<?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>IRCT20160208026446N3</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2018-06-03</date_registration>
      <primary_sponsor>Babol University of Medical Sciences</primary_sponsor>
      <public_title>The impact of Myo-inositol supplementation with sleep hygiene education on sleep quality in pregnant women</public_title>
      <acronym></acronym>
      <scientific_title>The impact of Myo-inositol supplementation with sleep hygiene education on sleep quality in pregnant women</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2018-04-07</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>60</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/31296</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Prevention, Randomization description: Blocked randomization with a block size of 4, for two groups (A, B). Random numbers (0 - 6) was generated using computer software, Blinding description: Blind groups include: participant, clinical caregiver, researcher, outcome evaluator, data analyst. Double blind study.
 Medications and placebo are coded by someone other than the investigator as group (1 and 2) and the investigator do not know which group is related to the drug.
The subjects are satisfied and informed that they may be Instead of medication, placebo is given to them. The distribution method With a block size of 4, for two groups (A, B). Random numbers (0 - 6) was generated using computer software.</study_design>
      <phase>3</phase>
      <hc_freetext>Sleep quality in pregnancy.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: myoinositol supplementation powder the ino folic commercial name containing 2000 mg of myoinositol and 200 μg of folic acid (manufactured by the company Lo.Li Pharma ) once a day (one sachet per night in a glass of water is dissolved) from gestational age 14 to 24 weeks). Intervention 2: Control group: placebo (folic acid powder 400 mcg + wheat flour total 2 grams) Once a day (one hour a sachet is dissolved in a glass of water) from the gestational age 14 weeks to 24 weeks for a total of 10 weeks .</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 There is no further information</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Molood Aghajani Delavar</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Babol University of Medical Sciences, Ganjafroz Avenue, Babol, Mazandaran, Iran</address>
        <city>Babol</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>47176-47745</zip>
        <telephone>+98 11 3236 0714</telephone>
        <email>moloodaghajani@yahoo.com</email>
        <affiliation>Babol University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Molood Aghajani Delavar</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Babol University of Medical Sciences, Ganjafroz Avenue, Babol, Mazandaran, Iran</address>
        <city>Babol</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>47176-47745</zip>
        <telephone>+98 11 3236 0714</telephone>
        <email>moloodaghajani@yahoo.com</email>
        <affiliation>Babol University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Conscious written consent
Pregnant women with singletone pregnancy
Age 18 and over
Gestational age of 14 weeks
Absence of chronic physical diseases such as diabetes, high blood pressure and cardiovascular disease
No history of taking prenatal drugs before pregnancy
No history of sleep disorders before pregnancy
Working women without night shift work
Non-smoking and alcohol
Lack of history of psychiatric use
No history of abortion in previous pregnancies</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>45 years</agemax>
      <gender>Female</gender>
      <exclusion_criteria>Severe depression or severe stress
Death experience of one of the first-degree relatives during pregnancy
Changes in sleep status due to travel</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>G47</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Sleep disorders</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Prevention</i_code>
      <i_code>Placebo</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group: myoinositol supplementation powder the ino folic commercial name containing 2000 mg of myoinositol and 200 μg of folic acid (manufactured by the company Lo.Li Pharma ) once a day (one sachet per night in a glass of water is dissolved) from gestational age 14 to 24 weeks)</i_keyword>
      <i_keyword>Control group: placebo (folic acid powder 400 mcg + wheat flour total 2 grams) Once a day (one hour a sachet is dissolved in a glass of water) from the gestational age 14 weeks to 24 weeks for a total of 10 weeks .</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Sleep Quality Score in Pittsburgh Sleep Quality Questionnaire. Timepoint: In the second trimester of pregnancy at weeks 24 to 28 and in the third trimester of pregnancy at weeks 37 to 38 of pregnancy. Method of measurement: Pittsburgh Sleep Quality Index Questionnaire.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Neonatal and pregnancy outcomes. Timepoint: The end of pregnancy for the outcome of pregnancy and infancy Method of measurement. Method of measurement: Questionnaire and complete the checklist using file.</sec_outcome>
      <sec_outcome>Side effect of drug. Timepoint: In the second trimester of pregnancy (week 24-28) and the third trimester of pregnancy (week 37_38). Method of measurement: Drug side effect checklist.</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>Babol University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2018-05-19</approval_date>
        <contact_name>Ethic Commitee of Babol University of Medical Sciences</contact_name>
        <contact_address>Babol University of Medical Sciences, Ganjafroz Avenue, Babol, Mazandaran, Iran Mazandaran Mazandaran Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
