Cesarean Scar Defects After Uterine Closure by Double-layer Barbed or Smooth Suture

Cesarean Section Complications Clinical Trial

Official title:

A Prospective Pilot Study Comparing Incidence and Characteristics of Cesarean Scar Defects After Uterine Closure by Double-layer Barbed or Smooth Suture

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04825821
• Other study ID #: BARB-CSCAR
• Status: Completed
• Start date: March 1, 2019
• Est. completion date: September 30, 2022

Study information

• Verified date: December 2022
• Source: Ospedale Policlinico San Martino
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 247
• Est. completion date: September 30, 2022
• Est. primary completion date: July 30, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Patients who underwent elective cesarean section at = 37 weeks of gestation

Exclusion Criteria:

• 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.

Related Conditions & MeSH terms

• Cesarean Section Complications
• Cicatrix
• Isthmocele
• Uterine Niche
• Uterine Scar Defects

Intervention

Procedure:
• Clinical and ultrasonographic assessment
Routinely assessment by objective examination and transvaginal ultrasonographic scan 6, 12, and 24 months after the surgical procedures

Locations

Country	Name	City	State
Italy	IRCCS Ospedale Policlinico San Martino	Genoa

Sponsors (1)

Lead Sponsor	Collaborator
Ospedale Policlinico San Martino

Country where clinical trial is conducted

Italy, 

References & Publications (3)

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of uterine scar defects	Number of simple and complex uterine scar defects is evaluated by transvaginal ultrasound	6 months after the cesarean section
Primary	Number of uterine scar defects	Number of simple and complex uterine scar defects is evaluated by transvaginal ultrasound	12 months after the cesarean section
Primary	Number of uterine scar defects	Number of simple and complex uterine scar defects is evaluated by transvaginal ultrasound	24 months after the cesarean section
Secondary	Residual myometrium thickness (RMT), depth, width and length of uterine scar defects	RMT, depth, width, and length are evaluated by transvaginal ultrasound	6 months after the cesarean section
Secondary	Residual myometrium thickness (RMT), depth, width and length of uterine scar defects	RMT, depth, width, and length are evaluated by transvaginal ultrasound	12 months after the cesarean section
Secondary	Residual myometrium thickness (RMT), depth, width and length of uterine scar defects	RMT, depth, width, and length are evaluated by transvaginal ultrasound	24 months after the cesarean section
Secondary	Number of patients with postmenstrual spotting	Number of patients with postmenstrual spotting is evaluated by medical interview	6 months after the cesarean section
Secondary	Number of patients with postmenstrual spotting	Number of patients with postmenstrual spotting is evaluated by medical interview	12 months after the cesarean section
Secondary	Number of patients with postmenstrual spotting	Number of patients with postmenstrual spotting is evaluated by medical interview	24 months after the cesarean section
Secondary	Number of patients with dysmenorrhea	Number of patients with dysmenorrhea is evaluated by medical interview with VAS (visual analogue scale)	6 months after the cesarean section
Secondary	Number of patients with dysmenorrhea	Number of patients with dysmenorrhea is evaluated by medical interview with VAS (visual analogue scale)	12 months after the cesarean section
Secondary	Number of patients with dysmenorrhea	Number of patients with dysmenorrhea is evaluated by medical interview with VAS (visual analogue scale)	24 months after the cesarean section