<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/NCT03837288</url>
  </required_header>
  <id_info>
    <org_study_id>Trial</org_study_id>
    <nct_id>NCT03837288</nct_id>
  </id_info>
  <brief_title>Cervical Cerclage for Singleton Pregnant on Vaginal Progesterone With Progressive Cervical Length Shortening</brief_title>
  <official_title>Cervical Cerclage for Singleton Pregnant on Vaginal Progesterone With Progressive Cervical Length Shortening</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Ain Shams University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Ain Shams University</source>
  <oversight_info>
    <has_dmc>Yes</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>
      The aim of this study is to&#xD;
&#xD;
      Determine whether cerclage with vaginal progesterone will:&#xD;
&#xD;
        1. Reduce the overall spontaneous preterm birth rate.&#xD;
&#xD;
        2. Prolong pregnancy latency.&#xD;
&#xD;
        3. Improve neonatal outcome. Compared to vaginal progesterone only, in patients with&#xD;
           progressive cervical shortening.&#xD;
&#xD;
      Research question:&#xD;
&#xD;
      Does cervical cerclage reduce the overall spontaneous preterm births in patients with&#xD;
      progressive cervical shortening.&#xD;
&#xD;
      Research Hypothesis In this current study, the investigators hypothesize that cervical&#xD;
      cerclage reduces spontaneous preterm births in patients with progressive cervical shortening&#xD;
      on vaginal progesterone only.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      A randomized controlled trial The study will be done in Ain Shams University Hospital&#xD;
      including women attending antenatal care clinic in Ain Shams University Hospital.&#xD;
&#xD;
      All patients entering the trial will be counselled and will sign a written consent explaining&#xD;
      the details of the trial. All the patients included in this study will undergo routine Fetal&#xD;
      anomaly scan at 18-24 weeks.Patients with cervical length &lt; 20 mm in routine anomaly scan&#xD;
      will :&#xD;
&#xD;
        1. Receive vaginal progesterone suppositories 200 mg daily.. (All patients will be&#xD;
           continued with vaginal progesterone until 37 completed weeks or until they develop&#xD;
           preterm rupture of membrane or preterm delivery).&#xD;
&#xD;
        2. Undergo routine follow up of cervical length every 1 to 2 weeks. Patients with&#xD;
           progressive shortening of cervical length less than 10 mm during routine follow up, will&#xD;
           have the option of continuing vaginal progesterone daily (Progesterone 200 mg vaginal&#xD;
           suppositories) alone, or having cervical cerclage placed in addition to daily vaginal&#xD;
           progesterone.&#xD;
&#xD;
      In cerclage group: all patients will sign a written consent for approval of cervical&#xD;
      cerclage.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Anticipated">April 22, 2019</start_date>
  <completion_date type="Anticipated">October 22, 2019</completion_date>
  <primary_completion_date type="Anticipated">September 20, 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>Prevention</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Gestational age of delivery</measure>
    <time_frame>&lt;37 weeks</time_frame>
    <description>After 37 weeks of pregnancy</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>New born birth weight</measure>
    <time_frame>At time of birth</time_frame>
    <description>less than 2 kg</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">60</enrollment>
  <condition>Preterm Labor</condition>
  <condition>Cervical Incompetence</condition>
  <arm_group>
    <arm_group_label>Vaginal progesterone only</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>continue on vaginal progesterone only</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Cervical cerclage plus vaginal progesterone</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>cerclage with vaginal progesterone.</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Cerclage</intervention_name>
    <description>Cervical cerclage under effect of spinal anaesthesia</description>
    <arm_group_label>Cervical cerclage plus vaginal progesterone</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Women aged: 20-38 years old.&#xD;
&#xD;
          2. Single living fetus.&#xD;
&#xD;
          3. The patient does not have history of preterm labor (before 37 weeks of gestation)&#xD;
&#xD;
          4. No history of cervical or uterine anomalies.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Congenital anomalies in the fetus discovered during the follow up.&#xD;
&#xD;
          2. History of spontaneous preterm births.&#xD;
&#xD;
          3. Evidence of imminent delivery, or uterine contractions.&#xD;
&#xD;
          4. Evidence of rupture of membranes, or intra amniotic infection.&#xD;
&#xD;
          5. Intra uterine fetal death.&#xD;
&#xD;
          6. Uterine or cervical anomalies.&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <gender_based>Yes</gender_based>
    <gender_description>Singleton pregnant.</gender_description>
    <minimum_age>20 Years</minimum_age>
    <maximum_age>38 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Yasser Shahawy</last_name>
    <role>Study Director</role>
    <affiliation>Ain Shams University</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Manal Fawzy</last_name>
    <phone>01012659658</phone>
    <email>manoly18loly@gmail.com</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Al Hassan Khedr</last_name>
    <phone>01006193797</phone>
    <email>Hasankhedr@gmail.com</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>AinshamsU</name>
      <address>
        <city>Cairo</city>
        <zip>+02</zip>
        <country>Egypt</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Manal Fawzy, Bachalori</last_name>
      <phone>01012659658</phone>
      <email>manoly18loly@gmail.com</email>
    </contact>
    <contact_backup>
      <last_name>Al Hassan Khedr, MD</last_name>
      <phone>01006193797</phone>
      <email>hasankhedr@gmail.com</email>
    </contact_backup>
  </location>
  <location_countries>
    <country>Egypt</country>
  </location_countries>
  <verification_date>February 2019</verification_date>
  <study_first_submitted>January 8, 2019</study_first_submitted>
  <study_first_submitted_qc>February 9, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">February 12, 2019</study_first_posted>
  <last_update_submitted>February 9, 2019</last_update_submitted>
  <last_update_submitted_qc>February 9, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">February 12, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Ain Shams University</investigator_affiliation>
    <investigator_full_name>Manal Mohammed Fawzy</investigator_full_name>
    <investigator_title>Principle invistigator</investigator_title>
  </responsible_party>
  <keyword>preterm labor</keyword>
  <keyword>cerclage</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Obstetric Labor, Premature</mesh_term>
    <mesh_term>Uterine Cervical Incompetence</mesh_term>
  </condition_browse>
  <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/NCT03837288
org study id: Trial
nct id: NCT03837288
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
The aim of this study is to

