Clinical trial NCT04825821: Cesarean Scar Defects After Uterine Closure by Double-layer Barbed or Smooth Suture
Official title: A Prospective Pilot Study Comparing Incidence and Characteristics of Cesarean Scar Defects After Uterine Closure by Double-layer Barbed or Smooth Suture
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Isthmocele
Uterine Scar Defects
Cesarean Section Complications
Uterine Niche
Keywords: Uterine scar defects
Uterine niche
Isthmocele
Lead sponsor: Ospedale Policlinico San Martino
Sponsor class: OTHER
First posted: 2021-04-01
Enrollment: 247
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients who underwent elective cesarean section at ≥37 weeks of gestation

Brief 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.


Eligibility criteria: 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.

Primary outcomes:
measure: Number of uterine scar defects
timeFrame: 6 months after the cesarean section
measure: Number of uterine scar defects
timeFrame: 12 months after the cesarean section
measure: Number of uterine scar defects
timeFrame: 24 months after the cesarean section
Secondary outcomes:
measure: Residual myometrium thickness (RMT), depth, width and length of uterine scar defects
timeFrame: 6 months after the cesarean section
measure: Residual myometrium thickness (RMT), depth, width and length of uterine scar defects
timeFrame: 12 months after the cesarean section
measure: Residual myometrium thickness (RMT), depth, width and length of uterine scar defects
timeFrame: 24 months after the cesarean section
measure: Number of patients with postmenstrual spotting
timeFrame: 6 months after the cesarean section
measure: Number of patients with postmenstrual spotting
timeFrame: 12 months after the cesarean section
measure: Number of patients with postmenstrual spotting
timeFrame: 24 months after the cesarean section
measure: Number of patients with dysmenorrhea
timeFrame: 6 months after the cesarean section
measure: Number of patients with dysmenorrhea
timeFrame: 12 months after the cesarean section
measure: Number of patients with dysmenorrhea
timeFrame: 24 months after the cesarean section
Other outcomes:
Locations:
city: Genoa
country: Italy
facility: IRCCS Ospedale Policlinico San Martino
Study officials:
affiliation: IRCCS Ospedale Policlinico San Martino
name: Fabio Barra, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
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.
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.