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

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ClinicalTrials.gov Identifier: NCT03851003
Recruitment Status : Completed
First Posted : February 22, 2019
Last Update Posted : August 2, 2022
Sponsor:
Information provided by (Responsible Party):
Dr. Aya Mohr-Sasson, Sheba Medical Center

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.

Condition or disease Intervention/treatment Phase
Cesarean Wound Disruption Procedure: Endometrial suturing Procedure: Non- endometrial suturing Device: Vaginal ultrasonography Other: Questionnaire Not Applicable

Detailed Description:

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. Common gynecological complains include chronic pelvic pain, dyspareunia, dysmenorrhea and postmenstrual spotting and infertility. Obstetric sequelae seem to be increasing such as cesarean scar ectopic pregnancy, placenta previa, and placenta accrete, all associated with major maternal morbidity and even mortality. 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. Probable risk factors suggested are single-layer myometrium closure, multiple CSs and uterine retroflexion, however, surgical technique of uterine incision closure seems to be the most important determinant of defect formation. It is proposed that continuous, non-locking absorbable sutures in two layers, without including much of decidua and without undue tight (constricting) pulling of sutures are likely to result in good healing of uterine scar. 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.

Material and Methods Prospective randomized single blinded study conducted in a single tertiary center. All women at term (≥37 weeks of gestation) with singleton pregnancy that are about to go threw cesarean section attending the pre- operative clinics, will be offered to participate in the study. After signing informed consent, women will be block randomized for one of two groups: A- uterine incision repair including suturing of the endometrium, B - uterine incision repair without including the endometrium. All operation will be performed by a single highly skilled obstetrician. All other stages of operations will be similar in both of the groups including: low segment incision, delivery of the fetus and the placenta, uterine revision, intraperitoneal uterine repair, use of stratafix thread in double layer suturing. Operative and post operative data will be collected from the medical files including: operation duration, estimated blood loss, operation complications ( hypotension, bladder gut or vascular perforation ) , post operative complications ( hemorrhage, endometritis, vascular - thromboembolic event, ileus ). All women will be invited to the gynecologic clinics six month post operation for vaginal sonographic evaluation of the uterine scar and for filling questionnaire concerning possibility of uterine scar defect ( spotting, pelvic pain, fertility abnormalities ).

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 130 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Uterine incision repair will include or exclude suturing of the endometrium
Masking: Single (Participant)
Masking Description: Women will not know which arm they were allocated to
Primary Purpose: Prevention
Official Title: The Influence of Endometrial Suturing During Cesarean Section on the Risk to Develop Uterine Scar Defect: A Randomized Control Study
Actual Study Start Date : January 1, 2019
Actual Primary Completion Date : July 1, 2022
Actual Study Completion Date : July 1, 2022

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Endometrial suturing
Uterine incision repair including suturing of the endometrium
Procedure: Endometrial suturing
Suturing will 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 )

Experimental: Non - Endometrial suturing
Uterine incision repair without suturing of the endometrium
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 )




Primary Outcome Measures :
  1. Number of participants with uterine scar defect six month post cesarean section [ Time Frame: Until six month post cesarean section, and through study completion, an average of 1 year ]
    Uterine scar defect with residual myometrium thickness of less then 2.5 mm


Secondary Outcome Measures :
  1. Spotting [ Time Frame: Through study completion, an average of 1 year ]
    The rate of spotting complains since operation reported by the women

  2. Abdominal pain [ Time Frame: Through study completion, an average of 1 year ]
    The rate of abdominal pain since operation reported by the women and estimated by "The Visual Analogue Scale" (VAS) for the estimation of pain. In this scale, women will be asked to mark the pain that they are experiencing on a 10cm-long horizontal line labeled "no pain" on the far left and "worst pain ever" on the far right. Pain intensity is determined by the length of the line as measured from the left-hand side to the point marked. The following cut points on the pain VAS will be use: no pain (0-0.4 cm), mild pain (0.5-4.4 cm), moderate pain (4.5-7.4 cm), and severe pain (7.5-10 cm).



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Ages Eligible for Study:   18 Years to 42 Years   (Adult)
Sexes Eligible for Study:   Female
Gender Based Eligibility:   Yes
Gender Eligibility Description:   Women
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03851003


Locations
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Israel
Dr. Aya Mohr-Sasson
Ramat-Gan, Israel, 56506
Sponsors and Collaborators
Sheba Medical Center
Publications of Results:
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Responsible Party: Dr. Aya Mohr-Sasson, Principal Investigator, Sheba Medical Center
ClinicalTrials.gov Identifier: NCT03851003    
Other Study ID Numbers: 5822-18-SMC
First Posted: February 22, 2019    Key Record Dates
Last Update Posted: August 2, 2022
Last Verified: July 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Dr. Aya Mohr-Sasson, Sheba Medical Center:
cesarean section
niche
uterine scar defect