      Determine whether cerclage with vaginal progesterone will:

        1. Reduce the overall spontaneous preterm birth rate.

        2. Prolong pregnancy latency.

        3. Improve neonatal outcome. Compared to vaginal progesterone only, in patients with
           progressive cervical shortening.

      Research question:

      Does cervical cerclage reduce the overall spontaneous preterm births in patients with
      progressive cervical shortening.

      Research Hypothesis In this current study, the investigators hypothesize that cervical
      cerclage reduces spontaneous preterm births in patients with progressive cervical shortening
      on vaginal progesterone only.
A randomized controlled trial The study will be done in Ain Shams University Hospital
      including women attending antenatal care clinic in Ain Shams University Hospital.

      All patients entering the trial will be counselled and will sign a written consent explaining
      the details of the trial. All the patients included in this study will undergo routine Fetal
      anomaly scan at 18-24 weeks.Patients with cervical length < 20 mm in routine anomaly scan
      will :

        1. Receive vaginal progesterone suppositories 200 mg daily.. (All patients will be
           continued with vaginal progesterone until 37 completed weeks or until they develop
           preterm rupture of membrane or preterm delivery).

        2. Undergo routine follow up of cervical length every 1 to 2 weeks. Patients with
           progressive shortening of cervical length less than 10 mm during routine follow up, will
           have the option of continuing vaginal progesterone daily (Progesterone 200 mg vaginal
           suppositories) alone, or having cervical cerclage placed in addition to daily vaginal
           progesterone.

      In cerclage group: all patients will sign a written consent for approval of cervical
      cerclage.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Prevention
masking: None (Open Label)
measure: Gestational age of delivery
time frame: <37 weeks
description: After 37 weeks of pregnancy
measure: New born birth weight
time frame: At time of birth
description: less than 2 kg
arm group label: Vaginal progesterone only
arm group type: No Intervention
description: continue on vaginal progesterone only
arm group label: Cervical cerclage plus vaginal progesterone
arm group type: Experimental
description: cerclage with vaginal progesterone.
intervention type: Procedure
intervention name: Cerclage
description: Cervical cerclage under effect of spinal anaesthesia
arm group label: Cervical cerclage plus vaginal progesterone
criteria: 
gender: Female
gender based: Yes
gender description: Singleton pregnant.
minimum age: 20 Years
maximum age: 38 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Yasser Shahawy
role: Study Director
affiliation: Ain Shams University
last name: Manal Fawzy
phone: 01012659658
email: manoly18loly@gmail.com
last name: Al Hassan Khedr
phone: 01006193797
email: Hasankhedr@gmail.com
facility: 
status: Recruiting
contact: 
contact backup: 
country: Egypt
responsible party type: Principal Investigator
investigator affiliation: Ain Shams University
investigator full name: Manal Mohammed Fawzy
investigator title: Principle invistigator
mesh term: Obstetric Labor, Premature
mesh term: Uterine Cervical Incompetence
sharing ipd: Undecided