<?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>IRCT20190718044259N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2019-10-08</date_registration>
      <primary_sponsor>Sabzevar University of Medical Sciences</primary_sponsor>
      <public_title>The effect of support through telephone counseling on breastfeeding problems and exclusive breastfeeding</public_title>
      <acronym></acronym>
      <scientific_title>The effect of post-natal counseling on breastfeeding problems and exclusive breastfeeding</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2017-09-01</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>85</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/40953</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Other, Purpose: Education/Guidance, Other design features: The content of telephone counseling is based on ministerial instructions, the WHO and other sources and each telephone consultation is divided into two parts: In the first part, the counselor questions the mother during the week and notes on the checklist The existing problem of consultation is to the extent that it is in line with the objectives of the research. The second part is dedicated advice on supporting exclusive breastfeeding, consulting with mothers and referrals to specialist centers, Randomization description: Block randomization was used for randomization. Sample allocation in the study was based on a random sequence provided by the statistics consultant (using statistical software). The sequence used was quadruple blocks.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Condition 1: Exclusive breastfeeding. Condition 2: breastfeeding problems. Condition 3: Cracked nipple.</hc_freetext>
      <i_freetext>Intervention 1: The intervention group will receive regular telephone counseling. The first phone call will be made within the first 48 hours after hospital discharge (day 3 to 5 after delivery). According to WHO studies and information, these days are the most important time, and mothers have the least access to health centers and hospitals because of their problems and child support.The second consultation is at 13-15 days postpartum.It takes an average of 20 minutes depending on the individual's needs. Each telephone consultation has two parts: In the first section, the counselor questions the mother during the week and notes in the checklist, based on the existing problem to the extent that it is in line with the research objectives. The second part is dedicated advice on supporting exclusive breastfeeding. Counseling is provided by a midwifery graduate student with specialized short-term training in postpartum counseling. The telephone is also provided to mothers so that they can contact the counselor if needed.Both groups will receive routine postpartum education and care (usually three times in 42-60 days) from the delivery site and the health care centers covered on a routine basis. Intervention 2: Control group: Care can be received from health centers according to the protocol of the Ministry of Health.</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>Undecided - It is not yet known if there will be a plan to make this available</results_IPD_plan>
      <results_IPD_description>Justification or reason for indecision in sharing IPD is Its release schedule is still unclear.</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Parastoo Amiri</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Tohidshahr Blvd</address>
        <city>Sabzevar</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>9617913112</zip>
        <telephone>+98 51 4401 8319</telephone>
        <email>Amiri.Parasto@gmail.com</email>
        <affiliation>Sabzevar University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Parastoo Amiri</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Tohidshahr Blvd</address>
        <city>Sabzevar</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>9617913114</zip>
        <telephone>+98 51 4401 8319</telephone>
        <email>Amiri.Parasto@gmail.com</email>
        <affiliation>Sabzevar University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Iranian nationality
No underlying disease
The singleton fetuses with normal birth weight and without congenital anomalies
No drugs and drugs that are contraindicated in lactation
Residence in the area
Phone access
No problem with speech and hearing</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>45 years</agemax>
      <gender>Female</gender>
      <exclusion_criteria>Infant death for any reason during the study
Maternal or neonatal illnesses that lead to discontinuation of breastfeeding by a specialist doctor</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>P92</hc_code>
      <hc_code>O91</hc_code>
      <hc_code>O92.1</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Feeding problems of newborn</hc_keyword>
      <hc_keyword>Infections of breast associated with pregnancy, the puerperium and lactation</hc_keyword>
      <hc_keyword>Cracked nipple associated with pregnancy, the puerperium, and lactation</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Prevention</i_code>
      <i_code>Other</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>The intervention group will receive regular telephone counseling. The first phone call will be made within the first 48 hours after hospital discharge (day 3 to 5 after delivery). According to WHO studies and information, these days are the most important time, and mothers have the least access to health centers and hospitals because of their problems and child support.The second consultation is at 13-15 days postpartum.It takes an average of 20 minutes depending on the individual's needs. Each telephone consultation has two parts: In the first section, the counselor questions the mother during the week and notes in the checklist, based on the existing problem to the extent that it is in line with the research objectives. The second part is dedicated advice on supporting exclusive breastfeeding. Counseling is provided by a midwifery graduate student with specialized short-term training in postpartum counseling. The telephone is also provided to mothers so that they can contact the counselor if needed.Both groups will receive routine postpartum education and care (usually three times in 42-60 days) from the delivery site and the health care centers covered on a routine basis.</i_keyword>
      <i_keyword>Control group: Care can be received from health centers according to the protocol of the Ministry of Health.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Mastitis. Timepoint: 13-15 days after childbirth. Method of measurement: Checklist, Ask the mother.</prim_outcome>
      <prim_outcome>Cracked nipple. Timepoint: 13-15 days after childbirth. Method of measurement: Checklist, Ask the mother.</prim_outcome>
      <prim_outcome>Exclusive breastfeeding In the last 24 hours(Human milk intake by infant without any supplements (water, fruit, non-human milk and food) except vitamins, minerals and medicines). Timepoint: 60 days after childbirth. Method of measurement: Checklist, Ask the mother.</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>Sabzevar University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2017-08-28</approval_date>
        <contact_name>ٍEthics Committee of Sabzevar University of Medical Sciences</contact_name>
        <contact_address>Tohidshahr Blvd Sabzevar Razavi Khorasan Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
