<?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>IRCT20090701002114N6</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2020-09-21</date_registration>
      <primary_sponsor>Khoram-Abad University of Medical Sciences</primary_sponsor>
      <public_title>the effect of hydralazine and nifedipine on  hypertension</public_title>
      <acronym></acronym>
      <scientific_title>Comparative study of the effect of hydralazine and nifedipine on acute hypertension in women with preeclampsia</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2020-09-12</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>60</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/50651</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Single blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: Randomization will be assigned to the study groups in a simple, even and odd manner. The randomization tool will be the use of a random number table in such a way that people in the group of even numbers are characteristic of group one, ie hydralazine, and people with odd numbers in the group. 2 nifedipine will be placed, Blinding description: In the group receiving nifedipine, four doses of the drug will be given to the patient according to the instructions and intravenous injection of distilled water will be used to blind the patient. In contrast, in the group receiving hydralazine, the main drug will be injected intravenously at a dose of 5 mg. People in this group will use the placebo in pill form.</study_design>
      <phase>N/A</phase>
      <hc_freetext>preeclampsia.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: In intervention group number one, which includes receiving hydralazine. 5 mg of this drug will be slowly injected intravenously and to blind the samples in this group, an oral drug that has no drug content will be used. Blood pressure is checked every 20 minutes, and if there is a blood pressure of 160 over 110 mm Hg and more, another dose of the drug is injected. Intervention 2: Intervention group: Intervention group number two includes receiving nifedipine, which will be used as a 10 mg tablet. Intravenous distilled water will be used to blind the samples in this group. Blood pressure is checked every 20 minutes and if there is a blood pressure of 160 over 110 mm Hg and more, another dose of the drug is prescribed.</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>Yes - There is a plan to make this available</results_IPD_plan>
      <results_IPD_description>What will be shared:
It is possible to share all the data while maintaining the principle of not mentioning the names of individuals

When:
One year after the publication of the related article

To whom:
Researchers of university centers

Conditions:
The data of the present study can be used after obtaining permission and approval from the Vice Chancellor for Research and Technology of Lorestan University of Medical Sciences

Where to obtain:
Refer to the project manager, Dr. Fatemeh Yari, with email address yari1672@yahoo.com, and contact number 09163613621

How to obtain:
After completing the research and publishing the relevant article, individuals can apply to the Vice Chancellor for Research and Technology of Lorestan University of Medical Sciences to receive documents and after obtaining permission from this department, send a confirmation from the Vice Chancellor for Research to the project manager. Can access documentation.

Comments:
</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Fatemeh Yari</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Medical school.,4 km Khorramabad Boroujerd Road.,Kamalvand</address>
        <city>Khorramabad</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>381351698</zip>
        <telephone>+98 66 3312 0133</telephone>
        <email>yari.f@lums.ac.ir</email>
        <affiliation>Khoram-Abad University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Fatemeh Yari</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Medical school.,4 km Khorramabad Boroujerd Road.,Kamalvand</address>
        <city>Khorramabad</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>381351698</zip>
        <telephone>+98 66 3312 0133</telephone>
        <email>yari.f@lums.ac.ir</email>
        <affiliation>Khoram-Abad University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Pregnant women 18 to 45 years old
Gestational age greater than or equal to 20 weeks
Blood pressure greater than or equal to 160 over 110</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>45 years</agemax>
      <gender>Female</gender>
      <exclusion_criteria>Maternal disease of any kind, including heart (heart arrhythmia - heart failure - chest pain, etc.), kidney, liver
Fetal disorders including intrauterine growth restriction (IUGR) and Oligohydramnios
Uncertain patterns of fetal heart rate</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code></hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>o14</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>Intervention group: In intervention group number one, which includes receiving hydralazine. 5 mg of this drug will be slowly injected intravenously and to blind the samples in this group, an oral drug that has no drug content will be used. Blood pressure is checked every 20 minutes, and if there is a blood pressure of 160 over 110 mm Hg and more, another dose of the drug is injected.</i_keyword>
      <i_keyword>Intervention group: Intervention group number two includes receiving nifedipine, which will be used as a 10 mg tablet. Intravenous distilled water will be used to blind the samples in this group. Blood pressure is checked every 20 minutes and if there is a blood pressure of 160 over 110 mm Hg and more, another dose of the drug is prescribed.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Systolic blood pressure. Timepoint: At the beginning of the study, then every twenty minutes until the blood pressure drops. Method of measurement: Using electronic blood pressure monitoring device.</prim_outcome>
      <prim_outcome>Diastolic blood pressure. Timepoint: At the beginning of the study, then every twenty minutes until the blood pressure drops. Method of measurement: Using electronic blood pressure monitoring device.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Average blood pressure. Timepoint: At the beginning of the study, then every twenty minutes until the blood pressure drops. Method of measurement: Using electronic blood pressure monitoring device.</sec_outcome>
      <sec_outcome>Time to achieve controlled blood pressure. Timepoint: At the beginning of the study, then every twenty minutes. Method of measurement: Used in hours and in minutes.</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>Khoram-Abad University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2020-08-05</approval_date>
        <contact_name>Ethics committee of Lorestan University of Medical Sciences</contact_name>
        <contact_address>Office of Research Ethics Committee, Vice Chancellor for Research and Technology of Lorestan University of Medical Sciences, University Campus Complex, km 3 of Khorramabad Boroujerd Road, Khorramabad Khorramabad Lorestan Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
