<?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>IRCT20190129042542N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2019-05-13</date_registration>
      <primary_sponsor>Shahid Beheshti University of Medical Sciences</primary_sponsor>
      <public_title>Evaluation of Breast Massage on the Mother's Need for support During Lactation and Successful Breastfeeding in Neonates born through Cesarean Section in the Selected Hospitals Affiliated to Shahid Beheshti University Medical Sciences 2019.</public_title>
      <acronym></acronym>
      <scientific_title>Evaluation of Breast Massage on the Mother's Need for support During Lactation and Successful Breastfeeding in Neonates born through Cesarean Section in the Selected Hospitals Affiliated to Shahid Beheshti University Medical Sciences 2019.</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2019-04-19</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>100</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/37199</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Supportive, Randomization description: In this study, a suitable sampling method (selection among mothers of candidates for cesarean section) based on inclusion criteria, and random allocation in two groups of intervention and control by simple random method.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Cesarean, Breast Massage, Lactation, Successful Breastfeeding, Neonates.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: Oketani breast massage included eight manual techniques performed within 60 sec and repeated for 15-20 min. Levels 1-3 of the given therapy were associated with the detachment of the bottom of the breast from its pectoralis major muscle. Furthermore, levels 4-6 involved pulling the whole breast with two thumbs down and to both sides by both hands. Additionally, level 7 included rotating the breast gently clockwise with stretching of its base, and level 8 was about milking the breast in four different directionsroup. This massage is done in two steps; first step before cesarean and the second in recovery after cesarean. Intervention 2: Control group:  receive routine care for the mothers in the control group and review Successful breastfeeding and mother's need support during lactation by IBFAT and LATCH tools.This review is done in two steps; first step during first breastfeeding after cesarean delivery and the second during the last breastfeeding before mom's discharged (The interval is 22 to 28 hours after cesarean 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>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 Incomplete Sampling</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Maryam Mahdizadeh Shahri</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Tehran, Hashemi Rafsanjani Hwy</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1985717443</zip>
        <telephone>+98 982188655366</telephone>
        <email>m.mahdizadeh.sh@gmail.com</email>
        <affiliation>Shahid Beheshti University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Manijeh Nourian</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Tehran, Hashemi Rafsanjani Hwy</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1985717443</zip>
        <telephone>+98 21 8865 5372</telephone>
        <email>manighea@yahoo.com</email>
        <affiliation>Shahid Beheshti University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
      <country2>Iran (Islamic Republic of)</country2>
      <country2>Iran (Islamic Republic of)</country2>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Single pregnancy
Maternal aged 18 to 35
Physical and mental illness is not based on mother's statement and file documentation
The gestational age is 37 to 41 weeks
There is no history of breast surgery, breast cancer, burn and scarring in the breast
There is not Prenatal illnesses, such as Gestational Diabetes(GDM), Preeclampsia, and viral diseases such as AIDS and Hepatitis.
There is not Prenatal abnormalities such as  Placental abruption, Placenta Previa, heart and respiratory diseases.</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>35 years</agemax>
      <gender>Female</gender>
      <exclusion_criteria>severe hemorrhage during cesarean section
Uterine inertia and atony during cesarean section
use any drugs that Suppression lactation
The mother has no desire for breastfeeding to the baby.
The mother has no desire for to continue to intervene.
The neonates is transmitted to the neonatal unit
Apgar scores  1 and 5 minutes in neonates less than 7</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code></hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword></hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Prevention</i_code>
      <i_code>Prevention</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group: Oketani breast massage included eight manual techniques performed within 60 sec and repeated for 15-20 min. Levels 1-3 of the given therapy were associated with the detachment of the bottom of the breast from its pectoralis major muscle. Furthermore, levels 4-6 involved pulling the whole breast with two thumbs down and to both sides by both hands. Additionally, level 7 included rotating the breast gently clockwise with stretching of its base, and level 8 was about milking the breast in four different directionsroup. This massage is done in two steps; first step before cesarean and the second in recovery after cesarean.</i_keyword>
      <i_keyword>Control group:  receive routine care for the mothers in the control group and review Successful breastfeeding and mother's need support during lactation by IBFAT and LATCH tools.This review is done in two steps; first step during first breastfeeding after cesarean delivery and the second during the last breastfeeding before mom's discharged (The interval is 22 to 28 hours after cesarean delivery).</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>The  first main variable in this study is successful breastfeeding. Timepoint: Time interval to measure the successful breast feeding variable, first breastfeeding and last one before discharge mother from hospital(22-28 hour after cesarean delivery). Method of measurement: instrument to assess successful breastfeeding is IBFAT(Infant Breastfeeding Assessment Tool).</prim_outcome>
      <prim_outcome>The second main variable in this study is mother's need support during lactation. Timepoint: Time interval to measure the  mother's need support during lactation variable, first breastfeeding and last one before discharge mother from hospital(22-28 hour after cesarean delivery). Method of measurement: instrument to assess mother's need support during lactation is LATCH(Breastfeeding Charting System and Documentation Tool).</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>Shahid Beheshti University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2019-01-28</approval_date>
        <contact_name>Ethics committee of Shahid Beheshti University of Medical Sciences</contact_name>
        <contact_address>in front of Shahid Rajaee Hospital,Intersection Hashemi Rafsanjani Hwy, Valiasr St, Tehran, Iran Tehran Tehran Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
