IsthmoceleNCT04825821
Cesarean Scar Defects After Uterine Closure by Double-layer Barbed or Smooth Suture
An observational study of Isthmocele and Uterine Scar Defects, run by Ospedale Policlinico San Martino at 1 site in Italy.
Trial summary
Late sequelae of a cesarean section related to a uterine scar defects include gynecological symptoms and obstetric complications. The aim of this study was to evaluate the incidence and characteristics of cesarean scar defects after uterine closure by double-layer barbed suture. 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, Uterine Scar Defects, Cesarean Section Complications
- What is being tested?
- Clinical and ultrasonographic assessment
- Type of treatment
- Surgery or procedure
- How many people
- 247 participants
- Where
- 1 siteItaly
- Study dates
- 1 Mar 2019to 30 Sep 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
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
Study population: Patients who underwent elective cesarean section at ≥37 weeks of gestation
Who may be able to join
- Patients who underwent elective cesarean section at ≥ 37 weeks of gestation
Who cannot join
- Patients who underwent concomitant surgical procedures during the cesarean section (i.e., tubal sterilization);
- Patients who underwent a previous abdominal surgery (with exception of appendectomy) including a cesarean section or other laparotomic/laparoscopic uterine surgical procedure (i.e., myomectomy);
- Patients who had a previous diagnosis of Mullerian uterine anomalies elective cesarean for the second time or after uterine surgery;
- Patients who had evidence of PAS disorders or placenta previa.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Prospective Pilot Study Comparing Incidence and Characteristics of Cesarean Scar Defects After Uterine Closure by Double-layer Barbed or Smooth Suture
Late sequelae of a cesarean section related to a uterine scar defects include gynecological symptoms and obstetric complications. The aim of this study was to evaluate the incidence and characteristics of cesarean scar defects after uterine closure by double-layer barbed suture.
- Being tested
- Clinical and ultrasonographic assessment
- Keywords
- Uterine scar defects, Uterine niche, Isthmocele
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Clinical and ultrasonographic assessmentProcedure or surgery
Routinely assessment by objective examination and transvaginal ultrasonographic scan 6, 12, and 24 months after the surgical procedures
| Study group | Role | What they receive |
|---|---|---|
| Low transverse hysterotomy closed by double-layer unidirectional barbed suture | Patients who had undergone cesarean section during which the low transverse hysterotomy was closed by double-layer unidirectional barbed suture Receives: Procedure: Clinical and ultrasonographic assessment | |
| Low transverse hysterotomy closed by conventional double-layer smooth suture | Patients who had undergone cesarean section during which the low transverse hysterotomy was closed by conventional double-layer smooth suture Receives: Procedure: Clinical and ultrasonographic assessment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of uterine scar defects
Number of simple and complex uterine scar defects is evaluated by transvaginal ultrasound
Measured: 6 months after the cesarean section
Number of uterine scar defects
Number of simple and complex uterine scar defects is evaluated by transvaginal ultrasound
Measured: 12 months after the cesarean section
Number of uterine scar defects
Number of simple and complex uterine scar defects is evaluated by transvaginal ultrasound
Measured: 24 months after the cesarean section
Secondary outcomes (9)
Residual myometrium thickness (RMT), depth, width and length of uterine scar defects
RMT, depth, width, and length are evaluated by transvaginal ultrasound
Measured: 6 months after the cesarean section
Residual myometrium thickness (RMT), depth, width and length of uterine scar defects
RMT, depth, width, and length are evaluated by transvaginal ultrasound
Measured: 12 months after the cesarean section
Residual myometrium thickness (RMT), depth, width and length of uterine scar defects
RMT, depth, width, and length are evaluated by transvaginal ultrasound
Measured: 24 months after the cesarean section
Number of patients with postmenstrual spotting
Number of patients with postmenstrual spotting is evaluated by medical interview
Measured: 6 months after the cesarean section
Number of patients with postmenstrual spotting
Number of patients with postmenstrual spotting is evaluated by medical interview
Measured: 12 months after the cesarean section
Number of patients with postmenstrual spotting
Number of patients with postmenstrual spotting is evaluated by medical interview
Measured: 24 months after the cesarean section
Number of patients with dysmenorrhea
Number of patients with dysmenorrhea is evaluated by medical interview with VAS (visual analogue scale)
Measured: 6 months after the cesarean section
Number of patients with dysmenorrhea
Number of patients with dysmenorrhea is evaluated by medical interview with VAS (visual analogue scale)
Measured: 12 months after the cesarean section
Number of patients with dysmenorrhea
Number of patients with dysmenorrhea is evaluated by medical interview with VAS (visual analogue scale)
Measured: 24 months after the cesarean section
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Apr 2021
- Study start1 Mar 2019
- Primary completion30 Jul 2022
- Study completion30 Sep 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for IsthmoceleStudies of the same condition, open and under way.
