<?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>IRCT2012061910068N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2012-07-05</date_registration>
      <primary_sponsor>Shahid Beheshti University of Medical Science</primary_sponsor>
      <public_title>Labor induction in term pregnant women of  with oral misoprostol or oxytocin</public_title>
      <acronym></acronym>
      <scientific_title>Induction and augmentation of labor with oral misoprostol versus oxytocin in term pregnancy: randomized controlled trial</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2008-01-01</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>285</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/10549</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment.</study_design>
      <phase>0 (exploratory trials)</phase>
      <hc_freetext>labor induction.</hc_freetext>
      <i_freetext>Intervention 1: In the oxytocin group, infusion rate of 2 mIU/min was prescribed for induction and gradually increased by 2 mIU/min every 15 minutes to a maximum dose of 36 mIU/min. In presence of any tachysystole (5 contractions in a 10-minute interval) or hypertonus (single contractions lasting 2 minutes or longer), or changes in fetal heart rate associated with tachysystole or hypertonus, infusion rate was decreased or stopped. Intervention 2: Initiation of labor induction was the time at which the first misoprostol dose was administered (group 1) or the oxytocin infusion was started (group 2).&#13;
In the misoprostol group, a tablet of 200 µg was dissolved in 200cc of water and 25cc was administered every two hours for up to 24 hours (10). The maximum dose was 300 µg. If the ideal pattern of contractions (at least 3 contractions per 10 minutes) was reached, misoprostol was no longer administered. &#13;
ّFetal heart monitoring and uterine contraction were also recorded.</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>Aida Moeini</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Department of Obstetrics and Gynecology, Tajrish Hospital, Tajrish Sq, Tehran, Iran.</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip></zip>
        <telephone>+98 21 2271 8000</telephone>
        <email>a.moeini64@gmail.com</email>
        <affiliation>Department of Obstetrics and Gynecology, Shahid Beheshti University of Medical Science</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Rezvan Aalami-Harandi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Department of Obstetrics and Gynecology, Tajrish Hospital, Tajrish Sq, Tehran, Iran.</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip></zip>
        <telephone>+98 21 2271 8000</telephone>
        <email>mahmaz2002@yahoo.com</email>
        <affiliation>Department of Obstetrics and Gynecology, Shahid Beheshti University of Medical Science</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Inclusion criteria: term pregnant women whom were candidate for vaginal delivery; gestational age of 38 to 42 weeks; birth weight of maximally 4000 grams; normal fetal heart rate; cephalic presentation; lack of uterine contractures; single pregnancy and Bishop Score of six and less.&#13;
The exclusion criteria were lack of satisfaction for incorporation in the study; having a positive history of uterine surgery including cesarean; intrauterine growth retardation (IUGR); oligohydramnios; placenta previa; umbilical cord prolapse; active herpes infection; symptoms of chorioamnionitis; hepatic or renal disease; non-reactive contraindications for prostaglandins use; contraindications for labor induction and idiopathic vaginal bleeding.</inclusion_criteria>
      <agemin>14 years</agemin>
      <agemax>40 years</agemax>
      <gender>Female</gender>
      <exclusion_criteria></exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>O00-O08</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Pregnancy with abortive outcome</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>In the oxytocin group, infusion rate of 2 mIU/min was prescribed for induction and gradually increased by 2 mIU/min every 15 minutes to a maximum dose of 36 mIU/min. In presence of any tachysystole (5 contractions in a 10-minute interval) or hypertonus (single contractions lasting 2 minutes or longer), or changes in fetal heart rate associated with tachysystole or hypertonus, infusion rate was decreased or stopped.</i_keyword>
      <i_keyword>Initiation of labor induction was the time at which the first misoprostol dose was administered (group 1) or the oxytocin infusion was started (group 2).&#13;
In the misoprostol group, a tablet of 200 µg was dissolved in 200cc of water and 25cc was administered every two hours for up to 24 hours (10). The maximum dose was 300 µg. If the ideal pattern of contractions (at least 3 contractions per 10 minutes) was reached, misoprostol was no longer administered. &#13;
ّFetal heart monitoring and uterine contraction were also recorded.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>The time from induction to delivery. Timepoint: 12, 18, and 24 hours during labor. Method of measurement: Data recording.</prim_outcome>
      <prim_outcome>The time from induction to the beginning of the active phase. Timepoint: 12, 18, and 24 hours during labor. Method of measurement: Data recording.</prim_outcome>
      <prim_outcome>Mode of delivery. Timepoint: 12, 18, and 24 hours during labor. Method of measurement: Data recording.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Maternal complications. Timepoint: Peri labor phase. Method of measurement: Data record.</sec_outcome>
      <sec_outcome>Fetal and neonatal status. Timepoint: Peri labor phase. Method of measurement: Data record.</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>Shahid Beheshti University of Medical Science</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2007-10-01</approval_date>
        <contact_name>Shaheed Beheshti University of Medical Sciences Ethics Committee</contact_name>
        <contact_address>Department of Obstetrics and Gynecology, Tajrish Hospital, Tajrish Sq, Tehran, Iran. Tehran  Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
