<?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>IRCT20200105046014N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2020-02-22</date_registration>
      <primary_sponsor>Mashhad University of Medical Sciences</primary_sponsor>
      <public_title>The effect of individual counseling on the intention to choose</public_title>
      <acronym>VBAC</acronym>
      <scientific_title>The effect of individual counseling through  Fogg model on the intention to choose vaginal birth after cesarean in pregnant mothers</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2020-03-01</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>68</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/44773</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Education/Guidance, Randomization description: Multi-stage sampling will be performed. The sampling frame is Mashhad comprehensive health centers. Initially, 2 comprehensive health centers are randomly selected from Mashhad comprehensive health centers (1,2,3,4, and 5). From each center, 4 covered base are selected according to the number of clients and appropriate locations for consultation. In order to prevent interaction and dissemination of information in two groups, two centers and totally 4 bases with random allocation are assigned to each group. The method of random assignment would be to have the name of the bases and the names of the groups written on separate papers and put in two separate envelopes. Then the names of two centers and one group from two envelopes are selected simultaneously. Sampling will be done at each base in an accessible manner.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Vaginal birth after cesarean delivery.</hc_freetext>
      <i_freetext>Intervention 1: intervention group:The 'intervention group" receives three Individual of Fogg model counseling sessions for 45-60 minutes and once every two weeks, based on a structure developed by the researcher and approved by a professor of psychology. Intervention 2: Control group: The "control group" receives routine counseling about vaginal birth after cesarean by midwives at health 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 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>Mahboobeh firoozi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>No. 9, west Fajr, Baharan Ave., Faramarzabbasi Blvd</address>
        <city>Mashhad</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>9137913199</zip>
        <telephone>0098 51 38591511-3</telephone>
        <email>Firoozim@mums.ac.ir</email>
        <affiliation>Mashhad University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Mahboobeh firoozi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>No. 9, west Fajr, Baharan Ave., Faramarzabbasi Blvd</address>
        <city>Mashhsd</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>9137913199</zip>
        <telephone>0098 51 38591511-3</telephone>
        <email>Firoozim@mums.ac.ir</email>
        <affiliation>Mashhad University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Iranian and resident of Mashhad
At least have the ability to read and write
Aged 18-35 years old
Single-pregnancy, A live embryo and a cephalic display
Amniotic fluid and placental placement are normal based on pregnancy ultra sonography
The interval between pregnancy and previous delivery is greater than 6 months.
The gestational age based on the LMP or the first trimester ultrasound is of 28-30 weeks.
History of once prior cesarean section
Do not have a history of infertility
Not having a medical cause for cesarean section, such as a transverse position, previous uterine surgery, etc.</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>35 years</agemax>
      <gender>Female</gender>
      <exclusion_criteria>indication of cesarean section.
Have a history of infertility.
Embryo abnormalities are contraindicated in normal delivery.
Have a medical or obstetric illness.
Non-transverse cesarean section.
Have a mental illness.</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>Behavior</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>intervention group:The 'intervention group" receives three Individual of Fogg model counseling sessions for 45-60 minutes and once every two weeks, based on a structure developed by the researcher and approved by a professor of psychology</i_keyword>
      <i_keyword>Control group: The "control group" receives routine counseling about vaginal birth after cesarean by midwives at health centers.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>The intent to choose Vaginal birth after cesarean. Timepoint: At the beginning of the study and 2 and 4 week after the intervention. Method of measurement: Intent selection choose the type of delivery checklist.</prim_outcome>
      <prim_outcome>Fogg Model Structures (Motivation, Ability, Stimulus). Timepoint: At the beginning of the study and 2 and 4 week after the intervention. Method of measurement: Fogg Model Structures (Motivation, Ability, Stimulus) the researcher-made questionnaire.</prim_outcome>
      <prim_outcome>Fear of delivery. Timepoint: At the beginning of the study and 2 and 4 week after the intervention. Method of measurement: Vijma's fear of delivery Questionnaire; Version A.</prim_outcome>
      <prim_outcome>Self-efficacy of delivery. Timepoint: At the beginning of the study and 2 and 4 week after the intervention. Method of measurement: Maternal self-efficacy questionnaire.</prim_outcome>
      <prim_outcome>Decision self-efficacy. Timepoint: At the beginning of the study and 2 and 4 week after the intervention. Method of measurement: Decision self-efficacy questionnaire.</prim_outcome>
      <prim_outcome>Decision Conflict. Timepoint: At the beginning of the study and 2 and 4 week after the intervention. Method of measurement: Decision Conflict 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>Mashhad University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2019-12-30</approval_date>
        <contact_name>Mashhad University of Medical Sciences and Health Services</contact_name>
        <contact_address>Khorasan Razavi - Mashhad-Ave. University- Facing Khayyayan University 18- Mashhad University of Medical Sciences- Vice-President of Research and Technology University Mashhad Razavi Khorasan Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
