<?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>IRCT2017080735540N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2017-10-07</date_registration>
      <primary_sponsor>Ilam’s Red Crescent Society</primary_sponsor>
      <public_title>breast feeding and support</public_title>
      <acronym></acronym>
      <scientific_title>Effect of mother to mother support  on breast feeding pattern and breast feeding duration among nulliparous women</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2009-06-22</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>240</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/26827</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Supportive, Other design features: Assigning samples to the groups by blocking method was done using the Random function and using Excel software.</study_design>
      <phase>3</phase>
      <hc_freetext>breast feeding.</hc_freetext>
      <i_freetext>Intervention 1: The phone number, address and name of at most 8 nulliparous mothers were given to two supporters with similar age, education status, socio-economic level, and residential area. The supporter called the mothers within 48 hours after discharge to introduce herself. Then, in the next phone calls and during the next 3 months. The mother’s call was unlimited and based on her need and she could call the supporter at any desired time. Moreover, the supporter called the mothers every week and encouraged them to continue exclusive breastfeeding. Question and answer sessions were also held in the presence of the supporters and the authors every two weeks during the first, second, and third months of study in the Red Crescent Society office in Ilam. Intervention 2: The control group program included the Routine trainings. The intervention group program included the Routine trainings plus the support from the 30 mothers with positive breast feeding experience during the 3 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>zolaykha karamolahi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Banjangnab, Central Hospital of Medical Sciences University, Nursing Midwifery Faculty, Ilam</address>
        <city>Ilam</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>6931343500</zip>
        <telephone>+98 84 3224 4224</telephone>
        <email>mohamad20101@gmail.com</email>
        <affiliation>Ilam University of Medical Science</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Shahnaz Tork Zahrani</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Valiasr St., Nursing College Campus, Nursing Midwifery Faculty, Tehran, Iran</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip></zip>
        <telephone>+98 21 8865 5366</telephone>
        <email>zahranishahnaz@yahoo.com</email>
        <affiliation>Shahid Beheshti University of Medical Science</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
      <country2>Iran (Islamic Republic of)</country2>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>The inclusion criteria for the mothers were as follows: willingness to participate, nulliparity, singleton pregnancy, residing in Ilam, being available and literate, gestational age of over 37 weeks at the time of delivery, no diagnosed debilitating disease in the mother or neonate, no fetal disorders during pregnancy, not requiring NICU stay.The inclusion criteria for the peer support were as follows: willingness to participate, residing in Ilam, being available and literate, Have a successful breastfeeding history, no diagnosed debilitating disease. Exclusion criteria:  Mothers not available for telephone counseling.</inclusion_criteria>
      <agemin>no limit</agemin>
      <agemax>no limit</agemax>
      <gender>Female</gender>
      <exclusion_criteria></exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>p92.5</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Suppressed lactation</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Other</i_code>
      <i_code>Other</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>The phone number, address and name of at most 8 nulliparous mothers were given to two supporters with similar age, education status, socio-economic level, and residential area. The supporter called the mothers within 48 hours after discharge to introduce herself. Then, in the next phone calls and during the next 3 months. The mother’s call was unlimited and based on her need and she could call the supporter at any desired time. Moreover, the supporter called the mothers every week and encouraged them to continue exclusive breastfeeding. Question and answer sessions were also held in the presence of the supporters and the authors every two weeks during the first, second, and third months of study in the Red Crescent Society office in Ilam.</i_keyword>
      <i_keyword>The control group program included the Routine trainings. The intervention group program included the Routine trainings plus the support from the 30 mothers with positive breast feeding experience during the 3 months after delivery</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Breastfeeding Patterns and Duration. Timepoint: The end of the first, second and third months. Method of measurement: evaluation of Breastfeeding Patterns and Duration.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Mother's satisfaction from breastfeeding. Timepoint: the end of  third month. Method of measurement: Lactation Satisfaction Form.</sec_outcome>
    </secondary_outcome>
    <secondary_sponsor>
      <sponsor_name>Vice Chancellor for research of Faculty of Nursing and Midwifery Shahid Beheshti</sponsor_name>
    </secondary_sponsor>
    <secondary_ids>
      <secondary_id>
        <sec_id></sec_id>
        <issuing_authority></issuing_authority>
      </secondary_id>
    </secondary_ids>
    <source_support>
      <source_name>Ilam’s Red Crescent Society</source_name>
      <source_name>Vice Chancellor for research of Faculty of Nursing and Midwifery Shahid Beheshti</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2009-07-13</approval_date>
        <contact_name>Ethics committee of Shahid Beheshti University of Medical Science</contact_name>
        <contact_address>Velengak, Tehran Tehran  Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
