<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/NCT03034434</url>
  </required_header>
  <id_info>
    <org_study_id>0154-16-RMB</org_study_id>
    <nct_id>NCT03034434</nct_id>
  </id_info>
  <brief_title>Cervical Recuperation After Vaginal Delivery</brief_title>
  <official_title>Sonography Evaluation of Cervical Recuperation After Vaginal Delivery</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Rambam Health Care Campus</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Rambam Health Care Campus</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>
      Patients after vaginal delivery will undergo 3 trans-vaginal ultrasounds in order to examine&#xD;
      the process of cervical recuperation post delivery.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Patients after vaginal delivery will be recruited after receiving a full explanation and&#xD;
      signing an informed consent.&#xD;
&#xD;
      The goal of the study is to examine cervical length after vaginal delivery at 3 different&#xD;
      time intervals:&#xD;
&#xD;
        1. 8 hours post delivery.&#xD;
&#xD;
        2. 24 hours post delivery.&#xD;
&#xD;
        3. 48 hours post delivery. At each interval a trans-vaginal ultrasound will be performed,&#xD;
           evaluating cervical length. At the end of the 3rd and final ultrasound, the patient will&#xD;
           finish her participation in the study/ Information regarding obstetric conditions such&#xD;
           as labor induction, gestational age at the time of delivery etc. will be collected from&#xD;
           patients' electronic files.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">March 14, 2017</start_date>
  <completion_date type="Actual">June 30, 2020</completion_date>
  <primary_completion_date type="Actual">February 29, 2020</primary_completion_date>
  <study_type>Observational [Patient Registry]</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <target_duration>5 Years</target_duration>
  <primary_outcome>
    <measure>Cervical length after vaginal delivery.</measure>
    <time_frame>Up to 48 hours post delivery.</time_frame>
    <description>Measurement of cervical length 8, 24, 48 hours after vaginal delivery by trans-vaginal ultrasound.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Differences in cervical length after vaginal delivery.</measure>
    <time_frame>Up to 48 hours post delivery.</time_frame>
    <description>Differences in cervical length after vaginal delivery as a factor of gestational age at delivery, means of labor induction, parity, etc.</description>
  </secondary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Actual">1384</enrollment>
  <condition>Cervix</condition>
  <arm_group>
    <arm_group_label>Patients after vaginal delivery</arm_group_label>
    <description>Patients after vaginal delivery willing to undergo 3 trans-vaginal ultrasounds within the 48 hours after delivery.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Trans-vaginal ultrasound</intervention_name>
    <description>Three trans-vaginal ultrasounds, the 1st to be performed 8 hours post delivery, the 2nd 24 hours after delivery and the 3rd 48 hours after delivery.</description>
    <arm_group_label>Patients after vaginal delivery</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Patients after vaginal delivery.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Any patient after vaginal delivery.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Any patient after cesarean section.&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <gender_based>Yes</gender_based>
    <gender_description>Female patients only.</gender_description>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>44 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Roy Lauterbach, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Rambam Health Care Campus</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Rambam health care campus</name>
      <address>
        <city>Haifa</city>
        <country>Israel</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Israel</country>
  </location_countries>
  <verification_date>July 2020</verification_date>
  <study_first_submitted>January 25, 2017</study_first_submitted>
  <study_first_submitted_qc>January 26, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 27, 2017</study_first_posted>
  <last_update_submitted>July 24, 2020</last_update_submitted>
  <last_update_submitted_qc>July 24, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">July 27, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Rambam Health Care Campus</investigator_affiliation>
    <investigator_full_name>ROY LAUTERBACH MD</investigator_full_name>
    <investigator_title>Principal investigator</investigator_title>
  </responsible_party>
  <patient_data>
    <sharing_ipd>Undecided</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/NCT03034434
org study id: 0154-16-RMB
nct id: NCT03034434
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Patients after vaginal delivery will undergo 3 trans-vaginal ultrasounds in order to examine
      the process of cervical recuperation post delivery.
Patients after vaginal delivery will be recruited after receiving a full explanation and
      signing an informed consent.

      The goal of the study is to examine cervical length after vaginal delivery at 3 different
      time intervals:

        1. 8 hours post delivery.

        2. 24 hours post delivery.

        3. 48 hours post delivery. At each interval a trans-vaginal ultrasound will be performed,
           evaluating cervical length. At the end of the 3rd and final ultrasound, the patient will
           finish her participation in the study/ Information regarding obstetric conditions such
           as labor induction, gestational age at the time of delivery etc. will be collected from
           patients' electronic files.
observational model: Cohort
time perspective: Prospective
measure: Cervical length after vaginal delivery.
time frame: Up to 48 hours post delivery.
description: Measurement of cervical length 8, 24, 48 hours after vaginal delivery by trans-vaginal ultrasound.
measure: Differences in cervical length after vaginal delivery.
time frame: Up to 48 hours post delivery.
description: Differences in cervical length after vaginal delivery as a factor of gestational age at delivery, means of labor induction, parity, etc.
arm group label: Patients after vaginal delivery
description: Patients after vaginal delivery willing to undergo 3 trans-vaginal ultrasounds within the 48 hours after delivery.
intervention type: Device
intervention name: Trans-vaginal ultrasound
description: Three trans-vaginal ultrasounds, the 1st to be performed 8 hours post delivery, the 2nd 24 hours after delivery and the 3rd 48 hours after delivery.
arm group label: Patients after vaginal delivery
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: Female
gender based: Yes
gender description: Female patients only.
minimum age: 18 Years
maximum age: 44 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Roy Lauterbach, MD
role: Principal Investigator
affiliation: Rambam Health Care Campus
facility: 
country: Israel
responsible party type: Principal Investigator
investigator affiliation: Rambam Health Care Campus
investigator full name: ROY LAUTERBACH MD
investigator title: Principal investigator
sharing ipd: Undecided