<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/NCT03039803</url>
  </required_header>
  <id_info>
    <org_study_id>1642/2016</org_study_id>
    <nct_id>NCT03039803</nct_id>
  </id_info>
  <brief_title>Impact of Double-layer Versus Single-layer Uterine Closure Suture in Cesarean Section on the Development of Postoperative Uterine Scar Deficiency</brief_title>
  <official_title>Impact of Double-layer Versus Single-layer Uterine Closure Suture in Cesarean Section on the Development of Postoperative Uterine Scar Deficiency: A Randomized Controlled Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Medical University of Vienna</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Medical University of Vienna</source>
  <brief_summary>
    <textblock>
      In recent decades, the rate of cesarean section delivery has steadily increased worldwide&#xD;
      ranging at 30% of deliveries, thus long-term risks after cesarean section need to be&#xD;
      evaluated. Postoperative risks include, among others, uterine scar rupture and placental&#xD;
      complications such as placenta previa and accreta- complications, which are possibly&#xD;
      associated with uterine scar dehiscence.&#xD;
&#xD;
      The prevalence of lower-segment uterine scar deficiency has previously been described as 63%.&#xD;
      One recent systematic review and meta analysis investigated closure techniques of low&#xD;
      transverse cesarean. No significant difference in risk of uterine scar defect comparing&#xD;
      single layer versus double layer closure could be detected (RR 0.53), whereas in women with&#xD;
      single layer closure, a lower residual myo-metrial thickness was observed (-2.6mm). However,&#xD;
      the authors do conclude that data is insufficient to determine the risk of uterine rupture,&#xD;
      dehiscence or gynecological outcomes due to insufficient power of available studies. A&#xD;
      recently published Randomized Controlled Trial concluded that double-layer closure with&#xD;
      unlocked first layer showed a better scar healing than locked single layer.&#xD;
&#xD;
      The investigators main objective is to identify if single-layer suture of the uterus during&#xD;
      cesarean section results in a higher rate of cesarean scar deficiency than double-layer&#xD;
      suture.&#xD;
&#xD;
      Interventions&#xD;
&#xD;
      Single- layer versus double- layer uterine closure Two different techniques of uterine&#xD;
      closure in cesarean section will be compared: single- layer versus double- layer continuous&#xD;
      uterotomy suture.&#xD;
&#xD;
      Standardized transvaginal sonography&#xD;
&#xD;
      Transvaginal ultrasound examination is carried out by one expert sonographer. The ultrasound&#xD;
      machine used for all examinations is GE Voluson E10.&#xD;
&#xD;
      Primary outcome: CS scar deficiency visualized in transvaginal ultrasound at 3 months after&#xD;
      CS (yes/no).&#xD;
&#xD;
      Secondary outcome: Myometrial thickness at the site of uterine scar (mm).&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">January 2017</start_date>
  <completion_date type="Anticipated">September 2019</completion_date>
  <primary_completion_date type="Anticipated">September 2019</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Double (Participant, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Cesarean section (CS) scar deficiency visualized in transvaginal ultrasound at 3 months after CS (yes/no).</measure>
    <time_frame>3 months</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Myometrial thickness at the site of uterine scar (mm).</measure>
    <time_frame>3 months</time_frame>
  </secondary_outcome>
  <other_outcome>
