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Clinical Impact of Uterine Repair During Cesarean Section with Barbed Suture on the Incidence of Isthmocele

RecruitingNAAges 18 Years - anyFemaleHospital Clinic of Barcelona
NCT06691750 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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.

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📋 Eligibility rules (as published)
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.
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What it tests

  • Barbed suture
  • Conventional smooth suture
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Where

1 site
Hospital Clínic de Barcelona
Barcelona, Spain
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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