<?xml version="1.0" encoding="utf-8"?>
<!DOCTYPE trials [
<!ELEMENT trials (trial+)>

<!ELEMENT trial (main,contacts,countries,criteria,health_condition_code,health_condition_keyword,intervention_code,
          intervention_keyword,primary_outcome,secondary_outcome,secondary_sponsor,secondary_ids,source_support,ethics_reviews)>

<!ELEMENT main (trial_id,utrn?,reg_name,date_registration,primary_sponsor,public_title,acronym?,scientific_title,scientific_acronym?,
          date_enrolment,type_enrolment,target_size,recruitment_status,url?,study_type,study_design,phase,hc_freetext?,i_freetext?,results_actual_enrolment,results_date_completed,results_url_link,results_summary,           results_date_posted,results_date_first_publication,results_baseline_char,results_participant_flow,results_adverse_events,results_outcome_measures,results_url_protocol,results_IPD_plan, results_IPD_description)>
<!ELEMENT trial_id (#PCDATA)>
<!ELEMENT utrn (#PCDATA)>
<!ELEMENT reg_name (#PCDATA)>
<!ELEMENT date_registration (#PCDATA)><!-- dd/mm/yyyy -->
<!ELEMENT primary_sponsor (#PCDATA)>
<!ELEMENT public_title (#PCDATA)>
<!ELEMENT acronym (#PCDATA)>
<!ELEMENT scientific_title (#PCDATA)>
<!ELEMENT scientific_acronym (#PCDATA)>
<!ELEMENT date_enrolment (#PCDATA)><!-- dd/mm/yyyy -->
<!ELEMENT type_enrolment (#PCDATA)>
<!ELEMENT target_size (#PCDATA)>
<!ELEMENT recruitment_status (#PCDATA)><!-- Pending,Recruiting,Suspended,Complete,Other -->
<!ELEMENT url (#PCDATA)>
<!ELEMENT study_type (#PCDATA)><!-- interventional,observational -->
<!ELEMENT study_design (#PCDATA)>
<!ELEMENT phase (#PCDATA)>
<!ELEMENT hc_freetext (#PCDATA)>
<!ELEMENT i_freetext (#PCDATA)>
<!ELEMENT results_actual_enrolment (#PCDATA)>
<!ELEMENT results_date_completed (#PCDATA)><!-- dd/mm/yyyy -->
<!ELEMENT results_url_link (#PCDATA)>
<!ELEMENT results_summary (#PCDATA)>
<!ELEMENT results_date_posted (#PCDATA)><!-- dd/mm/yyyy -->
<!ELEMENT results_date_first_publication (#PCDATA)><!-- dd/mm/yyyy -->
<!ELEMENT results_baseline_char (#PCDATA)>
<!ELEMENT results_participant_flow (#PCDATA)>
<!ELEMENT results_adverse_events (#PCDATA)>
<!ELEMENT results_outcome_measures (#PCDATA)>
<!ELEMENT results_url_protocol (#PCDATA)>
<!ELEMENT results_IPD_plan (#PCDATA)>
<!ELEMENT results_IPD_description (#PCDATA)>


<!ELEMENT contacts (contact+)>
<!ELEMENT contact (type,firstname,middlename,lastname,address,city,country1,zip,telephone,email,affiliation)>
<!ELEMENT type (#PCDATA)><!-- Public,Scientific -->
<!ELEMENT firstname (#PCDATA)>
<!ELEMENT middlename (#PCDATA)>
<!ELEMENT lastname (#PCDATA)>
<!ELEMENT address (#PCDATA)>
<!ELEMENT city (#PCDATA)>
<!ELEMENT country1 (#PCDATA)>
<!ELEMENT zip (#PCDATA)>
<!ELEMENT telephone (#PCDATA)>
<!ELEMENT email (#PCDATA)>
<!ELEMENT affiliation (#PCDATA)>

