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Cesarean Wound DisruptionNCT03851003

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

A study testing Endometrial suturing, Non- endometrial suturing and Vaginal ultrasonography in people with Cesarean Wound Disruption, run by Sheba Medical Center at 1 site in Israel.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 42 years, women onlyHealthy volunteers can take part
Conditions the study is for
Cesarean Wound Disruption
What is being tested?
Endometrial suturing, Non- endometrial suturing and Vaginal ultrasonography
Could I receive a placebo?
No, everyone receives an active treatment
How many people
130 participants
Where
1 siteIsrael
Study dates
1 May 2019to 1 Jul 2022
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 42 years
  • Women only
  • Healthy volunteers accepted
  • Adult

Who may be able to join

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

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

Israel1 site

  • Dr. Aya Mohr-Sasson

    Ramat Gan, 56506

Other trials in Israel

About this study

Official title: 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.

Read the 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 ).

Being tested
Endometrial suturing, Non- endometrial suturing, Vaginal ultrasonography, Questionnaire
Keywords
cesarean section, niche, uterine scar defect

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Endometrial suturingProcedure or surgery

    Suturing will include endometrium during cesarean incision repair

  • Non- endometrial suturingProcedure or surgery

    Suturing will not include endometrium during cesarean incision repair

  • Vaginal ultrasonographyDevice

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

  • QuestionnaireOther

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

Study groups in NCT03851003
Study groupRoleWhat they receive
Endometrial suturingExperimentalUterine incision repair including suturing of the endometrium
Receives: Procedure: Endometrial suturing; Device: Vaginal ultrasonography; Other: Questionnaire
Non - Endometrial suturingExperimentalUterine incision repair without suturing of the endometrium
Receives: Procedure: Non- endometrial suturing; Device: Vaginal ultrasonography; Other: Questionnaire

What is being measured

The primary outcome is the main question the study is designed to answer.

  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

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

Secondary outcomes (2)

  1. Spotting

    The rate of spotting complains since operation reported by the women

    Measured: Through study completion, an average of 1 year

  2. Abdominal pain

    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).

    Measured: Through study completion, an average of 1 year

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted22 Feb 2019
  2. Study start1 May 2019
  3. Primary completion1 Jul 2022
  4. Study completion1 Jul 2022

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Model description
Uterine incision repair will include or exclude suturing of the endometrium
Masking
Single blind
Who is masked
Participant
Enrolment
130 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03851003
Sponsor's protocol ID
5822-18-SMC
Status last verified
Sep 2023
First submitted
12 Feb 2019
Last updated
3 Oct 2023
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Publications

  • 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.

    PubMed 23728648

  • 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.

    PubMed 19565535

  • 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.

    PubMed 27393285

  • 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.

    PubMed 24373597

  • 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.

    PubMed 29416572

  • 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.

    PubMed 26409016

Questions about this trial

What is this clinical trial studying?

A study testing Endometrial suturing, Non- endometrial suturing and Vaginal ultrasonography in people with Cesarean Wound Disruption, run by Sheba Medical Center at 1 site in Israel.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 3 Oct 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Israel. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03851003, which also lists 6 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Oct 2023.

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