Clinical Impact of Uterine Repair During Cesarean Section with Barbed Suture on the Incidence of Isthmocele
NCT ID: NCT06691750
Last Updated: 2025-03-13
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
364 participants
INTERVENTIONAL
2024-11-22
2028-05-31
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
TRIPLE
Study Groups
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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.
Barbed suture
Size 0 barbed absorbable monofilament suture with unidirectional spikes that includes a loop in one of its ends, not requiring knots.
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.
Conventional smooth suture
Size 1 smooth multifilament absorbable polyglactin suture.
Interventions
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Barbed suture
Size 0 barbed absorbable monofilament suture with unidirectional spikes that includes a loop in one of its ends, not requiring knots.
Conventional smooth suture
Size 1 smooth multifilament absorbable polyglactin suture.
Eligibility Criteria
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Inclusion Criteria
* 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 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.
18 Years
FEMALE
Yes
Sponsors
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Hospital Clinic of Barcelona
OTHER
Responsible Party
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Cristina Mula Navarro
SPECIALIST IN OBSTETRIC AND GYNECOLOGY, MD
Locations
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Hospital Clínic de Barcelona
Barcelona, , Spain
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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HCB/2024/0196
Identifier Type: -
Identifier Source: org_study_id
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