Cesarean Scar Defects After Uterine Closure by Double-layer Barbed or Smooth Suture
NCT ID: NCT04825821
Last Updated: 2022-12-30
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
247 participants
OBSERVATIONAL
2019-03-01
2022-09-30
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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CASE_CONTROL
PROSPECTIVE
Study Groups
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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
Clinical and ultrasonographic assessment
Routinely assessment by objective examination and transvaginal ultrasonographic scan 6, 12, and 24 months after the surgical procedures
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
Clinical and ultrasonographic assessment
Routinely assessment by objective examination and transvaginal ultrasonographic scan 6, 12, and 24 months after the surgical procedures
Interventions
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Clinical and ultrasonographic assessment
Routinely assessment by objective examination and transvaginal ultrasonographic scan 6, 12, and 24 months after the surgical procedures
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* 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.
18 Years
FEMALE
Yes
Sponsors
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Ospedale Policlinico San Martino
OTHER
Responsible Party
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Fabio Barra
Principal Investigator
Principal Investigators
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Fabio Barra, MD
Role: PRINCIPAL_INVESTIGATOR
IRCCS Ospedale Policlinico San Martino
Locations
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IRCCS Ospedale Policlinico San Martino
Genoa, , Italy
Countries
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References
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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.
Alessandri 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.
Jordans 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.
Other Identifiers
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BARB-CSCAR
Identifier Type: -
Identifier Source: org_study_id