<?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>IRCT20230816059157N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2023-08-28</date_registration>
      <primary_sponsor>Shahroud University of Medical Sciences</primary_sponsor>
      <public_title>Investigating the effect of education and support on improving the reproductive health of pregnant adolescents</public_title>
      <acronym></acronym>
      <scientific_title>InvestigatingThe effect of educational and Supportive intervention on health performance and general self-efficacy of pregnant adolescents</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2023-08-23</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>136</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/72056</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Education/Guidance, Randomization description: Permutation block randomization method with blocks of four has been used. We assigned different permutations to numbers 1 to 6 in the following order.
1. AABB
2. ABAB
3. ABBA
4. BBAA
5. BABA
6. BAAB

Now, using the table of random numbers, we extracted the numbers from the table, and depending on whether one of the numbers 1 to 6 came, each of the blocks assigned to these numbers was selected until 36 blocks of 4 were selected. If the numbers 0, 7, 8, and 9 came up, we ignored them and continued this order to provide a complete list for the entire sample size.</study_design>
      <phase>N/A</phase>
      <hc_freetext>-.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: Educational class for pregnant teenagers with companions. The course will be held during 6 sessions of 60-90 minutes by the researcher in the conference hall of Vali Asr Hospital from the 25th week of pregnancy. Session intervals will be one week. The content of the class includes information about pregnancy and childbirth, pregnancy care, the effect of adequate sleep and rest, appropriate physical activity, proper diet, correct health practices, signs and symptoms of pregnancy, and teaching self-care behaviors and Self-efficacy to control distressing symptoms. The material said in the class will be repeated in the virtual network where the pregnant lady and her companion are members. Intervention 2: Control group: The control group will receive routine prenatal care.</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:
Information on primary and secondary outcomes can be shared

When:
The access period starts 6 months after the results are published

To whom:
For researchers working in academic and scientific institutions and people participating in research

Conditions:
Improving services to promote reproductive health in pregnant teenagers

Where to obtain:
Mrs. Dr. Shahrabanoo Salehin
09126311433
Shahroud - Haft Tir Square - Shahroud University of Medical Sciences
Postal code: 36147-73943
drbsalehin@gmail.com

Firoozeh Nourimand
09357149135
Fasa-Kanarestan Boulevard, 20 Alley, No. 32
Postal code: 7461858461
firozeh.nourimand@gmail.com

How to obtain:
Six months after the completion of the plan, we will be responsive to the mentioned people by calling, emailing, or texting, and the necessary documents will be sent to them via email within seven working days.

Comments:
</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Firoozeh Nourimand</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Fasa city, Kanarestan Blvd., No. 32, 20 Alley</address>
        <city>Fasa</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>7461858461</zip>
        <telephone>+98 71 5333 6950</telephone>
        <email>firozeh.nourimand@gmail.com</email>
        <affiliation>Shahroud University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Shahrabanoo Salehin</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Shahroud, 7 Tir Square - Shahroud University of Medical Sciences and Health Care Services</address>
        <city>Shahroud</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>۳۶۱۴۷-۷۳۹۴۳</zip>
        <telephone>+98 23 3239 5054</telephone>
        <email>drbsalehin@gmail.com</email>
        <affiliation>Shahroud University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Adolescents 10-19 years old
Married
Pregnant
Primigravida
18-24 weeks of pregnancy
Having a health file in the health centers of Fasa and its suburbs
Having the ability to speak and understand  Persian language
Informed consent to participate in research
Willingness to participate in classes with accompanying attendance</inclusion_criteria>
      <agemin>10 years</agemin>
      <agemax>19 years</agemax>
      <gender>Female</gender>
      <exclusion_criteria>Having a high-risk pregnancy, including diabetes, high blood pressure, and chronic diseases affecting pregnancy such as cardiovascular disease, lung disease, etc., and History or current mental problems
Experiencing a catastrophic life event in the past three months
Having physical movement restrictions (heart disease, lung disease, incompetent cervix, high-risk multiple pregnancies, continuous bleeding, Placenta Previa after 26 weeks, Gestational blood pressure)
Addiction to any kind of drugs, tobacco
Receiving special medicine due to a physical or psychological problem</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>N/A</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group: Educational class for pregnant teenagers with companions. The course will be held during 6 sessions of 60-90 minutes by the researcher in the conference hall of Vali Asr Hospital from the 25th week of pregnancy. Session intervals will be one week. The content of the class includes information about pregnancy and childbirth, pregnancy care, the effect of adequate sleep and rest, appropriate physical activity, proper diet, correct health practices, signs and symptoms of pregnancy, and teaching self-care behaviors and Self-efficacy to control distressing symptoms. The material said in the class will be repeated in the virtual network where the pregnant lady and her companion are members.</i_keyword>
      <i_keyword>Control group: The control group will receive routine prenatal care</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Health Performance and General Self-efficacy. Timepoint: Before the intervention - immediately after the end of the intervention - one month after the intervention. Method of measurement: Health practices questionnaire/ General Self-Eﬃcacy Scale (Sherer et al).</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Maternal and newborn outcomes such as high-risk pregnancy, birth weight of the baby, condition of the baby, type of delivery. Timepoint: immediately after child birth. Method of measurement: High-risk pregnancy (with/without),  birth weight (Kg),  condition of baby(hospitalization/Rooming in), type of delivery (NVD/cesarean section).</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>Shahroud University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2022-07-30</approval_date>
        <contact_name>Ethics Committee of Shahroud University of Medical Sciences</contact_name>
        <contact_address>Shahroud, 7 Tir Square - Shahroud University of Medical Sciences and Health Care Services Shahroud Semnan Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
