<?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>IRCT201105093706N6</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2011-07-02</date_registration>
      <primary_sponsor>Vice chancellor for research,Tabriz University of Medical Sciences</primary_sponsor>
      <public_title>Effect of telephone counseling on exclusive breastfeeding and postpartum depression</public_title>
      <acronym></acronym>
      <scientific_title>Effect of telephone counseling on exclusive breast feeding and postpartum depression: A randomized controlled trial.</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2011-07-21</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>366</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/3799</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Prevention, Other design features: Contents of the telephone counseling will be based on national, WHO, and other valid organizations guidelines. Each counseling has two parts: first, the counselor will ask the mother about their problems experienced during previous week and will note them in the checklist. Then counseling will be done about the problems. The second part of the counseling will be about support of exclusive breastfeeding and general recommendations for prevention of postpartum depression. Consultation with other persons like relatives of the mother or referring to specialty centers will be done, if necessary.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Condition 1: Postpartum depression. Condition 2: Exclusive breastfeeding.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: Regular counseling by telephone. The first counseling will be within 48 hours after hospital discharge. Next, there will be telephone contacts 2 times in the first week and once a week in 2-6 weeks. Each counseling will take about 20 minutes, which can vary upon requirement. Each session has two parts: first, the counselor will ask the mother about their problems experienced during previous week and will note them in the checklist. Then counseling will be done about the problems. The second part of the counseling will be about support of exclusive breastfeeding and general recommendations for prevention of postpartum depression. Counselor is a midwifery Master of Science student with special short-term training in postpartum care. The subjects in intervention group can also contact with the counselor by telephone. Both groups can receive routine care from the health centers (three times in the 6 weeks). Intervention 2: Control group: no intervention by the research team Both groups can receive routine care from the health centers (three times in the 6 weeks).</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>Shokranian Nafiseh</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Nursing &amp; Midwifery Faculty, South Shariati</address>
        <city>Tabriz</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip></zip>
        <telephone>+98 21 6669 2439</telephone>
        <email>shokraniannafiseh@yahoo.com</email>
        <affiliation>Tabriz University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Sakineh Mohammad-Alizadeh-Charandabi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Nursing &amp; Midwifery Faculty, South Shariati</address>
        <city>Tabriz</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip></zip>
        <telephone>+98 41 1479 0364</telephone>
        <email>alizades@tbzmed.ac.ir; smoalch@yahoo.com</email>
        <affiliation>Tabriz University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Inclusion criteria: being resident of Tehran; married; education more than six years; willing to have exclusive breastfeeding; giving birth to a single healthy baby with Apgar score of 7 or more in the fifth minute; easy access by telephone;  no problem in speech and hearing; not suffering from chronic disorders (diabetes, hypertension, thyroid disorders, asthma, or any other diseases) requiring prescription of drug (based on individual’s record);  no history of mental disorders requiring drug use including postpartum depression; not being smoker or drug user and no history of still birth or child death.&#13;
Exclusion criteria: No mother or newborn discharge within 72 hours after delivery and occurrence of an important emotional event like death of near relatives during the study period</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>
      <hc_code>P92</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Mild mental and behavioural disorders associated with the puerperium, not elsewhere classified</hc_keyword>
      <hc_keyword>Feeding problems of newborn</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Lifestyle</i_code>
      <i_code>N/A</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group: Regular counseling by telephone. The first counseling will be within 48 hours after hospital discharge. Next, there will be telephone contacts 2 times in the first week and once a week in 2-6 weeks. Each counseling will take about 20 minutes, which can vary upon requirement. Each session has two parts: first, the counselor will ask the mother about their problems experienced during previous week and will note them in the checklist. Then counseling will be done about the problems. The second part of the counseling will be about support of exclusive breastfeeding and general recommendations for prevention of postpartum depression. Counselor is a midwifery Master of Science student with special short-term training in postpartum care. The subjects in intervention group can also contact with the counselor by telephone. Both groups can receive routine care from the health centers (three times in the 6 weeks)</i_keyword>
      <i_keyword>Control group: no intervention by the research team Both groups can receive routine care from the health centers (three times in the 6 weeks)</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Exclusive breast-feeding during the last 24 hours. Timepoint: Once in 60 to 66th days postpartum. Method of measurement: Asking the question.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Postpartum depression scores. Timepoint: Once in 60-66th day after delivery. Method of measurement: Using 10 questions Edinburgh scale.</sec_outcome>
      <sec_outcome>How to receive preventive and curative care from public and private centers. Timepoint: During 6 weeks postpartum. Method of measurement: Self-administered form.</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,Tabriz University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2011-06-14</approval_date>
        <contact_name>Tabriz University of Medical Sciences, Reaserch deputy</contact_name>
        <contact_address>Tabriz-Golgasht street-Tabriz University of Medical Sciences-Building 2 - Floor 3 - Field Research Tabriz  Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
