<?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>IRCT20170326033142N2</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2018-07-28</date_registration>
      <primary_sponsor>Sanandaj University of Medical Sciences</primary_sponsor>
      <public_title>Traction effect with folly catheter on cervices ripening compared to vaginal misoprostol</public_title>
      <acronym></acronym>
      <scientific_title>Comparison of vaginal misoprostol with Foley catheter for cervical ripening and labor induction</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2016-09-22</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>120</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/25642</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Simple randomization.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Cervical ripening.</hc_freetext>
      <i_freetext>Intervention 1: In the first group (misoprostol group), misoprostol 25 μg (200μg Samisaz tablets divided by divaider) is placed in the posterior fornix of the vagina and will be repeated every 6 hours to a maximum of 3 doses (total 75 μg). If the patient does not spontaneously enter the phase of labor (regular uterine contractions accompanied by progressive changes in the cervix), after 12 hours of induced labor, oxytocin will be used to terminate the pregnancy. Intervention 2: In the second group (Foley catheter group), Foley catheter No. 16 in sterile conditions (washing the vagina with Betadine), through the cervix into the uterus and then the balloon is filled with 30 ml of distilled water to be placed behind the inner hole To put The other end of the catheter, to provide traction with normal saline 500ml bag and hang beside the bed. If after 6 hours, the patient does not spontaneously enter the phase of labor, induction of labor with oxytocin begins.</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:
All data is from the proposal, raw data and project reports

When:
Data is available from the legal system six months after publication for two years

To whom:
All persons will be able to access the Kurdistan University of Medical Sciences's request to the Kurdistan University of Medical Sciences.

Conditions:
For legal issues and the need to use data in future studies

Where to obtain:
Sorayya Rashidzadeh

How to obtain:
After submitting a request to the Kurdistan Research and Technology Dept. of Science and Technology, a call for submission is given.

Comments:
</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Dr. Sorayya Rashid Zadeh</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Be'sat Educational Hospita, Keshavarz St. Vakil 4way, Sanandaj, Kurdistan, Iran</address>
        <city>Sanandaj</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>66177-13446</zip>
        <telephone>+98 873328591015</telephone>
        <email>s.rashidzadeh@muk.ac.ir</email>
        <affiliation>Sanandaj University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Dr.Shoaleh Shahgheybi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Be'sat Educational Hospita, Keshavarz St. Vakil 4way, Sanandaj, Kurdistan, Iran</address>
        <city>Sanandaj</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>6617713446</zip>
        <telephone>+98 873328591015</telephone>
        <email>shahgheibi@yahoo.com</email>
        <affiliation>Sanandaj University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Women referring to the delivery block of Besat Hospital indicating the induction of labor.
Gestational age equal to or greater than 37 weeks
Satisfaction to participate in the research
intact chorionic membrane
Vortex presentation
Single pregnancy
Inappropriate cervix and Bishop score 1 equal to or less than 4</inclusion_criteria>
      <agemin>no limit</agemin>
      <agemax>no limit</agemax>
      <gender>Female</gender>
      <exclusion_criteria>fetal distress
Problems in controlling fetal heart sounds
severe pre-eclampsia
Intrauterine growth restriction
Contraindications for the use of prostaglandins
Regular uterine contractions
Early placental detachment
Placenta previa
Vaginal bleeding
Previous cesarean section or previous surgery on the uterus</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>O80</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Encounter for full-term uncomplicated delivery</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Treatment - Drugs</i_code>
      <i_code>Treatment - Other</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>In the first group (misoprostol group), misoprostol 25 μg (200μg Samisaz tablets divided by divaider) is placed in the posterior fornix of the vagina and will be repeated every 6 hours to a maximum of 3 doses (total 75 μg). If the patient does not spontaneously enter the phase of labor (regular uterine contractions accompanied by progressive changes in the cervix), after 12 hours of induced labor, oxytocin will be used to terminate the pregnancy.</i_keyword>
      <i_keyword>In the second group (Foley catheter group), Foley catheter No. 16 in sterile conditions (washing the vagina with Betadine), through the cervix into the uterus and then the balloon is filled with 30 ml of distilled water to be placed behind the inner hole To put The other end of the catheter, to provide traction with normal saline 500ml bag and hang beside the bed. If after 6 hours, the patient does not spontaneously enter the phase of labor, induction of labor with oxytocin begins.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Dilation. Timepoint: Every 1 hour. Method of measurement: Vaginal examination.</prim_outcome>
      <prim_outcome>Effacement. Timepoint: Every 1 hour. Method of measurement: Vaginal examination.</prim_outcome>
      <prim_outcome>Delivery progress time. Timepoint: Every 1 hour. Method of measurement: Vaginal examination.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome></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>Sanandaj University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2016-09-19</approval_date>
        <contact_name>KURDISTAN UNIVERSITY OF MEDICAL SCIENCES</contact_name>
        <contact_address>Kurdistan University of Medical Sciences Vice Chancellor in Research Affair Pasdaran Ave. Sanandaj Kurdistan Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
