<?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>IRCT20180411039267N3</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2019-07-13</date_registration>
      <primary_sponsor>Tabriz University of Medical Sciences</primary_sponsor>
      <public_title>Effect of  ephedrine on fetal and neonatal heart rate in emergency cesarean delivery due to fetal  bradycardia</public_title>
      <acronym></acronym>
      <scientific_title>A study of  effect of  prophylactic intravenous ephedrine on fetal and neonatal heart rate in emergency cesarean delivery due to fetal  bradycardia</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2019-06-01</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>96</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/32025</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: The cases will be randomly divided into two groups of 48 people in the study group and 48 people in the control group using random numbers table. In the event of odd, they would be placed in the ephedrine group and in the event of even, they would be placed in the placebo group, Blinding description: The administration of anesthesia and serum before and during anesthesia is performed by an anesthesiologist and anesthesia technician. So that one ml of bolus intravenous ephedrine (equivalent to 10 mg) is injected into the study group and one ml of sodium chloride 0.9% as a placebo is injected into the placebo group. Then, all data will be collected and recorded in the checklist by an other anesthesiologist who is unaware of the injected drug type and the division of the groups and is not in charge of anesthesia management. Pregnant women undergoing cesarean section are also unaware of the division of the groups.</study_design>
      <phase>3</phase>
      <hc_freetext>fetal  bradycardia, prophylactic intravenous ephedrine, emergency cesarean delivery.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: In 48 pregnant women with fetal bradycardia, as soon as mother's arrival into the operating room and after initial monitoring, one ml of intravenous ephedrine equivalent to 10 mg will be injected to the mother and its effect on the fetal and neonatal heart rate will be examined. Intervention 2: Control group: In 48 pregnant women with fetal bradycardia, as soon as mother's arrival into the operating room and after initial monitoring, one ml of intravenous sodium chloride 0.9% as a placebo will be injected to the mother and its effect on the fetal and neonatal heart rate will be examined.</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>Undecided - It is not yet known if there will be a plan to make this available</results_IPD_plan>
      <results_IPD_description>Justification or reason for indecision in sharing IPD is There is no more information.</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Reyhaneh Abri</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Department of Anesthesiology, Alzahra Hospital, South Artesh Street</address>
        <city>Tabriz</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>5174815811</zip>
        <telephone>+98 41 3553 9163</telephone>
        <email>reyhane.abri@gmail.com</email>
        <affiliation>Tabriz University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Reyhaneh Abri</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Department of Anesthesiology, Alzahra Hospital, South Artesh Street</address>
        <city>Tabriz</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>5174815811</zip>
        <telephone>+98 41 3553 9163</telephone>
        <email>reyhane.abri@gmail.com</email>
        <affiliation>Tabriz University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Term pregnancy
Physical status of American society of Anesthesiology (ASA) class I or II
fetal  bradycardia
candidate for emergency cesarean with spinal anesthesia
Informed consent
18 to 45 years old</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>45 years</agemax>
      <gender>Female</gender>
      <exclusion_criteria>Contraindication of regional anesthesia
Gestational hypertension, preeclampsia, eclampsia
HELLP syndrome (Hemolysis, increased liver enzyms, low platelet)
Maternal co-existing disease such as heart disease which ephedrine administration is contraindicated
Emergency Cesarean section due to peripartum hemorrhage, umbilical cord prolapse</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>Placebo</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group: In 48 pregnant women with fetal bradycardia, as soon as mother's arrival into the operating room and after initial monitoring, one ml of intravenous ephedrine equivalent to 10 mg will be injected to the mother and its effect on the fetal and neonatal heart rate will be examined.</i_keyword>
      <i_keyword>Control group: In 48 pregnant women with fetal bradycardia, as soon as mother's arrival into the operating room and after initial monitoring, one ml of intravenous sodium chloride 0.9% as a placebo will be injected to the mother and its effect on the fetal and neonatal heart rate will be examined.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Fetal and neonatal heart rate. Timepoint: Measuring fetal heart rate at the entrance to the operating room, one minute after ephedrine or placebo injection, immediately after the spinal anesthesia, measuring the neonatal heart rate immediately, 5 and 10 minutes after birth. Method of measurement: The fetal heart rate is measured by sonochade and neonatal heart rate by pulse oximeter and will be recorded in the checklist prepared for this purpose.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>APGAR score in the 1, 5, 10th minutes of birth. Timepoint: in the 1, 5, 10th minutes after birth. Method of measurement: Observe and examination of the baby in minutes 1, 5 and 10.</sec_outcome>
      <sec_outcome>Admission rate of the neonate in NICU. Timepoint: While baby's transfer to the neonatal ward or NICU. Method of measurement: Record from the patient file.</sec_outcome>
      <sec_outcome>Neonatal arterial blood gases. Timepoint: Immediately after clamp of umbilical cord. Method of measurement: neonatal arterial blood gases analysis.</sec_outcome>
      <sec_outcome>Maternal blood pressure and the need for additional ephedrine. Timepoint: Every 2 minutes up to 10 minutes, then every 5 minutes up to 30 minutes, and then every 10 minutes until the end of operation. Method of measurement: Measurement by non-invasive barometer cuff of vital signs monitoring device.</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>2018-10-08</approval_date>
        <contact_name>Ethics committee of Tabriz University of Medical Sciences</contact_name>
        <contact_address>Department of Anesthesiology, Alzahra hospital, South artesh street Tabriz East Azarbaijan Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
