<?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>IRCT20190410043227N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2019-08-24</date_registration>
      <primary_sponsor>Shiraz University of Medical Sciences</primary_sponsor>
      <public_title>Comparison of effect of isometric exercises and pelvic tilt on the lumbar and pelvic pain  in  primary gravida women</public_title>
      <acronym></acronym>
      <scientific_title>Comparison of effect of isometric exercises and pelvic tilt on the lumbar and pelvic pain  in secondary trimester in primary gravida women</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2019-08-09</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>120</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/38956</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Permuted block randomization with a block size of 3 is used. Different permutations with the following sequence assigned to 1-6 include A=STUDY1, B=STUDY2, C=CONTROL, 1.ABC, 2.ACB, 3.BAC, 4.BCA, 5.CAB and 6.CBA. The numbers are now extracted from a table of random numbers in a way that 55 blocks of size 3 are selected one at a time and depending on the corresponding randomly-selected number between 1 and 6. Zero, seven, eight and nine are ignored if selected, and the procedure continues until the list is completed for the whole sample.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Condition 1: Back pain. Condition 2: Pelvic pain.</hc_freetext>
      <i_freetext>Intervention 1: In the first group, isometric exercises are performed in the supine position. Over the course of eight weeks, is done five times a week. It is done five times per week and it involves the isometric contraction of the abdominal transverse muscles, the gluteal and the bottom of the pelvis, that each contraction is kept 5 seconds and 5 seconds rest with iteration 10 times. Intervention 2: In the second group, the tilt exercise is performed in the supine position with the bent over of the knees and hip on the ground. While the legs extend outwards and stomach muscles and lower pelvis and buttock are contract, they lift the joint from the ground. With a deep breath, they hold the position for five seconds and then released. Then they place their buttock on the ground and relax their musceles for 5 seconds. The exercises are performed within five days of the week for eight weeks with a repeat of 2 times a day. Intervention 3: In the control group, only routine pregnancy cares is done and Do not see any training.</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>Undecided - It is not yet known if there will be a plan to make this available</results_IPD_plan>
      <results_IPD_description>Justification or reason for indecision in sharing IPD is No More Info</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Sara Jomhouri Angali</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Faculty of nursing and midwifery, Namazi Square, Zand Ave.,</address>
        <city>Shiraz</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>7193613119</zip>
        <telephone>+98 71 3647 4254</telephone>
        <email>s.jomhouri@gmail.com</email>
        <affiliation>Shiraz University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Sara Jomhouri Angali</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Faculty of nursing and midwifery, Namazi Square, Zand Ave.,</address>
        <city>Shiraz</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>7193613119</zip>
        <telephone>+98 71 3647 4254</telephone>
        <email>s.jomhouri@gmail.com</email>
        <affiliation>Shiraz University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Primary gravida women
Age 18-35
16-28 weeks of pregnancy
Visual Analog Scale(VAS) score of 20mm-70mm
Normal Body Mass Index(BMI)
Not having a history of back pain before pregnancy
Not having a practice ban during pregnancy
Having reading and writing skills
Satisfaction and willingness to participate in the study</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>35 years</agemax>
      <gender>Female</gender>
      <exclusion_criteria></exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>M54.5</hc_code>
      <hc_code>R10.3</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>low back pain</hc_keyword>
      <hc_keyword>Pain localized to other parts of lower abdomen</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Treatment - Other</i_code>
      <i_code>Treatment - Other</i_code>
      <i_code>N/A</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>In the first group, isometric exercises are performed in the supine position. Over the course of eight weeks, is done five times a week. It is done five times per week and it involves the isometric contraction of the abdominal transverse muscles, the gluteal and the bottom of the pelvis, that each contraction is kept 5 seconds and 5 seconds rest with iteration 10 times.</i_keyword>
      <i_keyword>In the second group, the tilt exercise is performed in the supine position with the bent over of the knees and hip on the ground. While the legs extend outwards and stomach muscles and lower pelvis and buttock are contract, they lift the joint from the ground. With a deep breath, they hold the position for five seconds and then released. Then they place their buttock on the ground and relax their musceles for 5 seconds. The exercises are performed within five days of the week for eight weeks with a repeat of 2 times a day.</i_keyword>
      <i_keyword>In the control group, only routine pregnancy cares is done and Do not see any training.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Visual Analogue Scale score of back pain. Timepoint: Before intervention, 4 &amp; 8 weeks later. Method of measurement: Visual Analogue Scale questionnaire.</prim_outcome>
      <prim_outcome>Pelvic pain severity. Timepoint: Before intervention, 4 &amp; 8 weeks later. Method of measurement: Active Straight Leg Raise(ASLR) test.</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>Shiraz University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2019-03-05</approval_date>
        <contact_name>Ethics committee of Shiraz University of Medical Sciences</contact_name>
        <contact_address>Central building of Shiraz University of Medical Sciences, Zand Ave., Shiraz Fars Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
