<?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>IRCT2016121431416N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2017-05-11</date_registration>
      <primary_sponsor>Nursing and Midwifery Care Research Center, Isfahan University of Medical Sciences.</primary_sponsor>
      <public_title>Effect Postpartum care at home on postpartum outcome</public_title>
      <acronym></acronym>
      <scientific_title>Aimed to investigate the effect of Postpartum care at home on postpartum outcome.</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2015-08-06</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>62</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/24716</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Single, Purpose: Health service research.</study_design>
      <phase>N/A</phase>
      <hc_freetext>The relationship of postpartum care at home with postpartum outcomes.</hc_freetext>
      <i_freetext>Intervention 1: The postpartum cares will present at intervention group: Folder forming;  folder investigation and familiarity with mother’s situation; history taking of mother and her newborn due to the aims of the study; physical examination of mothers and newborn and postpartum involution situation; prescription of nutritious complements; training and consulting in the fields of  postpartum cares of mother and her newborn and safe reproductive consulting; investigating of mother’s awareness level and their environment; necessary education about mother and newborn due to their need to mother and family; exercise after birth; breastfeeding method will run to do simulation. The care of the intervention group was conducted at three stages by two expert midwives for 45 to 90 minutes. The educational package contained physical examination of the mother and the infant; evaluating the condition of getting back to normal after delivery and necessary educations about the mother; the infant and the family members. The correct method of performing postpartum exercises and breastfeeding were educated through simulation to the mother and her companion. Intervention 2: The postpartum cares will do at control group according to hospitals prior process and phone number will be placed them to will respond. According to routine care, the first care hospital care in the second and third  care were performed by midwives in health centers in accordance with the national standards.&#13;
  Then data  by using  the health folder  and getting the history of the mothers were completed.</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>Parvin Bahadoran</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Nursing and Midwifery Care Research Center, Faculty of Nursing and Midwifery, Isfahan University of Medical Sciences, Isfahan, Iran.</address>
        <city>Isfahan</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip></zip>
        <telephone>+98 31 3792 2937</telephone>
        <email>bahadoran@nm.mui.ac.ir</email>
        <affiliation>Nursing and Midwifery Care Research Center, Faculty of Nursing and Midwifery, Isfahan University of </affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Parvin Bahadoran</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Nursing and Midwifery Care Research Center, Faculty of Nursing and Midwifery, Isfahan University of Medical Sciences, Isfahan, Iran.</address>
        <city>Isfahan</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip></zip>
        <telephone>+98 31 3792 2937</telephone>
        <email>bahadoran@nm.mui.ac.ir</email>
        <affiliation>Nursing and Midwifery Care Research Center, Isfahan University of Medical Sciences, Isfahan, Iran</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>(Inclusion criteria:  accessibility to the residents of the participants; providing written consent form; having a natural delivery with no complications; having a healthy norm neonate; does not require any special care; mother’s, families and house’s appropriate condition; the presence of one of the family members during home visits and exclusion criteria: The lack of care on two occasions completely).</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>48 years</agemax>
      <gender>Female</gender>
      <exclusion_criteria></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>N/A</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>The postpartum cares will present at intervention group: Folder forming;  folder investigation and familiarity with mother’s situation; history taking of mother and her newborn due to the aims of the study; physical examination of mothers and newborn and postpartum involution situation; prescription of nutritious complements; training and consulting in the fields of  postpartum cares of mother and her newborn and safe reproductive consulting; investigating of mother’s awareness level and their environment; necessary education about mother and newborn due to their need to mother and family; exercise after birth; breastfeeding method will run to do simulation. The care of the intervention group was conducted at three stages by two expert midwives for 45 to 90 minutes. The educational package contained physical examination of the mother and the infant; evaluating the condition of getting back to normal after delivery and necessary educations about the mother; the infant and the family members. The correct method of performing postpartum exercises and breastfeeding were educated through simulation to the mother and her companion.</i_keyword>
      <i_keyword>The postpartum cares will do at control group according to hospitals prior process and phone number will be placed them to will respond. According to routine care, the first care hospital care in the second and third  care were performed by midwives in health centers in accordance with the national standards.&#13;
  Then data  by using  the health folder  and getting the history of the mothers were completed.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Postpartum care at home. Timepoint: In three-stage visits (1st to 3rd day, 10th to 15th day, and 42 to 60 day). Method of measurement: Using researcher-made questionnaires that include breastfeeding pattern (1 questions), awareness of maternal health (16 questions), awareness of child health (5 questions), husband’s behavior (13 items), and mother’s satisfied.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Breastfeeding pattern, awareness of maternal health, awareness of child health, husband’s behavior, and mother’s satisfied. Timepoint: In three-stage visits (1st to 3rd day, 10th to 15th day, and 42 to 60 day). Method of measurement: Using researcher-made questionnaires that include breastfeeding pattern (1 questions), awareness of maternal health (16 questions), awareness of child health (5 questions), husband’s behavior (13 items), and mother’s satisfied.</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>Nursing and Midwifery Care Research Center, Isfahan University of Medical Sciences.</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2015-02-18</approval_date>
        <contact_name>Isfahan University of Medical Sciences</contact_name>
        <contact_address>Department of Reproductive Health, women’s health Research Center, School of Nursing and Midwifery, Isfahan University of Medical Sciences, Isfahan, Iran isfahan  Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
