<?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>IRCT20091023002624N25</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2018-04-04</date_registration>
      <primary_sponsor>Iran University of Medical Sciences</primary_sponsor>
      <public_title>3 methods of cervical ripening in term pregnancies.</public_title>
      <acronym></acronym>
      <scientific_title>A comparison between the effect of Dilapan, extra amniotic normal saline infusion and oral misoprostol  for cervical ripening in term pregnancies.</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2018-05-22</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>120</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/29964</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Simple, individual randomization using sealed envelops.</study_design>
      <phase>2-3</phase>
      <hc_freetext>Delivery.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: In misoprostol group, 50 microgram misoprostol will be administered orally , then cervix will be checked for Bishop Score after 6 hours.In the case of unripe cervix, the next 50 microgram misoprostol will be administered. After 12 hours, induction of labor with oxytocin will be started. Intervention 2: Intervention group: In dilapan group, dilapan will be inserted in cervix for 6 hours and after 6 hours cervix will be checked for Bishop Score and in the case of unripe cervix, dilapan will be remained in place. After 12 hours, dilapan will be removed and induction of labor with oxytocin will be started. Intervention 3: Intervention group: In EASI group, a folly catheter will be inserted in the cervical canal and normal saline will be entered the extra amniotic space as 30 cc per hour. After 6 hours cervix will be checked for Bishop Score and in the case of unripe cervix, EASI will be remained. After 12 hours, EASI will be removed and induction of labor with oxytocin will be started similar to the other groups.</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>Yes - There is a plan to make this available</results_IPD_plan>
      <results_IPD_description>What will be shared:
Presenting at a paper, congress or seminars.

When:
After publication of the paper.

To whom:
Iran University of Medical Sciences

Conditions:
Permission from Iran University of Medical Sciences

Where to obtain:
From Iran University of Medical Sciences

How to obtain:
Request from Iran University of Medical Sciences.

Comments:
</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Maryam Kashanian</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Molavi street, Molavi Cross</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>۱۱۶۸۷۴۳۵۱۴</zip>
        <telephone>+98 21 5563 3244</telephone>
        <email>maryamka@iums.ac.ir</email>
        <affiliation>Iran University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Maryam Kashanian</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Molavi street, Molavi Cross</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>۱۱۶۸۷۴۳۵۱۴</zip>
        <telephone>+98 21 5563 3244</telephone>
        <email>maryamka@iums.ac.ir</email>
        <affiliation>Iran University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Pregnancy
parity 1
gestational age of 40-42 weeks
singletone
cephalic presentation
Bishop score of less than 5
age of less than 40</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>40 years</agemax>
      <gender>Female</gender>
      <exclusion_criteria>ruptured membrane
history of using prostaglandine during present pregnancy
previous uterine scare
known asthma
high diastolic blood pressure</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>O80-O84</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Delivery</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Treatment - Drugs</i_code>
      <i_code>Treatment - Drugs</i_code>
      <i_code>Treatment - Drugs</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group: In misoprostol group, 50 microgram misoprostol will be administered orally , then cervix will be checked for Bishop Score after 6 hours.In the case of unripe cervix, the next 50 microgram misoprostol will be administered. After 12 hours, induction of labor with oxytocin will be started.</i_keyword>
      <i_keyword>Intervention group: In dilapan group, dilapan will be inserted in cervix for 6 hours and after 6 hours cervix will be checked for Bishop Score and in the case of unripe cervix, dilapan will be remained in place. After 12 hours, dilapan will be removed and induction of labor with oxytocin will be started.</i_keyword>
      <i_keyword>Intervention group: In EASI group, a folly catheter will be inserted in the cervical canal and normal saline will be entered the extra amniotic space as 30 cc per hour. After 6 hours cervix will be checked for Bishop Score and in the case of unripe cervix, EASI will be remained. After 12 hours, EASI will be removed and induction of labor with oxytocin will be started similar to the other groups.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Duration up to cervical ripening (bishop score of 7 or more). Timepoint: 6 and 12 hours. Method of measurement: vaginal exam.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>En duration of the active phase of labor. Timepoint: En every 2 hours. Method of measurement: En vaginal exam.</sec_outcome>
      <sec_outcome>Duration of the second stage of labor. Timepoint: every 1 hours. Method of measurement: vaginal exam.</sec_outcome>
      <sec_outcome>Number of deliveries within the first 24 hours. Timepoint: After delivery. Method of measurement: Date sheet.</sec_outcome>
      <sec_outcome>Interval between beginning of the intervention till delivery. Timepoint: After delivery. Method of measurement: Data sheet.</sec_outcome>
      <sec_outcome>Rout of delivery. Timepoint: After delivery. Method of measurement: Data sheet.</sec_outcome>
      <sec_outcome>Indications for cesarean. Timepoint: After delivery. Method of measurement: Data sheet.</sec_outcome>
      <sec_outcome>Uterine tachysystole. Timepoint: during labor. Method of measurement: tocography.</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>Iran University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2018-01-02</approval_date>
        <contact_name>Ethics committee of Iran University of Medical Sciences</contact_name>
        <contact_address>Iran University of Medical Sciences, Hemmat Highway Tehran Tehran Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
