<?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>IRCT201603109568N15</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2016-03-22</date_registration>
      <primary_sponsor>Maternal, Fetal and Neonatal Research Center, Tehran University of Medical Sciences</primary_sponsor>
      <public_title>Vaginal progesterone plus cervical pessary for preventing preterm birth</public_title>
      <acronym></acronym>
      <scientific_title>The effectiveness of  the combined treatment with vaginal progesterone plus cervical pessary compared to vaginal progesterone monotherapy for the prevention of preterm birth: a randomized clinical trial.</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2014-08-01</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>144</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/10140</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Prevention.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Preterm delivery.</hc_freetext>
      <i_freetext>Intervention 1: Intervention Group:&#13;
Cervical pessary inserted by an obstetrician, between 18-20 weeks of gestation, in an outpatient setting.A vaginal speculum examination was done to determine the appropriate size. The site with the smallest diameter was placed upwards to surround the cervix. The patients were asked to report any vaginal or pelvic discomfort. The pessary was removed by a simple vaginal examination in the 37th week of gestation, or earlier if the patient presented with rupture of membranes, vaginal bleeding, or painful uterine contractions despite tocolytics. These patients received 400 mg of vaginal progesterone once daily before going to bed until 37th week of gestation. Intervention 2: Control Group:&#13;
Patients received 400 mg of vaginal progesterone once daily before going to bed until 37th week of gestation.</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></results_IPD_plan>
      <results_IPD_description></results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Niloofar Karbasian</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>29, Shabnam, Yekom st, Saadat abad</address>
        <city>tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1998736917</zip>
        <telephone>+98 21 2209 5518</telephone>
        <email>nfkarbasian@gmail.com</email>
        <affiliation>Tehran University of Medical Scienses</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Dr. Mahdi Sheikh</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Maternal, Fetal and Neonatal Research Center, Vali-Asr Hospital, Keshavarz Blvd..</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip></zip>
        <telephone>+98 21 6659 1316</telephone>
        <email>mahdisheikh@gmail.com</email>
        <affiliation>Tehran University of Medical Scienses</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Inclusion criteria: 18-40 years of age; singleton gestation; 18-22 gestational weeks; cervical length of less than 25 millimeters by transvaginal ultrasound; no cervical dilation; no history of any medical illness.&#13;
&#13;
Exclusion criteria: : any medical illness upon enrollment; having urogenital infection; major fetal abnormalities; painful regular uterine contractions; placenta previa; ruptured membranes; active vaginal bleeding; history of cone biopsy; refusing to provide informed consent to participate in the study.</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>40 years</agemax>
      <gender>Female</gender>
      <exclusion_criteria></exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>O60.1</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Preterm spontaneous labour with preterm delivery</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Treatment - Devices</i_code>
      <i_code>Treatment - Drugs</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention Group:&#13;
Cervical pessary inserted by an obstetrician, between 18-20 weeks of gestation, in an outpatient setting.A vaginal speculum examination was done to determine the appropriate size. The site with the smallest diameter was placed upwards to surround the cervix. The patients were asked to report any vaginal or pelvic discomfort. The pessary was removed by a simple vaginal examination in the 37th week of gestation, or earlier if the patient presented with rupture of membranes, vaginal bleeding, or painful uterine contractions despite tocolytics. These patients received 400 mg of vaginal progesterone once daily before going to bed until 37th week of gestation.</i_keyword>
      <i_keyword>Control Group:&#13;
Patients received 400 mg of vaginal progesterone once daily before going to bed until 37th week of gestation.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Preterm birth before 37 weeks of gestation. Timepoint: monthly, after the intervention, untill 37th week of gestational. Method of measurement: clinical delivery and the time is assessed based on ultrasound imaging.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Low birth weight (LBW) delivery. Timepoint: After birth. Method of measurement: weighing scale.</sec_outcome>
      <sec_outcome>Premature rupture of membranes. Timepoint: after the intervention. Method of measurement: clinical examination.</sec_outcome>
      <sec_outcome>Chorioamnionitis. Timepoint: after the intervention. Method of measurement: diagnosed based on placental pathology after delivery.</sec_outcome>
      <sec_outcome>Requirement for NICU admission. Timepoint: after the intervention. Method of measurement: clinical examination.</sec_outcome>
      <sec_outcome>Fetal or neonatal death rate. Timepoint: after the intervention. Method of measurement: clinical examination.</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>Maternal, Fetal and Neonatal Research Center, Tehran University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2010-08-20</approval_date>
        <contact_name>Ethics Committee of the Tehran University of Medical Sciences</contact_name>
        <contact_address>Tehran University of Medical Sciences, Enghelab Street. Tehran  Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
