<?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>IRCT20160524028038N6</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2020-06-30</date_registration>
      <primary_sponsor>Yasouj University of Medical Sciences</primary_sponsor>
      <public_title>Sildenafil Citrate with melatonin and intrauterine growth restriction</public_title>
      <acronym></acronym>
      <scientific_title>Evaluation  of the effect of Sildenafil Citrate with melatonin on intrauterine growth restriction</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2019-10-20</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>88</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/49187</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: Randomization method: use block; Random unit: Individual; Randomization tool: Statistical software; Sequence Building: Using randomized 4 in 4 blocks; Hiding method: Use envelopes in the package, Blinding description: The blinding method is patients and physicians will not be aware of their allocation to study groups and all medications will be placed into same capsules of size, shape and color by the pharmacist.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Intrauterine growth restriction.</hc_freetext>
      <i_freetext>Intervention 1: Group A (sildenafil): In this group, sildenafil citrate tablets (Vizarcin), 25 mg orally every eight hours for four weeks. Intervention 2: Group B (Melatonin): In this group, melatonin tablets (Razak Pharmaceutical Company, Iran) are prescribed three mg three times a day (morning, lunch, before bed) for four weeks. Intervention 3: Group C (sildenafil with melatonin): In this group, the drug dose will be the same as the drug group A and B. Intervention 4: Group D: Plasbo drug containing starch is prescribed in the same way as the above intervention groups.</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>No - There is not a plan to make this available</results_IPD_plan>
      <results_IPD_description>Justification or reason for not sharing IPD is No more information</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Shakiba Amirjani</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>No. 7916839319, Shahid Jalil Ave., Yasuj Town, Kohgiluyeh and Boyer-Ahmad</address>
        <city>Yasuj</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>7916839319</zip>
        <telephone>+98 74 3333 7251</telephone>
        <email>Shakiba.amirjani@gmail.com</email>
        <affiliation>Yasouj University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Shakiba Amirjani</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>No. 7916839319, Shahid Jalil Ave., Yasuj Town, Kohgiluyeh and Boyer-Ahmad</address>
        <city>Yasuj</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>7916839319</zip>
        <telephone>+98 74 3333 7251</telephone>
        <email>Shakiba.amirjani@gmail.com</email>
        <affiliation>Yasouj University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Single-pregnancy pregnancy with IUGR
Pregnancy's age between 26 and 32 weeks
Mother's age between 18 to 45 years
No using alcohol and cigarettes
Normal anomaly scan
The absence of fetal with known or suspected anomalies
No gestational or chronic diagnosed diabetes
Not using other vasodilator drugs such as nitric oxide and calcium channel blockers</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>45 years</agemax>
      <gender>Female</gender>
      <exclusion_criteria>Lack of follow-up
Unwillingness to participate in the study
Complications such as premature rupture of membrane, vaginal bleeding, and intrauterine infection
Sildenafil sensitivity and tolerance to side effects (flushing, visual disturbances, severe drop in blood pressure and hearing impairment)</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>P05</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Disorders of newborn related to slow fetal growth and fetal malnutrition</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Treatment - Drugs</i_code>
      <i_code>Treatment - Drugs</i_code>
      <i_code>Treatment - Drugs</i_code>
      <i_code>Placebo</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Group A (sildenafil): In this group, sildenafil citrate tablets (Vizarcin), 25 mg orally every eight hours for four weeks.</i_keyword>
      <i_keyword>Group B (Melatonin): In this group, melatonin tablets (Razak Pharmaceutical Company, Iran) are prescribed three mg three times a day (morning, lunch, before bed) for four weeks.</i_keyword>
      <i_keyword>Group C (sildenafil with melatonin): In this group, the drug dose will be the same as the drug group A and B.</i_keyword>
      <i_keyword>Group D: Plasbo drug containing starch is prescribed in the same way as the above intervention groups.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Weight percentile. Timepoint: At each visit pregnancy. Method of measurement: Ultrasound.</prim_outcome>
      <prim_outcome>Abdominal circumference growth. Timepoint: At each visit pregnancy. Method of measurement: Ultrasound.</prim_outcome>
      <prim_outcome>Fetal amniotic fluid index. Timepoint: At each visit pregnancy. Method of measurement: Ultrasound.</prim_outcome>
      <prim_outcome>Pregnancy duration. Timepoint: End of pregnancy. Method of measurement: Questionnaire.</prim_outcome>
      <prim_outcome>Neonate anthropometric measurements (height and weight). Timepoint: Delivery time. Method of measurement: Scales and meters.</prim_outcome>
      <prim_outcome>Quality of life. Timepoint: End of intervention. Method of measurement: Questionnaire.</prim_outcome>
      <prim_outcome>Sleep quality. Timepoint: End of intervention. Method of measurement: Questionnaire.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome></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>Yasouj University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2019-10-20</approval_date>
        <contact_name>Ethics committee of Yasuj University of Medical Sciences</contact_name>
        <contact_address>No. 7916839319, Shahid Jalil Ave., Yasuj Town, kohgiluyeh and boyer-ahmad یاسوج Kohgilouyeh-va-Boyrahmad Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