    <measure>The presence or absence of a CS scar pregnancy in a consecutive pregnancy</measure>
    <time_frame>up to 25 years</time_frame>
  </other_outcome>
  <other_outcome>
    <measure>Occurence of uterine rupture in a consecutive pregnancy</measure>
    <time_frame>up to 25 years</time_frame>
  </other_outcome>
  <other_outcome>
    <measure>CS scar deficiency visualized in transvaginal ultrasound (yes/no) in early pregnancy in a consecutive pregnancy</measure>
    <time_frame>up to 25 years</time_frame>
  </other_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">200</enrollment>
  <condition>Cesarean Section</condition>
  <condition>Uterine Scar Deficiency</condition>
  <condition>Myometrial Thickness</condition>
  <condition>Single-layer Continuous Uterotomy Suture</condition>
  <condition>Double-layer Continuous Uterotomy Suture</condition>
  <condition>Transvaginal Ultrasound</condition>
  <arm_group>
    <arm_group_label>single-layer continuous uterotomy suture</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Single-layer continuous uterotomy suture</description>
  </arm_group>
  <arm_group>
    <arm_group_label>double-layer continuous uterotomy suture</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>double-layer continuous uterotomy suture</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>uterine closure during cesarean section</intervention_name>
    <arm_group_label>double-layer continuous uterotomy suture</arm_group_label>
    <arm_group_label>single-layer continuous uterotomy suture</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  First cesarean section&#xD;
&#xD;
          -  Scheduled cesarean section at Department of Obstetrics and Gynecology, Medical&#xD;
             University of Vienna&#xD;
&#xD;
          -  Age ≥ 18 years&#xD;
&#xD;
          -  Informed Consent&#xD;
&#xD;
          -  Cesarean section at ≥ 37+0 weeks of gestation&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Previous cesarean section&#xD;
&#xD;
          -  Emergency cesarean section&#xD;
&#xD;
          -  Cesarean section &lt; 37+0 weeks of gestation&#xD;
&#xD;
          -  Corporal incision during cesarean section&#xD;
&#xD;
          -  Diseases which favor wound healing disruptions (e.g. chronic inflammatory diseases)&#xD;
&#xD;
          -  Uterine anatomic anomalies&#xD;
&#xD;
          -  BMI &gt; 35kg/m2&#xD;
&#xD;
          -  Placenta previa&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>50 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_contact>
    <last_name>Marianne Koch, Dr.</last_name>
    <phone>0043 1 40400 29150</phone>
    <email>marianne.koch@meduniwien.ac.at</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Samir Helmy-Bader, Dr.</last_name>
    <phone>0043 1 40400 29150</phone>
    <email>samir.helmy@meduniwien.ac.at</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Medical University of Vienna</name>
      <address>
        <city>Vienna</city>
        <country>Austria</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Samir Helmy, Ass.Prof.</last_name>
      <phone>+4314040029150</phone>
      <email>samir.helmy@meduniwien.ac.at</email>
    </contact>
    <contact_backup>
      <last_name>Marianne Koch, Dr.</last_name>
      <phone>+4314040029150</phone>
      <email>marianne.koch@meduniwien.ac.at</email>
    </contact_backup>
  </location>
  <location_countries>
    <country>Austria</country>
  </location_countries>
  <reference>
    <citation>Ofili-Yebovi D, Ben-Nagi J, Sawyer E, Yazbek J, Lee C, Gonzalez J, Jurkovic D. Deficient lower-segment Cesarean section scars: prevalence and risk factors. Ultrasound Obstet Gynecol. 2008 Jan;31(1):72-7. doi: 10.1002/uog.5200.</citation>
    <PMID>18061960</PMID>
  </reference>
