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

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

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.

Study Overview

• Status: Recruiting
• Conditions: Infertility; Pelvic Pain; Uterine Niche; Isthmocele; Spotting; Cesarean Scar Defect; Niche; Uterine Abnormal Bleeding
• Intervention / Treatment: Device: Barbed suture; Device: Conventional smooth suture

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.

• Study Type: Interventional
• Enrollment (Estimated): 364
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Cristina Mula; Phone Number: +34 635486919; Email: mula@clinic.cat

Study Locations

• Spain
  • Barcelona, Spain
    • Recruiting
    • Hospital Clinic de Barcelona
    • Contact: Cristina Mula; Phone Number: +34 635486919; Email: mula@clinic.cat

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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.	Device: Barbed suture; Size 0 barbed absorbable monofilament suture with unidirectional spikes that includes a loop in one of its ends, not requiring knots.
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.	Device: Conventional smooth suture; Size 1 smooth multifilament absorbable polyglactin suture.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Intrauterine molecular markers of hypoxia and inflammation	Concentrations of the following biomarkers will be assessed by analyzing an endocavitary lavage of the uterus: VEGF-A (an indirect marker of tissue hypoxia associated with angiogenesis and vasculogenesis), G-CSF, IL-1β, IL-6, IL-10, and TNF-α (inflammatory cytokines), as well as HIF1A (hypoxia-inducible transcription factor).	Six months after cesarean section.
Symptoms	Evaluation of symptoms related to CSD six months after cesarean section, measured as the presence of one or more of the following: prolonged postpartum bleeding, spotting, abnormal menstrual bleeding, dysmenorrhea, pelvic pain and/or dyspareunia.	Six months after cesarean section.
Risk factors	Collection of individual data in relation to the patient characteristics and the surgical procedure to evaluate potential risk factors. Individual data: Age at inclusion, ethnicity, educational level, parity, number of cesarean deliveries, history of uterine surgery or other abdominal surgeries, body mass index, smoking status, gestational or pregestational diabetes, hypertension, other medical conditions. Surgical data: Location of the hysterotomy, need for additional hemostatic sutures, need for hemostatic material at the surgical site, requirement for antifibrinolytic or uterotonic treatment to control bleeding, estimated blood loss during the surgery.	Through study completion, an average of 2 years.
Ultrasonographic myometrial texture patterns		Six months after cesarean section.
Stiffness of the uterine scar	Stiffness differences of the uterine scar between the two groups will be compared by measuring the strain ratio (SR).	Six months after cesarean section.
Perinatal outcomes in following pregnancies	Perinatal outcomes in subsequent pregnancies will be measured as the presence of one of the following: miscarriage, ectopic pregnancy, uterine rupture, placental accretism, cesarean delivery among others.	Through study completion, an average of 4 years.

Collaborators and Investigators

• Sponsor: Hospital Clinic of Barcelona

Study record dates

Study Major Dates

• Study Start (Actual): November 22, 2024
• Primary Completion (Estimated): November 1, 2027
• Study Completion (Estimated): May 1, 2028

Study Registration Dates

• First Submitted: November 12, 2024
• First Submitted That Met QC Criteria: November 14, 2024
• First Posted (Actual): November 15, 2024

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: March 10, 2025
• Last Verified: November 1, 2024

More Information

Terms related to this study

• Keywords: Cesarean section; Isthmocele; Barbed suture; Uterine niche; Cesarean scar defect
• Additional Relevant MeSH Terms: Urogenital Diseases; Genital Diseases; Pain; Neurologic Manifestations; Infertility; Pelvic Pain
• Other Study ID Numbers: HCB/2024/0196

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No