- 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
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 247 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ospedale Policlinico San Martino
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Fabio Barra, Ospedale Policlinico San Martino
- Investigators
- Fabio Barra, MD, Principal investigator, IRCCS Ospedale Policlinico San Martino
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04825821
- Sponsor's protocol ID
- BARB-CSCAR
- Status last verified
- Dec 2022
- First submitted
- 27 Mar 2021
- Last updated
- 30 Dec 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Agarwal S, D'Souza R, Ryu M, Maxwell C. Barbed vs conventional suture at cesarean delivery: A systematic review and meta-analysis. Acta Obstet Gynecol Scand. 2021 Jun;100(6):1010-1018. doi: 10.1111/aogs.14080. Epub 2021 Feb 5.
PubMed 33404082Alessandri F, Evangelisti G, Centurioni MG, Gustavino C, Ferrero S, Barra F. Fishbone double-layer barbed suture in cesarean section: a help in preventing long-term obstetric sequelae? Arch Gynecol Obstet. 2021 Sep;304(3):573-576. doi: 10.1007/s00404-021-06121-8.
PubMed 34146146Jordans IPM, de Leeuw RA, Stegwee SI, Amso NN, Barri-Soldevila PN, van den Bosch T, Bourne T, Brolmann HAM, Donnez O, Dueholm M, Hehenkamp WJK, Jastrow N, Jurkovic D, Mashiach R, Naji O, Streuli I, Timmerman D, van der Voet LF, Huirne JAF. Sonographic examination of uterine niche in non-pregnant women: a modified Delphi procedure. Ultrasound Obstet Gynecol. 2019 Jan;53(1):107-115. doi: 10.1002/uog.19049.
PubMed 29536581
Study at a glance
From the registry record, last updated by the sponsor on 30 Dec 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Pilot Study Comparing Incidence and Characteristics of Cesarean Scar Defects After Uterine Closure by Double-layer Barbed or Smooth Suture
- ClinicalTrials.gov ID
- NCT04825821
- Acronym / sponsor ID
- BARB-CSCAR
- Keywords
- Uterine scar defects, Uterine niche, Isthmocele
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 247 participants (actual)
- Lead sponsor
- Ospedale Policlinico San MartinoUniversity, hospital or other
- Study start
- 1 Mar 2019 (actual)
- Primary completion
- 30 Jul 2022 (actual)
- Study completion
- 30 Sep 2022 (actual)
- First posted
- 1 Apr 2021 (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.
Late sequelae of a cesarean section related to a uterine scar defects include gynecological symptoms and obstetric complications. The aim of this study was to evaluate the incidence and characteristics of cesarean scar defects after uterine closure by double-layer barbed suture.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Low transverse hysterotomy closed by double-layer unidirectional barbed suture | – | Procedure: Clinical and ultrasonographic assessmentPatients who had undergone cesarean section during which the low transverse hysterotomy was closed by double-layer unidirectional barbed suture |
| Low transverse hysterotomy closed by conventional double-layer smooth suture | – | Procedure: Clinical and ultrasonographic assessmentPatients who had undergone cesarean section during which the low transverse hysterotomy was closed by conventional double-layer smooth suture |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Patients who underwent elective cesarean section at ≥37 weeks of gestation
Key inclusion criteria (1 listed)
- Patients who underwent elective cesarean section at ≥ 37 weeks of gestation
Key exclusion criteria (4 listed)
- Patients who underwent concomitant surgical procedures during the cesarean section (i.e., tubal sterilization);
- Patients who underwent a previous abdominal surgery (with exception of appendectomy) including a cesarean section or other laparotomic/laparoscopic uterine surgical procedure (i.e., myomectomy);
- Patients who had a previous diagnosis of Mullerian uterine anomalies elective cesarean for the second time or after uterine surgery;
- Patients who had evidence of PAS disorders or placenta previa.