  <reference>
    <citation>Roberge S, Demers S, Berghella V, Chaillet N, Moore L, Bujold E. Impact of single- vs double-layer closure on adverse outcomes and uterine scar defect: a systematic review and metaanalysis. Am J Obstet Gynecol. 2014 Nov;211(5):453-60. doi: 10.1016/j.ajog.2014.06.014. Epub 2014 Jun 6.</citation>
    <PMID>24912096</PMID>
  </reference>
  <reference>
    <citation>Clark SL, Koonings PP, Phelan JP. Placenta previa/accreta and prior cesarean section. Obstet Gynecol. 1985 Jul;66(1):89-92.</citation>
    <PMID>4011075</PMID>
  </reference>
  <reference>
    <citation>Gilliam M, Rosenberg D, Davis F. The likelihood of placenta previa with greater number of cesarean deliveries and higher parity. Obstet Gynecol. 2002 Jun;99(6):976-80. doi: 10.1016/s0029-7844(02)02002-1.</citation>
    <PMID>12052584</PMID>
  </reference>
  <reference>
    <citation>Miller DA, Chollet JA, Goodwin TM. Clinical risk factors for placenta previa-placenta accreta. Am J Obstet Gynecol. 1997 Jul;177(1):210-4. doi: 10.1016/s0002-9378(97)70463-0.</citation>
    <PMID>9240608</PMID>
  </reference>
  <reference>
    <citation>Silver RM. Abnormal Placentation: Placenta Previa, Vasa Previa, and Placenta Accreta. Obstet Gynecol. 2015 Sep;126(3):654-668. doi: 10.1097/AOG.0000000000001005.</citation>
    <PMID>26244528</PMID>
  </reference>
  <reference>
    <citation>Thurn L, Lindqvist PG, Jakobsson M, Colmorn LB, Klungsoyr K, Bjarnadottir RI, Tapper AM, Bordahl PE, Gottvall K, Petersen KB, Krebs L, Gissler M, Langhoff-Roos J, Kallen K. Abnormally invasive placenta-prevalence, risk factors and antenatal suspicion: results from a large population-based pregnancy cohort study in the Nordic countries. BJOG. 2016 Jul;123(8):1348-55. doi: 10.1111/1471-0528.13547. Epub 2015 Jul 29.</citation>
    <PMID>26227006</PMID>
  </reference>
  <reference>
    <citation>Roberge S, Demers S, Girard M, Vikhareva O, Markey S, Chaillet N, Moore L, Paris G, Bujold E. Impact of uterine closure on residual myometrial thickness after cesarean: a randomized controlled trial. Am J Obstet Gynecol. 2016 Apr;214(4):507.e1-507.e6. doi: 10.1016/j.ajog.2015.10.916. Epub 2015 Nov 11.</citation>
    <PMID>26522861</PMID>
  </reference>
  <reference>
    <citation>Dodd JM, Anderson ER, Gates S, Grivell RM. Surgical techniques for uterine incision and uterine closure at the time of caesarean section. Cochrane Database Syst Rev. 2014 Jul 22;(7):CD004732. doi: 10.1002/14651858.CD004732.pub3.</citation>
    <PMID>25048608</PMID>
  </reference>
  <verification_date>August 2018</verification_date>
  <study_first_submitted>November 27, 2016</study_first_submitted>
  <study_first_submitted_qc>January 30, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">February 1, 2017</study_first_posted>
  <last_update_submitted>August 22, 2018</last_update_submitted>
  <last_update_submitted_qc>August 22, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">August 23, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Medical University of Vienna</investigator_affiliation>
    <investigator_full_name>Samir Helmy</investigator_full_name>
    <investigator_title>Dr.</investigator_title>
  </responsible_party>
  <!-- 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/NCT03039803
org study id: 1642/2016
nct id: NCT03039803
lead sponsor: 
In recent decades, the rate of cesarean section delivery has steadily increased worldwide
      ranging at 30% of deliveries, thus long-term risks after cesarean section need to be
      evaluated. Postoperative risks include, among others, uterine scar rupture and placental
      complications such as placenta previa and accreta- complications, which are possibly
      associated with uterine scar dehiscence.