<!ELEMENT countries (country2+)>
<!ELEMENT country2 (#PCDATA)>

<!ELEMENT criteria (inclusion_criteria,agemin,agemax,gender,exclusion_criteria)>
<!ELEMENT inclusion_criteria (#PCDATA)>
<!ELEMENT agemin (#PCDATA)>
<!ELEMENT agemax (#PCDATA)>
<!ELEMENT gender (#PCDATA)>
<!ELEMENT exclusion_criteria (#PCDATA)>

<!ELEMENT health_condition_code (hc_code+)>
<!ELEMENT hc_code (#PCDATA)>

<!ELEMENT health_condition_keyword (hc_keyword+)>
<!ELEMENT hc_keyword (#PCDATA)>

<!ELEMENT intervention_code (i_code+)>
<!ELEMENT i_code (#PCDATA)>

<!ELEMENT intervention_keyword (i_keyword+)>
<!ELEMENT i_keyword (#PCDATA)>

<!ELEMENT primary_outcome (prim_outcome+)>
<!ELEMENT prim_outcome (#PCDATA)>

<!ELEMENT secondary_outcome (sec_outcome+)>
<!ELEMENT sec_outcome (#PCDATA)>

<!ELEMENT secondary_sponsor (sponsor_name+)>
<!ELEMENT sponsor_name (#PCDATA)>

<!ELEMENT secondary_ids (secondary_id+)>
<!ELEMENT secondary_id (sec_id,issuing_authority)>
<!ELEMENT sec_id (#PCDATA)>
<!ELEMENT issuing_authority (#PCDATA)>

