Exclusion Criteria:
- Patient age <18 or >55
- Case urgency deemed too great for consent
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Andet
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Enkelt
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
|
Aktiv komparator: 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.
|
|
Eksperimentel: 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.
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Compliance/Feasibility
Tidsramme: 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
Tidsramme: 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
|
Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Feasibility: Enrollment
Tidsramme: 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
Tidsramme: Duration of the study, approximately 2 years
|
Duration of the study, approximately 2 years
|
|
|
Incidence of Intraoperative Vomiting between groups
Tidsramme: Duration of the study, approximately 2 years
|
Duration of the study, approximately 2 years
|
|
|
Total operative time between groups
Tidsramme: 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
Tidsramme: Duration of the study, approximately 2 years
|
In minutes
|
Duration of the study, approximately 2 years
|
|
10 Minute Uterine Tone Score between groups
Tidsramme: 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
|
Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Sponsor
Efterforskere
- Studieleder: Jess Ansari, MD, MS, Stanford University
Datoer for undersøgelser
Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.
Studer store datoer
Studiestart (Anslået)
1. juni 2026
Primær færdiggørelse (Anslået)
1. juni 2029
Studieafslutning (Anslået)
1. juni 2029
Datoer for studieregistrering
Først indsendt
19. maj 2026
Først indsendt, der opfyldte QC-kriterier
19. maj 2026
Først opslået (Faktiske)
26. maj 2026
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
27. maj 2026
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
22. maj 2026
Sidst verificeret
1. april 2026
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- 84585
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
INGEN
IPD-planbeskrivelse
No patient level data is anticipated to be shared with other researchers for future use after this study.
Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter
Studerer et amerikansk FDA-reguleret lægemiddelprodukt
Ingen
Studerer et amerikansk FDA-reguleret enhedsprodukt
Ingen
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