Clinical Impact of Uterine Repair During Cesarean Section with Barbed Suture on the Incidence of Isthmocele
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
Hospital Clinic of Barcelona
364 participants
Nov 22, 2024
INTERVENTIONAL
Conditions
Summary
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.
Eligibility
Inclusion Criteria4
- 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 Criteria5
- 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.
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Interventions
Size 0 barbed absorbable monofilament suture with unidirectional spikes that includes a loop in one of its ends, not requiring knots.
Size 1 smooth multifilament absorbable polyglactin suture.
Locations(1)
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NCT06691750