<?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>IRCT201507073706N26</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2016-02-03</date_registration>
      <primary_sponsor>Vice chancellor for research, Tabriz University of Medical Sciences</primary_sponsor>
      <public_title>The effect of saffron syrup on the labor pain intensity, anxiety and duration of labor</public_title>
      <acronym></acronym>
      <scientific_title>The effect of saffron syrup on the labor pain intensity, anxiety and duration of labor in primiparous women: a randomized controlled trial</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2016-02-01</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>96</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/3816</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment.</study_design>
      <phase>3</phase>
      <hc_freetext>Normal labor and delivery.</hc_freetext>
      <i_freetext>Intervention 1: The first intervention group: 80 to 240 ml syrup (made by Yashil drug company, Aras)containing 750 mg saffron and 200 mg of  sugar palms in 240 ml syrup. 80 ml of the syrup will be taken when cervical dilation is around 3 to 4 cm and there are at least 3 uterine contractions in 10 minutes lasting for 45 to 60 seconds. It will be repeated every two hours for maximum three doses considering pain intensity, uterine contraction, and pattern of fetal heart rate. Intervention 2: The second intervention group: 80 to 240 ml syrup (made by Yashil drug company, Aras) containing 750 mg saffron and artificial sugar (Isonalt) in 240 ml syrup. 80 ml of the syrup will be taken when cervical dilation is around 3 to 4 cm and there are at least 3 uterine contractions in 10 minutes lasting for 45 to 60 seconds. It will be repeated every two hours for maximum three doses considering pain intensity, uterine contraction, and pattern of fetal heart rate. Intervention 3: Control group: 80 to 240 ml syrup (made by Yashil drug company, Aras) containing placebo of saffron and artificial sugar (Isonalt) in 240 ml syrup (identical in color, smell and taste with the saffron syrups. 80 ml of the syrup will be taken when cervical dilation is around 3 to 4 cm and there are at least 3 uterine contractions in 10 minutes lasting for 45 to 60 seconds. It will be repeated every two hours for maximum three doses considering pain intensity, uterine contraction, and pattern of fetal heart.</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>Roghayeh mohammadie rad</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Faculty of Nursing &amp; Midwifery, South Shariatie Ave., Tabriz, Postal code: 5138947977</address>
        <city>Tabriz</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip></zip>
        <telephone>+98 41 3479 6969</telephone>
        <email>rmradobs@gmail.com</email>
        <affiliation>Nursing &amp; Midwifery Faculty, Tabriz University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Sakineh Mohammad-Alizadeh-Charandabi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Faculty of Nursing &amp; Midwifery, South Shariatie Ave., Tabriz, Postal code: 5138947977</address>
        <city>Tabriz</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip></zip>
        <telephone>+98 41 3479 6969</telephone>
        <email>alizades@tbzmed.ac.ir, mhammadalizadehs@gmail.com</email>
        <affiliation>Faculty of Nursing &amp; Midwifery, Tabriz University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Inclusion criteria: aged 18 to 35 years; nulliparous; gestational age of 38 to 41 weeks; spontaneous onset of labor; singleton pregnancy with estimated fetal weight of 2500 to 4000 grams and cephalic presentation; no use of any herbal and anti anxiety drugs in the past 12 hours; reactive non stress test; body mass index of 19.8 to 30 kg/m²; having 8 years education or higher.&#13;
Exclusion criteria: history of surgery on the uterus, cervix or vagina; allergy to saffron; known chronic diseases including hypertension, diabetes, diseases of the respiratory, cardiovascular, endocrine, etc.; history of mental illnesses; speech, hearing, visual or mental problems; known indications for caesarean section; premature rupture of membranes for more than 12 hours; any known fetal abnormalities; known fetal growth retardation</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>35 years</agemax>
      <gender>Female</gender>
      <exclusion_criteria></exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>080.0</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Spontaneous vertex delivery</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Treatment - Drugs</i_code>
      <i_code>Treatment - Drugs</i_code>
      <i_code>Treatment - Drugs</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>The first intervention group: 80 to 240 ml syrup (made by Yashil drug company, Aras)containing 750 mg saffron and 200 mg of  sugar palms in 240 ml syrup. 80 ml of the syrup will be taken when cervical dilation is around 3 to 4 cm and there are at least 3 uterine contractions in 10 minutes lasting for 45 to 60 seconds. It will be repeated every two hours for maximum three doses considering pain intensity, uterine contraction, and pattern of fetal heart rate.</i_keyword>
      <i_keyword>The second intervention group: 80 to 240 ml syrup (made by Yashil drug company, Aras) containing 750 mg saffron and artificial sugar (Isonalt) in 240 ml syrup. 80 ml of the syrup will be taken when cervical dilation is around 3 to 4 cm and there are at least 3 uterine contractions in 10 minutes lasting for 45 to 60 seconds. It will be repeated every two hours for maximum three doses considering pain intensity, uterine contraction, and pattern of fetal heart rate.</i_keyword>
      <i_keyword>Control group: 80 to 240 ml syrup (made by Yashil drug company, Aras) containing placebo of saffron and artificial sugar (Isonalt) in 240 ml syrup (identical in color, smell and taste with the saffron syrups. 80 ml of the syrup will be taken when cervical dilation is around 3 to 4 cm and there are at least 3 uterine contractions in 10 minutes lasting for 45 to 60 seconds. It will be repeated every two hours for maximum three doses considering pain intensity, uterine contraction, and pattern of fetal heart.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Severity of labor pain. Timepoint: every one hour from about 3 cm cervical dilation to the end of the second stage of labor; one and 18 to 24 hours after delivery. Method of measurement: visual analogue scale (VAS) for pain.</prim_outcome>
      <prim_outcome>Intensity of anxiety. Timepoint: at baseline, 3 to 4 hours after starting intervention, and 18 to 24 postpartum. Method of measurement: Spielberger state questionnaire and visual analogue scale for anexity.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Duration of first stage of labor (active phase). Timepoint: from 4 cm to 10 cm cervical dilatation. Method of measurement: Partogramm form.</sec_outcome>
      <sec_outcome>Duration of second stage of labor. Timepoint: from 10 cm cervical dilation to delivery. Method of measurement: Partogramm form.</sec_outcome>
      <sec_outcome>Duration of third stage of labor. Timepoint: immediately after birth to expultion of placenta and fetal membranes. Method of measurement: Partogramm form.</sec_outcome>
      <sec_outcome>Hemoglobin. Timepoint: at baseline and 18 to 24 hours after birth. Method of measurement: labratory test.</sec_outcome>
      <sec_outcome>Score of delivery experience. Timepoint: 18 to 24 hour after delivery. Method of measurement: delivery experience questionnaire.</sec_outcome>
      <sec_outcome>Woman satisfaction rate. Timepoint: 18 to 24 hour after delivery. Method of measurement: one question with likert options.</sec_outcome>
      <sec_outcome>Amount of oxytocin used. Timepoint: during the intervention. Method of measurement: observation.</sec_outcome>
      <sec_outcome>Hematocrit. Timepoint: at baseline and 18 to 24 hours after birth. Method of measurement: labratory test.</sec_outcome>
      <sec_outcome>Newborn bilirubin. Timepoint: 18 to 24 hours after delivery. Method of measurement: Billi Check device.</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, Tabriz University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2015-12-07</approval_date>
        <contact_name>Tabriz University of Medical Sciences</contact_name>
        <contact_address>Research Deputy, 3rd floor, Centeral building No 2 , Tabriz University of Medical Sciences, Golgasht St., Tabriz Tabriz  Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
