<?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>IRCT2012103011324N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2013-01-13</date_registration>
      <primary_sponsor>Ahwaz Jundishapur University of Medical Science, Vice Chancellor for Research and Technology</primary_sponsor>
      <public_title>Comparison between misoprostol and oxytocine in cervical ripening for labour induction: a randomized clinical trial</public_title>
      <acronym></acronym>
      <scientific_title>Comparison between misoprostol and oxytocine in cervical ripening for labour induction: a randomized clinical trial</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2013-01-20</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>190</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/11590</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment.</study_design>
      <phase>2-3</phase>
      <hc_freetext>Failed medical induction of labour.</hc_freetext>
      <i_freetext>Intervention 1: For women who receive misopristol, 50 mcg of medication in posterior fornix of vagina will be placed. The dose every 4 hours to 25 mcg can be repeated up to a pattern of at least 3 contraction in 10 minutes get. The maximum dose of 200 mcg. If this is the contractile pattern up to 4 hours after injection of the seventh dose drug is created, it will be deemed a failure of induction of labour. After acquiring the contractile pattern will not be prescribing other ideal misopristol. Intervention 2: For oxytocin group 2 mU/min of the drug  for intravenous infusion will be used in intervals of 30 minutes 2 times the amount of the drug, as long as proper contractile pattern. The dose up to maximum 20 mU/min infusion is increased and the limit will be preserved. If desired the contractile pattern up to 15 mU did, failure of induction of delivery will be considered. Even after the acquisition of optimum pattern of contractile administered oxytocin will continue. As soon as a person to the extent of the contraction phase, optimal heart rate achieved the embryo will be evaluated. Amniotomy will be conducted when the Bishop score over 7 and Bishop cervix over 6 cm. In cases of tachysystole (contraction or more over the course of 10 minutes) and hiprtone/hypersystole of the uterus (uterine contraction with a duration of over 2 minutes) and in the absence of fetal heart rate changes, the usual way to treat these issues will. In the case of hiprerstimulation syndrome or fetal hypoxia, disconnected and induction will be performing a cesarean section.</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>Mehrnooh Namazi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Ahwaz Jundishapur University of Medical Sciences , Esfand avenue , Golestan bulvard</address>
        <city>Ahwaz</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>61357-15794</zip>
        <telephone>+91 63006324</telephone>
        <email>mohamadjafari-r@ajums.ac.ir ; alinazeri_76@yahoo.com ; mnamazi1979@yahoo.com</email>
        <affiliation>Ahwaz Jndishapur University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Razie Mohamadjafari</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Ahwaz Jundishapur University of Medical Science , Esfand avenue , Golestan bulvard</address>
        <city>Ahwaz</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>61357-15794</zip>
        <telephone>+98 61 1222 2114</telephone>
        <email>alinazeri_76@yahoo.com;  mnamazi1979@yahoo.com; mohamadjafari-r@ajums.ac.ir</email>
        <affiliation>Ahwaz Jundishapur University of Medical Science</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Entry criteria : Medical indication for the induction of delivery; Single twin pregnancies; Gestational age more than 36 weeks; Vertex presentation ;The normal heart rate of embryos .The exit criteria: The embryo-pelvic dystocia; An estimated weight of over 4000 grams or evidence of a lack of fitness cephalopelvic ; Abnormal vaginal bleeding or any placenta previa; The number of pregnancy over 4; Fetal malformation; Previous uterine scar; Any situation that does not cause vaginal delivery indication, Any contraindication use of misopristol ; Severe polyhydramnios</inclusion_criteria>
      <agemin>no limit</agemin>
      <agemax>no limit</agemax>
      <gender>Female</gender>
      <exclusion_criteria></exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>O61.0</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Failed induction (of labour) by:•oxytocin•prostaglandins</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>For women who receive misopristol, 50 mcg of medication in posterior fornix of vagina will be placed. The dose every 4 hours to 25 mcg can be repeated up to a pattern of at least 3 contraction in 10 minutes get. The maximum dose of 200 mcg. If this is the contractile pattern up to 4 hours after injection of the seventh dose drug is created, it will be deemed a failure of induction of labour. After acquiring the contractile pattern will not be prescribing other ideal misopristol</i_keyword>
      <i_keyword>For oxytocin group 2 mU/min of the drug  for intravenous infusion will be used in intervals of 30 minutes 2 times the amount of the drug, as long as proper contractile pattern. The dose up to maximum 20 mU/min infusion is increased and the limit will be preserved. If desired the contractile pattern up to 15 mU did, failure of induction of delivery will be considered. Even after the acquisition of optimum pattern of contractile administered oxytocin will continue. As soon as a person to the extent of the contraction phase, optimal heart rate achieved the embryo will be evaluated. Amniotomy will be conducted when the Bishop score over 7 and Bishop cervix over 6 cm. In cases of tachysystole (contraction or more over the course of 10 minutes) and hiprtone/hypersystole of the uterus (uterine contraction with a duration of over 2 minutes) and in the absence of fetal heart rate changes, the usual way to treat these issues will. In the case of hiprerstimulation syndrome or fetal hypoxia, disconnected and induction will be performing a cesarean section</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Bishop index. Timepoint: Baseline and every 30 minutes during the intervention and at the end of the intervention. Method of measurement: The questionnaire.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Infantile complication. Timepoint: Baseline and every 30 minutes during the intervention and at the end of the intervention. Method of measurement: Apgar score.</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>Ahwaz Jundishapur University of Medical Science, Vice Chancellor for Research and Technology</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2012-06-09</approval_date>
        <contact_name>Ahwaz Ethic Committee of Jundishapur University of Medical Sciences</contact_name>
        <contact_address>Ahwaz Jundishapur University of Medical Sciences , Esfand avenue , Golestan bulvard Ahwaz  Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
