<?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>IRCT2016091929873N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2016-11-05</date_registration>
      <primary_sponsor>Isfahan Research Department of Medical Sciences</primary_sponsor>
      <public_title>The effect of vitamin B6 in the prevention of postpartum depression</public_title>
      <acronym></acronym>
      <scientific_title>Effect of prescribed vitamin B6 for depression among “mothers at risk for postpartum depression” during    the third trimester at selected health care centers Isfahan city 2016.</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2016-02-24</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>80</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/23904</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Single blinded, Placebo: Used, Assignment: Parallel, Purpose: Prevention.</study_design>
      <phase>N/A</phase>
      <hc_freetext>postpartum depression.</hc_freetext>
      <i_freetext>Intervention 1: Case group receive {2 tablets B6 (40mg; oral) daily; from week 28 till end pregnancy; after delivery1 tablet B6 (40mg; oral) daily for one month}. Every two weeks, Researcher phone calls to ensure, they were reminded of pills on phone and mentioned the subjects’ use of pill. Edinburgh postpartum depression questionnaires were completed by research’s units before intervention and 1.5 months after delivery. Intervention 2: Control group receive { placebo 2 tablets oral ; daily from week 28 till end pregnancy, after delivery receiving placebo 1 tablet oral ; daily for a month} . The Placebo tablet has 6.2 mm in diameter and 100 mg weight and made from corn starch. The placebo tablet is Simulated of vitamin tablet B6 Amin pharmaceutical factory. Every two weeks, Researcher phone calls to ensure, they were reminded of pills on phone and mentioned the subjects’ use of pill. Edinburgh postpartum depression questionnaires were completed by research’s units before intervention and 1.5 months after delivery.</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>Maryam khodadad</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Isfahan University of Medical Science, Hezar Jerib Street, Shiraz Gate,  Isfahan</address>
        <city>Isfahan</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>8174673461</zip>
        <telephone>+98 31 3792 7532</telephone>
        <email>mkhodadad@nm.mui.ac.irm418.khodadad@gmail.com</email>
        <affiliation>Isfahan University of Medical Science</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Parvin Bahadoran</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Isfahan University of Medical Science, Hezar Jerib Street, Shiraz Gate,  Isfahan</address>
        <city>Isfahan</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>8174673461</zip>
        <telephone>+98 31 3792 7532</telephone>
        <email>bahadoran@nm.mui.ac.ir</email>
        <affiliation>Isfahan University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
      <country2>Iran (Islamic Republic of)</country2>
      <country2>Iran (Islamic Republic of)</country2>
      <country2>Iran (Islamic Republic of)</country2>
      <country2>Iran (Islamic Republic of)</country2>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Inclusion criteria: The criterion for entering this study was at least one risk factor of postpartum depression; physical health of pregnant mother; lack of current depression. Exclusion criteria: prenatal depression at third trimester; unwillingness to continue the study at any time</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>45 years</agemax>
      <gender>Female</gender>
      <exclusion_criteria></exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>F53.0</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Mild mental and behavioural disorders associated with the puerperium, not elsewhere classified</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Placebo</i_code>
      <i_code>Placebo</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Case group receive {2 tablets B6 (40mg; oral) daily; from week 28 till end pregnancy; after delivery1 tablet B6 (40mg; oral) daily for one month}. Every two weeks, Researcher phone calls to ensure, they were reminded of pills on phone and mentioned the subjects’ use of pill. Edinburgh postpartum depression questionnaires were completed by research’s units before intervention and 1.5 months after delivery.</i_keyword>
      <i_keyword>Control group receive { placebo 2 tablets oral ; daily from week 28 till end pregnancy, after delivery receiving placebo 1 tablet oral ; daily for a month} . The Placebo tablet has 6.2 mm in diameter and 100 mg weight and made from corn starch. The placebo tablet is Simulated of vitamin tablet B6 Amin pharmaceutical factory. Every two weeks, Researcher phone calls to ensure, they were reminded of pills on phone and mentioned the subjects’ use of pill. Edinburgh postpartum depression questionnaires were completed by research’s units before intervention and 1.5 months after delivery.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Postpartum depression. Timepoint: The depression was evaluated baseline before intervention /and 1.5 month after delivery. Method of measurement: Edinburgh standard questioner.</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>Isfahan Research Department of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2016-02-24</approval_date>
        <contact_name>Isfahan University of Medical Sciences</contact_name>
        <contact_address>Isfahan University of Medical Sciences, Hezar Jerib Street , Isfahan Isfahan  Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
