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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18+
SponsorHospital Clinic of Barcelona

About this 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.

Eligibility criteria

Qualifiers

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.

Disqualifiers

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.

Trial design

Treatments tested in this trial

  • Barbed suture
  • Conventional smooth suture

Treatment groups

364 Participants
are divided into 2 treatment groups

Sponsors and collaborators