<?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>IRCT20191014045106N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2020-02-19</date_registration>
      <primary_sponsor>Shahid Beheshti University of Medical Sciences</primary_sponsor>
      <public_title>Comparison of Oral Misoprostol Tablets and Oxytocin for the Induction of Labor inPremature Rupture of Membranes</public_title>
      <acronym>مقایسه اثر میزوپرستول خوراکی و اکسی توسین وریدی در القا زایمان</acronym>
      <scientific_title>Comparison of Oral Misoprostol Tablets and Oxytocin for the Induction of Labor inPremature Rupture of Membranes</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2019-11-22</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>160</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/43101</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: This study was a clinical trial involving 160 pregnant mothers, ranging from 34 to 42 week Pregnancy is referred to premature rupture of the embryo and go to Mahdieh Hospital Will do, it will be done. cervical examination and Bishop score and description It will be done. After definitive diagnosis of splenic rupture in speculum or positive fren test, patients are randomly divided into two groups for induction of labor.</study_design>
      <phase>3</phase>
      <hc_freetext>Labor in premature rupture of fetal protective membranes.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group:The case group will be given 50 micrograms of misoprostol orally every 4 hours up to a maximum of 5 doses. Intervention 2: Control group:In the control group, oral placebo and intravenous oxytocin in ringer serum will be started at a dose of 2mlu / min and will be performed every 2 minutes up to 40mlu / min.</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:
Comparison of Oral Misoprostol Tablets and Oxytocin for the Induction of Labor in Premature Rupture of Membranes,
All of its results can be used to manage diseases.

When:
Access 5 months after the results are published

To whom:
Academic and scientific researchers

Conditions:
Management and Medical Care

Where to obtain:
Mahdieh Hospital or Shahid Beheshti University of Medical Sciences

How to obtain:
In a Written Letter to the Documentation Authorities of Mahdie Hospital of Shahid Beheshti Medical University

Comments:
</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Maryam Mohammadi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Mahdieh Hospital, Boroujerdi Street</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1234567890</zip>
        <telephone>+98 21 5506 2644</telephone>
        <email>dr.maryam671@gmail.com</email>
        <affiliation>Shahid Beheshti University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Maryam Mohammadi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Mahdieh Hospital, Boroujerdi Street</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1234567890</zip>
        <telephone>+98 21 5506 2644</telephone>
        <email>dr.maryam671@gmail.com</email>
        <affiliation>Shahid Beheshti University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Definitive diagnosis of rupture of the sachet on examination with speculum or positive frenne test
Gestational age between 34 and 42 weeks
Cephalic presentation
Bishop score ≤5
Indication of vaginal termination of pregnancy
Parity less than five
Absence of active labor
Absence of active labor</inclusion_criteria>
      <agemin>no limit</agemin>
      <agemax>no limit</agemax>
      <gender>Female</gender>
      <exclusion_criteria>The presence of any fetal heart rate abnormalities
A history of cesarean section or uterine scarring
Contraindications for vaginal delivery such as placenta peria
Known allergy to prostaglandin (skin manifestations, hives, rash, shortness of breath, cough, chest pain and blurred vision after previous prostaglandin use)
Estimated baby weight over 4 kg
Active labor means at least 3 contractions with sufficient force and duration of at least 40 seconds within 10 minutes.
Active cardiovascular disease, asthma, glaucoma
Vaginal bleeding</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>Z00.12</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Encounter for routine child health examination</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Treatment - Drugs</i_code>
      <i_code>Placebo</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group:The case group will be given 50 micrograms of misoprostol orally every 4 hours up to a maximum of 5 doses.</i_keyword>
      <i_keyword>Control group:In the control group, oral placebo and intravenous oxytocin in ringer serum will be started at a dose of 2mlu / min and will be performed every 2 minutes up to 40mlu / min.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Age. Timepoint: Baseline. Method of measurement: questionnaire.</prim_outcome>
      <prim_outcome>Pregnancy age. Timepoint: Baseline. Method of measurement: questionnaire.</prim_outcome>
      <prim_outcome>Delivery time. Timepoint: During delivery. Method of measurement: questionnaire.</prim_outcome>
      <prim_outcome>First and fifth minute apgar. Timepoint: First and fifth minute. Method of measurement: Based on Apgar score determination by examiner.</prim_outcome>
      <prim_outcome>Postpartum hemorrhage. Timepoint: Immediately after delivery. Method of measurement: View by examiner / Yes, No.</prim_outcome>
      <prim_outcome>Excretion of neonatal meconium. Timepoint: After birth. Method of measurement: View by examiner / Yes, No.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Side Effects Of Misoprostol. Timepoint: Postpartum. Method of measurement: Question about person / fever, nausea, Vomiting, diarrhea.</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 Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2019-09-04</approval_date>
        <contact_name>Ethics committee of Shahid Beheshti University of Medical Sciences</contact_name>
        <contact_address>Shahid Beheshti University of Medical Sciences, Arabi Ave, Daneshjoo Blvd, Velenjak, chamran highway,Tehran, Iran.7th Floor, Bldg No.2 . Tehran Tehran Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
