<?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>IRCT2013112515544N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2014-01-03</date_registration>
      <primary_sponsor>Vice chancellor for research,Nursing &amp; Midwifery Faculty of Shahid Beheshty University of Medical Sc</primary_sponsor>
      <public_title>Comparison of the effect of nipple stimulation with syntocinon drug on the induction of labour</public_title>
      <acronym></acronym>
      <scientific_title>Comparison of the effect of nipple stimulation and infusion of syntocinon on the induction of labour in nulliparous women and its outcomes</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2013-10-20</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>140</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/14791</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Diagnostic.</study_design>
      <phase>2-3</phase>
      <hc_freetext>labour induction.</hc_freetext>
      <i_freetext>Intervention 1: nipple stimulation ( intervention group). In this group unilateral breast stimulation perform for 15 minutes and then 15 minutes rest to 6 hours period. Intervention 2: control group (infusion of syntocinon): 10 units syntocinon add into one litter of ringer serum. Infusion start with 2.5 mu/min and  add 2.5mu/min every 15 minutes up to 40 mu/min.</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>Negar Hariri</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Intersection of Valiasr-Nyayesh street,Tehran</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>4741741996</zip>
        <telephone>+98 11 2526 3296</telephone>
        <email>negarhariri@yahoo.com</email>
        <affiliation>Nursing &amp; Midwifery Faculty of Shahid Beheshty Medical Science University</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Shahnaz Torkzahrani</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Intersection of Valiasr-Nyayesh street,Tehran</address>
        <city>Tehrran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>198571443</zip>
        <telephone>+98 218865536671</telephone>
        <email>zahranishahnaz@yahoo.com</email>
        <affiliation>Nursing &amp; Midwifery Faculty of Shahid Beheshty Medical Science University</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Inclusion criteria:      &#13;
age of18-35 years old, gestational age of 38-42 weeks based on LMP or ultrasound before 26 weeks؛ requiring termination of pregnancy for fetal or maternal indications؛ nulliparous wemon؛ single fetous with cephalic presentation؛ intact membrane؛ bishop score&lt; 4؛ body mass index between 20 to 30؛ estimated fetal weight between ( 4500-2500 gr )؛ lack of any kind of diseases and high risk pregnancy؛ not use of any kind of chemical drug or herb to start labour for 48 hours before admission؛ lack of any problems (eg, tumor) in the breast. &#13;
 Exclusion criteria: Incidence of each type of obstetric emergencies (such as cord prolapse )؛ discontinuing of the study by patient request ؛spontaneous rupture of membrane before 4-5cm dilatation.</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>35 years</agemax>
      <gender>Female</gender>
      <exclusion_criteria></exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>O61</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Failed induction of labour</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Treatment - Other</i_code>
      <i_code>Treatment - Drugs</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>nipple stimulation ( intervention group). In this group unilateral breast stimulation perform for 15 minutes and then 15 minutes rest to 6 hours period.</i_keyword>
      <i_keyword>control group (infusion of syntocinon): 10 units syntocinon add into one litter of ringer serum. Infusion start with 2.5 mu/min and  add 2.5mu/min every 15 minutes up to 40 mu/min.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Bishop score. Timepoint: every2 hours during first stage of labour. Method of measurement: by vaginal examination.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Abnormal fetal heart rate. Timepoint: During the study. Method of measurement: Fetel monitoring device.</sec_outcome>
      <sec_outcome>Apgar score. Timepoint: 1&amp;5 minute after delivery. Method of measurement: Apgar scoring System.</sec_outcome>
      <sec_outcome>Pain intensity. Timepoint: During the study. Method of measurement: Mcgill ruler.</sec_outcome>
      <sec_outcome>Lenght of the first and second stages of labor. Timepoint: End of delivery. Method of measurement: minute.</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,Nursing &amp; Midwifery Faculty of Shahid Beheshty University of Medical Sc</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2013-10-20</approval_date>
        <contact_name>"Ethics committee of Shahid Beheshti University of Medical Sciences"</contact_name>
        <contact_address>Shahid Aarabi street, Yaman street, Shahid Chamran highway, Tehran Tehran  Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
