<?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>IRCT201110052248N7</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2013-01-25</date_registration>
      <primary_sponsor>Research Deputy of Tehran University of Medical Sciences</primary_sponsor>
      <public_title>The Effect of a prenatal yoga programme in the second and third trimester of pregnancy on the Anxiety and pregnancy outcomes at primiparouse women</public_title>
      <acronym>yoga and pregnancy</acronym>
      <scientific_title>The Effect of a prenatal yoga programme in the second and third trimester of pregnancy on the Anxiety and pregnancy outcomes at primiparouse women</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2012-01-21</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>60</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/1882</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Prevention.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Pregnancy.</hc_freetext>
      <i_freetext>Intervention 1: Subjects in the control group will be received routine nursing care from hospital staff nursing, yoga practice will be not provided to the control group. All the variables will be assessed in the control group. Intervention 2: Subjects in the experimental group will be started yoga programme at the 26 week of gestation. The women will be received a booklet (pamphlets) and tape cassette (CD), for self study, that will explains the principles and benefits of each yoga practice. All will be asked to practice at home three times a week by the end of 37 weeks. Maternal anxiety will be evaluated in 26th  and the end of 37th   week of gestation. Maternal satisfaction of yoga programme will evaluated by self-made questionnaire in the end of 37 week of gestation. The first measurement of pain intensity in labour will taken when cervical dilatation will be 3-4 cm. the second and the third measurement will be evaluated when 2 hours after the first assessment and 2 hours after the second assessment cervical dilatation, respectively. Length of labor will be recorded by using the standard clock. Apgar scores and newborn’s weight will be recorded in demographic questionnaire.</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>fereshteh jahdi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Tehran - Tohid Square - Nusrat East -Nursing And Midwifery Faculty - University of Medical Sciences Tehran</address>
        <city>tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip></zip>
        <telephone>+216 6921185</telephone>
        <email>jahdi_fr@yahoo.com</email>
        <affiliation>Nursing And Midwifery Faculty - University of Medical Sciences Tehran</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>fereshteh jahdi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Tehran - Tohid Square - Nusrat East - Nursing And Midwifery Faculty - University of Medical Sciences Tehran</address>
        <city>tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip></zip>
        <telephone>+216 6937120</telephone>
        <email>jahdi_fr@yahoo.com</email>
        <affiliation>Nursing And Midwifery Faculty - University of Medical Sciences Tehran</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Not having recognized physically diseases such as heart disease, respiratory, kidney and maternal mental illness -There are not complications pregnancy such as  placenta previa,Placental abruption, increased or decreased blood pressure,Increased and decreased abnormal volume of amniotic fluid , Display abnormal fetuses confirmed by sonography-Elimination of obese women and skinny BMI according to (less than19/8 and more than 26) - non-elective cesarean section -  Not having of experience of doing yoga- there are no obvious abnormalities or fetal growth retardation in the fetus confirmed by ultrasound</inclusion_criteria>
      <agemin>no limit</agemin>
      <agemax>no limit</agemax>
      <gender>Female</gender>
      <exclusion_criteria></exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>O00-O99</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>pregnancy, childbirth and the puerperium</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Other</i_code>
      <i_code>Other</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Subjects in the control group will be received routine nursing care from hospital staff nursing, yoga practice will be not provided to the control group. All the variables will be assessed in the control group.</i_keyword>
      <i_keyword>Subjects in the experimental group will be started yoga programme at the 26 week of gestation. The women will be received a booklet (pamphlets) and tape cassette (CD), for self study, that will explains the principles and benefits of each yoga practice. All will be asked to practice at home three times a week by the end of 37 weeks. Maternal anxiety will be evaluated in 26th  and the end of 37th   week of gestation. Maternal satisfaction of yoga programme will evaluated by self-made questionnaire in the end of 37 week of gestation. The first measurement of pain intensity in labour will taken when cervical dilatation will be 3-4 cm. the second and the third measurement will be evaluated when 2 hours after the first assessment and 2 hours after the second assessment cervical dilatation, respectively. Length of labor will be recorded by using the standard clock. Apgar scores and newborn’s weight will be recorded in demographic questionnaire.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Level of anxiety. Timepoint: Week 26, end of  37 weeks. Method of measurement: Beck Anxiety Questionnaire.</prim_outcome>
      <prim_outcome>Pain intensity. Timepoint: Labor time. Method of measurement: Visual pain ruler.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Newborn’s weight. Timepoint: Time of Birth. Method of measurement: Gram.</sec_outcome>
      <sec_outcome>Delivery type. Timepoint: Delivery time. Method of measurement: Natural - Cesarean section - Delivery of Tools.</sec_outcome>
      <sec_outcome>The first and fifth minute Apgar score. Timepoint: After delivery. Method of measurement: Number.</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>Research Deputy of Tehran University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2011-04-17</approval_date>
        <contact_name>Tehran University of Medical Sciences</contact_name>
        <contact_address>Tehran - Keshavarz Blvd - Central Headquarters Building - Tehran University of Medical Sciences tehran  Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
