<?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>IRCT20170506033834N6</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2021-08-10</date_registration>
      <primary_sponsor>Tabriz University of Medical Sciences</primary_sponsor>
      <public_title>The effect of supportive home care and counseling on maternal and breastfeeding performance after cesarean section in primiparous women: a randomized clinical trial</public_title>
      <acronym></acronym>
      <scientific_title>The effect of supportive home care and counseling on maternal and breastfeeding performance after cesarean section in primiparous women: a randomized clinical trial</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2021-08-16</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>60</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/57663</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Supportive, Randomization description: Participants will be assigned to two groups of intervention (home care recipient) and control, using RAS software using random blocking method with 4 and 6 blocks with a ratio of 1: 1. For hiding, the allocation type will be written on paper and numbered in a series of opaque envelopes (Allocation Concealment). The envelopes will be opened sequentially by the person not involved in the sampling.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Postpartum.</hc_freetext>
      <i_freetext>Intervention 1: For intervention group, three home care and supportive counseling sessions will be held during 3 and 7 days, and one month after birth including training maternal self care (breast care, nutrition principles in breastfeeding, care of sutures, sexual relationship resuming and contraception counseling), infant care, evaluating stress, and training coping skills. Intervention 2: Control group: The control group will receive only routine postpartum care.</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 No more data</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Mahsa Ferasati</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Azadi Street, South Shariati, Faculty of Nurcing and Midwifery, Tabriz</address>
        <city>Tabriz</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>5138947977</zip>
        <telephone>+98 41 3479 6770</telephone>
        <email>Mah.ferasati2020@gmail.com</email>
        <affiliation>Tabriz University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Dr. Roghaiyeh Nourizadeh</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Azadi St, South Shariati, Faculty of Nursing and Midwifery, Tabriz</address>
        <city>Tabriz</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>5138947977</zip>
        <telephone>+98 41 3479 6770</telephone>
        <email>nourizadehr@tbzmed.ac.ir</email>
        <affiliation>Tabriz University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Primiparous women who gave birth by cesarean section
Age18-35 years
Delivery of a single baby with intrauterine age over 37 weeks
Having a desire to breastfeed
Living in Ardabil</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>35 years</agemax>
      <gender>Female</gender>
      <exclusion_criteria>Existence of systemic and chronic diseases or aggravating                                                                                                   disorders during pregnancy and childbirth, including gestational or overt diabetes, blood pressure disorders, Heart disease and ...
Breast anomaly or history of breast surgery
Depressive disorders before pregnancy and childbirth
Cases of infant anomaly and death
Lack of rooming for mother and baby due to hospitalization of the baby
Breastfeeding contraindications (Women undergoing                                                                                                              chemotherapy, women with HIV infection, women with untreated active tuberculosis, and consumption Radioactive drugs, anti-metabolites and illicit drugs during lactation and ...)</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>Z39</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Encounter for maternal postpartum care and examination</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Behavior</i_code>
      <i_code>Behavior</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>For intervention group, three home care and supportive counseling sessions will be held during 3 and 7 days, and one month after birth including training maternal self care (breast care, nutrition principles in breastfeeding, care of sutures, sexual relationship resuming and contraception counseling), infant care, evaluating stress, and training coping skills.</i_keyword>
      <i_keyword>Control group: The control group will receive only routine postpartum care</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Score of maternal functioning. Timepoint: 10 days, 2 and 4 months after cesarean. Method of measurement: Barkin Index of Maternal Functioning.</prim_outcome>
      <prim_outcome>Frequency of Breastfeeding and defecation. Timepoint: 10 days, 2 and 4 months after cesarean. Method of measurement: Breastfeeding Practice Checklist.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Score of breastfeeding Self-Efficacy. Timepoint: 10 days, 2 and 4 months after cesarean. Method of measurement: Breastfeeding Self-Efficacy Scale.</sec_outcome>
      <sec_outcome>Score of maternal Self-Efficacy. Timepoint: 10 days, 2 and 4 months after cesarean. Method of measurement: Maternal Self-Efficacy Questionnaire.</sec_outcome>
      <sec_outcome>Infant weight. Timepoint: After birth, 2 and 4 months after cesarean. Method of measurement: Health record.</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>Tabriz University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2020-11-09</approval_date>
        <contact_name>Ethics Commite of Tabriz University of Medical Sciences</contact_name>
        <contact_address>Azadi Street, South Shariati, Faculty of Nursing and Midwifery Tabriz East Azarbaijan Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
