xml: <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/NCT05997498</url>
    </required_header>
    <id_info>
      <org_study_id>Mechanical Dilatation CS</org_study_id>
      <nct_id>NCT05997498</nct_id>
    </id_info>
    <brief_title>Mechanical Dilatation of the Cervix at Elective Caesarean Section on Post-operative Morbidity</brief_title>
    <official_title>The Effect of Mechanical Dilatation of the Cervix at Elective Caesarean Section on Post-operative Morbidity</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Beni-Suef University</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Beni-Suef University</source>
    <oversight_info>
      <is_fda_regulated_drug>No</is_fda_regulated_drug>
      <is_fda_regulated_device>No</is_fda_regulated_device>
    </oversight_info>
    <brief_summary>
      <textblock>
        The study aims to evaluate the effects of cervical dilatation during cesarean section on&#xD;
        postoperative maternal morbidity through different clinical parameters.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        A randomized double-blind clinical trial comparing cervical dilatation during caesarean&#xD;
        section to no intervention.&#xD;
  &#xD;
          -  Study participants and sample size This study will include pregnant women with a&#xD;
             singleton fetus at term ≥37 weeks of gestation and will be scheduled for elective&#xD;
             caesarean section. Eligible participants will be allocated either to the study group&#xD;
             (women with intraoperative cervical dilatation) or the control group (women with no&#xD;
             intraoperative cervical dilatation).&#xD;
  &#xD;
          -  Types of interventions Mechanical dilatation of the cervix using a finger, sponge&#xD;
             forceps during non-labour caesarean section ***Randomization and Allocation A&#xD;
             statistician prepared a computer-generated random tableand placed the group allocation&#xD;
             in serially numbered closed opaque envelopes in a 1:1 ratio. Packing, sealing and&#xD;
             numbering will be performed by two independent doctors other than the investigator.&#xD;
  &#xD;
        Patients are allocated to either study group (cervical dilatation) or control group (no&#xD;
        cervical dilatation). Allocation will be never changed after opening the envelopes. All&#xD;
        patients are blinded to the allocation to avoid bias.&#xD;
  &#xD;
        **Neither the investigator nor the outcome assessor following up the patient postoperatively&#xD;
        are aware whether the patient had undergone cervical dilation during the cesarean section or&#xD;
        not (double-blinding). Randomization coding tables will be hidden from the investigator till&#xD;
        the end of the study.&#xD;
  &#xD;
        Group I (dilation group): in which mechanical cervical dilatation will be done.&#xD;
  &#xD;
        Group II (Non-dilation group): in which no mechanical cervical dilatation will be done. *****&#xD;
        ***Study procedure:&#xD;
  &#xD;
        After taking informed written consent, the recruited patients will be subjected to the&#xD;
        following:&#xD;
  &#xD;
        Clinical examination:&#xD;
  &#xD;
          -  History: personal (age, duration of marriage), present (any current medical or surgical&#xD;
             diseases and any current medication), Past (history of any medical disorder) and&#xD;
             obstetric history (including Parity, Gestational age, obstetric complications).&#xD;
             Indications for cesarean were determined as malposition of the fetal head, head-pelvis&#xD;
             incompatibility, disrupted fetal heart rate.&#xD;
  &#xD;
          -  General examination: assessment of body mass index (BMI) ,vital data (pulse, blood&#xD;
             pressure, temperature), cardiac and chest auscultation to exclude contraindications for&#xD;
             anesthesia.&#xD;
  &#xD;
          -  Abdominal examination: assessment of fundal level, fetal lie and presentation liquor&#xD;
             volume and previous scar if present.&#xD;
  &#xD;
          -  Vaginal examination: to exclude cervical changes.&#xD;
  &#xD;
          -  Ultrasound examination: to assess fetal viability, determine gestational age and exclude&#xD;
             major anomalies.&#xD;
  &#xD;
        Steps:&#xD;
  &#xD;
          -  Informed consent will be obtained from women who will be invited to participate in the&#xD;
             research after an explanation of the benefits and risks of this trial.&#xD;
  &#xD;
          -  All caesarean sections will be performed by a senior registrar capable of doing&#xD;
             uncomplicated elective cesarean sections.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">August 30, 2023</start_date>
    <completion_date type="Anticipated">February 20, 2024</completion_date>
    <primary_completion_date type="Anticipated">January 30, 2024</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>Prevention</primary_purpose>
      <masking>Double (Participant, Investigator)</masking>
