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

NCT03851003 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 130

Last updated 2023-10-03

No results posted yet for this study

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

Interventions

PROCEDURE

Endometrial suturing

Suturing will include endometrium during cesarean incision repair

PROCEDURE

Non- endometrial suturing

Suturing will not include endometrium during cesarean incision repair

DEVICE

Vaginal ultrasonography

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

OTHER

Questionnaire

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

Sponsors & Collaborators

  • Sheba Medical Center

    lead OTHER_GOV

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
42 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2019-05-01
Primary Completion
2022-07-01
Completion
2022-07-01

Countries

  • Israel

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03851003 on ClinicalTrials.gov