<?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>IRCT20190415043278N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2019-05-27</date_registration>
      <primary_sponsor>Qazvin University of Medical Sciences</primary_sponsor>
      <public_title>Comparison Of The Effect Of Misoprostol On Induction Of Labour In Term Pregnancy: Double Blind  Randomized Clinical Trial</public_title>
      <acronym>--</acronym>
      <scientific_title>Comparison Of The Effect Of Misoprostol On Induction Of Labour In Term Pregnancy: Double Blind  Randomized Clinical Trial</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2019-05-22</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>300</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/39054</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: Simply randomize to three equal groups using Random allocation (Software) in one of the following three groups:
  A: Fifty micrograms of vaginal misoprostol (Cytotec, Searle, England) and cervical placenta
B: Fifty micrograms of cystic myosoprostol (Cytotec, Searle, England) and vaginal placenta
C: Fifty micrograms of subcutaneous misoprostol (Cytotec, Searle, England) and vaginal placenta, Blinding description: double blind a randomized clinical trial(patient and researcher).</study_design>
      <phase>2-3</phase>
      <hc_freetext>Reduce The Duration Of Induction To Delivery In Pregnant Mothers.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: vaginal misoprostol. Intervention 2: Intervention group: sub lingual misoprostol. Intervention 3: Intervention group: cervical misoprostol. Intervention 4: Control group: cervical placebo. Intervention 5: Control group: vaginal placebo.</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:
A Portion Of The Information, Such As Information On The Main Outcome Or The Like,Can be Shared.

When:
Start The Access Period 6 Months After Printing Results. "

To whom:
Only Available To Scholars Working In Academic And Academic Institutions

Conditions:
If Another Clinical Trial Is Performed,The Same Is Done

Where to obtain:
Email

How to obtain:
After Receiving E-mail And Proproozal And Ensuring That Information Is Not Misused

Comments:
Without Elaborate</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Mahtab Dadashaliha</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Tohid Street</address>
        <city>Qazvin</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>3491658875</zip>
        <telephone>+98 28 3322 9304</telephone>
        <email>dadashaliham@yahoo.com</email>
        <affiliation>Qazvin University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Mahtab Madashaliha</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Tohid Street</address>
        <city>Qazvin</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>3491658875</zip>
        <telephone>+98 28 3322 9304</telephone>
        <email>dadashaliham@yahoo.com</email>
        <affiliation>Qazvin University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Single Viable Term Fetus, Gestational Age&gt;=39 Week, Fetal Weight &lt; 4 kg , Cephalic, AFI&gt;5, Nst Active ,No Pelvic Stricture, Bishop Score &lt;5 ,IUGR Grade 1, Mild Diabetic, Pre eclampsia, Chronic Hypertension ,PPROM, Post Date Pregnancy</inclusion_criteria>
      <agemin>no limit</agemin>
      <agemax>no limit</agemax>
      <gender>Female</gender>
      <exclusion_criteria>IUGR Grade &gt;1,Fetus Malformation , Previous Uterine Scar , Multi Parity &gt;2 , OT&gt;38 ,Chorioamnionitis , Olygo &amp; Poly Hydramniotic ,Macrosomia , Nst Non Reactive ,History of a Mothers Seizure , Hypotension-Renal &amp; Heart Diese, Gestational Age &lt; 36 Week.</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code></hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword></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>
      <i_code>Placebo</i_code>
      <i_code>Placebo</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group: vaginal misoprostol</i_keyword>
      <i_keyword>Intervention group: sub lingual misoprostol</i_keyword>
      <i_keyword>Intervention group: cervical misoprostol</i_keyword>
      <i_keyword>Control group: cervical placebo</i_keyword>
      <i_keyword>Control group: vaginal placebo</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Comparison Of The InitiationI Induction Interval And The Time Of Onset Of Pain In The Three Groups Of Pregnant Mothers (Vaginal, Cervical, Sublingual) Referring To Maternity Hospitals (Mehregan, Kosar) In Qazvin. Timepoint: Admision in Labure. Method of measurement: Time.</prim_outcome>
      <prim_outcome>Comparison Of The Duration Of Induction To Delivery In Three Groups Of Pregnant Mothers (Vaginal, Cervical, Sublingual) Referring To Maternity Hospitals (Mehregan, Kosar) In Qazvin. Timepoint: Admision in Labure. Method of measurement: Time.</prim_outcome>
      <prim_outcome>3) Comparison Of Delivery Type In Three Groups Of Pregnant Mothers (Vaginal, Cervical, Sublingual) Referring To Maternity Hospitals (Mehregan, Kosar) In Qazvin. Timepoint: Admision in Labure. Method of measurement: NVD , C/S.</prim_outcome>
      <prim_outcome>Comparison Of The Complications Of Clinical And Uterine Medication In Three Groups Of Pregnant Mothers (Vaginal, Cervical, Sublingual) Referring To Maternity Hospitals (Mehregan, Kosar) In Qazvin. Timepoint: Admision in Labure. Method of measurement: Tachycardia (presence Of 5 Or More Uterine Contractions In 10 minutes), Excessive Uterine Stimulation (Any Condition That Causes Abnormal Fetal Heart Rate), Uterine Hypertonia (Any Uterine Contraction Lasting More Than Two Minutes), Start Time Suitable Contractions Of Uterus, Interval Between Initiation Of Induction And Delivery, Type Of Delivery, Meconium Excretion, Fetal Death, Apgar Score In the First And Fifth Minutes, And The Need For NICU Neonates Due To Low Apgar Score And Side Effects Of The Drug. Digestive Complications Include Nausea, Vomiting, Diarrhea, Fever And Headache.</prim_outcome>
      <prim_outcome>Comparison Of fetal Complications (Heart Rate And Meconium Excretion) In Three Groups Of Pregnant Mothers (Vaginal, Cervical, Sublingual) Referring To Maternity Hospitals (Mehregan, Kosar) in Qazvin. Timepoint: Admision in Labure. Method of measurement: Number Of Meconium Excretion, Fetal Death, Apgar Score In First And Fifth Minutes, And Need For NICU Neonates due to Low Apgar Score.</prim_outcome>
      <prim_outcome>Comparison Of Neonatal Outcomes (Apgar, Asphyxia) In Three Groups Of Pregnant Mothers (Vaginal, Cervical, Sublingual) Referring To Maternity Hospitals (Mehregan, Kosar) In Qazvin. Timepoint: Admision in labure after birth. Method of measurement: Apgar Less Than 7 Will be Sent To Examine The Umbilical Cord Blood Sample For Examination Of The Umbilical Cord PH.</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>Qazvin University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2019-03-13</approval_date>
        <contact_name>Qazvin University Of Medical Science</contact_name>
        <contact_address>Navab Street Qazvin Qazvin Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
