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

NCT06691750 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 364

Last updated 2025-03-13

No results posted yet for this study

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.

Conditions

  • Isthmocele
  • Cesarean Scar Defect
  • Pelvic Pain
  • Spotting
  • Infertility
  • Uterine Niche
  • Uterine Abnormal Bleeding
  • Niche

Interventions

DEVICE

Barbed suture

Size 0 barbed absorbable monofilament suture with unidirectional spikes that includes a loop in one of its ends, not requiring knots.

DEVICE

Conventional smooth suture

Size 1 smooth multifilament absorbable polyglactin suture.

Sponsors & Collaborators

  • Hospital Clinic of Barcelona

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2024-11-22
Primary Completion
2027-11-30
Completion
2028-05-31

Countries

  • Spain

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06691750 on ClinicalTrials.gov