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

Study acronym: CESARIS
StatusRecruiting
PhaseNot applicable
Started
View on ClinicalTrials.gov ↗

Record History

  1. Trial status: Not Yet Recruiting to Recruiting
    • Study sites: 0 to 1
    • Start date changed from estimate of Nov 2024 to Nov 22, 2024
    v2
  2. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT06691750
Lead Sponsor Hospital Clinic of Barcelona
Conditions
(from sponsor)		 Isthmocele, Cesarean Scar Defect, Pelvic Pain, Spotting, Infertility, Uterine Niche, Uterine Abnormal Bleeding, Niche
Related terms Infertility, Metrorrhagia, Pelvic Pain
Enrollment 364 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov