<?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>IRCT201201308878N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2012-05-05</date_registration>
      <primary_sponsor>Tabriz University Of Medical Sciences</primary_sponsor>
      <public_title>Magnesium Sulfate In Adverse With Nifedipine In suppression preterm labor  In Pregnant With Preterm Labor</public_title>
      <acronym></acronym>
      <scientific_title>Magnesium Sulfate In Adverse With Nifedipine In Suppression Preterm labor  In Pregnant With Preterm Labor</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2012-04-20</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>80</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/9362</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Preterm labor.</hc_freetext>
      <i_freetext>Intervention 1: First group (A) will be giving 4 gram  Magnesium Sulfate as a loading dose then countining 2 gram every hour until 48 hours(positive Patella reflex ,at least 12 times respiratory rates,urine output at least 30mm)at the same time this group will be giving Placebo tablet instead of Nifedipine. Intervention 2: The other group will be giving Nifedipine tablet(20mg) after half an hour will be given other 20 mg of Nifedipine tablet,if contractions persist ,giving 20 mg Nifedipin  will be countining  every 3-8 hours   until contractions will subside.at the same time serum Ringer with microset will be conduct as Plasebo.</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>Fereshteh Fartash</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Sought Shariaty Street</address>
        <city>Tabriz</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>5138851559</zip>
        <telephone>+98 41 1666 1428</telephone>
        <email>fereshtefartash@gmail.comfereshtehfartash@yahoo.com</email>
        <affiliation>Nursing and Midwifery University of Tabriz</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Fahimeh Sehhatieh Shafaee</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Sought Shariaty Street</address>
        <city>Tabriz</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>5138856913</zip>
        <telephone>+98 41 1477 7379</telephone>
        <email>Fahimehsehhatie@yahoo.comsehhatief@tbzmed.ac.ir</email>
        <affiliation>Nursing And Midwifery Of Tabriz University</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Criteria  include more than 6 contractions per hour resulting in a demonstrated cervical change or presumed prior cervical change (transvaginal cervical length &lt; 2.5 cm, &gt;50% cervical effacement, or cervical dilation ≥2 cm) ;Gestational ages are between 26-34   ; Bloody show  ; Nully fetus pregnant  ; Intact membranes  ; BP&gt;90 mmhg in Nifedipine group  &#13;
exclude criteria&#13;
Oligohydramnios and polyhydramnios  ;Nonreactive nonstress test results   ;Positive contraction stress test results ; Absent or reversed diastolic flow upon Doppler examination of umbilical blood flow ; Repetitive severe variable decelerations ;Significant vaginal bleeding consistent with abruption  and placenta previa   ; PPROM  ;Multi fetus pregnancy   ;BP&lt;90 mmhg in  Nifedipine group  ; Intrauterine infection  ; Pyelonefrites   ;Preeclampse and GTM  and anomalies</inclusion_criteria>
      <agemin>14 years</agemin>
      <agemax>45 years</agemax>
      <gender>Female</gender>
      <exclusion_criteria></exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>O60.0</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Preterm labour without delivery</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>First group (A) will be giving 4 gram  Magnesium Sulfate as a loading dose then countining 2 gram every hour until 48 hours(positive Patella reflex ,at least 12 times respiratory rates,urine output at least 30mm)at the same time this group will be giving Placebo tablet instead of Nifedipine</i_keyword>
      <i_keyword>The other group will be giving Nifedipine tablet(20mg) after half an hour will be given other 20 mg of Nifedipine tablet,if contractions persist ,giving 20 mg Nifedipin  will be countining  every 3-8 hours   until contractions will subside.at the same time serum Ringer with microset will be conduct as Plasebo</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Effecement. Timepoint: In addmission. Method of measurement: Vaginal examination.</prim_outcome>
      <prim_outcome>Dillatation. Timepoint: In admmision. Method of measurement: Vaginal examination.</prim_outcome>
      <prim_outcome>Length and diuration of contractions. Timepoint: Every 10 minute. Method of measurement: Abdominal tough of uterus.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Feeling of fetal movment by mother. Timepoint: In an hour. Method of measurement: Abdominal touching.</sec_outcome>
      <sec_outcome>Unreliable paterns of fetal heart rate. Timepoint: In 20 minnutes. Method of measurement: Record by monitoring devices.</sec_outcome>
      <sec_outcome>Newborn Apgar. Timepoint: In first and fifth min. Method of measurement: Apgars score.</sec_outcome>
      <sec_outcome>ABG of umblical cord blood. Timepoint: After birth. Method of measurement: ABG devices.</sec_outcome>
      <sec_outcome>Meconium. Timepoint: After birth. Method of measurement: Finding meconium on neuborn skin or amniotic fluid or amblical cord.</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>Tabriz University Of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2011-11-21</approval_date>
        <contact_name>Medical Science Of Tabriz University</contact_name>
        <contact_address>Tabriz,  Golgasht St. Tabriz  Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
