<?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>IRCT201705146582N26</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2017-07-24</date_registration>
      <primary_sponsor>Vice chancellor for Research, University Of Tabriz Medical Sciences</primary_sponsor>
      <public_title>The effect of counselling on pregnancy outcomes in pregnant teenage women</public_title>
      <acronym></acronym>
      <scientific_title>The effect of counselling on pregnancy outcomes in pregnant teenage women: a randomized controlled clinical trial</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2017-05-14</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>120</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/7044</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Prevention.</study_design>
      <phase>2-3</phase>
      <hc_freetext>Condition 1: Complications of pregnancy. Condition 2: Teenage pregnancy.</hc_freetext>
      <i_freetext>Intervention 1: control group: Routine prenatal cares for pregnant women. Intervention 2: Intervention group: 5 sessions of group counselling will be conducted for 60 minutes in a room with comfortable and relaxing environment by the researcher. The minimum number of participants in each session will be 5 and the maximum will be 9 while the applied language for counselling will be in native. At the end of each session, individual counselling will be held for research participants upon their request. A contact number will be given to research participants in case they have any questions. The counselling content include training and consulting teenager's pregnancy symptoms, complications and introducing methods of prevention. After group introduction in the first session, participants are informed of the time and number of counselling sessions; they are further informed about pregnancy and its effective associative factors. In the second session, Participants are further counselled about the physiologic and hormonal changes during pregnancy, vaccination, and proper breathing techniques. Additional training and counselling regarding nutrition, personal hygiene, oral hygiene (mouth and dental cleanness) and pregnancy exercises along with proper breathing training will be given to them in the third session. In the fourth session, Participants are informed of the risks and complications involving teenage pregnancy (e.g. preterm labor, low birth weight, IUGR, etc), breastfeeding counselling as well as proper breathing techniques during labor, whereas in the fifth session, participants get familiar with symptoms of labor pain and its associated risks, childbirth type and family planning. Eventually in the final stage, private counselling sessions will be held for pregnant teenagers in the presence of their husbands which is based on their questions and problems. &#13;
Control group: The control group will receive the routine prenatal cares.</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></results_IPD_plan>
      <results_IPD_description></results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Mahin Kamalifard</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Nursing &amp; Midwifery Faculty, Shariaty st.</address>
        <city>Tabriz</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>5138947977</zip>
        <telephone>+98 41 3479 6770</telephone>
        <email>kamalifardm@tbzmed.ac.ir</email>
        <affiliation>Master Of Sciences Of Midwifery</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Mahin Kamalifard</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Nursing &amp; Midwifery Faculty, Shariaty st.</address>
        <city>Tabriz</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>5138947977</zip>
        <telephone>+98 41 3479 6770</telephone>
        <email>kamalifardm@tbzmed.ac.ir</email>
        <affiliation>Nursing &amp; Midwifery, Tabriz University Of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>The inclusion criteria include 11 to 19-year-old pregnant women; with 20-24 weeks of gestational age; having their first, second, and third pregnancy; with contact numbers for future follow-up who have participated in at least 2 sessions of the total counselling sessions; have scored below 12 according to Edinburg's Depression Scale prior to intervention; and have shown willingness to give birth in Tamin Ejtemaie and Alavi hospitals of Ardebil. &#13;
Exclusion criteria: Having any physical illnesses (e.g. epilepsy, heart disease, etc.); showing signs of mental illnesses according to patients; having history of hospitalization due to side effects from current pregnancy ( e.g. placental abruption; hemorrhage; preeclampsia; etc.); having history of preterm delivery and the presence of other risking factors associated to preterm delivery; diagnosis of fetal abnormalities; and previous participation in physiologic childbirth classes are among the exclusion criteria.</inclusion_criteria>
      <agemin>11 years</agemin>
      <agemax>19 years</agemax>
      <gender>Female</gender>
