<?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>IRCT20100109003027N19</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2018-01-10</date_registration>
      <primary_sponsor>Vice-Chancellor for Research of Tabriz University of Medical Sciences</primary_sponsor>
      <public_title>Effect of prechildbirth counselling on breastfeeding practice of mothers</public_title>
      <acronym></acronym>
      <scientific_title>Effect of prechildbirth counselling on breastfeeding practice of mothers with previous breastfeeding failure</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2017-10-23</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>108</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/3010</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Prevention, Randomization description: The number of pregnant women who were eligible to enter the study was selected by random blocking (stratification based on the type of delivery) using the WWW.RANDOM.ORG site with blocks 4 and 6 with a ratio of 1: 1 to two groups (receiving Counseling and control) will be allocated.
The type of assignment is written on paper, written in matched envelopes, and will be numbered(Allocation Concealment).Assignment Sequences will be conducted by the person not involved in the research. The projects will be opened in the order of the participants in the study, and the type of intervention received will be determined by each contributor.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Prevention.</hc_freetext>
      <i_freetext>Intervention 1: actation counseling in the intervention group (54 persons) during group counseling sessions, in groups of 7 to 5, each session will start for 60-90 minutes and 4 sessions with a weekly intervals. Intervention 2: Control group: This group will receive only routine health care during pregnancy.on the 15th ,2nd and 4th month after delivery,breastfeeding self-efficacy questionnaire and breastfeeding practice checklist including a checklist for neonatal weighing,the frequency of exclusive breastfeeding and the frequency of breastfeeding problems will be completed and then in two groups will be compared.</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 نمونه گیری قبل از سال 1397 شروع شده است</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>shiva havizari</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Faculty of Nursing &amp; Midwifery, South Shariati Street Tabriz</address>
        <city>Tabriz</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>5154639354</zip>
        <telephone>+98 41 3479 6770</telephone>
        <email>Shiva.havizary@gmail.com</email>
        <affiliation>Tabriz University of Medical Science</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>fahimeh sehhatie shafaie</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Tabriz,South Shariati,nursing &amp; midwifery faculty)</address>
        <city>Tabriz</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>51745-347</zip>
        <telephone>+98 41 3479 6770</telephone>
        <email>Fahimehsehhatie@tbzmed.ac.ir</email>
        <affiliation>Tabriz university of medical sciences(nursing &amp; midwifery faculty)</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Having reading and writing literacy
resident of Tabriz
her last breastfeeding failed (failure in this study is meant for mothers who have passed a term pregnancy and have given birth to a healthy baby, yet for some reasons have used infant formulas alone or in combination with  breastfeeding in order to feed their infants during the first 6 months of birth)
have a singleton pregnancy
able to attend continuously in counseling sessions
be in her third trimester of pregnancy</inclusion_criteria>
      <agemin>no limit</agemin>
      <agemax>no limit</agemax>
      <gender>Female</gender>
      <exclusion_criteria>recognized abnormalities in the fetus including congenital anomalies of the heart, brain, kidneys, visual problems, gastrointestinal upsets, cleft lip and cleft palate, oral and maxillofacial abnormalities, etc
High risk pregnancy including  preeclampsia, diabetes preterm labor, premature rupture of embryonic veins, thromboembolism, heart disease and third trimester bleeding
contraindications for lactation (women with galactosomal infants; women taking certain drugs; women undergoing breast cancer treatment, women with HIV infection, women with active herpes simplex virus infection, women with Untreated tuberculosis, women who abuse drugs and, have no control over their alcohol consumption, and mental disorders which cause the mothers can not regularly feed their infants).</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>O92</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Other disorders of breast and lactation associated with childbirth</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Prevention</i_code>
      <i_code>Prevention</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>actation counseling in the intervention group (54 persons) during group counseling sessions, in groups of 7 to 5, each session will start for 60-90 minutes and 4 sessions with a weekly intervals.</i_keyword>
      <i_keyword>Control group: This group will receive only routine health care during pregnancy.on the 15th ,2nd and 4th month after delivery,breastfeeding self-efficacy questionnaire and breastfeeding practice checklist including a checklist for neonatal weighing,the frequency of exclusive breastfeeding and the frequency of breastfeeding problems will be completed and then in two groups will be compared.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Neonatal weigh rate. Timepoint: 15 days, 2 and 4 months after childbirth. Method of measurement: Checklist designed by the research team related to neonatal weighing.</prim_outcome>
      <prim_outcome>Determine the frequency of exclusive breastfeeding. Timepoint: 15 days, 2 and 4 months after childbirth. Method of measurement: Exclusive Breastfeeding Checklist.</prim_outcome>
      <prim_outcome>Determine the self-efficacy of mothers with failure of previous breastfeeding. Timepoint: 15days,2 and 4 months after childbirth. Method of measurement: BSES questionnaire.</prim_outcome>
      <prim_outcome>Determine the frequency of Breastfeeding Problems. Timepoint: 15days,2 and 4 months after childbirth. Method of measurement: Checklist the frequency of breastfeeding problems.</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>Vice-Chancellor for Research of Tabriz University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2017-10-11</approval_date>
        <contact_name>Ethics committee of Tabriz Univercity of Medical Sciences</contact_name>
        <contact_address>Research department, third floor, central construction number 2, Tabriz University of Medical Sciences, Golgasht Street, Azadi Avenue, Tabriz, East azerbaijan  Tabriz Tabriz East Azarbaijan Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
