IsthmoceleCESARISNCT06691750
Clinical Impact of Uterine Repair During Cesarean Section With Barbed Suture on the Incidence of Isthmocele
A study testing Barbed suture and Conventional smooth suture in people with Isthmocele and Cesarean Scar Defect, run by Hospital Clinic of Barcelona at 1 site in Spain.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Isthmocele, Cesarean Scar Defect, Pelvic Pain
- What is being tested?
- Barbed suture and Conventional smooth suture
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 420 participants
- Where
- 1 siteSpain
- Study dates
- 22 Nov 2024to May 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Spain1 site, 1 recruiting
- Recruiting
Hospital Clínic de Barcelona
Barcelona
Cristina Mula, +34 635486919, mula@clinic.cat
About this study
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
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.
Read the 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.
- Conditions
- Isthmocele, Cesarean Scar Defect, Pelvic Pain, Spotting, Infertility, Uterine Niche
- Being tested
- Barbed suture, Conventional smooth suture
- Keywords
- Isthmocele, Uterine niche, Cesarean scar defect, Barbed suture, Cesarean section
- Medical subject headings
- Pelvic Pain, Metrorrhagia, Infertility
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Barbed sutureDevice
Size 0 barbed absorbable monofilament suture with unidirectional spikes that includes a loop in one of its ends, not requiring knots.
Conventional smooth sutureDevice
Size 1 smooth multifilament absorbable polyglactin suture.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Device: Conventional smooth suture |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of Isthmocele
Rate of isthmocele at nine to twelve months after cesarean section examined by transvaginal ultrasonography with hysterosonography.
Measured: Nine to twelve 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[%]).
Measured: Nine to twelve months after cesarean section.
Secondary outcomes (6)
Intrauterine molecular markers of hypoxia and inflammation
Concentrations of the following biomarkers will be assessed by analyzing an endocavitary lavage of the uterus: SDF-1/CXCL12 (an indirect marker of tissue hypoxia), G-CSF, IL-1β, IL-6, IL-10 and TNF-α (inflammatory cytokines).
Measured: Nine to twelve 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.
Measured: Nine to twelve 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.
Measured: Through study completion, an average of 2 years.
Ultrasonographic myometrial texture patterns
Measured: Nine to twelve 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).
Measured: Nine to twelve 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.
Measured: Through study completion, an average of 4 years.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Nov 2024
- Study start22 Nov 2024
- Primary completionDec 2027 (estimated)
- Study completionMay 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for IsthmoceleStudies of the same condition, open and under way.
- More trials run by Hospital Clinic of BarcelonaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- A randomized, controlled, triple-blind, two-parallel clinical trial.
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 420 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hospital Clinic of Barcelona
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Cristina Mula Navarro, Hospital Clinic of Barcelona
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06691750
- Sponsor's protocol ID
- HCB/2024/0196
- Acronym
- CESARIS
- Status last verified
- Oct 2026
- First submitted
- 12 Nov 2024
- Last updated
- 3 Nov 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06691750
- Acronym / sponsor ID
- CESARIS / HCB/2024/0196
- Conditions
- Isthmocele, Cesarean Scar Defect, Pelvic Pain, Spotting, Infertility, Uterine Niche
- Keywords
- Isthmocele, Uterine niche, Cesarean scar defect, Barbed suture, Cesarean section
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 420 participants (estimated)
- Lead sponsor
- Hospital Clinic of BarcelonaUniversity, hospital or other
- Study start
- 22 Nov 2024 (actual)
- Primary completion
- Dec 2027 (estimated)
- Study completion
- May 2028 (estimated)
- First posted
- 15 Nov 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- A randomized, controlled, triple-blind, two-parallel clinical trial.
| Arm | Type | Receives |
|---|---|---|
| Study Group: Uterine repair with barbed suture | Experimental | Device: Barbed sutureUterine closure following cesarean section is carried out using an unlocked single-layer barbed suture with an endometrium-free technique. |
| Control Group: Uterine repair with conventional smooth suture | Active comparator | Device: Conventional smooth sutureUterine 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Barbed sutureSize 0 barbed absorbable monofilament suture with unidirectional spikes that includes a loop in one of its ends, not requiring knots. | Device | Study Group: Uterine repair with barbed suture |
| Conventional smooth sutureSize 1 smooth multifilament absorbable polyglactin suture. | Device | Control Group: Uterine repair with conventional smooth suture |
Primary outcome
Rate of Isthmocele
Time frame: Nine to twelve months after cesarean section.
Rate of isthmocele at nine to twelve months after cesarean section examined by transvaginal ultrasonography with hysterosonography.
Ultrasonographic Measurements of Isthmocele
Time frame: Nine to twelve months after cesarean section.
Ultrasonographic characteristics of isthmocele measured by niche length, niche depth, niche width, residual myometrial thickness (RMT) and niche size (niche depth/niche depth+RMTx100[%]).
6 secondary outcomes
Intrauterine molecular markers of hypoxia and inflammation
Time frame: Nine to twelve months after cesarean section.
Symptoms
Time frame: Nine to twelve months after cesarean section.
Risk factors
Time frame: Through study completion, an average of 2 years.
Ultrasonographic myometrial texture patterns
Time frame: Nine to twelve months after cesarean section.
Stiffness of the uterine scar
Time frame: Nine to twelve months after cesarean section.
Perinatal outcomes in following pregnancies
Time frame: Through study completion, an average of 4 years.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Nov 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Barbed suture and Conventional smooth suture in people with Isthmocele and Cesarean Scar Defect, run by Hospital Clinic of Barcelona at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 3 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Cristina Mula (+34 635486919, mula@clinic.cat), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rate of Isthmocele (time frame: Nine to twelve months after cesarean section.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Nov 2026.