<?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>IRCT20200614047768N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2020-06-21</date_registration>
      <primary_sponsor>Mashhad University of Medical Sciences</primary_sponsor>
      <public_title>The impact of  counseling on decision self-efficacy and intention</public_title>
      <acronym>VBAC</acronym>
      <scientific_title>The impact of supportive counseling on decision self-efficacy and intention to Vaginal Birth after Caesarean in prior cesarean section mothers</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2020-07-20</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>60</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/48909</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Education/Guidance, Randomization description: Random allocation of groups will be such that the names of the databases that are randomly selected and the names of the groups are written on separate papers and placed in two separate envelopes.Then the name of a database and a group of direct envelopes are selected simultaneously. Thus, one base from the center will be allocated to the intervention group and one base from each center will be allocated to the control group, and a total of two bases will be allocated to the control group and two bases to the intervention group. Then, sampling will be done inside each center.</study_design>
      <phase>N/A</phase>
      <hc_freetext>vaginal birth after cesarean.</hc_freetext>
      <i_freetext>Intervention 1: "Intervention Group" Consulting package based on the supportive counseling approach includes: 1- Two individual supportive counseling sessions for each session of 45 minutes and in the middle of the week and in person and face to face 2- Pamphlet and link of the messenger channel.Content of counseling sessions based on supportive counseling steps includes the first session: explanation (right to choose the type of delivery, natural childbirth mechanism, recurrent cesarean complications), reassurance (benefits of natural childbirth for mother and baby, comparison of benefits and losses of natural childbirth after cesarean section, amount The success of natural childbirth after cesarean section), the content of the second session: guidance (methods of awakening in Libra, relaxation techniques in Liber, different positions in Libra and childbirth, mobile support, helping to remove barriers to selection from his point of view), encouragement (experience Her mothers have had a back-to-back presentation of her statistics, her success rate, and leave for emotional discharge (listening to clients talk about their feelings, beliefs, experiences, and expectations about childbirth).At the end of the first session, the delivery of the pamphlet and the link of the messenger channel will be provided (channel content includes: showing cesarean section and natural childbirth animation (taken from the educational contents of the Ministry of Health and uploading the audio file of the interview with mothers who have had a successful back). 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 There is no further information</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>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>
      <contact>
        <type>scientific</type>
        <firstname>Roghayeh Pakdaman</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>No.40,Karimi 1,Sardaran st.17 Shahrivar North.</address>
        <city>Bojnourd</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>9415658969</zip>
        <telephone>+98 58 3226 2332</telephone>
        <email>pakdamanr971@ 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
The interval between pregnancy and previous delivery is greater than 6 months
Childbirth fear score less than 85 from Vijima questionnaire version A, which indicates no clinical fearand  Single-pregnancy
A live embryo and a cephalic display Amniotic fluid and placental placement are normal based on pregnancy ultra sonography in trimester 2
. The gestational age based on the LMP or the first trimester ultrasound is of 28-30 weeks
BMI 19/8-29/9
History of once prior cesarean section
Do not have a history of infertility
Do not have a history of mental  and medical illness
No complication of midwifery(Preeclampsia, diabetes, etc)
Not having a medical cause for cesarean section
No history of any surgery on the uterus other than a transverse incision below the previous cesarean section</inclusion_criteria>
      <agemin>no limit</agemin>
      <agemax>no limit</agemax>
      <gender>Female</gender>
      <exclusion_criteria>Not participating to attend at least one counseling session
Not participating to take the test after research
Indication of pregnancy termination before the end of the research period
Failure to receive channel content and pamphlets
Occurrence of medical disease and obstetric complication during research</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" Consulting package based on the supportive counseling approach includes: 1- Two individual supportive counseling sessions for each session of 45 minutes and in the middle of the week and in person and face to face 2- Pamphlet and link of the messenger channel.Content of counseling sessions based on supportive counseling steps includes the first session: explanation (right to choose the type of delivery, natural childbirth mechanism, recurrent cesarean complications), reassurance (benefits of natural childbirth for mother and baby, comparison of benefits and losses of natural childbirth after cesarean section, amount The success of natural childbirth after cesarean section), the content of the second session: guidance (methods of awakening in Libra, relaxation techniques in Liber, different positions in Libra and childbirth, mobile support, helping to remove barriers to selection from his point of view), encouragement (experience Her mothers have had a back-to-back presentation of her statistics, her success rate, and leave for emotional discharge (listening to clients talk about their feelings, beliefs, experiences, and expectations about childbirth).At the end of the first session, the delivery of the pamphlet and the link of the messenger channel will be provided (channel content includes: showing cesarean section and natural childbirth animation (taken from the educational contents of the Ministry of Health and uploading the audio file of the interview with mothers who have had a successful back)</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  Vaginal birth after cesarean. Timepoint: At the beginning of the study  and 4 week after the intervention. Method of measurement: Intent selection choose the type of delivery checklist.</prim_outcome>
      <prim_outcome>Decision self-efficacy. Timepoint: At the beginning of the study 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 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>2020-06-15</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>
