Clinical trial NCT06691750: Clinical Impact of Uterine Repair During Cesarean Section with Barbed Suture on the Incidence of Isthmocele
Official title: 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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
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
Lead sponsor: Hospital Clinic of Barcelona
Sponsor class: OTHER
First posted: 2024-11-15
Enrollment: 364
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: A randomized, controlled, double-blind, two-parallel clinical trial.
Primary purpose: PREVENTION

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.

Detailed description: A randomized controlled trial will be conducted among pregnant women, irrespective of their pregnancy risk, undergoing cesarean sections at a tertiary care hospital. Participants will be randomly assigned to one of two groups: the intervention group, which will receive barbed suture for myometrial repair following the cesarean section, or the control group, which will receive conventional smooth suture. This study aims to compare a range of outcomes related to clinical, ultrasonographic, and molecular parameters of the uterine scar and the development of isthmocele.

Main hypothesis: The use of barbed suture for hysterorrhaphy during cesarean section, compared to conventional smooth sutures, results in reduced ischemia and necrosis of the myometrial tissue, facilitating better healing. This is associated with a lower incidence of isthmocele at six months postpartum, and a decrease in its ultrasound dimensions, evaluated by transvaginal ultrasound with hysterosonography.

Secondary hypothesis:

* The use of barbed suture during cesarean delivery leads to a reduction in molecular biomarker levels of hypoxia and inflammation within the uterine cavity.
* The employment of barbed suture is associated with a decrease in the frequency of symptoms related to isthmocele in the short term, or a lower intensity of symptoms if they occur, compared to conventional suture.
* Patients who develop isthmocele after cesarean delivery present predisposing myometrial characteristics and additional risk factors compared to patients with normal healing.
* The study of myometrial texture patterns based on ultrasound images of the uterine wall in the postpartum period following cesarean delivery may provide predictive data regarding the risk of developing isthmocele at six months postpartum.
* The stiffness of the uterine scar measured by the strain ratio (SR) is lower among patients included in the barbed suture group than in patients in the conventional suture group.
* Uterine repair with barbed suture during the cesarean section leads to better perinatal outcomes in the subsequent pregnancies.

Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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.

Primary outcomes:
measure: Rate of Isthmocele
timeFrame: Six months after cesarean section.
measure: Ultrasonographic Measurements of Isthmocele
timeFrame: Six months after cesarean section.
Secondary outcomes:
measure: Intrauterine molecular markers of hypoxia and inflammation
timeFrame: Six months after cesarean section.
measure: Symptoms
timeFrame: Six months after cesarean section.
measure: Risk factors
timeFrame: Through study completion, an average of 2 years.
measure: Ultrasonographic myometrial texture patterns
timeFrame: Six months after cesarean section.
measure: Stiffness of the uterine scar
timeFrame: Six months after cesarean section.
measure: Perinatal outcomes in following pregnancies
timeFrame: Through study completion, an average of 4 years.
Other outcomes:
Locations:
city: Barcelona
country: Spain
facility: Hospital Clínic de Barcelona
Study officials:
References: