<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT03787381</url>
  </required_header>
  <id_info>
    <org_study_id>5562-18-SMC</org_study_id>
    <nct_id>NCT03787381</nct_id>
  </id_info>
  <brief_title>Uterine Niche After Cesarean Section</brief_title>
  <acronym>AMSRM</acronym>
  <official_title>Factors Influencing the Development of Uterine Niche After Cesarean Delivery</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Sheba Medical Center</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Sheba Medical Center</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      In the past decade several articles have described a defect that can be seen on ultrasound at&#xD;
      the site of cesarean delivery scar, known as a 'niche' .An incompletely healed scar is a&#xD;
      long-term complication of cesarean delivery and is associated with symptoms such as&#xD;
      postmenstual spotting, dysmenorrhoea, chronic pelvic pain dyspareunia and subfertility. This&#xD;
      study aimes to evaluate the prevalence of niche in a large cohort study after long term&#xD;
      follow up since operation, and characterize the risk factors for its development and for&#xD;
      symptoms to appear.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      As the rate of cesarean deliveries continues to increase, concern regarding the association&#xD;
      between delivery by cesarean section and long-term maternal morbidity has been growing . In&#xD;
      the past decade several articles have described a defect that can be seen on ultrasound at&#xD;
      the site of the cesarean delivery scar, known as a 'niche' .A 'niche' describes the presence&#xD;
      of a hypoechoic area within the myometrium of the lower uterine segment, reflecting a&#xD;
      discontinuation of the myometrium at the site of a previous cesarean delivery . An&#xD;
      incompletely healed scar is a long-term complication of cesarean delivery and is associated&#xD;
      with symptoms such as postmenstual spotting, dysmenorrhoea, chronic pelvic pain dyspareunia&#xD;
      and subfertility.&#xD;
&#xD;
      The reported prevalence of a niche in non-pregnant women varies depending on the criteria&#xD;
      used to define a niche, the time of evaluation since operation, method of detection, and&#xD;
      study population. Osser et al. used the definition 'any visible defect' , Bij de Vaate et al.&#xD;
      used 'any indentation of at least 1 mm and van der Voet used a cut-off level of 2 mm,&#xD;
      however, consensus on the exact cut-off levels is lacking. As approximate evaluation to the&#xD;
      operation, the prevalence reported is higher, as early scanning may facilitate the&#xD;
      recognition of the location of the caesarean delivery scar in the uterine wall due to&#xD;
      incomplete scar healing, with no definition of the most appropriate time since operation.&#xD;
      Commonly used methods to evaluate the presence of a niche are trans vaginal ultrasound,&#xD;
      sonohysterography and hysteroscopy with detection rate of approximately ~50% of women with&#xD;
      previous cesarean section in all methods with no definition of the gold standard.&#xD;
&#xD;
      The aim of this study in to evaluate the prevalence of niche in a large cohort study after&#xD;
      long term follow up since operation and characterize the risk factors for its development and&#xD;
      for symptoms to appear.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">January 10, 2019</start_date>
  <completion_date type="Actual">June 1, 2022</completion_date>
  <primary_completion_date type="Actual">June 1, 2022</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Diagnostic</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Diagnosis of uterine niche</measure>
    <time_frame>Estimated time of two years</time_frame>
    <description>Based on uterine scar measurement -indentation at the site of the cesarean scar with a depth of at least 2 mm</description>
  </primary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">282</enrollment>
  <condition>Uterine Scar From Previous Cesarean Delivery (Diagnosis)</condition>
  <arm_group>
    <arm_group_label>Intervention</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>Uterine scar will be evaluated by vaginal ultrasound examination</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Ultrasound</intervention_name>
    <description>Vaginal ultrasound examination</description>
    <arm_group_label>Intervention</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Women after cesarean delivery&#xD;
&#xD;
          -  Minimum interval of 3 months since operation&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Uterine scar other than low segment cesarean section ( s/p myomectomy, S/p T scar)&#xD;
&#xD;
          -  Morbidly adherent placenta during pregnancy&#xD;
&#xD;
          -  Cesarean hysterectomy&#xD;
&#xD;
          -  Uterine anomaly&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>42 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Aya Mohr Sasson, M.D</last_name>
    <role>Principal Investigator</role>
    <affiliation>Sheba Medical Center, Tel-Hashomer</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Sheba Medical Center</name>
      <address>
        <city>Ramat Gan</city>
        <country>Israel</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Israel</country>
  </location_countries>
  <results_reference>
    <citation>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.</citation>
    <PMID>24373597</PMID>
  </results_reference>
  <results_reference>
    <citation>Naji O, Abdallah Y, Bij De Vaate AJ, Smith A, Pexsters A, Stalder C, McIndoe A, Ghaem-Maghami S, Lees C, Brolmann HA, Huirne JA, Timmerman D, Bourne T. Standardized approach for imaging and measuring Cesarean section scars using ultrasonography. Ultrasound Obstet Gynecol. 2012 Mar;39(3):252-9. doi: 10.1002/uog.10077.</citation>
    <PMID>21858885</PMID>
  </results_reference>
  <results_reference>
    <citation>Roberge S, Boutin A, Chaillet N, Moore L, Jastrow N, Demers S, Bujold E. Systematic review of cesarean scar assessment in the nonpregnant state: imaging techniques and uterine scar defect. Am J Perinatol. 2012 Jun;29(6):465-71. doi: 10.1055/s-0032-1304829. Epub 2012 Mar 7.</citation>
    <PMID>22399223</PMID>
  </results_reference>
  <results_reference>
    <citation>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.</citation>
    <PMID>26409016</PMID>
  </results_reference>
  <results_reference>
    <citation>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.</citation>
    <PMID>19565535</PMID>
  </results_reference>
  <results_reference>
    <citation>Osser OV, Jokubkiene L, Valentin L. Cesarean section scar defects: agreement between transvaginal sonographic findings with and without saline contrast enhancement. Ultrasound Obstet Gynecol. 2010 Jan;35(1):75-83. doi: 10.1002/uog.7496.</citation>
    <PMID>20034000</PMID>
  </results_reference>
  <verification_date>June 2022</verification_date>
  <study_first_submitted>December 19, 2018</study_first_submitted>
  <study_first_submitted_qc>December 20, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">December 26, 2018</study_first_posted>
  <last_update_submitted>June 23, 2022</last_update_submitted>
  <last_update_submitted_qc>June 23, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">June 24, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Sheba Medical Center</investigator_affiliation>
    <investigator_full_name>Dr. Aya Mohr-Sasson</investigator_full_name>
    <investigator_title>Principal Investigator</investigator_title>
  </responsible_party>
  <keyword>cesarean section, niche, uterine scar defect</keyword>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT03787381
org study id: 5562-18-SMC
nct id: NCT03787381
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
In the past decade several articles have described a defect that can be seen on ultrasound at
      the site of cesarean delivery scar, known as a 'niche' .An incompletely healed scar is a
      long-term complication of cesarean delivery and is associated with symptoms such as
      postmenstual spotting, dysmenorrhoea, chronic pelvic pain dyspareunia and subfertility. This
      study aimes to evaluate the prevalence of niche in a large cohort study after long term
      follow up since operation, and characterize the risk factors for its development and for
      symptoms to appear.
As the rate of cesarean deliveries continues to increase, concern regarding the association
      between delivery by cesarean section and long-term maternal morbidity has been growing . In
      the past decade several articles have described a defect that can be seen on ultrasound at
      the site of the cesarean delivery scar, known as a 'niche' .A 'niche' describes the presence
      of a hypoechoic area within the myometrium of the lower uterine segment, reflecting a
      discontinuation of the myometrium at the site of a previous cesarean delivery . An
      incompletely healed scar is a long-term complication of cesarean delivery and is associated
      with symptoms such as postmenstual spotting, dysmenorrhoea, chronic pelvic pain dyspareunia
      and subfertility.

      The reported prevalence of a niche in non-pregnant women varies depending on the criteria
      used to define a niche, the time of evaluation since operation, method of detection, and
      study population. Osser et al. used the definition 'any visible defect' , Bij de Vaate et al.
      used 'any indentation of at least 1 mm and van der Voet used a cut-off level of 2 mm,
      however, consensus on the exact cut-off levels is lacking. As approximate evaluation to the
      operation, the prevalence reported is higher, as early scanning may facilitate the
      recognition of the location of the caesarean delivery scar in the uterine wall due to
      incomplete scar healing, with no definition of the most appropriate time since operation.
      Commonly used methods to evaluate the presence of a niche are trans vaginal ultrasound,
      sonohysterography and hysteroscopy with detection rate of approximately ~50% of women with
      previous cesarean section in all methods with no definition of the gold standard.

      The aim of this study in to evaluate the prevalence of niche in a large cohort study after
      long term follow up since operation and characterize the risk factors for its development and
      for symptoms to appear.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Diagnostic
masking: None (Open Label)
measure: Diagnosis of uterine niche
time frame: Estimated time of two years
description: Based on uterine scar measurement -indentation at the site of the cesarean scar with a depth of at least 2 mm
arm group label: Intervention
arm group type: Other
description: Uterine scar will be evaluated by vaginal ultrasound examination
intervention type: Device
intervention name: Ultrasound
description: Vaginal ultrasound examination
arm group label: Intervention
criteria: 
gender: Female
minimum age: 18 Years
maximum age: 42 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Aya Mohr Sasson, M.D
role: Principal Investigator
affiliation: Sheba Medical Center, Tel-Hashomer
facility: 
country: Israel
citation: 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
citation: Naji O, Abdallah Y, Bij De Vaate AJ, Smith A, Pexsters A, Stalder C, McIndoe A, Ghaem-Maghami S, Lees C, Brolmann HA, Huirne JA, Timmerman D, Bourne T. Standardized approach for imaging and measuring Cesarean section scars using ultrasonography. Ultrasound Obstet Gynecol. 2012 Mar;39(3):252-9. doi: 10.1002/uog.10077.
PMID: 21858885
citation: Roberge S, Boutin A, Chaillet N, Moore L, Jastrow N, Demers S, Bujold E. Systematic review of cesarean scar assessment in the nonpregnant state: imaging techniques and uterine scar defect. Am J Perinatol. 2012 Jun;29(6):465-71. doi: 10.1055/s-0032-1304829. Epub 2012 Mar 7.
PMID: 22399223
citation: 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
citation: 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
citation: Osser OV, Jokubkiene L, Valentin L. Cesarean section scar defects: agreement between transvaginal sonographic findings with and without saline contrast enhancement. Ultrasound Obstet Gynecol. 2010 Jan;35(1):75-83. doi: 10.1002/uog.7496.
PMID: 20034000
responsible party type: Principal Investigator
investigator affiliation: Sheba Medical Center
investigator full name: Dr. Aya Mohr-Sasson
investigator title: Principal Investigator
sharing ipd: No