<?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>IRCT20180110038302N6</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2020-06-27</date_registration>
      <primary_sponsor>Alborz University of Medical Sciences</primary_sponsor>
      <public_title>Evaluation of the effectiveness of progressive muscle relaxation on maternal and neonatal outcomes on  primary parous women with preeclampsia</public_title>
      <acronym></acronym>
      <scientific_title>Evaluation of the effectiveness of progressive muscle relaxation on maternal and neonatal outcomes on  primiparous women with preeclampsia in Kamali  hospital,Karaj, Iran 2019-2020</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2020-03-19</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>88</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/46105</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Block Balance Randomization 4th is accomplished with software. In this method size of the whole Blocks are equal. In this study with 88 sample sizes,   blocks are 22 th and the size of each block is 4 th .The number of participants in the control and intervention group is equal(44 in each group).</study_design>
      <phase>N/A</phase>
      <hc_freetext>Preeclampsia.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: using progressive muscle relaxation, which is done for 12 sessions by 6 weeks and 2 sessions per week. Intervention 2: Control group:beside routine prenatal care,No action will be taken for the control group.</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 This study is not finished yet.</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Mansooreh Yazdkhusti</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>West Buali street, Alborz University of Medical Sciences</address>
        <city>Karaj</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>3149969415</zip>
        <telephone>+98 26 3428 7483</telephone>
        <email>Mansoyazd@yahoo.com</email>
        <affiliation>Alborz medical science university</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Mansooreh Yazdkhusti</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>West Buali street, Alborz University of Medical Sciences</address>
        <city>Karaj</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>3149969415</zip>
        <telephone>+98 26 3428 7483</telephone>
        <email>Mansoyazd@yahoo.com</email>
        <affiliation>Alborz University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>primary parous women with 26-34 weeks gestational age
singleton pregnancy
non-severe preeclampsia criterias
low risk results in the frist and second trimester fetal screenings
persiane race and at least having reading and writing literacy</inclusion_criteria>
      <agemin>no limit</agemin>
      <agemax>no limit</agemax>
      <gender>Female</gender>
      <exclusion_criteria>physical and mental illnesses (such as cardio-respiratory disease, diabetes mellitus and gestational diabetes, seizure, depression, anxiety disorders ,etc)
history of infertility and/or repeated miscarriage
vaginal hemorrhage and/or leaking amniotic fluid and/or uterine contractions
recent severe stress and/or anxiety
intrauterine growth restriction
usage of alcohol and/or cigarettes and/or drugs</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>O15.00</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Eclampsia in pregnancy, unspecified trimester</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Other</i_code>
      <i_code>Other</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group: using progressive muscle relaxation, which is done for 12 sessions by 6 weeks and 2 sessions per week</i_keyword>
      <i_keyword>Control group:beside routine prenatal care,No action will be taken for the control group.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Blood pressure. Timepoint: before and after 6 weeks of intervention. Method of measurement: mercury sphygmo manometer.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Proteinuria. Timepoint: before and after 6 weeks of intervention. Method of measurement: collect a 24-hr clean midstream urine sample.</sec_outcome>
      <sec_outcome>Fasting blood sugar. Timepoint: before and after 6 weeks of intervention. Method of measurement: glucometer.</sec_outcome>
      <sec_outcome>Maternal  weight gaining. Timepoint: before and after 6 weeks of intervention. Method of measurement: digital scale.</sec_outcome>
      <sec_outcome>Turn to severe preeclampsia. Timepoint: after 6 weeks of intervention. Method of measurement: collect a 24-hr clean midstream urine sample and mercury sphygmo manometer.</sec_outcome>
      <sec_outcome>Delivery gestational age. Timepoint: after 6 weeks of intervention. Method of measurement: hospital document.</sec_outcome>
      <sec_outcome>Amniotic fluid index. Timepoint: before and after 6 weeks of intervention. Method of measurement: ultra sonogram.</sec_outcome>
      <sec_outcome>Fetal movement. Timepoint: before and after 6 weeks of intervention. Method of measurement: none stress test.</sec_outcome>
      <sec_outcome>Fetal heart rate. Timepoint: before and after 6 weeks of intervention. Method of measurement: none stress test.</sec_outcome>
      <sec_outcome>Apgar score. Timepoint: after 6 weeks of intervention. Method of measurement: hospital document.</sec_outcome>
      <sec_outcome>Antropometric index. Timepoint: after 6 weeks of intervention. Method of measurement: hospital document.</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>Alborz University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2020-05-01</approval_date>
        <contact_name>Ethics committee of Alborz University of Medical Sciences</contact_name>
        <contact_address>West Buali street, Alborz University of Medical Sciences Karaj Alborz Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
