<?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>IRCT2012091710746N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2012-10-02</date_registration>
      <primary_sponsor>Research Council of Tehran UniversityMaternal Fetal Neonatal Research Center</primary_sponsor>
      <public_title>The survey Support Social &amp; Psychological Effects on attachment of mother – child and its effects on breast feeding</public_title>
      <acronym>attachment of mother &amp; breast feeding</acronym>
      <scientific_title>The survey Support Social &amp; Psychological Effects on attachment of mother – child and its effects on breast feeding</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2013-12-15</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>30</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/11160</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Health service research.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Behaviour and Emotional disorder.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group in addition to routine prenatal care from 3 to 9 months, once or twice a month, six to eight sessions of supportive psychotherapy will be performed by clinical psychologist. The first visit is usually discharged after 3-7 days of birth at the end of the month and the first, third; sixth, ninth and twelfth mother to infant attachment behavior in group will be monitored and recorded using checklists Avant. Attachment indicators before and after intervention in both groups and between groups were examined. Intervention 2: The control group will receive routine care during pregnancy. The first visit is usually discharged after 3-7 days of birth at the end of the month and the first, third; sixth, ninth and twelfth mother to infant attachment behavior in group will be monitored and recorded using checklists Avant. Attachment indicators before and after intervention in both groups and between groups were examined.</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>Nasrin Abedinia</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Maternal Fetal Neonatal Research Center,vali Asr Hospital, Imam Khomeini Hospital</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip></zip>
        <telephone>+98 21 6119 2357</telephone>
        <email>nasrin.abedinia@yahoo.com; nasrin.abedinia@gmail.com; abedinia@farabi.tums.ac.ir</email>
        <affiliation>Maternal Fetal Neonatal Health Research Center</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Nasrin Abedinia</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Maternal Fetal Neonatal Research center vali asr hospital Imam Khomeini Hospital</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip></zip>
        <telephone>+98 21 6119 2357</telephone>
        <email>nasrin.abedinia@yahoo.com; nasrin.abedinia@gmail.com; abedinia@farabi.tums.ac.ir</email>
        <affiliation>Maternal Fetal Neonatal Research Center</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>All pregnant women who have not  high risk  and severe mental health problems .</inclusion_criteria>
      <agemin>20 years</agemin>
      <agemax>44 years</agemax>
      <gender>Female</gender>
      <exclusion_criteria></exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>F93</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Emotional disorders with onset specific to childhood</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Behavior</i_code>
      <i_code>Other</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group in addition to routine prenatal care from 3 to 9 months, once or twice a month, six to eight sessions of supportive psychotherapy will be performed by clinical psychologist. The first visit is usually discharged after 3-7 days of birth at the end of the month and the first, third; sixth, ninth and twelfth mother to infant attachment behavior in group will be monitored and recorded using checklists Avant. Attachment indicators before and after intervention in both groups and between groups were examined.</i_keyword>
      <i_keyword>The control group will receive routine care during pregnancy. The first visit is usually discharged after 3-7 days of birth at the end of the month and the first, third; sixth, ninth and twelfth mother to infant attachment behavior in group will be monitored and recorded using checklists Avant. Attachment indicators before and after intervention in both groups and between groups were examined.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Attachment. Timepoint: One or two times during pregnancy and postpartum months 1-3-6-9-12. Method of measurement: Questionnaire Avant.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Social support,. Timepoint: Before and after study. Method of measurement: Questionnaire made by the researcher.</sec_outcome>
      <sec_outcome>Self-esteem. Timepoint: Before and after study. Method of measurement: Questionnaire made by the researcher.</sec_outcome>
      <sec_outcome>Anxiety and depression. Timepoint: Before and after study. Method of measurement: Questionnaire made by the researcher.</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>Research Council of Tehran UniversityMaternal Fetal Neonatal Research Center</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2012-08-27</approval_date>
        <contact_name>Research Council of Tehran University, Etics Committee</contact_name>
        <contact_address>ghods Avenu Keshavarz Bluvar Tehran  Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