      The prevalence of lower-segment uterine scar deficiency has previously been described as 63%.
      One recent systematic review and meta analysis investigated closure techniques of low
      transverse cesarean. No significant difference in risk of uterine scar defect comparing
      single layer versus double layer closure could be detected (RR 0.53), whereas in women with
      single layer closure, a lower residual myo-metrial thickness was observed (-2.6mm). However,
      the authors do conclude that data is insufficient to determine the risk of uterine rupture,
      dehiscence or gynecological outcomes due to insufficient power of available studies. A
      recently published Randomized Controlled Trial concluded that double-layer closure with
      unlocked first layer showed a better scar healing than locked single layer.

      The investigators main objective is to identify if single-layer suture of the uterus during
      cesarean section results in a higher rate of cesarean scar deficiency than double-layer
      suture.

      Interventions

      Single- layer versus double- layer uterine closure Two different techniques of uterine
      closure in cesarean section will be compared: single- layer versus double- layer continuous
      uterotomy suture.

      Standardized transvaginal sonography

      Transvaginal ultrasound examination is carried out by one expert sonographer. The ultrasound
      machine used for all examinations is GE Voluson E10.

      Primary outcome: CS scar deficiency visualized in transvaginal ultrasound at 3 months after
      CS (yes/no).

      Secondary outcome: Myometrial thickness at the site of uterine scar (mm).
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Double (Participant, Outcomes Assessor)
measure: Cesarean section (CS) scar deficiency visualized in transvaginal ultrasound at 3 months after CS (yes/no).
time frame: 3 months
measure: Myometrial thickness at the site of uterine scar (mm).
time frame: 3 months
measure: The presence or absence of a CS scar pregnancy in a consecutive pregnancy
time frame: up to 25 years
measure: Occurence of uterine rupture in a consecutive pregnancy
time frame: up to 25 years
measure: CS scar deficiency visualized in transvaginal ultrasound (yes/no) in early pregnancy in a consecutive pregnancy
time frame: up to 25 years
arm group label: single-layer continuous uterotomy suture
arm group type: Active Comparator
description: Single-layer continuous uterotomy suture
arm group label: double-layer continuous uterotomy suture
arm group type: Active Comparator
description: double-layer continuous uterotomy suture
intervention type: Procedure
intervention name: uterine closure during cesarean section
arm group label: double-layer continuous uterotomy suture
arm group label: single-layer continuous uterotomy suture
criteria: 
gender: Female
minimum age: 18 Years
maximum age: 50 Years
healthy volunteers: No
last name: Marianne Koch, Dr.
phone: 0043 1 40400 29150
email: marianne.koch@meduniwien.ac.at
last name: Samir Helmy-Bader, Dr.
phone: 0043 1 40400 29150
email: samir.helmy@meduniwien.ac.at
facility: 
status: Recruiting
contact: 
contact backup: 
country: Austria
citation: Ofili-Yebovi D, Ben-Nagi J, Sawyer E, Yazbek J, Lee C, Gonzalez J, Jurkovic D. Deficient lower-segment Cesarean section scars: prevalence and risk factors. Ultrasound Obstet Gynecol. 2008 Jan;31(1):72-7. doi: 10.1002/uog.5200.
PMID: 18061960
citation: Roberge S, Demers S, Berghella V, Chaillet N, Moore L, Bujold E. Impact of single- vs double-layer closure on adverse outcomes and uterine scar defect: a systematic review and metaanalysis. Am J Obstet Gynecol. 2014 Nov;211(5):453-60. doi: 10.1016/j.ajog.2014.06.014. Epub 2014 Jun 6.
PMID: 24912096
citation: Clark SL, Koonings PP, Phelan JP. Placenta previa/accreta and prior cesarean section. Obstet Gynecol. 1985 Jul;66(1):89-92.
PMID: 4011075
citation: Gilliam M, Rosenberg D, Davis F. The likelihood of placenta previa with greater number of cesarean deliveries and higher parity. Obstet Gynecol. 2002 Jun;99(6):976-80. doi: 10.1016/s0029-7844(02)02002-1.
PMID: 12052584
citation: Miller DA, Chollet JA, Goodwin TM. Clinical risk factors for placenta previa-placenta accreta. Am J Obstet Gynecol. 1997 Jul;177(1):210-4. doi: 10.1016/s0002-9378(97)70463-0.
PMID: 9240608
citation: Silver RM. Abnormal Placentation: Placenta Previa, Vasa Previa, and Placenta Accreta. Obstet Gynecol. 2015 Sep;126(3):654-668. doi: 10.1097/AOG.0000000000001005.
PMID: 26244528
citation: Thurn L, Lindqvist PG, Jakobsson M, Colmorn LB, Klungsoyr K, Bjarnadottir RI, Tapper AM, Bordahl PE, Gottvall K, Petersen KB, Krebs L, Gissler M, Langhoff-Roos J, Kallen K. Abnormally invasive placenta-prevalence, risk factors and antenatal suspicion: results from a large population-based pregnancy cohort study in the Nordic countries. BJOG. 2016 Jul;123(8):1348-55. doi: 10.1111/1471-0528.13547. Epub 2015 Jul 29.
PMID: 26227006
citation: Roberge S, Demers S, Girard M, Vikhareva O, Markey S, Chaillet N, Moore L, Paris G, Bujold E. Impact of uterine closure on residual myometrial thickness after cesarean: a randomized controlled trial. Am J Obstet Gynecol. 2016 Apr;214(4):507.e1-507.e6. doi: 10.1016/j.ajog.2015.10.916. Epub 2015 Nov 11.
PMID: 26522861
citation: Dodd JM, Anderson ER, Gates S, Grivell RM. Surgical techniques for uterine incision and uterine closure at the time of caesarean section. Cochrane Database Syst Rev. 2014 Jul 22;(7):CD004732. doi: 10.1002/14651858.CD004732.pub3.
PMID: 25048608
responsible party type: Principal Investigator
investigator affiliation: Medical University of Vienna
investigator full name: Samir Helmy
investigator title: Dr.