<?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>IRCT20200519047509N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2020-11-13</date_registration>
      <primary_sponsor>Oroumia University of Medical Sciences</primary_sponsor>
      <public_title>The effect of educational intervention based on the Theory of Planned Behavior on the intention and Behavior of vaginal birth after Previous  cesarean  among pregnant women.</public_title>
      <acronym></acronym>
      <scientific_title>The effect of educational intervention based on the Theory of Planned Behavior on the intention and Behavior of vaginal birth after Previous  cesarean  among pregnant women referred to health centers in Ardabil.</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2020-07-22</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>70</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/48456</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Education/Guidance, Randomization description: In this way, the numbers 1 to 70 are written on separate papers and poured into a bowl. And participants selects one of these papers from inside the bowl. Even numbers will be entered into the control group and odd numbers will be 
assigned to the intervention group.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Vaginal delivery after a history of cesarean section.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: for the intervention group, face-to-face training will be arranged in 4 training sessions, which are held once a week. Training classes will be held in groups of 7 to 10 people so that group discussions are possible. The educational content of all groups will be the same and will be adjusted based on the needs assessment of the analysis of pre-test results. The educational content will be based on the structures of the theory of planned behavior. The time of face-to-face training will be 90 minutes. It will include topics related to the advantages and disadvantages of each of the cesarean delivery methods and VBAC, etc. Also, educational pictures and videos related to the delivery process will be used for training. In the last session of the educational intervention, the post-test questionnaire was completed in both intervention and control groups, and also a month later, it will be completed again in both groups. To measure the change in behavior, telephone follow-up of the type of delivery after delivery will be done in both groups. Intervention 2: Control group: this group receives prenatal routine trainings. In addition, in order to observe research ethics, at the end of the intervention, a training session is held to observe research ethics and a pamphlet containing educational content is delivered to this group. Corona hygiene will be observed.</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>Yes - There is a plan to make this available</results_IPD_plan>
      <results_IPD_description>What will be shared:
After identifying the completed questionnaires before and after the intervention, the target group will be provided to the ethics committee and will be kept in a safe place for a limited time....

When:
5 years

To whom:
Research team and esteemed members of the University Ethics Committee

Conditions:
Only for members of the research team and inspectors of the ethics committee for verification

Where to obtain:
Tamara Dargahi

How to obtain:
Contact and coordinate with all members of the research team

Comments:
</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Tamara Dargahi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Faculty of Nursing and Midwifery, 11 km of Serro Campus Road, Nazloo</address>
        <city>Urmia</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>5756115111</zip>
        <telephone>+98 45 3372 7064</telephone>
        <email>Khiavi.t.research@gmail.com</email>
        <affiliation>Oroumia University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Dr Roghayyeh Bayrami</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>School of Nursing and Midwifery ,11 km of sero  Pardis Nazloo Road,</address>
        <city>Urmia</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>5756115111</zip>
        <telephone>+98 44 3275 4921</telephone>
        <email>Rozabayrami@yahoo.com</email>
        <affiliation>Oroumia University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Reading and writing Persian literacy
Age range 18 to 35 years
Single pregnancy
Pregnancy 26 to 34 weeks
Lack of medical indications for cesarean section
Lack of mental illness
No vertical incisions in the abdomen
If the cause of previous cesarean section is not present in this pregnancy
Having consent to participate in research</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>35 years</agemax>
      <gender>Female</gender>
      <exclusion_criteria>Any disease added to the pregnancy that makes cesarean section unavoidable for the mother
Suffering from any complications during pregnancy such as high blood pressure during pregnancy, decolman, fetal death, premature rupture of membrane, preterm delivery
Failure to attend more than one training session</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: for the intervention group, face-to-face training will be arranged in 4 training sessions, which are held once a week. Training classes will be held in groups of 7 to 10 people so that group discussions are possible. The educational content of all groups will be the same and will be adjusted based on the needs assessment of the analysis of pre-test results. The educational content will be based on the structures of the theory of planned behavior. The time of face-to-face training will be 90 minutes. It will include topics related to the advantages and disadvantages of each of the cesarean delivery methods and VBAC, etc. Also, educational pictures and videos related to the delivery process will be used for training. In the last session of the educational intervention, the post-test questionnaire was completed in both intervention and control groups, and also a month later, it will be completed again in both groups. To measure the change in behavior, telephone follow-up of the type of delivery after delivery will be done in both groups.</i_keyword>
      <i_keyword>Control group: this group receives prenatal routine trainings. In addition, in order to observe research ethics, at the end of the intervention, a training session is held to observe research ethics and a pamphlet containing educational content is delivered to this group. Corona hygiene will be observed.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Intention to have a normal delivery. Timepoint: At the beginning of the study (before the intervention), the last session of the intervention and one month after the intervention. Method of measurement: Researcher-made validity and reliability questionnaire.</prim_outcome>
      <prim_outcome>Behavior of normal delivery after a history of cesarean section. Timepoint: At the beginning of the study (before the intervention), the last session of the intervention and one month after the intervention. Method of measurement: Researcher-made validity and reliability 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>Urmia University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2020-05-13</approval_date>
        <contact_name>Ethics Committee of Urmia University of Medical Sciences</contact_name>
        <contact_address>Emergency Alley, Resalat Blvd., Urmia Urmia West Azarbaijan Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
