<?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>IRCT201011275181N3</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2012-01-12</date_registration>
      <primary_sponsor>Caspian Pharmaceutical Company</primary_sponsor>
      <public_title>Comparing the Oxytocin made in Iran with Oxytocin from foreign country for induction of labor</public_title>
      <acronym></acronym>
      <scientific_title>A comparative study of the use of oxytocin (Iranian-made and foreign) in the induction of labor.</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2011-04-09</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>100</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/5549</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment.</study_design>
      <phase>3</phase>
      <hc_freetext>Long labor.</hc_freetext>
      <i_freetext>Intervention 1: The group 1 (oxytocin), First 10 units oxytocin spilled in 1000 cc of blood Ringer (2/5mu/min) Then four drops per minute infusion rate 2 / 5 is increased to the maximum mu / min 40 in.&#13;
The same amount will continue. After a good start uterine contractions, vaginal examination will be done  if the patient Prom every hour and in rupture of  the amniotic soc  every 2 hour and every half hour inuterine contractions. mother's vital signs will be controlled before  oxytocin induction and then each hour. If signs of fetal distress or uterine hyperstimulation appears, oxytocin is stopped. In an extreme case of improved The uterus  stimulation and fetal distress, re-infusion with  previous dose begins and continues with the same sequence. If 6 hours after induction does not change, the patient with pain induction is regarded as a failure of Bishop Score and Induction will be stopped But if you switch off the induction of cervical, induction continues. The rate of cervical dilatation and effacement during the induction phase of active labor and every 30 minutes every 15 minutes during the second stage of labor is controlled To determine the progress of labor. Intervention 2: The group 2 (oxytocip), First 10 units oxytocin spilled in 1000 cc of blood Ringer (2/5mu/min) Then four drops per minute infusion rate 2 / 5 is increased to the maximum mu / min 40 in.&#13;
The same amount will continue. After a good start uterine contractions, vaginal examination will be done  if the patient Prom every hour and in rupture of  the amniotic soc  every 2 hour and every half hour inuterine contractions. mother's vital signs will be controlled before  oxytocin induction and then each hour. If signs of fetal distress or uterine hyperstimulation appears, oxytocin is stopped. In an extreme case of improved The uterus  stimulation and fetal distress, re-infusion with  previous dose begins and continues with the same sequence. If 6 hours after induction does not change, the patient with pain induction is regarded as a failure of Bishop Score and Induction will be stopped But if you switch off the induction of cervical, induction continues. The rate of cervical dilatation and effacement during the induction phase of active labor and every 30 minutes every 15 minutes during the second stage of labor is controlled To determine the progress of labor.</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></firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address></address>
        <city></city>
        <country1></country1>
        <zip></zip>
        <telephone></telephone>
        <email></email>
        <affiliation></affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Rashidi Batool</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Imam Khomeini Hospital, Vali-Asr Hospital, Tehran University of Medical Sciences</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip></zip>
        <telephone>+98 21 6658 1616</telephone>
        <email>bhrashidi@yahoo.com</email>
        <affiliation>Vali-E-Asr Reproductive Health Research Center</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Inclusion criteria: one Fetal pregnancy; Cephalic presentation; intact amniotic membrane; Reactive NST; less than 3 uterus contraction per 10 minutes.  Exclusion criteria: regular contraction (more than 6 contraction per hours); fetal death; Amniotomy contra indication; mother age less than 18 years; previous C/S; Multiparty (&gt;3); Chorioamniotit; Asthma history; Multiple gestation; Placenta previa; Non Cephalic presentation; Glucoma; Vaginal bleeding; sensitivity to Prostoglandin; irregular in fetal heart rate; contra indication of vaginal delivery.</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>40 years</agemax>
      <gender>Female</gender>
      <exclusion_criteria></exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>O63</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Long labour</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Treatment - Drugs</i_code>
      <i_code>Treatment - Drugs</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>The group 1 (oxytocin), First 10 units oxytocin spilled in 1000 cc of blood Ringer (2/5mu/min) Then four drops per minute infusion rate 2 / 5 is increased to the maximum mu / min 40 in.&#13;
The same amount will continue. After a good start uterine contractions, vaginal examination will be done  if the patient Prom every hour and in rupture of  the amniotic soc  every 2 hour and every half hour inuterine contractions. mother's vital signs will be controlled before  oxytocin induction and then each hour. If signs of fetal distress or uterine hyperstimulation appears, oxytocin is stopped. In an extreme case of improved The uterus  stimulation and fetal distress, re-infusion with  previous dose begins and continues with the same sequence. If 6 hours after induction does not change, the patient with pain induction is regarded as a failure of Bishop Score and Induction will be stopped But if you switch off the induction of cervical, induction continues. The rate of cervical dilatation and effacement during the induction phase of active labor and every 30 minutes every 15 minutes during the second stage of labor is controlled To determine the progress of labor.</i_keyword>
      <i_keyword>The group 2 (oxytocip), First 10 units oxytocin spilled in 1000 cc of blood Ringer (2/5mu/min) Then four drops per minute infusion rate 2 / 5 is increased to the maximum mu / min 40 in.&#13;
The same amount will continue. After a good start uterine contractions, vaginal examination will be done  if the patient Prom every hour and in rupture of  the amniotic soc  every 2 hour and every half hour inuterine contractions. mother's vital signs will be controlled before  oxytocin induction and then each hour. If signs of fetal distress or uterine hyperstimulation appears, oxytocin is stopped. In an extreme case of improved The uterus  stimulation and fetal distress, re-infusion with  previous dose begins and continues with the same sequence. If 6 hours after induction does not change, the patient with pain induction is regarded as a failure of Bishop Score and Induction will be stopped But if you switch off the induction of cervical, induction continues. The rate of cervical dilatation and effacement during the induction phase of active labor and every 30 minutes every 15 minutes during the second stage of labor is controlled To determine the progress of labor.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Cesarian Section. Timepoint: at the end of induction of labor. Method of measurement: C/S or vaginal delivery.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Duration of labor induction. Timepoint: Since the beginning of induction to delivery time. Method of measurement: Based on time.</sec_outcome>
      <sec_outcome>Duration of first labor period. Timepoint: begining of induction until delivery time. Method of measurement: based on hours.</sec_outcome>
      <sec_outcome>During the second stage of labor. Timepoint: Onset of contractions to full cervical dilatation. Method of measurement: Based on time.</sec_outcome>
      <sec_outcome>Uterine hyper stimulation. Timepoint: Time of  contraction is more than two minutes. Method of measurement: Based on an specialist  examination.</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>Caspian Pharmaceutical Company</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2009-12-20</approval_date>
        <contact_name>Vice Chancellor for Research,Tehran University of Medical Sciences</contact_name>
        <contact_address>Bulding of Vice Chancellor for Research, Ghods St., Keshavarz Blvd. Tehran  Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
