<?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>IRCT20230819059186N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2023-08-25</date_registration>
      <primary_sponsor>Combined Military Hospital Rawalpindi Pakistan</primary_sponsor>
      <public_title>THE USE OF ASSISTED PRE-PROCEDURAL ULTRASONOGRAPHY VERSUS LANDMARK TECHNIQUE IN IDENITIFYING EPIDURAL SPACE IN WOMEN REQUESTING LABOR ANALGESIA</public_title>
      <acronym></acronym>
      <scientific_title>THE USE OF ASSISTED PRE-PROCEDURAL ULTRASONOGRAPHY VERSUS LANDMARK TECHNIQUE IN IDENITIFYING EPIDURAL SPACE IN WOMEN REQUESTING LABOR ANALGESIA</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2023-04-18</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>250</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/72166</url>
      <study_type>observational</study_type>
      <study_design>Randomization: N/A, Blinding: Not blinded, Placebo: Not used, Assignment: Single, Purpose: Health service research.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Labor Analgesia.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group 1: Patients in Group L followed the standard blind landmark technique for insertion of the epidural catheter in the L4-L5 space under strict aseptic measures in the procedure room in the sitting position. In case of dural puncture, the space above was then identified and epidural was inserted. Intervention 2: Intervention group 2:  Patients in Group U were also prepped in the recovery room under aseptic measures for the USG procedure. A standard curvy-linear probe was placed and the parasagittal view of the L5-S1 space was identified and L4-L5 space was identified by counting upwards. After correct placement and confirmation of the space, the probe was then rotated, and the transverse view was obtained. Epidural space was then identified between the ligamentum flavum and dural space.</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 Will be decided in due course of time after permission from institution concerned</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Syed Aqib Ali Shah</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>No 22 Saddar Rawalpindi</address>
        <city>Rawalpindi</city>
        <country1>Pakistan</country1>
        <zip>46000</zip>
        <telephone>+92 51 9273426</telephone>
        <email>aqibalishahsyed@gmail.com</email>
        <affiliation>Combined Military Hospital Rawalpindi Pakistan</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Munim ilyas</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>No. 22 Saddar Rawalpindi</address>
        <city>Rawalpindi</city>
        <country1>Pakistan</country1>
        <zip>46000</zip>
        <telephone>+92 51 9273426</telephone>
        <email>aqibalishahsyed@gmail.com</email>
        <affiliation>Combined Military Hospital Rawalpindi Pakistan</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Pakistan</country2>
    </countries>
    <criteria>
      <inclusion_criteria>included all ASA I and II patients between 20-35 years of age presenting in labor after achieving term.</inclusion_criteria>
      <agemin>20 years</agemin>
      <agemax>35 years</agemax>
      <gender>Female</gender>
      <exclusion_criteria>patients with history of back pain, surgeries of the spine, on-going medical treatment for backache, patients unwilling to be included in the study, patients with coagulation disorders or on anti-coagulants and BMI greater than 35 kg/m2.</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 - Other</i_code>
      <i_code>Treatment - Other</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group 1: Patients in Group L followed the standard blind landmark technique for insertion of the epidural catheter in the L4-L5 space under strict aseptic measures in the procedure room in the sitting position. In case of dural puncture, the space above was then identified and epidural was inserted.</i_keyword>
      <i_keyword>Intervention group 2:  Patients in Group U were also prepped in the recovery room under aseptic measures for the USG procedure. A standard curvy-linear probe was placed and the parasagittal view of the L5-S1 space was identified and L4-L5 space was identified by counting upwards. After correct placement and confirmation of the space, the probe was then rotated, and the transverse view was obtained. Epidural space was then identified between the ligamentum flavum and dural space.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Primary variables measured were mean number of tries for epidural insertion (taking the needle out and then re-introduction), mean number of needle re-directions (without taking out from skin), difference between actual measured needle length (AML) versus USG measured needle length (UML) and number of dural punctures between the USG and landmark group. Timepoint: Primary variables measured were mean number of tries for epidural insertion (taking the needle out and then re-introduction), mean number of needle re-directions (without taking out from skin), difference between actual measured needle length (AML) versus USG measured needle length (UML) and number of dural punctures between the USG and landmark group. Method of measurement: The patients were divided into the ultrasonography group (Group U) (n=125) and the landmark group (Group L) (n=125). Primary variables measured were mean number of tries for epidural insertion (taking the needle out and then re-introduction), mean number of needle re-directions (without taking out from skin), difference between actual measured needle length (AML) versus USG measured needle length (UML) and number of dural punctures between the USG and landmark group.</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>Combined Military Hospital Rawalpindi Pakistan</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2023-04-17</approval_date>
        <contact_name>Ethical committee/ institutional review board Combined Military Hospital Rawalpindi</contact_name>
        <contact_address>Street 22 Saddar Rawalpindi Rawalpindi Punjab Pakistan</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
