<?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>IRCT20180903040936N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2019-01-05</date_registration>
      <primary_sponsor>Arak University of Medical Sciences</primary_sponsor>
      <public_title>The effect of Bupivacaine and Ropivacaine on labor Pain</public_title>
      <acronym></acronym>
      <scientific_title>Comparison of efficacy of painless delivery with epidural analgesia with Bupivacain and Rupivacain in womwn candidating Analgesia labor</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2019-06-10</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>112</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/34035</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Using random numbers table, patients randomly divided into two groups of painless epidural delivery with bupivacaine and rupivacaine, Blinding description: In this study, only the anesthetist responsible for the study is aware of the type of study and the studied groups, while the patients are under the epiderdal analgesia and are not aware of the type of injectable drug.َAlso intern is responsible for the plan that is responsible for filling the questionnaire. It is not aware of the type of groups in terms of injectable drugs, and only knows the groups based on A and B, and completes questionnaires on the basis of it.</study_design>
      <phase>2-3</phase>
      <hc_freetext>Epidural analgesia with two drugs, Bupivacaine and Rupivacaine.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group:In the first group, after obtaining informed consent, 56 pregnant mothers with natural epidural analgesia (epidural analgesia) are contracted with bupivacaine. The patients received 3-5 cc / kg of crystalloid fluid and placed the necessary monitoring In sitting mode, the L3-L4 or L4-L5 space is inserted into the epidural analgesia using the gauge20 needle, then the epidural catheter is fixed. Patients in this group use a 4-6 cc marcaine, 125.0% and 5 μg fentanyl as single dose block epithelium. For preservative dosage, the combination of marcaine is 125% and fentanyl 002/0 is used at 6-10cc / h. Intervention 2: Intervention group: In the second group, the rupivacaine group, after obtaining informed consent, 56 pregnant mothers will be subjected to oral aphrodisiacs with epidural analgesia (epidural analgesia) with ropivacaine. Patients after taking 3-5 cc / kg of crystalloid fluid and placing sequestered monitoring from L3-L4 or L4-L5 space using gage20 needle under epidural analgesia with rupivacaine and then fix epidural catheter . Patients in this group use a 4-6 cc marcaine, 125.0% and 5 μg fentanyl as single dose block epithelium. For preservative dosage, the combination of marcaine is 125% and fentanyl% 002/0 is used at 6-10 cc / h.</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 No more information</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Narges Anousheh</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Ashrafi Esfahani Highway</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1476985574</zip>
        <telephone>+98 21 4449 7630</telephone>
        <email>nargesanousheh1994@gmail.com</email>
        <affiliation>Arak University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Narges Anousheh</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Ashrafi Esfahani Highway</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1476985574</zip>
        <telephone>+98 21 4449 7630</telephone>
        <email>nargesanousheh1994@gmail.com</email>
        <affiliation>Arak University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Mothers with one fetus
Pregnant mothers who are candidates for vaginal delivery (Physiological delivery)
Nullipar pregnant mothers are candidates for vaginal delivery
Pregnant women referring to Taleghani Hospital with informed consent to participate in the study.
Mothers with ASA grade one and two
Pregnant mothers between the weeks 37-42 Who are perfectly pregnant
Pregnant mothers who are candidates for vaginal delivery, who are satisfied with epidertal analgesia</inclusion_criteria>
      <agemin>no limit</agemin>
      <agemax>no limit</agemax>
      <gender>Female</gender>
      <exclusion_criteria>Patients in the epidural group who undergo epidural block failure after an epidural analgesia.
Pregnant mothers who are candidates for cesarean section for emergency reasons (such as placental abruption, umbilical cord prolapse, etc.).</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>Treatment - Drugs</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group:In the first group, after obtaining informed consent, 56 pregnant mothers with natural epidural analgesia (epidural analgesia) are contracted with bupivacaine. The patients received 3-5 cc / kg of crystalloid fluid and placed the necessary monitoring In sitting mode, the L3-L4 or L4-L5 space is inserted into the epidural analgesia using the gauge20 needle, then the epidural catheter is fixed. Patients in this group use a 4-6 cc marcaine, 125.0% and 5 μg fentanyl as single dose block epithelium. For preservative dosage, the combination of marcaine is 125% and fentanyl 002/0 is used at 6-10cc / h.</i_keyword>
      <i_keyword>Intervention group: In the second group, the rupivacaine group, after obtaining informed consent, 56 pregnant mothers will be subjected to oral aphrodisiacs with epidural analgesia (epidural analgesia) with ropivacaine. Patients after taking 3-5 cc / kg of crystalloid fluid and placing sequestered monitoring from L3-L4 or L4-L5 space using gage20 needle under epidural analgesia with rupivacaine and then fix epidural catheter . Patients in this group use a 4-6 cc marcaine, 125.0% and 5 μg fentanyl as single dose block epithelium. For preservative dosage, the combination of marcaine is 125% and fentanyl% 002/0 is used at 6-10 cc / h.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Average cesarean section. Timepoint: After intervention, observing the progression of labor and the occurrence of problems requires intervention. Method of measurement: Examination.</prim_outcome>
      <prim_outcome>Average active delivery time. Timepoint: After the intervention, when the cervical dilatation reaches 4 to 8 centimeters. Method of measurement: Examination.</prim_outcome>
      <prim_outcome>Average duration of second stage of labor. Timepoint: After the intervention, from the beginning of the full dilation of the uterus until the birth of the baby. Method of measurement: Examination.</prim_outcome>
      <prim_outcome>The average satisfaction of the patient. Timepoint: 2 hours after intervention. Method of measurement: Based on satisfaction checklist.</prim_outcome>
      <prim_outcome>Number of use of labor aid tool. Timepoint: Up to 3 hours after intervention. Method of measurement: Number.</prim_outcome>
      <prim_outcome>Mean Apgar score of 1 and 5 minutes. Timepoint: After the intervention, 1 and 5 minutes after childbirth. Method of measurement: Apgar score check list.</prim_outcome>
      <prim_outcome>Average motor blocking effect. Timepoint: After intervention, up to 2 hours after childbirth. Method of measurement: Scoring patient in the checklist.</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>Arak University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2018-09-21</approval_date>
        <contact_name>Ethics committee of Arak University of Medical Sciences</contact_name>
        <contact_address>Sardasht, Basij Square, next to Amiralmomenin Hospital, Arak University of Medical Sciences Arak Markazi Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
