<?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>IRCT2012091710746N2</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2013-02-04</date_registration>
      <primary_sponsor>Research Council of Tehran University of Medical Sciences - Research Center for Maternal Fetal Infan</primary_sponsor>
      <public_title>Maternal mood disorder and its effects on infant sleep And effect of behavioral and educational interventions on maternal and infant sleep</public_title>
      <acronym>Mood and anxiety disorders during pregnancy on infant sleep</acronym>
      <scientific_title>Maternal mood disorder and its effects on infant sleep And effect of behavioral and educational interventions on maternal and infant sleep</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2013-04-21</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>200</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/11161</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Prevention.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Condition 1: Mood disorder. Condition 2: Anxiety disorder.</hc_freetext>
      <i_freetext>Intervention 1: That includes a 45-minute meeting to provide information about the structure and strategy of sleep Including maternal sleep hygiene strategies to improve maternal sleep, deep breathing and relaxation techniques, and information on the baby sleep. This manual can be read at home. In the first week to the fifth week to provide information and offer solutions to call with persons about individual problems.&#13;
Mothers in the control group, only 10 minutes of sleep hygiene and 2 phone calls in weeks 3 and 5 to make contact with the group for final review. The phone does not do any advice if you have any questions will be answered. Intervention 2: In the control group, only 10 minutes of sleep hygiene mother and two telephone calls at weeks 3 and 5 to make contact with the group for final review will be conducted. The phone does not do any advice you have any questions will be answered.</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>Vali Asr Hospital</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip></zip>
        <telephone>+98 21 6119 2357</telephone>
        <email>nasrin_abedinia@yahoo.com</email>
        <affiliation>Research Center for Maternal Fetal Infant</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Nasrin Abedinia</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Vali asr Hospital</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip></zip>
        <telephone>+98 21 6119 2357</telephone>
        <email>nasrin.abedinia@yahoo.com</email>
        <affiliation>Research Center for Maternal Fetal Infant</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>The study included women who are pregnant for the first time; they do not have history of recurrent miscarriage, infertility treatment, medication or hospitalization due to mental health problems or have insomnia; no chronic kidney disease, heart, liver, stomach and other chronic disorders; no problem with the delivery and having healthy baby and not any pregnancy complications such as gestational diabetes, pre eclampsia, premature delivery; there are not any fetal problems that lead to emergency cesarean delivery, otherwise the baby is healthy, and also there are not low birth weight or Apgar score with abnormal any chronic disease neonatal in infants.</inclusion_criteria>
      <agemin>20 years</agemin>
      <agemax>42 years</agemax>
      <gender>Female</gender>
      <exclusion_criteria></exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>F39</hc_code>
      <hc_code>F41.9</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Unspecified mood [affective] disorder</hc_keyword>
      <hc_keyword>Anxiety disorder, unspecified</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Behavior</i_code>
      <i_code>Treatment - Drugs</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>That includes a 45-minute meeting to provide information about the structure and strategy of sleep Including maternal sleep hygiene strategies to improve maternal sleep, deep breathing and relaxation techniques, and information on the baby sleep. This manual can be read at home. In the first week to the fifth week to provide information and offer solutions to call with persons about individual problems.&#13;
Mothers in the control group, only 10 minutes of sleep hygiene and 2 phone calls in weeks 3 and 5 to make contact with the group for final review. The phone does not do any advice if you have any questions will be answered.</i_keyword>
      <i_keyword>In the control group, only 10 minutes of sleep hygiene mother and two telephone calls at weeks 3 and 5 to make contact with the group for final review will be conducted. The phone does not do any advice you have any questions will be answered.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Effect  on maternal sleep. Timepoint: Postpartum and 6 months after delivery. Method of measurement: 1- Edinburg 2- Beck 3- STAI 4-Pittsburgh Sleep Quality Index.</prim_outcome>
      <prim_outcome>Effect  on infant sleeping. Timepoint: Postpartum and 6 months after delivery. Method of measurement: Questionnaire of researcher making.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Treatment of  Depression. Timepoint: 6 months after delivery. Method of measurement: 1- edinburg  test 2- Beck  Inventory.</sec_outcome>
      <sec_outcome>Treatment of anxiety. Timepoint: 6 months after delivery. Method of measurement: STAY test.</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 University of Medical Sciences - Research Center for Maternal Fetal Infan</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2013-01-14</approval_date>
        <contact_name>Tehran University of Medical Sciences Ethics Committee</contact_name>
        <contact_address>Ghods Avenu, Keshavarz Boulevard Tehran  Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
