Clinical Impact of Uterine Repair During Cesarean Section With Barbed Suture on the Incidence of Isthmocele (CESARIS)
Clinical Impact of Uterine Repair During Cesarean Section With Barbed Suture on the Incidence of Isthmocele and Its Ultrasound and Molecular Characteristics: a Randomized Controlled Trial
Pregnant women, irrespective of their pregnancy risk, who undergo a cesarean section for any reason will be randomized to one of two suturing techniques: conventional suture or barbed suture for uterine repair after the cesarean section. Following surgery, these patients will be followed up for clinical outcomes, ultrasound evaluation of the uterine scar, and study of the hypoxic-inflammatory environment of the uterine cavity.
Przegląd badań
Status
Warunki
Interwencja / Leczenie
Szczegółowy opis
A randomized controlled trial will be conducted among pregnant women, irrespective of their pregnancy risk, undergoing cesarean sections at a tertiary care hospital. Participants will be randomly assigned to one of two groups: the intervention group, which will receive barbed suture for myometrial repair following the cesarean section, or the control group, which will receive conventional smooth suture. This study aims to compare a range of outcomes related to clinical, ultrasonographic, and molecular parameters of the uterine scar and the development of isthmocele.
Main hypothesis: The use of barbed suture for hysterorrhaphy during cesarean section, compared to conventional smooth sutures, results in reduced ischemia and necrosis of the myometrial tissue, facilitating better healing. This is associated with a lower incidence of isthmocele at six months postpartum, and a decrease in its ultrasound dimensions, evaluated by transvaginal ultrasound with hysterosonography.
Secondary hypothesis:
- The use of barbed suture during cesarean delivery leads to a reduction in molecular biomarker levels of hypoxia and inflammation within the uterine cavity.
- The employment of barbed suture is associated with a decrease in the frequency of symptoms related to isthmocele in the short term, or a lower intensity of symptoms if they occur, compared to conventional suture.
- Patients who develop isthmocele after cesarean delivery present predisposing myometrial characteristics and additional risk factors compared to patients with normal healing.
- The study of myometrial texture patterns based on ultrasound images of the uterine wall in the postpartum period following cesarean delivery may provide predictive data regarding the risk of developing isthmocele at six months postpartum.
- The stiffness of the uterine scar measured by the strain ratio (SR) is lower among patients included in the barbed suture group than in patients in the conventional suture group.
- Uterine repair with barbed suture during the cesarean section leads to better perinatal outcomes in the subsequent pregnancies.
Typ studiów
Zapisy (Szacowany)
Faza
- Nie dotyczy
Kontakty i lokalizacje
Kontakt w sprawie studiów
- Nazwa: Cristina Mula
- Numer telefonu: +34 635486919
- E-mail: mula@clinic.cat
Lokalizacje studiów
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Barcelona, Hiszpania
- Rekrutacyjny
- Hospital Clínic de Barcelona
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Kontakt:
- Cristina Mula
- Numer telefonu: +34 635486919
- E-mail: mula@clinic.cat
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-
Kryteria uczestnictwa
Kryteria kwalifikacji
Wiek uprawniający do nauki
Akceptuje zdrowych ochotników
Płeć kwalifikująca się do nauki
Opis
Inclusion Criteria:
- Pregnant women who deliver at Hospital Clinic of Barcelona by a planned, intrapartum or urgent cesarean section, irrespective of their pregnancy risk.
- Had accepted to participate in the study during the third trimester of gestation.
- Patients who accept a 6-month follow-up visit.
- Minimal maternal age of 18 years old.
Exclusion Criteria:
- Patients who end up delivering in another center.
- Patients who deliver by vaginal route.
- Patients diagnosed with isthmocele prior to the current pregnancy.
- Need for histerectomy in the following 6 months after delivery.
- Patients with known allergies to any of the components of the barbed suture.
Plan studiów
Jak projektuje się badanie?
Szczegóły projektu
- Główny cel: Zapobieganie
- Przydział: Randomizowane
- Model interwencyjny: Przydział równoległy
- Maskowanie: Potroić
Broń i interwencje
Grupa uczestników / Arm |
Interwencja / Leczenie |
|---|---|
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Eksperymentalny: Study Group: Uterine repair with barbed suture
Uterine closure following cesarean section is carried out using an unlocked single-layer barbed suture with an endometrium-free technique. |
Size 0 barbed absorbable monofilament suture with unidirectional spikes that includes a loop in one of its ends, not requiring knots. |
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Aktywny komparator: Control Group: Uterine repair with conventional smooth suture
Uterine repair following cesarean section is performed using a conventional smooth polyglactin suture with a continuous single-layer, endometrium-free technique, in accordance with the standard procedure at our center. |
Size 1 smooth multifilament absorbable polyglactin suture. |
Co mierzy badanie?
