<?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>IRCT201101065556N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2012-05-28</date_registration>
      <primary_sponsor>Rafsanjan  University of Medical sciences and Health Services</primary_sponsor>
      <public_title>Studying  effects of the sysembrium seeds consumption on spontaneous labor in nuliparus</public_title>
      <acronym></acronym>
      <scientific_title>Studying  effects of the sysembrium seeds consumption on spontaneous labor in primigravid</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2007-01-20</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>170</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/5965</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Used, Assignment: Parallel, Purpose: Supportive.</study_design>
      <phase>2-3</phase>
      <hc_freetext>pregnancy,childbirth.</hc_freetext>
      <i_freetext>Intervention 1: non intervention group at 37th week of gestational (term time)  consume daily a one glass of warm water and one  spoon of sugar. Intervention 2: According to the resources 28 packets which contain 10 gram of sysembrium – seeds were given to the intervention group at 37th week of gestational (term time) along with the questionnaires. They had trained to consume daily a pocket of London rocket – seeds with one glass of warm water and one  spoon of sugar and mark the table which is devised at the back of the questionnaires of the intervention group for the assurance of their consumption.</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>Neda  Mohammadinia</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>111; Nursing &amp; Midwifery College; Baloch  Bolv; Iranshahr; Sistan  Balochistan  Province</address>
        <city>Iiranshahr</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>111</zip>
        <telephone>+98 54 7331 0483</telephone>
        <email>mohammadinia@zaums.ac.ir;  mohammadinia55@yahoo.com</email>
        <affiliation>Zahedan Univercity of  Medical  Sciences and Health Services</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Neda Mohammadi Nia</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Nursing &amp; Midwifery College; Baloch  Bolv; Iranshahr, Sistan Balochistan  Province</address>
        <city>Iranshahr</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>111</zip>
        <telephone>+98 54 7331 0483</telephone>
        <email>mohammadinia@zaums.ac.ir;mohammadinia55@yahoo.com</email>
        <affiliation>Zahedan  University  of Medical  Sciences and Health Services</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Inclusion criteria: the Iranian primgravida;  hadn’t used any scientific or herbal methods in order fasilating their parturition; referr to one of the seven health care centers in the city for their gestational cares; candid for vaginal delivery and didn’t have any recognized or predictable problems for cesarean as they entered to the study; Their parturition had planed to perform in Nicknafas educational health care center of Rafsanjan&#13;
Exclusion criteria: unIranian national; multigravid; used any scientific or herbal methods in order fasilating their parturition; referr to one of personal health care centers in the city for their gestational cares; candid for cesarean delivery and  have  recognized or predictable problems for cesarean as they entered to the study; unknown or not planned where their parturition.</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>30 years</agemax>
      <gender>Female</gender>
      <exclusion_criteria></exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>O60</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Preterm labour and delivery</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Placebo</i_code>
      <i_code>Treatment - Drugs</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>non intervention group at 37th week of gestational (term time)  consume daily a one glass of warm water and one  spoon of sugar</i_keyword>
      <i_keyword>According to the resources 28 packets which contain 10 gram of sysembrium – seeds were given to the intervention group at 37th week of gestational (term time) along with the questionnaires. They had trained to consume daily a pocket of London rocket – seeds with one glass of warm water and one  spoon of sugar and mark the table which is devised at the back of the questionnaires of the intervention group for the assurance of their consumption</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Spontaneus labour. Timepoint: Refered  to hospital(labour time) and post intervention. Method of measurement: Questionaire.</prim_outcome>
      <prim_outcome>Cervix maturation. Timepoint: Post intervention. Method of measurement: Cervix examination &amp; questionaire.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Newborn apgar score. Timepoint: First and fifth minute of post partum. Method of measurement: Standard scale apgar.</sec_outcome>
    </secondary_outcome>
    <secondary_sponsor>
      <sponsor_name>Rafsanjan Nursing &amp; Midwifery College</sponsor_name>
    </secondary_sponsor>
    <secondary_ids>
      <secondary_id>
        <sec_id></sec_id>
        <issuing_authority></issuing_authority>
      </secondary_id>
    </secondary_ids>
    <source_support>
      <source_name>Rafsanjan  University of Medical sciences and Health Services</source_name>
      <source_name>Rafsanjan Nursing &amp; Midwifery College</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2006-08-20</approval_date>
        <contact_name>Rafsanjan  University of  Medical Science and Health Services Ethics  Comitte</contact_name>
        <contact_address>111111;  aliebnabitaleb square; rafsanjanUniversity of  Medical Science; kerman rafsanjan  Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
