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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

Status: Recruiting
Location: See location...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
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
Participation Requirements
Sex: Female
Minimum Age: 18
Healthy Volunteers: t
View:

• 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.

Locations
Other Locations
Spain
Hospital Clínic de Barcelona
RECRUITING
Barcelona
Contact Information
Primary
Cristina Mula
mula@clinic.cat
+34 635486919
Time Frame
Start Date: 2024-11-22
Estimated Completion Date: 2028-05
Participants
Target number of participants: 364
Treatments
Experimental: 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.
Active_comparator: 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.
Related Therapeutic Areas
Sponsors
Leads: Hospital Clinic of Barcelona

This content was sourced from clinicaltrials.gov