      <masking_description>A statistician prepared a computer-generated random tableand placed the group allocation in serially numbered closed opaque envelopes in a 1:1 ratio. Packing, sealing and numbering will be performed by two independent doctors other than the investigator.&#xD;
  Patients are allocated to either study group (cervical dilatation) or control group (no cervical dilatation). Allocation will be never changed after opening the envelopes. All patients are blinded to the allocation to avoid bias.&#xD;
  Neither the investigator nor the outcome assessor following up the patient postoperatively are aware whether the patient had undergone cervical dilation during the cesarean section or not (double-blinding). Randomization coding tables will be hidden from the investigator till the end of the study.</masking_description>
    </study_design_info>
    <primary_outcome>
      <measure>postpartum 6th month scar thickness</measure>
      <time_frame>6 months after delivery</time_frame>
      <description>measure the thickness of the residual myometrial tissue (RMT) in mm by transvaginal ultrsound</description>
    </primary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Anticipated">180</enrollment>
    <condition>Cesarean Section Complications</condition>
    <arm_group>
      <arm_group_label>dilation group</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>mechanical cervical dilatation will be done.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>control</arm_group_label>
      <arm_group_type>No Intervention</arm_group_type>
      <description>in which no mechanical cervical dilatation will be done.</description>
    </arm_group>
    <intervention>
      <intervention_type>Procedure</intervention_type>
      <intervention_name>mechanical cervical dilatation</intervention_name>
      <description>mechanical cervical dilatation during elective cesarean section</description>
      <arm_group_label>dilation group</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
          Elective Cs (primary or repeated CS)&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
          Medical or obstetric conditions that may put them at risk for uterine atony and postpartum&#xD;
          hemorrhage and infection, such as:&#xD;
  &#xD;
            -  Emergency Cesarean section&#xD;
  &#xD;
            -  Chorioamnionitis.&#xD;
  &#xD;
            -  Preterm caesarean section.&#xD;
  &#xD;
            -  Multiple gestations.&#xD;
  &#xD;
            -  Fever during admission.&#xD;
  &#xD;
            -  Rupture of membranes.&#xD;
  &#xD;
            -  Anemia&#xD;
        </textblock>
      </criteria>
      <gender>Female</gender>
      <minimum_age>20 Years</minimum_age>
      <maximum_age>40 Years</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_contact>
      <last_name>Salem</last_name>
      <phone>01272842226</phone>
      <phone_ext>02</phone_ext>
      <email>sara_abdallah100@yahoo.com</email>
    </overall_contact>
    <location>
      <facility>
        <name>Beni-suef university Hospital</name>
        <address>
          <city>Banī Suwayf</city>
          <state>Beni Suef</state>
          <zip>62521</zip>
          <country>Egypt</country>
        </address>
      </facility>
    </location>
    <location_countries>
      <country>Egypt</country>
    </location_countries>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>July 26, 2023</study_first_submitted>
    <study_first_submitted_qc>August 15, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 18, 2023</study_first_posted>
    <last_update_submitted>August 15, 2023</last_update_submitted>
    <last_update_submitted_qc>August 15, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 18, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>Beni-Suef University</investigator_affiliation>
      <investigator_full_name>Sara Abdallah Mohamed Salem</investigator_full_name>
      <investigator_title>principle investigator/Lecturer of Gynecology and obstetrics Faculty of medicine Beni-Suef University</investigator_title>
    </responsible_party>
    <keyword>Cesarean Section</keyword>
    <keyword>Mechanical Dilatation</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Dilatation, Pathologic</mesh_term>
    </condition_browse>
    <patient_data>
      <sharing_ipd>Yes</sharing_ipd>
      <ipd_info_type>Study Protocol</ipd_info_type>
      <ipd_info_type>Statistical Analysis Plan (SAP)</ipd_info_type>
      <ipd_info_type>Informed Consent Form (ICF)</ipd_info_type>
      <ipd_info_type>Clinical Study Report (CSR)</ipd_info_type>
    </patient_data>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: 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/NCT05997498
  org study id: Mechanical Dilatation CS
  nct id: NCT05997498
  lead sponsor: 
  is fda regulated drug: No
  is fda regulated device: No
  The study aims to evaluate the effects of cervical dilatation during cesarean section on
        postoperative maternal morbidity through different clinical parameters.
  A randomized double-blind clinical trial comparing cervical dilatation during caesarean
        section to no intervention.
  