Podstawowe miary wyniku
Miara wyniku |
Opis środka |
Ramy czasowe |
|---|---|---|
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Rate of Isthmocele
Ramy czasowe: Nine to twelve months after cesarean section.
|
Rate of isthmocele at nine to twelve months after cesarean section examined by transvaginal ultrasonography with hysterosonography. |
Nine to twelve months after cesarean section.
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Ultrasonographic Measurements of Isthmocele
Ramy czasowe: Nine to twelve months after cesarean section.
|
Ultrasonographic characteristics of isthmocele measured by niche length, niche depth, niche width, residual myometrial thickness (RMT) and niche size (niche depth/niche depth+RMTx100[%]). |
Nine to twelve months after cesarean section.
|
Miary wyników drugorzędnych
Miara wyniku |
Opis środka |
Ramy czasowe |
|---|---|---|
|
Intrauterine molecular markers of hypoxia and inflammation
Ramy czasowe: Nine to twelve months after cesarean section.
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Concentrations of the following biomarkers will be assessed by analyzing an endocavitary lavage of the uterus: SDF-1/CXCL12 (an indirect marker of tissue hypoxia), G-CSF, IL-1β, IL-6, IL-10 and TNF-α (inflammatory cytokines). |
Nine to twelve months after cesarean section.
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Symptoms
Ramy czasowe: Nine to twelve months after cesarean section.
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Evaluation of symptoms related to CSD six months after cesarean section, measured as the presence of one or more of the following: prolonged postpartum bleeding, spotting, abnormal menstrual bleeding, dysmenorrhea, pelvic pain and/or dyspareunia. |
Nine to twelve months after cesarean section.
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Risk factors
Ramy czasowe: Through study completion, an average of 2 years.
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Collection of individual data in relation to the patient characteristics and the surgical procedure to evaluate potential risk factors. Individual data: Age at inclusion, ethnicity, educational level, parity, number of cesarean deliveries, history of uterine surgery or other abdominal surgeries, body mass index, smoking status, gestational or pregestational diabetes, hypertension, other medical conditions. Surgical data: Location of the hysterotomy, need for additional hemostatic sutures, need for hemostatic material at the surgical site, requirement for antifibrinolytic or uterotonic treatment to control bleeding, estimated blood loss during the surgery. |
Through study completion, an average of 2 years.
|
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Ultrasonographic myometrial texture patterns
Ramy czasowe: Nine to twelve months after cesarean section.
|
Nine to twelve months after cesarean section.
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Stiffness of the uterine scar
Ramy czasowe: Nine to twelve months after cesarean section.
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Stiffness differences of the uterine scar between the two groups will be compared by measuring the strain ratio (SR). |
Nine to twelve months after cesarean section.
|
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Perinatal outcomes in following pregnancies
Ramy czasowe: Through study completion, an average of 4 years.
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Perinatal outcomes in subsequent pregnancies will be measured as the presence of one of the following: miscarriage, ectopic pregnancy, uterine rupture, placental accretism, cesarean delivery among others. |
Through study completion, an average of 4 years.
|
Współpracownicy i badacze
Sponsor
Daty zapisu na studia
Główne daty studiów
Rozpoczęcie studiów (Rzeczywisty)
Zakończenie podstawowe (Szacowany)
Ukończenie studiów (Szacowany)
Daty rejestracji na studia
Pierwszy przesłany
Pierwszy przesłany, który spełnia kryteria kontroli jakości
Pierwszy wysłany (Rzeczywisty)
Aktualizacje rekordów badań
Ostatnia wysłana aktualizacja (Rzeczywisty)
Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości
Ostatnia weryfikacja
Więcej informacji
Terminy związane z tym badaniem
Słowa kluczowe
Dodatkowe istotne warunki MeSH
- Choroby układu moczowo-płciowego
- Choroby narządów płciowych
- Ból
- Objawy neurologiczne
- Procesy patologiczne
- Choroby układu moczowo-płciowego kobiet
- Choroby układu moczowo-płciowego kobiet i powikłania ciąży
- Choroby macicy
- Choroby narządów płciowych, kobiety
- Krwotok
- Krwotok z macicy
- Stany patologiczne, oznaki i objawy
- Objawy i symptomy
- Bezpłodność
- Ból miednicy
- Krwotok maciczny
Inne numery identyfikacyjne badania
- HCB/2024/0196
Plan dla danych uczestnika indywidualnego (IPD)
Planujesz udostępniać dane poszczególnych uczestników (IPD)?
Informacje o lekach i urządzeniach, dokumenty badawcze
Bada produkt leczniczy regulowany przez amerykańską FDA
Bada produkt urządzenia regulowany przez amerykańską FDA
produkt wyprodukowany i wyeksportowany z USA
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