Recruiting NA Isthmocele

New treatment option for Isthmocele

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

ClinicalTrials.gov ID: NCT06691750

What this study is testing

What it's testing
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.
  • Which group you join is decided by chance.

A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.

Who can take part

Ages 18 and older, women only. Healthy volunteers may be eligible.

You may be able to join if

  • 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.

You likely can't join if

  • 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.

The study team makes the final eligibility decision.

Where it's taking place

  • Barcelona, Spain

Questions & answers

Do participants get paid in this trial?

This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.

Is it free to join, and do I need insurance?

Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.

How long does this study last?

The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.

Who can join this trial?

This study is enrolling female, 18 years and older. Healthy volunteers may be eligible. The study team makes the final eligibility decision.

Where is this trial taking place?

Study sites include Barcelona, Spain. Enter your location above to see the nearest site and check your eligibility.

Explore other conditions

BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.