<?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>IRCT201109107520N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2011-12-29</date_registration>
      <primary_sponsor>Vice Chancellor for research, Kermanshah University of Medical Sciences (KUMS)</primary_sponsor>
      <public_title>Extra-Amniotic Normal Saline Infusion plus Hydrocortisone versus Prostaglandin E2 Suppository for Pregnancy Termination</public_title>
      <acronym>EASI</acronym>
      <scientific_title>Comparison of Extra-Amniotic Normal Saline Infusion plus Hydrocortisone versus Prostaglandin E2 Suppository for Pregnancy Termination</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2004-04-20</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>50</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/8006</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment.</study_design>
      <phase>2-3</phase>
      <hc_freetext>Induction of labor, termination of pregnancy.</hc_freetext>
      <i_freetext>Intervention 1: Prostaglandin group (25 patients) was received two doses of prostaglandin E2 intra vaginal suppository (Dinoprostone) 3mg every 4 hour. In both groups, 6 hours after the last dose of prostaglandin and removal of Foley catheter, induction with high dose Oxytocin (according to Alabama University Protocol) was initiated up to 24 hours maximum. Intervention 2: In EASHI group (25 patients), under sterile conditions, a coworker inserted a No. 14 Foley catheter through the cervical canal and balloon was filled with 20 ml water and fixed. Then 360 ml sterile Normal Saline with 100 mg. Hydrocortisone was infused at a rate of 30 ml per hours into the extra amniotic space. The Foley catheter was checked every hour for spontaneous expulsion. If it was tolerated by patients, the infusion continued up to 12 hours maximum. In both groups, 6 hours after the last dose of prostaglandin and removal of Foley catheter, induction with high dose Oxytocin (according to Alabama University Protocol) was initiated up to 24 hours maximum.</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>Dr. Farahnaz Keshavarzi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Imam Reza Hospital, Parastar Boulevard, Sorkheh Lyzheh</address>
        <city>Kermanshah</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip></zip>
        <telephone>+98 83 1724 2893</telephone>
        <email>fnkeshavarzi@kums.ac.ir , fnkeshavarzi@yahoo.com</email>
        <affiliation>Kermanshah University of Medical Sciences (KUMS)</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Dr. Farahnaz Keshavarzi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Imam Reza Hospital, Parastar Boulevard, Sorkheh Lyzheh</address>
        <city>Kermanshah</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip></zip>
        <telephone>+98 83 1724 2893</telephone>
        <email>fnkeshavarzi@kums.ac.ir ,fnkeshavarzi@yahoo.com , mkhoshay@yahoo.com</email>
        <affiliation>Kermanshah University of Medical Sciences (KUMS)</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Inclusion criteria :Multiparus لreater than or equal to 4; Bishop Score less than or equal to 2; Gestational age 14-28 weeks; Amniotic sac intact; Fetal indication of Pregnancy Termination. Exclusion criteria : Placenta Previa; Uterus Anomalies; Rupture of Membrane; History of Hypertension; Fever; Cardiac Disease; Previous Scar on the Uterus; Drug Sensitivity (Prostaglandin E2 and Hydrocortisone); contraction of uterus.</inclusion_criteria>
      <agemin>15 years</agemin>
      <agemax>45 years</agemax>
      <gender>Female</gender>
      <exclusion_criteria></exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>O04</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Medical abortion:  Incl: termination of pregnancy: legal</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Treatment - Drugs</i_code>
      <i_code>Treatment - Drugs</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Prostaglandin group (25 patients) was received two doses of prostaglandin E2 intra vaginal suppository (Dinoprostone) 3mg every 4 hour. In both groups, 6 hours after the last dose of prostaglandin and removal of Foley catheter, induction with high dose Oxytocin (according to Alabama University Protocol) was initiated up to 24 hours maximum.</i_keyword>
      <i_keyword>In EASHI group (25 patients), under sterile conditions, a coworker inserted a No. 14 Foley catheter through the cervical canal and balloon was filled with 20 ml water and fixed. Then 360 ml sterile Normal Saline with 100 mg. Hydrocortisone was infused at a rate of 30 ml per hours into the extra amniotic space. The Foley catheter was checked every hour for spontaneous expulsion. If it was tolerated by patients, the infusion continued up to 12 hours maximum. In both groups, 6 hours after the last dose of prostaglandin and removal of Foley catheter, induction with high dose Oxytocin (according to Alabama University Protocol) was initiated up to 24 hours maximum.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Mean time from initiation of induction till expultion of conception. Timepoint: Hour. Method of measurement: Excretion products of pregnancy.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>The need to curettage. Timepoint: 24 hours after fetus expultion. Method of measurement: Residual of conception based on ultrasonography.</sec_outcome>
      <sec_outcome>Uterus hyperton. Timepoint: Hour. Method of measurement: The Uterine contractions of more than two minutes.</sec_outcome>
      <sec_outcome>Placenta retention. Timepoint: Every 20 minutes. Method of measurement: Retention of placenta up to half an hour after expulsion of fetus.</sec_outcome>
      <sec_outcome>Success rate of pregnancy termination. Timepoint: hour. Method of measurement: Expultion of pregnancy conception.</sec_outcome>
      <sec_outcome>Diarrhea. Timepoint: Every 4 hours. Method of measurement: The passage of three or more loose or watery stools a day.</sec_outcome>
      <sec_outcome>Fever. Timepoint: Every 4 hours. Method of measurement: Temperature above 38 ° C sublingual.</sec_outcome>
      <sec_outcome>Hypertension. Timepoint: Every 4  hours. Method of measurement: Blood pressure greater than or equal to 140/90 mm Hg.</sec_outcome>
      <sec_outcome>Hypotension. Timepoint: Every 4  hours. Method of measurement: Blood pressure less than 90/70 mm Hg.</sec_outcome>
      <sec_outcome>Tachy systole. Timepoint: Hour. Method of measurement: More than 6 uterine contractions in ten minutes.</sec_outcome>
      <sec_outcome>Nausea, vomiting. Timepoint: Every 4  hours. Method of measurement: Based on patient complaints and symptoms of disease by observing investigator.</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>Vice Chancellor for research, Kermanshah University of Medical Sciences (KUMS)</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2011-09-27</approval_date>
        <contact_name>Ethics Committee of Kermanshah University of Medical Sciences</contact_name>
        <contact_address>Vice Chancellor for research, Kermanshah University of Medical Sciences (KUMS), Building No. 2, Shahid Beheshti Blvd Kermanshah  Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
