<?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>IRCT20230706058685N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2023-08-08</date_registration>
      <primary_sponsor>Alborz University of Medical Sciences</primary_sponsor>
      <public_title>The Effect of midwife-led Childbearing Counseling on Fertility Motivation and Empowerment of Women</public_title>
      <acronym></acronym>
      <scientific_title>The Effect of Midwife-led Childbearing Counseling compared to routine care on Fertility Motivation and Empowerment of Women Referring to Health Centers</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2023-08-21</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>130</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/71180</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Education/Guidance, Randomization description: The Samples Are Selected As Available and Then the People Are Randomly Assigned to Two Control and Intervention Groups in Blocks of size 4 (4 people). Random Blocks Will Be Generated Through the Site (www.sealedenvelope.com). For Concealment, the Randomized Sequences Are Placed in Sealed Envelopes and Numbered Sequentially.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Midwife led consuling.</hc_freetext>
      <i_freetext>Intervention 1: Intervention Group: The Intervention Group With 65 People Who Will Receive the Intervention Include of Face-to-Face Counseling in the Form of 4 One-Hour Sessions (15-20 people). The Content of the Child-Bearing Educational Counseling Sessions Will Be Compiled by the Research Team with an Emphasis on the Contents of the Questionnaires of Fertility Motivations and Women's Empowerment Based on the Guidelines of the Ministry of Health As Well As Reliable Sources and Sites, and Will Include Discussions in the Field of Self-Knowledge, Planning, Factors Affecting the Correct Decision-Making for Fertility and Child-Bearing, and the Importance of Women's Independence to Make Free Decisions on Various Reproductive Health Issues, Including the Aspect of Family Planning. Each Counseling Session Will Include the Presentation of Appropriate Content, Assignments and Feedback to the Participants, As Well As a Review of the Previous Sessions. Intervention 2: Control Group: Including 65 People Who Will Receive Routine Care of the Centers.</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 There Is No Further Information.</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Zahra Mehdizadeh Tourzani</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>North Taleghani Blvd; Taleghani Square, Alborz University of Medical Sciences</address>
        <city>Karaj</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>3149779453</zip>
        <telephone>+98 26 3428 7425</telephone>
        <email>zahramehdizadeh_t@yahoo.com</email>
        <affiliation>Alborz University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Zahra Mehdizadeh Tourzani</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>North Taleghani Blvd; Taleghani Square, Alborz University of Medical Sciences</address>
        <city>Karaj</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>3149779453</zip>
        <telephone>+98 26 3428 7425</telephone>
        <email>zahramehdizadeh_t@yahoo.com</email>
        <affiliation>Alborz University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Iranian Muslim Couple
Able to Speak Persian Language
Having Minimum Reading and Writing Literacy
Without Previous Marriage of Each Couple
Having a Child at Least Two Years Old</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>45 years</agemax>
      <gender>Female</gender>
      <exclusion_criteria>Addiction in Each of the Couples
Severe Chronic Physical and Mental Diseases in Each of the Couples
Secondary Infertility Diagnosed in Each of the Couples
Experience of Extreme Stress in Each of the Couples (During the Last Six Months)</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>Lifestyle</i_code>
      <i_code>N/A</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention Group: The Intervention Group With 65 People Who Will Receive the Intervention Include of Face-to-Face Counseling in the Form of 4 One-Hour Sessions (15-20 people). The Content of the Child-Bearing Educational Counseling Sessions Will Be Compiled by the Research Team with an Emphasis on the Contents of the Questionnaires of Fertility Motivations and Women's Empowerment Based on the Guidelines of the Ministry of Health As Well As Reliable Sources and Sites, and Will Include Discussions in the Field of Self-Knowledge, Planning, Factors Affecting the Correct Decision-Making for Fertility and Child-Bearing, and the Importance of Women's Independence to Make Free Decisions on Various Reproductive Health Issues, Including the Aspect of Family Planning. Each Counseling Session Will Include the Presentation of Appropriate Content, Assignments and Feedback to the Participants, As Well As a Review of the Previous Sessions.</i_keyword>
      <i_keyword>Control Group: Including 65 People Who Will Receive Routine Care of the Centers.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Women's Fertility Motivation. Timepoint: Measuring the Fertility Motivation Score of Women Before and One Month After the Intervention. Method of measurement: Miller's Fertility Motivation Questionnaire with Two Positive Dimensions Including 34 Questions and Negative Including 19 Questions.</prim_outcome>
      <prim_outcome>Women's Empowerment. Timepoint: Measuring Women's Empowerment Before and One Month After the Intervention. Method of measurement: Dr. Cohen's Empowerment of Women Questionnaire with 38 Questions in Four Cultural, Individual - Family, Social and Family Planning Dimensions.</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>Alborz University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2023-07-02</approval_date>
        <contact_name>Alborz University of Medical Sciences</contact_name>
        <contact_address>North Taleghani Blvd;  Taleghani Square Karaj Alborz Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
