The Influence of Endometrial Suturing on the Risk of Uterine Scar Defect

NCT03851003 | Completed

• 1 other identifier: 5822-18-SMC
• Study Type: interventional
• Target: 130
• Locations: 1 country
• Sites: 1

Brief Summary

Caesarean section (CS) is the commonest major operation performed on women worldwide with progressively rising incidence. Consequently, long-term adverse sequelae due to uterine scar defect have been increasing. Given the association between uterine scar defect and gynecological symptoms, obstetric complications and potentially with subfertility, it is important to elucidate the etiology in order to develop preventive strategies. Surgical technique of uterine incision closure seems to be the most important determinant of defect formation. The aim of this prospective randomized study is to evaluate specifically the influence of inclusion versus exclusion of the endometrium during suturing the uterine incision on the risk to develop uterine scar defect.

Conditions

Cesarean Wound Disruption

Keywords

cesarean section; niche; uterine scar defect

Outcome Measures

Primary Outcomes (1)

• Number of participants with uterine scar defect six month post cesarean section

  Uterine scar defect with residual myometrium thickness of less then 2.5 mm

  Until six month post cesarean section, and through study completion, an average of 1 year

Secondary Outcomes (2)

• Spotting

  Through study completion, an average of 1 year

• Abdominal pain

  Through study completion, an average of 1 year

Study Arms (2)

Endometrial suturing

EXPERIMENTAL

Uterine incision repair including suturing of the endometrium

Procedure: Endometrial suturing; Device: Vaginal ultrasonography; Other: Questionnaire

Non - Endometrial suturing

EXPERIMENTAL

Uterine incision repair without suturing of the endometrium

Procedure: Non- endometrial suturing; Device: Vaginal ultrasonography; Other: Questionnaire

Interventions

Endometrial suturing PROCEDURE

Suturing will include endometrium during cesarean incision repair

Endometrial suturing

Non- endometrial suturing PROCEDURE

Suturing will not include endometrium during cesarean incision repair

Non - Endometrial suturing

Vaginal ultrasonography DEVICE

All women will be invited six month post operation for vaginal sonographic evaluation of the uterine scar

Endometrial suturing; Non - Endometrial suturing

Questionnaire OTHER

All women will be invited six month post operation for filling questionnaire concerning possibility of uterine scar defect ( spotting, pelvic pain, fertility abnormalities )

Endometrial suturing; Non - Endometrial suturing

Eligibility Criteria

• Age: 18 Years - 42 Years
• Gender Eligibility Details: Women
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Term pregnancy (≥37 weeks of gestation)
• Elective CS

You may not qualify if:

• Uterine scar
• Thrombophilia
• Dysmorphic uterus
• Connective tissue disorder

Sponsors & Collaborators

• Sheba Medical Center: lead

Study Sites (1)

Dr. Aya Mohr-Sasson

Ramat Gan, 56506, Israel

Location

Related Publications (6)

• Mathai M, Hofmeyr GJ, Mathai NE. Abdominal surgical incisions for caesarean section. Cochrane Database Syst Rev. 2013 May 31;2013(5):CD004453. doi: 10.1002/14651858.CD004453.pub3.

  PMID: 23728648 RESULT

• Wang CB, Chiu WW, Lee CY, Sun YL, Lin YH, Tseng CJ. Cesarean scar defect: correlation between Cesarean section number, defect size, clinical symptoms and uterine position. Ultrasound Obstet Gynecol. 2009 Jul;34(1):85-9. doi: 10.1002/uog.6405.

  PMID: 19565535 RESULT

• Tulandi T, Cohen A. Emerging Manifestations of Cesarean Scar Defect in Reproductive-aged Women. J Minim Invasive Gynecol. 2016 Sep-Oct;23(6):893-902. doi: 10.1016/j.jmig.2016.06.020. Epub 2016 Jul 5.

  PMID: 27393285 RESULT

• van der Voet LF, Bij de Vaate AM, Veersema S, Brolmann HA, Huirne JA. Long-term complications of caesarean section. The niche in the scar: a prospective cohort study on niche prevalence and its relation to abnormal uterine bleeding. BJOG. 2014 Jan;121(2):236-44. doi: 10.1111/1471-0528.12542.

  PMID: 24373597 RESULT

• Sholapurkar SL. Etiology of Cesarean Uterine Scar Defect (Niche): Detailed Critical Analysis of Hypotheses and Prevention Strategies and Peritoneal Closure Debate. J Clin Med Res. 2018 Mar;10(3):166-173. doi: 10.14740/jocmr3271w. Epub 2018 Jan 26.

  PMID: 29416572 RESULT

• Vervoort AJ, Uittenbogaard LB, Hehenkamp WJ, Brolmann HA, Mol BW, Huirne JA. Why do niches develop in Caesarean uterine scars? Hypotheses on the aetiology of niche development. Hum Reprod. 2015 Dec;30(12):2695-702. doi: 10.1093/humrep/dev240. Epub 2015 Sep 25.

  PMID: 26409016 RESULT

MeSH Terms

Interventions

Surveys and Questionnaires

Intervention Hierarchy (Ancestors)

Data Collection; Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: Women will not know which arm they were allocated to
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: Uterine incision repair will include or exclude suturing of the endometrium

Study Record Dates

• First Submitted: February 12, 2019
• First Posted: February 22, 2019
• Study Start: May 1, 2019
• Primary Completion: July 1, 2022
• Study Completion: July 1, 2022
• Last Updated: October 3, 2023

Record last verified: 2023-09

Locations

IL (1)