<?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>IRCT2013060313565N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2013-12-07</date_registration>
      <primary_sponsor>Vice chancellor for research, Shaheed Beheshti University of Medical Sciences</primary_sponsor>
      <public_title>Effects of Postpartum Care at Home on the Health of the Mother and Suckling</public_title>
      <acronym></acronym>
      <scientific_title>Presenting a Pattern of Postpartum Care at Home and Its&#13;
 Effects on the Health of the Mother and the Suckling</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2013-10-23</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>270</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/13379</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Health service research.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Postpartum Period.</hc_freetext>
      <i_freetext>Intervention 1: The type of intervention for both groups is providing service in accordance with the approved pattern at home and to visit in days of 3-5 and 13-15 after the delivery. Visits are done by trained midwives or nurses. The average time of visit is considered between 30-45 minutes, which is flexible according to mothers’ demands.The service provider’s phone number is given to mothers in case of any problems. Caregivers will be trained before the intervention, so there will be integration in the caring method. Intervention 2: The control group won’t be provided with home service.</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>Parastoo Amiri</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Velenjak,Shaheed Beheshti Faculty of medicine,Eighth floor,Public health &amp; Community medicine department</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip></zip>
        <telephone>+98 21 2243 9936</telephone>
        <email>Amiri.Parasto@gmail.com ; Amiri_Parasto@yahoo.com</email>
        <affiliation>Shaheed Beheshti university of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Dr.Hourieh Shamshiri Milani</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Velenjak,Shaheed Beheshti Faculty of medicine,Eighth floor,Public health &amp; Community medicine department</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip></zip>
        <telephone>+98 21 2243 9936</telephone>
        <email>Hourieh_Milani@yahoo.com</email>
        <affiliation>Shaheed 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>Inclusion criteria: Iranian nationality; no gestational hypertension, preeclampsia and gestational diabetes; single embryo with normal birth weight;no congenital anomalies; having a score less than 14 in Edinburg questionnaire. Exclusion criteria: unwillingness to continue the study for any reason; immigration from the areas of study</inclusion_criteria>
      <agemin>15 years</agemin>
      <agemax>45 years</agemax>
      <gender>Female</gender>
      <exclusion_criteria></exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>Z39.1, Z39</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Care and examination of lactating mother, Routine postpartum follow-up</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Prevention</i_code>
      <i_code>Prevention</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>The type of intervention for both groups is providing service in accordance with the approved pattern at home and to visit in days of 3-5 and 13-15 after the delivery. Visits are done by trained midwives or nurses. The average time of visit is considered between 30-45 minutes, which is flexible according to mothers’ demands.The service provider’s phone number is given to mothers in case of any problems. Caregivers will be trained before the intervention, so there will be integration in the caring method.</i_keyword>
      <i_keyword>The control group won’t be provided with home service.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Using supplementation in mother in intervention and control groups. Timepoint: 42-60 days after intervention. Method of measurement: questionarie.</prim_outcome>
      <prim_outcome>Using supplementation in suckling in intervention and control groups. Timepoint: 42-60 days after intervention. Method of measurement: questionarie.</prim_outcome>
      <prim_outcome>Using the contraceptive methods in intervention and control groups. Timepoint: 42-60 days after intervention. Method of measurement: questionarie.</prim_outcome>
      <prim_outcome>Incidence of  Postpartum depression in intervention and control groups. Timepoint: 42-60 days after intervention. Method of measurement: Edinburg questionarie.</prim_outcome>
      <prim_outcome>Mother hospitalization due to complications after childbirth in intervention and control groups. Timepoint: 42-60 days after intervention. Method of measurement: questionarie.</prim_outcome>
      <prim_outcome>Exclusive feeding with breast milk in intervention and control groups. Timepoint: 42-60 days after intervention. Method of measurement: questionarie.</prim_outcome>
      <prim_outcome>Breast problems in intervention and control groups. Timepoint: 42-60 days after intervention. Method of measurement: questionarie.</prim_outcome>
      <prim_outcome>Constipation in intervention and control groups. Timepoint: 42-60 days after intervention. Method of measurement: questionarie.</prim_outcome>
      <prim_outcome>Hemorrhoids in intervention and control groups. Timepoint: 42-60 days after intervention. Method of measurement: questionarie.</prim_outcome>
      <prim_outcome>Backache and lumbago in intervention and control groups. Timepoint: 42-60 days after intervention. Method of measurement: questionarie.</prim_outcome>
      <prim_outcome>Fatigue in intervention and control groups. Timepoint: 42-60 days after intervention. Method of measurement: questionarie.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Satisfaction rate in intervention and control groups. Timepoint: 42-60 days after intervention. Method of measurement: questionares.</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>Vice chancellor for research, Shaheed Beheshti University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2012-11-11</approval_date>
        <contact_name>Shaheed Beheshti University of Medical Sciences</contact_name>
        <contact_address>Velenjak , Shahid Chamran Highway Tehran  Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
