<?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>IRCT20120915010841N10</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2018-12-12</date_registration>
      <primary_sponsor>Hamedan University of Medical Sciences</primary_sponsor>
      <public_title>The effect of spinal opioids on labor pain</public_title>
      <acronym></acronym>
      <scientific_title>Comparison of intra techal injection of  fentanyl and sufentanil  on the onset, duration and quality of   analgesia  in vaginal delivery under spinal  anesthesia .</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2018-07-23</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>50</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/33948</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: In this study, the randomization method is used as a 4-block . In this way, according to the sample size, 12 blocks are identified, and in each of these four blocks, two of each group will be written in the form of letters A or B. This means that two A and two B are written in each block, although the order of the writing of the four letters A and B will be different in each block. The periodic numbers table will then be used to determine the order of block selection, Blinding description: All patients, after entering the operating room using Angiocath 18, received 500 ml  of Ringer serum and  patient's primary vital signs are measured by a non-invasive monitoring device.
Then the patient is placed in a sitting position and placed under spinal anesthesia with spinal Quincke needle number 25 in L4-L5 or L3-L4 space, and after leaving the cerebrospinal fluid from the needle tip and correcting the subarachnoid space,1.5 ml of one of the two  drugs fentanyl or sufentanil that prepared by an anesthetist nurse ((Which does not know the study)) in syringes of the same size and shape  ,  is drawn into sterile syringe  by  anesthetist  and is injected into the sub-arachnoid space,  in each patient  two groups A or B. Thus, the patient, anesthetist (assessor), and an analyzer  are not aware of any prescriptive substance.</study_design>
      <phase>2-3</phase>
      <hc_freetext>Vaginal delivery under spinal analgesia.</hc_freetext>
      <i_freetext>Intervention 1: First intervention group: After receiving 500 ml of Ringer's serum  patients were placed in a sitting position after  and  25  Quinke needle  inserted into L3-L4 or L4-L5 space and after observing the coming out  of cerebro spinal fluid from the sub arachnoid space, in the first group(A), 1.5 ml of fentanyl is injected by an anesthetist who has no known medication in sterile syringe and injected into the subarachnoid space. Intervention 2: Second intervention group:   After receiving 500 ml of Ringer's serum  patients were placed in a sitting position after  and 25  Quinke needle inserted into L3-L4 or L4-L5 space and after observing the  coming out of cerebrospinal fluid from the sub arachnoid space, In the second  group(B), 1.5 ml of sufentanyl is injected by an anesthetist who has no known medication in sterile syringe and injected into the subarachnoid 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 Because the study is not finished yet.</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Nahid Manouchehrian</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Fatemieh Hospital, Pasdaran Street</address>
        <city>Hamadan</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>6517789971</zip>
        <telephone>+98 81 3827 7012</telephone>
        <email>manuchehriann@gmail.com</email>
        <affiliation>Hamedan University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Nahid Manouchehrian</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Fatemieh Hospital, Pasdaran Street</address>
        <city>Hamadan</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>6517789971</zip>
        <telephone>+98 81 3827 7012</telephone>
        <email>manuchehriann@gmail.com</email>
        <affiliation>Hamedan University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Patients with class 1 and 2  of physical status(ASA)
The second pregnancy
Gestational age 36 to 40 weeks
Aged 18 to 45 years old
Active phase of labor(Cervical dilatation is more than 5 cm)</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>45 years</agemax>
      <gender>Female</gender>
      <exclusion_criteria>Heart disease
Diabetes
Spinal anesthesia Contraindication(High ICP, coagulation problems, shock, anemia)
History of opioid  use  in 24 hours before delivery</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>074.6</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Other complications of spinal and epidural anaesthesia during labour and 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 intervention group: After receiving 500 ml of Ringer's serum  patients were placed in a sitting position after  and  25  Quinke needle  inserted into L3-L4 or L4-L5 space and after observing the coming out  of cerebro spinal fluid from the sub arachnoid space, in the first group(A), 1.5 ml of fentanyl is injected by an anesthetist who has no known medication in sterile syringe and injected into the subarachnoid space.</i_keyword>
      <i_keyword>Second intervention group:   After receiving 500 ml of Ringer's serum  patients were placed in a sitting position after  and 25  Quinke needle inserted into L3-L4 or L4-L5 space and after observing the  coming out of cerebrospinal fluid from the sub arachnoid space, In the second  group(B), 1.5 ml of sufentanyl is injected by an anesthetist who has no known medication in sterile syringe and injected into the subarachnoid space.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Time to start analgesia. Timepoint: After doing spinal analgesia. Method of measurement: Calculation of the time from the moment of spinal analgesia is just the feeling of pain relief by the patient.</prim_outcome>
      <prim_outcome>Duration of analgesia. Timepoint: Since the reduction in the patient's pain until the restart of pain. Method of measurement: Calculate the time  when the vas of  pain  decreases to less than 4 until vas of  pain increases again to more than 4.</prim_outcome>
      <prim_outcome>Quality of analgesia. Timepoint: After performing spinal analgesia every 5 minutes to 15 minutes and then every 15 minutes to 3 hours. Method of measurement: Use a 10-cm ruler to determine the vas of pain by patient.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Mother's heart rate. Timepoint: After performing spinal analgesia every 5 minutes to 15 minutes and then every 15 minutes to 3 hours. Method of measurement: Pulse oximetry device.</sec_outcome>
      <sec_outcome>Duration of the first stage of labor. Timepoint: Since the onset of labor pain before the baby's birth. Method of measurement: Calculate the dilation time of cervix at 5 cm to the full  dilation  of cervix.</sec_outcome>
      <sec_outcome>Duration of the second stage of labor. Timepoint: After baby birth. Method of measurement: Calculation from the time of  full dilation of cervix  until birth  time of the baby.</sec_outcome>
      <sec_outcome>Sedation Score. Timepoint: After performing spinal analgesia every 5 minutes to 15 minutes and then every 15 minutes to 3 hours. Method of measurement: Ramsay Score.</sec_outcome>
      <sec_outcome>Nausea and vomiting. Timepoint: During the first and second stages of Labor. Method of measurement: Observation  and ask the patient.</sec_outcome>
      <sec_outcome>Itching. Timepoint: During the first and second stages of Labor. Method of measurement: Observation.</sec_outcome>
      <sec_outcome>Baby  Apgar. Timepoint: The first and fifth minutes after birth of the baby. Method of measurement: Apgar Score.</sec_outcome>
      <sec_outcome>Fetal  heart  rate. Timepoint: After performing spinal analgesia every 5 minutes to 15 minutes and then every 15 minutes to 3 hours. Method of measurement: Fetal heart monitoring device.</sec_outcome>
      <sec_outcome>Need to do cesarean section. Timepoint: During the first and second stages of Labor. Method of measurement: Seeing the transfer to the operating room for cesarean section.</sec_outcome>
      <sec_outcome>Satisfaction. Timepoint: After baby birth. Method of measurement: Ask the patient.</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>Hamedan University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2018-06-30</approval_date>
        <contact_name>Ethics committee of Hamadan University of Medical Sciences</contact_name>
        <contact_address>Hamadan University of Medical Sciences, Mahdie Street Hamadan Hamadan Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
