<?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>IRCT20180427039436N4</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2019-07-14</date_registration>
      <primary_sponsor>Iran University of Medical Sciences</primary_sponsor>
      <public_title>prenatal care education on spouses of primiparous women</public_title>
      <acronym></acronym>
      <scientific_title>Comparison of the Effect of prenatal care education on spouses of primiparous women, in face-to-face and social network based on Pregnancy Experience and  Fear of Child Birth</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2019-08-06</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>76</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/40470</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: N/A, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Education/Guidance.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Virtual education and face to face education of prenatal care.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: Education based on social networking (on Telegram): The educational content is according to country standard instructions. In addition, sending messages based on Mayer's multimedia in form of text, image, podcast, video cast, in the MPEG-4 format. The maximum of films time will be 10-15 minute. Intervention 2: Face to face learning group:In this group, the spouses of primiparous women, receive educational content through face to face, in four sessions.Educational content at the first session of nutrition during pregnancy (weeks 24-28), second session of  fetal growth and development and mental health and preparation for motherhood and fatherhood (parental role) (weeks 28-30), third session of the benefits and disadvantages of normal delivery, cesarean section, analgesics and pain relief Childbirth, delivery method selection, delivery planning (weeks 33-32), fourth session of baby care and neonatal symptoms (Week 37).</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 it is will be known in future.</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Zari Dolatabadi Takabi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Rashid Yasemi St</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1996713883</zip>
        <telephone>+98 21 4365 1000</telephone>
        <email>DOLATABADI.Z@IUMS.AC.IR</email>
        <affiliation>Iran University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Zari Dolatabadi Takabi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Rashid Yasemi St</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1996713883</zip>
        <telephone>+98 21 4365 1000</telephone>
        <email>DOLATABADI.Z@IUMS.AC.IR</email>
        <affiliation>Iran University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Inclusion Criteria for mothers:
Iranian nationality
Women aged 35-18
primiparous women with gestational age of 20 weeks
being literate for reading and writing
singleton pregnancy and low risk pregnancy
No history of infertility
Participate in childbirth preparation classes
Not having a history of any physical, psychological disease, addiction to cigarettes, alcohol and psychotropic substances according to self report.
Inclusion Criteria for fathers:
First experience of fatherhood
At least 18 years old
Iranian nationality
Having a common home and living with a spouse
being literate for reading and writing
Having a mobile phone or a computer with the ability to install the telegram application until the end of the study
Not having a history of any physical, psychological disease, addiction to cigarettes, alcohol and psychotropic substances according to self report.
No bad event since three months before the intervention</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>35 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Being absent more than two sessions of childbirth classes
Leave the group
Not responding to messages sent by the researcher for at least one week during the study
Indication of high risk pregnancy during study
Preterm labor</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>Other</i_code>
      <i_code>Other</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group: Education based on social networking (on Telegram): The educational content is according to country standard instructions. In addition, sending messages based on Mayer's multimedia in form of text, image, podcast, video cast, in the MPEG-4 format. The maximum of films time will be 10-15 minute.</i_keyword>
      <i_keyword>Face to face learning group:In this group, the spouses of primiparous women, receive educational content through face to face, in four sessions.Educational content at the first session of nutrition during pregnancy (weeks 24-28), second session of  fetal growth and development and mental health and preparation for motherhood and fatherhood (parental role) (weeks 28-30), third session of the benefits and disadvantages of normal delivery, cesarean section, analgesics and pain relief Childbirth, delivery method selection, delivery planning (weeks 33-32), fourth session of baby care and neonatal symptoms (Week 37).</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Pregnancy experience. Timepoint: Before intervention at 20 weeks gestational and 36-38 weeks of gestational age. Method of measurement: Brief version of pregnancy experience scale.</prim_outcome>
      <prim_outcome>Delivery expectancy/experience questionnaire. Timepoint: Before intervention at 20 weeks gestational and 36-38 weeks of gestational age. Method of measurement: Wijma delivery expectancy/experience questionnaire.</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>Iran University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2019-06-10</approval_date>
        <contact_name>Ethics Committee Of Iran University of Medical Sciences</contact_name>
        <contact_address>Hemat Highway next to Milad Tower, Tehran Tehran Tehran Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