          -  Study participants and sample size This study will include pregnant women with a
             singleton fetus at term ≥37 weeks of gestation and will be scheduled for elective
             caesarean section. Eligible participants will be allocated either to the study group
             (women with intraoperative cervical dilatation) or the control group (women with no
             intraoperative cervical dilatation).
  
          -  Types of interventions Mechanical dilatation of the cervix using a finger, sponge
             forceps during non-labour caesarean section ***Randomization and Allocation A
             statistician prepared a computer-generated random tableand placed the group allocation
             in serially numbered closed opaque envelopes in a 1:1 ratio. Packing, sealing and
             numbering will be performed by two independent doctors other than the investigator.
  
        Patients are allocated to either study group (cervical dilatation) or control group (no
        cervical dilatation). Allocation will be never changed after opening the envelopes. All
        patients are blinded to the allocation to avoid bias.
  
        **Neither the investigator nor the outcome assessor following up the patient postoperatively
        are aware whether the patient had undergone cervical dilation during the cesarean section or
        not (double-blinding). Randomization coding tables will be hidden from the investigator till
        the end of the study.
  
        Group I (dilation group): in which mechanical cervical dilatation will be done.
  
        Group II (Non-dilation group): in which no mechanical cervical dilatation will be done. *****
        ***Study procedure:
  
        After taking informed written consent, the recruited patients will be subjected to the
        following:
  
        Clinical examination:
  
          -  History: personal (age, duration of marriage), present (any current medical or surgical
             diseases and any current medication), Past (history of any medical disorder) and
             obstetric history (including Parity, Gestational age, obstetric complications).
             Indications for cesarean were determined as malposition of the fetal head, head-pelvis
             incompatibility, disrupted fetal heart rate.
  
          -  General examination: assessment of body mass index (BMI) ,vital data (pulse, blood
             pressure, temperature), cardiac and chest auscultation to exclude contraindications for
             anesthesia.
  
          -  Abdominal examination: assessment of fundal level, fetal lie and presentation liquor
             volume and previous scar if present.
  
          -  Vaginal examination: to exclude cervical changes.
  
          -  Ultrasound examination: to assess fetal viability, determine gestational age and exclude
             major anomalies.
  
        Steps:
  
          -  Informed consent will be obtained from women who will be invited to participate in the
             research after an explanation of the benefits and risks of this trial.
  
          -  All caesarean sections will be performed by a senior registrar capable of doing
             uncomplicated elective cesarean sections.
  allocation: Randomized
  intervention model: Parallel Assignment
  primary purpose: Prevention
  masking: Double (Participant, Investigator)
  masking description: A statistician prepared a computer-generated random tableand placed the group allocation in serially numbered closed opaque envelopes in a 1:1 ratio. Packing, sealing and numbering will be performed by two independent doctors other than the investigator.
  Patients are allocated to either study group (cervical dilatation) or control group (no cervical dilatation). Allocation will be never changed after opening the envelopes. All patients are blinded to the allocation to avoid bias.
  Neither the investigator nor the outcome assessor following up the patient postoperatively are aware whether the patient had undergone cervical dilation during the cesarean section or not (double-blinding). Randomization coding tables will be hidden from the investigator till the end of the study.
  measure: postpartum 6th month scar thickness
  time frame: 6 months after delivery
  description: measure the thickness of the residual myometrial tissue (RMT) in mm by transvaginal ultrsound
  arm group label: dilation group
  arm group type: Experimental
  description: mechanical cervical dilatation will be done.
  arm group label: control
  arm group type: No Intervention
  description: in which no mechanical cervical dilatation will be done.
  intervention type: Procedure
  intervention name: mechanical cervical dilatation
  description: mechanical cervical dilatation during elective cesarean section
  arm group label: dilation group
  criteria: 
  gender: Female
  minimum age: 20 Years
  maximum age: 40 Years
  healthy volunteers: No
  last name: Salem
  phone: 01272842226
  phone ext: 02
  email: sara_abdallah100@yahoo.com
  facility: 
  country: Egypt
  responsible party type: Principal Investigator
  investigator affiliation: Beni-Suef University
  investigator full name: Sara Abdallah Mohamed Salem
  investigator title: principle investigator/Lecturer of Gynecology and obstetrics Faculty of medicine Beni-Suef University
  mesh term: Dilatation, Pathologic
  sharing ipd: Yes
  ipd info type: Study Protocol
  ipd info type: Statistical Analysis Plan (SAP)
  ipd info type: Informed Consent Form (ICF)
  ipd info type: Clinical Study Report (CSR)