<?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>IRCT20191007045023N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2019-11-08</date_registration>
      <primary_sponsor>Iran University of Medical Sciences</primary_sponsor>
      <public_title>The effect of phenylephrine on blood pressure and nausea and vomiting in pregnant women</public_title>
      <acronym></acronym>
      <scientific_title>Comparison of the Effect of Phenylephrine Prophylactic Infusion with Placebo Group on Hypertension and Nausea and Vomiting of Pregnant Women During Cesarean Section Under Spinal Anesthesia</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2019-01-01</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>120</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/43083</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: A quadratic permutation block method was used. Subjects in blocks 1, 3 and 5 entered  into the control group and subjects in blocks 2, 4 and 6 entered into the intervention group and simple randomized table was used to select blocks.
The random assignment sheet will be used by trained personnel to assign patients to study groups (Concealment), Blinding description: The placebo was similar to the drug regarding shape of syringe, color, and volume  and the researcher and patient were not aware of the type of injection or placebo.
The outcome assessor did not know the types of the patient's intervention and only had the patient's specific code.</study_design>
      <phase>3</phase>
      <hc_freetext>Pregnancy.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: In the intervention group, 35 µg / kg phenylephrine was injected. Spinal anesthesia was performed with 12 mg bupivacaine 0.6% in a sitting position in the L3-L4 or L5-L4 space using the G25 spinal needle. After anesthesia, the patient was placed in the retina position with a slight displacement of the uterus to prevent uterine pressure on the aorta and vena cows. By the time of the baby's birth, blood pressure is measured every two minutes. Intervention 2: Control group: 0.9% normal saline serum was injected. Then spinal anesthesia was performed with 12 mg Bupivacaine 0.5% in sitting position in space of L3-L4 or L5-L4 using spinal needle G25.</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:
The data will be available one month after the responsible person's approval

When:
The access period will start from 2019 to 2021

To whom:
Data will be available to researchers working in the university.

Conditions:
Just for performing research

Where to obtain:
Refer to the responsible person for accessing the data

How to obtain:
The data will be available one month after the responsible person's approval

Comments:
</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Amineh Shafei nia</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Molavi street, Molavi intersection, Ferdowsi garden station</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>۱۱۶۸۷۴۳۵۱۴11</zip>
        <telephone>+98 21 5560 6034</telephone>
        <email>shafeinia.a@iums.ac.ir</email>
        <affiliation>Iran University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Amineh Shafei nia</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Molavi street, Molavi intersection, Ferdowsi garden station</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1168743514</zip>
        <telephone>+98 21 5560 6034</telephone>
        <email>shafeinia.a@iums.ac.ir</email>
        <affiliation>Iran University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Pregnant women 18-45 years
Pregnant women candidates for cesarean section by spinal anesthesia
ASA Class 1 and 2
Elective cesarean section</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>45 years</agemax>
      <gender>Female</gender>
      <exclusion_criteria>history of allergy to phenylephrine
BMI&gt;30 Kg/M2
hypertension (&gt;140/90 mmHg)
contraindication for spinal anesthesia
severe cardiovascular disease
prematurity
emergency cesarean section
inadequate analgesia after spinal anesthesia</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>O10</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Pre-existing hypertension complicating pregnancy, childbirth and the puerperium</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>Intervention group: In the intervention group, 35 µg / kg phenylephrine was injected. Spinal anesthesia was performed with 12 mg bupivacaine 0.6% in a sitting position in the L3-L4 or L5-L4 space using the G25 spinal needle. After anesthesia, the patient was placed in the retina position with a slight displacement of the uterus to prevent uterine pressure on the aorta and vena cows. By the time of the baby's birth, blood pressure is measured every two minutes.</i_keyword>
      <i_keyword>Control group: 0.9% normal saline serum was injected. Then spinal anesthesia was performed with 12 mg Bupivacaine 0.5% in sitting position in space of L3-L4 or L5-L4 using spinal needle G25.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Systolic blood pressure. Timepoint: every two minutes. Method of measurement: sphygmomanometer.</prim_outcome>
      <prim_outcome>Diastolic blood pressure. Timepoint: every two minutes. Method of measurement: sphygmomanometer.</prim_outcome>
      <prim_outcome>Heart rate. Timepoint: every two minutes. Method of measurement: puls oxymetrie.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Arterial pressure. Timepoint: Every two minutes. Method of measurement: Sphygmomanometer.</sec_outcome>
      <sec_outcome>SPO2. Timepoint: Every two minutes. Method of measurement: Pulse oximetry.</sec_outcome>
      <sec_outcome>Nausea. Timepoint: One time, imminently after delivery. Method of measurement: Observing.</sec_outcome>
      <sec_outcome>PH. Timepoint: One time, imminently after delivery. Method of measurement: Blood sample.</sec_outcome>
      <sec_outcome>PCO2. Timepoint: One time, imminently after delivery. Method of measurement: Blood sample.</sec_outcome>
      <sec_outcome>HCO3. Timepoint: One time, imminently after delivery. Method of measurement: Blood sample.</sec_outcome>
      <sec_outcome>Apgar 1. Timepoint: One time, imminently after delivery. Method of measurement: Observing.</sec_outcome>
      <sec_outcome>Apgar 5. Timepoint: One time, imminently after delivery. Method of measurement: Observing.</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>Iran University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2018-03-05</approval_date>
        <contact_name>Ethics committee of Iran University of Medical Sciences</contact_name>
        <contact_address>Next to Milad Tower, Hemat Highway ,Tehran Tehran Tehran Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