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 |
|---|---|---|
| Clinical and ultrasonographic assessmentRoutinely assessment by objective examination and transvaginal ultrasonographic scan 6, 12, and 24 months after the surgical procedures | Procedure or surgery | Low transverse hysterotomy closed by conventional double-layer smooth suture, Low transverse hysterotomy closed by double-layer unidirectional barbed suture |
Primary outcome
Number of uterine scar defects
Time frame: 6 months after the cesarean section
Number of simple and complex uterine scar defects is evaluated by transvaginal ultrasound
Number of uterine scar defects
Time frame: 12 months after the cesarean section
Number of simple and complex uterine scar defects is evaluated by transvaginal ultrasound
Number of uterine scar defects
Time frame: 24 months after the cesarean section
Number of simple and complex uterine scar defects is evaluated by transvaginal ultrasound
9 secondary outcomes
Residual myometrium thickness (RMT), depth, width and length of uterine scar defects
Time frame: 6 months after the cesarean section
Residual myometrium thickness (RMT), depth, width and length of uterine scar defects
Time frame: 12 months after the cesarean section
Residual myometrium thickness (RMT), depth, width and length of uterine scar defects
Time frame: 24 months after the cesarean section
Number of patients with postmenstrual spotting
Time frame: 6 months after the cesarean section
Number of patients with postmenstrual spotting
Time frame: 12 months after the cesarean section
Number of patients with postmenstrual spotting
Time frame: 24 months after the cesarean section
Number of patients with dysmenorrhea
Time frame: 6 months after the cesarean section
Number of patients with dysmenorrhea
Time frame: 12 months after the cesarean section
Number of patients with dysmenorrhea
Time frame: 24 months after the cesarean section
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Dec 2022.
- Background: PubMed 33404082Agarwal S, D'Souza R, Ryu M, Maxwell C. Barbed vs conventional suture at cesarean delivery: A systematic review and meta-analysis. Acta Obstet Gynecol Scand. 2021 Jun;100(6):1010-1018. doi: 10.1111/aogs.14080. Epub 2021 Feb 5.
- Background: PubMed 34146146Alessandri F, Evangelisti G, Centurioni MG, Gustavino C, Ferrero S, Barra F. Fishbone double-layer barbed suture in cesarean section: a help in preventing long-term obstetric sequelae? Arch Gynecol Obstet. 2021 Sep;304(3):573-576. doi: 10.1007/s00404-021-06121-8.
- Background: PubMed 29536581Jordans IPM, de Leeuw RA, Stegwee SI, Amso NN, Barri-Soldevila PN, van den Bosch T, Bourne T, Brolmann HAM, Donnez O, Dueholm M, Hehenkamp WJK, Jastrow N, Jurkovic D, Mashiach R, Naji O, Streuli I, Timmerman D, van der Voet LF, Huirne JAF. Sonographic examination of uterine niche in non-pregnant women: a modified Delphi procedure. Ultrasound Obstet Gynecol. 2019 Jan;53(1):107-115. doi: 10.1002/uog.19049.
- Individual participant dataSharing planned: Undecided
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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. This study is not recruiting at the moment.
Fabio Barra, MD principal investigator
IRCCS Ospedale Policlinico San Martino
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Isthmocele and Uterine Scar Defects, run by Ospedale Policlinico San Martino at 1 site in Italy.
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 1 inclusion and 4 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: finished, as of the sponsor's last update on 30 Dec 2022. 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 Italy. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of uterine scar defects (time frame: 6 months after the cesarean section). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04825821, which also lists 3 linked publications.
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 30 Dec 2022.