<?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>IRCT20220509054795N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2022-05-12</date_registration>
      <primary_sponsor>Koç University</primary_sponsor>
      <public_title>The effect of motivational interviewing birth preference</public_title>
      <acronym></acronym>
      <scientific_title>The effect of motivational interviewing throughout pregnancy on birth preference: a randomized controlled trial</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2019-03-01</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>100</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/63431</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Education/Guidance, Randomization description: A total of 100 pregnant women who met the inclusion criteria, i.e. those who referred to obstetrics polyclinics of Çanakkale Onsekiz Mart University Healthcare, Practice and Research Hospital and Çanakkale State Hospital during 01 March 2019-02 March 2020. Were assigned to the experimental group or the control group (50 women in each group) by randomization using the random sampling method. Randomization was performed by assigning numbers to the pregnant women according to their order of presentation using a table of random numbers to assign the first number in the experimental group and the second number in the control group.</study_design>
      <phase>N/A</phase>
      <hc_freetext>None.</hc_freetext>
      <i_freetext>Intervention 1: To support vaginal delivery, three motivational interviews, initiated during pregnancy (Week 26-28) and continued in the postnatal period, were conducted with the experimental group. Motivational interviews in the third trimester were preferred as this is a period close to delivery. The interviews were conducted individually since the motivational interviewing technique is an individual-based method.Timeline of Motivational Interviews (MIs) was as follows; The first interview: Antenatal week 26-28 The second interview: Antenatal week 32-34 The third interview: Postnatal day 1. Intervention 2: Since it would not be ethically appropriate to apply no intervention in the control group, individual nutrition training was provided during pregnancy in this group. The content of this training included managing nutrition during pregnancy, important nutrients during pregnancy, weight gain during pregnancy, and nutritional recommendations in physiological changes during pregnancy.</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 not yet known if there will be a plan to make this available</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Eda Cangöl</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Çanakkale Onsekiz Mart University Terzioğlu Campus, Faculty of Health Sciences</address>
        <city>Çanakkale</city>
        <country1>Turkey</country1>
        <zip>17000</zip>
        <telephone>+90 286 218 13 97</telephone>
        <email>edacangol@comu.edu.tr</email>
        <affiliation>Çanakkale Onsekiz Mart University</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Eda Cangöl</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Çanakkale Onsekiz Mart University Terzioğlu Campus, Faculty of Health Sciences</address>
        <city>Çanakkale</city>
        <country1>Turkey</country1>
        <zip>17000</zip>
        <telephone>+90 286 218 13 97</telephone>
        <email>edacangol@comu.edu.tr</email>
        <affiliation>Çanakkale Onsekiz Mart University</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Turkey</country2>
    </countries>
    <criteria>
      <inclusion_criteria>-	Primigravid status (women experiencing their 1st pregnancy)
-	Married (civil marriage) pregnant women in gestational week 26-28,
-       50% of the experimental group and the control group consisted of pregnant women from rural areas,
-	Pregnant women no physical disability,
-       No diagnosis of a psychiatric condition (verbally confirmed),
-       Subjects willing to participate in the study,
-       Those without pregnancy considered ‘risky’,
-       Pregnant women without planned cesarean section</inclusion_criteria>
      <agemin>no limit</agemin>
      <agemax>no limit</agemax>
      <gender>Female</gender>
      <exclusion_criteria>know how to read and write
not be a foreign national</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>Behavior</i_code>
      <i_code>Other</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>To support vaginal delivery, three motivational interviews, initiated during pregnancy (Week 26-28) and continued in the postnatal period, were conducted with the experimental group. Motivational interviews in the third trimester were preferred as this is a period close to delivery. The interviews were conducted individually since the motivational interviewing technique is an individual-based method.Timeline of Motivational Interviews (MIs) was as follows; The first interview: Antenatal week 26-28 The second interview: Antenatal week 32-34 The third interview: Postnatal day 1</i_keyword>
      <i_keyword>Since it would not be ethically appropriate to apply no intervention in the control group, individual nutrition training was provided during pregnancy in this group. The content of this training included managing nutrition during pregnancy, important nutrients during pregnancy, weight gain during pregnancy, and nutritional recommendations in physiological changes during pregnancy.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Mother's perception of self-efficacy regarding labor. Timepoint: Pretest and posttest. Method of measurement: Self-Sufficiency in Labor Scale-Short Form.</prim_outcome>
      <prim_outcome>The intent of motivational Interview, significance, confidence-efficacy parameters. Timepoint: Pretest and post-test. Method of measurement: MI Rating Scale.</prim_outcome>
      <prim_outcome>Fear of childbirth. Timepoint: Pretest and post-test. Method of measurement: Delivery Expectancy/Experience Questionnaire (W-DEQ), version A.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Mother's perception of self-efficacy regarding labor. Timepoint: after 1 month. Method of measurement: Self-Sufficiency in Labor Scale-Short Form.</sec_outcome>
      <sec_outcome>The intent of motivational Interview, significance, confidence-efficacy parameters. Timepoint: after 1 month. Method of measurement: MI Rating Scale.</sec_outcome>
      <sec_outcome>Fear of childbirth. Timepoint: after 1 month. Method of measurement: Wijma Delivery Expectancy/Experience Questionnaire (W-DEQ), version B.</sec_outcome>
      <sec_outcome>Mode of Delivery. Timepoint: after 1 month. Method of measurement: Postnatal Maternal Information Form.</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>Koç University</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2016-04-06</approval_date>
        <contact_name>Approval was obtained from Uşak University Ethics Committee</contact_name>
        <contact_address>1 September Campus/Usak University Uşak Uşak Turkey</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
