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.
Tutkimuksen yleiskatsaus
Tila
Ehdot
Interventio / Hoito
Yksityiskohtainen kuvaus
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.
Opintotyyppi
Ilmoittautuminen (Arvioitu)
Vaihe
- Ei sovellettavissa
Yhteystiedot ja paikat
Opiskeluyhteys
- Nimi: Cristina Mula
- Puhelinnumero: +34 635486919
- Sähköposti: mula@clinic.cat
Opiskelupaikat
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Barcelona, Espanja
- Rekrytointi
- Hospital Clínic de Barcelona
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Ottaa yhteyttä:
- Cristina Mula
- Puhelinnumero: +34 635486919
- Sähköposti: mula@clinic.cat
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-
Osallistumiskriteerit
Kelpoisuusvaatimukset
Opintokelpoiset iät
Hyväksyy terveitä vapaaehtoisia
Sukupuolet, jotka voivat opiskella
Kuvaus
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.
Opintosuunnitelma
Miten tutkimus on suunniteltu?
Suunnittelun yksityiskohdat
- Ensisijainen käyttötarkoitus: Ennaltaehkäisy
- Jako: Satunnaistettu
- Inventiomalli: Rinnakkaistehtävä
- Naamiointi: Kolminkertaistaa
Aseet ja interventiot
Osallistujaryhmä / Arm |
Interventio / Hoito |
|---|---|
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Kokeellinen: 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. |
|
Active Comparator: 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. |
Mitä tutkimuksessa mitataan?
Ensisijaiset tulostoimenpiteet
Tulosmittaus |
Toimenpiteen kuvaus |
Aikaikkuna |
|---|---|---|
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Rate of Isthmocele
Aikaikkuna: Nine to twelve months after cesarean section.
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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
Aikaikkuna: Nine to twelve months after cesarean section.
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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.
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Toissijaiset tulostoimenpiteet
Tulosmittaus |
Toimenpiteen kuvaus |
Aikaikkuna |
|---|---|---|
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Intrauterine molecular markers of hypoxia and inflammation
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: Nine to twelve months after cesarean section.
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Nine to twelve months after cesarean section.
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Stiffness of the uterine scar
Aikaikkuna: 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
Aikaikkuna: 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.
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Yhteistyökumppanit ja tutkijat
Sponsori
Opintojen ennätyspäivät
Opi tärkeimmät päivämäärät
Opiskelun aloitus (Todellinen)
Ensisijainen valmistuminen (Arvioitu)
Opintojen valmistuminen (Arvioitu)
Opintoihin ilmoittautumispäivät
Ensimmäinen lähetetty
Ensimmäinen toimitettu, joka täytti QC-kriteerit
Ensimmäinen Lähetetty (Todellinen)
Tutkimustietojen päivitykset
Viimeisin päivitys julkaistu (Todellinen)
Viimeisin lähetetty päivitys, joka täytti QC-kriteerit
Viimeksi vahvistettu
Lisää tietoa
Tähän tutkimukseen liittyvät termit
Muita asiaankuuluvia MeSH-ehtoja
- Urogenitaaliset sairaudet
- Sukuelinten sairaudet
- Kipu
- Neurologiset ilmenemismuodot
- Patologiset prosessit
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