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

September 29, 2023 updated by: Dr. Aya Mohr-Sasson, Sheba Medical Center

The Influence of Endometrial Suturing During Cesarean Section on the Risk to Develop Uterine Scar Defect: A Randomized Control Study

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 ).

Study Type

Interventional

Enrollment (Actual)

130

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Israel
      • Ramat-Gan, Israel, 56506
        • Dr. Aya Mohr-Sasson

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 42 years (Adult)

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

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

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / 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
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 )
Procedure: Non- endometrial suturing
Suturing will not include endometrium during cesarean incision repair

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Until six month post cesarean section, and through study completion, an average of 1 year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Spotting
Time Frame: Through study completion, an average of 1 year
The rate of spotting complains since operation reported by the women
Through study completion, an average of 1 year
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).
Through study completion, an average of 1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sheba Medical Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 1, 2019

Primary Completion (Actual)

July 1, 2022

Study Completion (Actual)

July 1, 2022

Study Registration Dates

First Submitted

February 12, 2019

First Submitted That Met QC Criteria

February 20, 2019

First Posted (Actual)

February 22, 2019

Study Record Updates

Last Update Posted (Actual)

October 3, 2023

Last Update Submitted That Met QC Criteria

September 29, 2023

Last Verified

September 1, 2023

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 5822-18-SMC

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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