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

NCT06691750 | Recruiting

• 1 other identifier: HCB/2024/0196
• Study Type: interventional
• Target: 364
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Isthmocele; Uterine niche; Cesarean scar defect; Barbed suture; Cesarean section

Outcome Measures

Primary Outcomes (2)

• Rate of Isthmocele

  Rate of isthmocele six months after cesarean section examined by transvaginal ultrasonography with hysterosonography.

  Six months after cesarean section.

• Ultrasonographic Measurements of Isthmocele

  Ultrasonographic characteristics of isthmocele measured by niche length, niche depth, niche width, residual myometrial thickness (RMT) and niche size (niche depth/niche depth+RMTx100\[%\]).

  Six months after cesarean section.

Secondary Outcomes (6)

• Intrauterine molecular markers of hypoxia and inflammation

  Six months after cesarean section.

• Symptoms

  Six months after cesarean section.

• Risk factors

  Through study completion, an average of 2 years.

• Ultrasonographic myometrial texture patterns

  Six months after cesarean section.

• Stiffness of the uterine scar

  Six months after cesarean section.

Study Arms (2)

Study Group: Uterine repair with barbed suture

EXPERIMENTAL

Uterine closure following cesarean section is carried out using an unlocked single-layer barbed suture with an endometrium-free technique.

Device: Barbed suture

Control Group: Uterine repair with conventional smooth suture

ACTIVE COMPARATOR

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.

Device: Conventional smooth suture

Interventions

Barbed suture DEVICE

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

Study Group: Uterine repair with barbed suture

Conventional smooth suture DEVICE

Size 1 smooth multifilament absorbable polyglactin suture.

Control Group: Uterine repair with conventional smooth suture

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify 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 may not qualify 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.

Sponsors & Collaborators

• Hospital Clinic of Barcelona: lead

Study Sites (1)

Hospital Clínic de Barcelona

Barcelona, Spain

RECRUITING

MeSH Terms

Conditions

Pelvic Pain; Metrorrhagia; Infertility

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Uterine Hemorrhage; Uterine Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Hemorrhage; Pathologic Processes

Central Study Contacts

Cristina Mula

CONTACT

+34 635486919; mula@clinic.cat

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: SPECIALIST IN OBSTETRIC AND GYNECOLOGY, MD

Model Details: A randomized, controlled, double-blind, two-parallel clinical trial.

Study Record Dates

• First Submitted: November 12, 2024
• First Posted: November 15, 2024
• Study Start: November 22, 2024
• Primary Completion (Estimated): November 1, 2027
• Study Completion (Estimated): May 1, 2028
• Last Updated: March 13, 2025

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)