      <exclusion_criteria></exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>(P01.-)</hc_code>
      <hc_code>P00.4</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Maternal complications of pregnancy</hc_keyword>
      <hc_keyword>Fetus and newborn affected by maternal nutritional disorders</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Other</i_code>
      <i_code>Other</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>control group: Routine prenatal cares for pregnant women</i_keyword>
      <i_keyword>Intervention group: 5 sessions of group counselling will be conducted for 60 minutes in a room with comfortable and relaxing environment by the researcher. The minimum number of participants in each session will be 5 and the maximum will be 9 while the applied language for counselling will be in native. At the end of each session, individual counselling will be held for research participants upon their request. A contact number will be given to research participants in case they have any questions. The counselling content include training and consulting teenager's pregnancy symptoms, complications and introducing methods of prevention. After group introduction in the first session, participants are informed of the time and number of counselling sessions; they are further informed about pregnancy and its effective associative factors. In the second session, Participants are further counselled about the physiologic and hormonal changes during pregnancy, vaccination, and proper breathing techniques. Additional training and counselling regarding nutrition, personal hygiene, oral hygiene (mouth and dental cleanness) and pregnancy exercises along with proper breathing training will be given to them in the third session. In the fourth session, Participants are informed of the risks and complications involving teenage pregnancy (e.g. preterm labor, low birth weight, IUGR, etc), breastfeeding counselling as well as proper breathing techniques during labor, whereas in the fifth session, participants get familiar with symptoms of labor pain and its associated risks, childbirth type and family planning. Eventually in the final stage, private counselling sessions will be held for pregnant teenagers in the presence of their husbands which is based on their questions and problems. &#13;
Control group: The control group will receive the routine prenatal cares.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Delivery Characteristics (duration of active phase and second stage of labor). Timepoint: During labor. Method of measurement: Using partograph and mother's admission forms.</prim_outcome>
      <prim_outcome>Pain score. Timepoint: In 6-8 centimeters dilations. Method of measurement: Using VAS tools.</prim_outcome>
      <prim_outcome>Receiving Oxytocin during labor. Timepoint: During labor. Method of measurement: Observation and assessment of mother' obstetrical chart.</prim_outcome>
      <prim_outcome>Hematocrit and Hemoglobin. Timepoint: Pregnancy at early stage and during labor. Method of measurement: Cell catheter device.</prim_outcome>
      <prim_outcome>Maternal weight gain during pregnancy. Timepoint: Pregnancy at early stage and during labor. Method of measurement: Adult weighing scale.</prim_outcome>
      <prim_outcome>The frequency of preterm delivery. Timepoint: During labor / At the time of delivery. Method of measurement: Observation and assessment of mother' obstetrical chart.</prim_outcome>
      <prim_outcome>Number of prenatal visits. Timepoint: End of pregnancy. Method of measurement: Assessment the mothers health chart.</prim_outcome>
      <prim_outcome>The frequency of caesarean delivery /C-section. Timepoint: During labor / At the time of delivery. Method of measurement: Observation and assessment of mother' obstetrical chart.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>First and fifth minute Apgar score. Timepoint: Immediately and 5 minuets after birth. Method of measurement: Apgar score.</sec_outcome>
      <sec_outcome>Anthropometric indicators. Timepoint: Immediately after birth. Method of measurement: Baby weighing scales, Fabric tape measure.</sec_outcome>
      <sec_outcome>Postpartum Depression. Timepoint: Prior to and at the end of intervention. Method of measurement: Filling out depression questionnaire before and after intervention.</sec_outcome>
      <sec_outcome>Breastfeeding. Timepoint: At the end of intervention. Method of measurement: Interview.</sec_outcome>
      <sec_outcome>Family planning. Timepoint: At the end of intervention. Method of measurement: Interview.</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>Vice chancellor for Research, University Of Tabriz Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2017-05-16</approval_date>
        <contact_name>Ethics committee of Tabriz University of Medical Sciences</contact_name>
        <contact_address>Nursing and Midwifery Faculty, Shariaty street Tabriz  Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