<!ELEMENT source_support (source_name+)>
<!ELEMENT source_name (#PCDATA)>

<!ELEMENT ethics_reviews (ethics_review+)>
<!ELEMENT ethics_review (status,approval_date,contact_name,contact_address,contact_phone,contact_email)>
<!ELEMENT status (#PCDATA)><!-- Not approved,Approved,NA -->
<!ELEMENT approval_date (#PCDATA)><!-- dd/mm/yyyy -->
<!ELEMENT contact_name (#PCDATA)>
<!ELEMENT contact_address (#PCDATA)>
<!ELEMENT contact_phone (#PCDATA)>
<!ELEMENT contact_email (#PCDATA)>
]>
<trials>
  <trial>
    <main>
      <trial_id>IRCT20200215046496N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2020-03-24</date_registration>
      <primary_sponsor>Tehran University of Medical Sciences</primary_sponsor>
      <public_title>Assessing the effect of supplemental injectable progesterone on complicated monochorionic diamnionic twin pregnanciy with radiofrequency ablation with cercival length of 25 mm or above on TVS</public_title>
      <acronym></acronym>
      <scientific_title>Assessing the effect of supplemental injectable progesterone on complicated monochorionic diamnionic twin pregnanciy with radiofrequency ablation with cercival length of 25 mm or above on TVS</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2019-03-17</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>80</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/45842</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Simple randomization
To the number of samples in each group, letters A or B were written on cards and put in a pocket. Prior to each intervention a card was taken out determining the patient allocation to case or control group, Blinding description: Follow up and result assessment of patients were performed by health care providers who were blind to allocation and the final results were available to the researcher and data analyzer by codes A and B.</study_design>
      <phase>3</phase>
      <hc_freetext>complicated monochorionic diamnionic twin pregnancy.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group:  monochorionic twin pregnancies complicated with anomalous fetus or selective IUGR of a co-twin with cervical length more than 25 millimeters undergoing radiofrequency ablation, supplemental injectable progesterone in the form of 17hydroxyprogesterone caproate will be administered intramuscularly and the same dose will be injected weekly until 36 weeks gestation. the patients will be compared to the control group for whom , only the RFA is done and no further drug administration is performed. Intervention 2: . Intervention 3: Control group: monochorionic complicated twin pregnancies by anomalous fetus or selective IUGR  and a cervical length more than 25mm, undergo ablation of the abnormal co-twin with radiofrequency and no supplemental progesterone and pregnancy outcome is followed.RFA is a single session procedure done through a needle using radiofrequency waves, resulting in occlusion of the abnormal co-twin cord and intrauterine fetal death while the other continue to grow.</i_freetext>
      <results_actual_enrolment></results_actual_enrolment>
      <results_date_completed></results_date_completed>
      <results_url_link></results_url_link>
      <results_summary></results_summary>
      <results_date_posted></results_date_posted>
      <results_date_first_publication></results_date_first_publication>
      <results_baseline_char></results_baseline_char>
      <results_participant_flow></results_participant_flow>
      <results_adverse_events></results_adverse_events>
      <results_outcome_measures></results_outcome_measures>
      <results_url_protocol></results_url_protocol>
      <results_IPD_plan>Undecided - It is not yet known if there will be a plan to make this available</results_IPD_plan>
      <results_IPD_description>Justification or reason for indecision in sharing IPD is discussing with colleagues</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Fough-o-Zaman Jabbari</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Karimkhan</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1597856511</zip>
        <telephone>+98 21 4216 0000</telephone>
        <email>forouq.jabbari@gmail.com</email>
        <affiliation>Tehran University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Fatemeh Rahimi Sharbaaf</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Karim Khan</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1597856511</zip>
        <telephone>+98 912 113 4105</telephone>
        <email>rahimish@sina.tums.ac.ir</email>
        <affiliation>Tehran University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>complicated monochorionic diamnionic twin pregnanciy with radiofrequency ablation with cercival length of 25 mm or above on TVS
intrauterine growth restriction or anomaly of one of the twins</inclusion_criteria>
      <agemin>no limit</agemin>
      <agemax>no limit</agemax>
      <gender>Female</gender>
      <exclusion_criteria>personal history of cervical insufficiency or second trimester recurrent pregnancy loos
history of preterm delivery in previous pregnancies
cerclage
twin-twin transfusion syndrome (TTTS)</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code></hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword></hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Treatment - Drugs</i_code>
      <i_code></i_code>
      <i_code>Treatment - Surgery</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group:  monochorionic twin pregnancies complicated with anomalous fetus or selective IUGR of a co-twin with cervical length more than 25 millimeters undergoing radiofrequency ablation, supplemental injectable progesterone in the form of 17hydroxyprogesterone caproate will be administered intramuscularly and the same dose will be injected weekly until 36 weeks gestation. the patients will be compared to the control group for whom , only the RFA is done and no further drug administration is performed.</i_keyword>
      <i_keyword></i_keyword>
      <i_keyword>Control group: monochorionic complicated twin pregnancies by anomalous fetus or selective IUGR  and a cervical length more than 25mm, undergo ablation of the abnormal co-twin with radiofrequency and no supplemental progesterone and pregnancy outcome is followed.RFA is a single session procedure done through a needle using radiofrequency waves, resulting in occlusion of the abnormal co-twin cord and intrauterine fetal death while the other continue to grow.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Decreasing rate of preterm delivery. Timepoint: termination of pregnancy. Method of measurement: tele-follow up.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Neonate admission to NICU. Timepoint: after delivery. Method of measurement: tele-follow up.</sec_outcome>
      <sec_outcome>Preterm premature rupture of membranes. Timepoint: termination of pregnancy. Method of measurement: tele-follow up.</sec_outcome>
    </secondary_outcome>
    <secondary_sponsor>
      <sponsor_name></sponsor_name>
    </secondary_sponsor>
    <secondary_ids>
      <secondary_id>
        <sec_id></sec_id>
        <issuing_authority></issuing_authority>
      </secondary_id>
    </secondary_ids>
    <source_support>
      <source_name>Tehran University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2019-02-26</approval_date>
        <contact_name>Iran national committee of ethics in biomedical research</contact_name>
        <contact_address>Karim khan st Tehran Tehran Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
