<?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>IRCT20180623040197N2</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2019-02-11</date_registration>
      <primary_sponsor>Qazvin University of Medical Sciences</primary_sponsor>
      <public_title>Comparative evaluation of the effect of Iyengar and Hata Yoga on the outcomes of labor in pregnant women</public_title>
      <acronym></acronym>
      <scientific_title>Comparative evaluation of the effect of Iyengar and Hata Yoga on the outcomes of labor in pregnant women</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2019-05-20</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>72</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/35231</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Education/Guidance, Randomization description: Researcher After initiating the sampling and obtaining a written consent from eligible pregnant mothers (in terms of entry criteria), 72 pregnant women will first be selected in an accessible manner, then they will be selected by random allocation method without placement of individuals. Each pregnant mother who qualifies for study will be placed in a triangular ball of blue (Hatha Yoga) of 24, a red ball (Yoga practitioner) of 24, a green ball (control) of 24, and a pregnant mother of an orb On the basis of that orb, the orb enters the hatta yoga group or the yoga or control group.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Condition 1: Preeclampsia. Condition 2: Preterm labor.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group 1:  Hata YogaFrom 28 to 32 weeks of gestation, two weekly sessions take part in yoga sessions. Intervention 2: Intervention group 2: yoga iyengarFrom 28 to 32 weeks of gestation, two weekly sessions take part in yoga sessions. Intervention 3: Control group: Pregnant mother does not receive any intervention.</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 the impact of yoga on the consequences of childbirth

When:
6 months after printing results

To whom:
Ghazvin University of Medical Sciences
Health Centers
Yoga Pregnancy Centers

Conditions:
Through the authoritative university website

Where to obtain:
Ghazvin, Qazvin University of Medical Sciences, Faculty of Nursing and Midwifery

How to obtain:
Send message to authors email

Comments:
</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>leili yekefallah</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Qazvin university of medical science, Bahonar, Qazvin</address>
        <city>Qazvin</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>34411743148</zip>
        <telephone>+98 28 3333 6001</telephone>
        <email>yekefallah@qums.ac.ir</email>
        <affiliation>Qazvin University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Leili Yekefallah</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Qazvin University of Medical Sciences, Bahonar, Qazvin</address>
        <city>Qazvin</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>3441341184</zip>
        <telephone>+98 0283338034</telephone>
        <email>yekefallah@qums.ac.ir</email>
        <affiliation>Qazvin University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Having informed consent to participate in the study
The age group 18 to 35 years
Having normal pregnancy according to the written diagnosis of gynecologist
First and single-crocheted pregnancy
Ability to read and write
Having a normal body mass index (between 8/19 and 26)
Pregnancy age 26-28 weeks</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>35 years</agemax>
      <gender>Female</gender>
      <exclusion_criteria>Having experience in yoga classes or regular exercise (Pilates, Tai Chi)
Having an abnormal fetus or IUGR.
Choosing the method of elective cesarean delivery.</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>O15.1</hc_code>
      <hc_code>O42.10</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Eclampsia in labor</hc_keyword>
      <hc_keyword>Premature rupture of membranes, onset of labor more than 24 hours following rupture, unspecified weeks of gestation</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Prevention</i_code>
      <i_code>Prevention</i_code>
      <i_code>N/A</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group 1:  Hata YogaFrom 28 to 32 weeks of gestation, two weekly sessions take part in yoga sessions.</i_keyword>
      <i_keyword>Intervention group 2: yoga iyengarFrom 28 to 32 weeks of gestation, two weekly sessions take part in yoga sessions.</i_keyword>
      <i_keyword>Control group: Pregnant mother does not receive any intervention</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Type of delivery. Timepoint: in the beginning of the study (before the intervention) and 2 weeks after completion of the delivery. Method of measurement: Outcome of delivery Questionnaire.</prim_outcome>
      <prim_outcome>Anesthesia. Timepoint: in the beginning of the study (before the intervention) and 2 weeks after completion of the delivery. Method of measurement: Outcome of delivery Questionnaire.</prim_outcome>
      <prim_outcome>Occurrence Premature rupture of the water bag. Timepoint: in the beginning of the study (before the intervention) and 2 weeks after completion of the delivery. Method of measurement: Outcome of delivery Questionnaire.</prim_outcome>
      <prim_outcome>Occurrence and  Episiotomy degree. Timepoint: in the beginning of the study (before the intervention) and 2 weeks after completion of the delivery. Method of measurement: Outcome of delivery Questionnaire.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Preterm delivery. Timepoint: in the beginning of the study (before the intervention) and 2 weeks after completion of the delivery. Method of measurement: Outcome of delivery Questionnaire.</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>Qazvin University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2018-11-10</approval_date>
        <contact_name>Ethics committee of Qazvin university of medical science</contact_name>
        <contact_address>Qazvin University of Medical Sciences, Shahid Bahonar Blvd. Qazvin Qazvin Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
