<?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>IRCT20180128038535N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2018-02-22</date_registration>
      <primary_sponsor>Jahrom University of Medical Sciences</primary_sponsor>
      <public_title>The effect of subcutaneous and intracutaneous injection  of distilled sterilized water and normal saline  on the severity of childbirth pain</public_title>
      <acronym></acronym>
      <scientific_title>Comparative study of the effect of subcutaneous and intracutaneous injection  of distilled sterilized water  and normal saline  on the severity of pain, duration, and some outcomes of labor in primipara women</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2013-05-05</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>164</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/29337</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Triple blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: In order to randomize, the cards are prepared and four numbers 1, 2, 3, and 4 are written and placed inside the packets in an unspecified manner and research unit  remove one of the envelopes, if there is a number 1 in the group
 of intracutaneous of injection  distilled sterilized water, number 2 
subcutaneous injection of distilled sterilized water, number 3 in the group intracutaneous of  injection  normal saline  and number 4 in the subcutaneous group of injection normal saline are placed, Blinding description: Clinical care (interventionist) is unaware of the goals of the study.The assessor from the group assigned to the samples is not aware.The 
researcher does not know from the group assigned to the specimens.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Study of the effect of  injection distilled sterilized water and normal saline on the severity of labor pain.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group:Intracutaneous injection of distilled sterilized water. Intervention 2: Intervention group: Subcutaneous injection of distilled sterilized water. Intervention 3: control group: Intracutaneous normal saline injection. Intervention 4: Control group: Subcateneous normal saline injection.</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>Mehri Rezaie</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Ostad Motahari Blvd</address>
        <city>Jahrom</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>5415713597</zip>
        <telephone>+98 71 5433 3002</telephone>
        <email>mehrangize_rezai@yahoo.com</email>
        <affiliation>Jahrom University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Mehri Rezaie</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Ostad Motahari Blvd</address>
        <city>Jahrom</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>5415713597</zip>
        <telephone>+98 71 5433 3002</telephone>
        <email>mehrangize_rezai@yahoo.com</email>
        <affiliation>Jahrom University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Pregnant women aged between 18 and 35 years old
Primiparous women
Gestational age between 37-41 full weeks
Singletone pregnancy
Head presentation
There are at least 3 contractions in 10 minutes
Dilatation of cervix 4-6 cm
Fetus station -1 to down
Effacement of cervix more than 50%</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>35 years</agemax>
      <gender>Female</gender>
      <exclusion_criteria>All high risk pregnant women (preeclampsia, diabetes, oligo-hydramnios, polyhydramnios, etc)
Applying any pharmacological or non-pharmacological method to reduce labor pain
Drug abuse
Fetal distress</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>R52.9</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Pain, unspecified</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Treatment - Other</i_code>
      <i_code>Treatment - Other</i_code>
      <i_code>Treatment - Other</i_code>
      <i_code>Treatment - Other</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group:Intracutaneous injection of distilled sterilized water</i_keyword>
      <i_keyword>Intervention group: Subcutaneous injection of distilled sterilized water</i_keyword>
      <i_keyword>control group: Intracutaneous normal saline injection</i_keyword>
      <i_keyword>Control group: Subcateneous normal saline injection</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Severity of labor pain. Timepoint: 5 minutes before the intervention and 30, 60, 90, 120, 150 and 180 minutes after the intervention. Method of measurement: Visual analogue  Scale of McGill Pain.</prim_outcome>
      <prim_outcome>Duration of the active phase of the first stage of labor. Timepoint: Immediately after intervention. Method of measurement: Kronometer.</prim_outcome>
      <prim_outcome>Duration of the second stage of laborپس از مداخله. Timepoint: After the intervention. Method of measurement: Kronometer.</prim_outcome>
      <prim_outcome>Satisfaction of delivery. Timepoint: After the intervention. Method of measurement: questionnaire.</prim_outcome>
      <prim_outcome>Type of delivery. Timepoint: After the intervention. Method of measurement: observation.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Perineum status after delivery. Timepoint: after the intervention. Method of measurement: Observation and examination.</sec_outcome>
      <sec_outcome>Tear type. Timepoint: after the intervention. Method of measurement: Observation and examination.</sec_outcome>
      <sec_outcome>Rupture degree. Timepoint: after the intervention. Method of measurement: Observation and examination.</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>Jahrom University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2013-02-01</approval_date>
        <contact_name>Ethics committee of Jahrom University of Medical Sciences</contact_name>
        <contact_address>Ostad Motahari Bvld, University campus Jahrom Fars Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
