<?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>IRCT20091219002889N12</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2022-02-22</date_registration>
      <primary_sponsor>Esfahan University of Medical Sciences</primary_sponsor>
      <public_title>The effect of Auriculotherapy on postpartum hemorrhage and its consequences</public_title>
      <acronym></acronym>
      <scientific_title>The effect of Auriculotherapy on postpartum hemorrhage and its consequences</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2022-01-21</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>106</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/60862</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: At first, all mothers who go to the maternity hospital of the selected hospital for delivery will be evaluated by easy sampling method. Then, mothers who meet the inclusion criteria will be randomly divided into two groups: uriculotherapy (intervention) and control. To do this, sealed envelopes will be used. White envelopes are prepared in 106 pieces and the letter A is placed inside 53 of them and the letter B is placed inside 53 of them, and then the lid of the envelopes will be closed. The envelopes are placed in a box. Mothers referred for delivery will take an envelope out of the box after examining the inclusion criteria and will be placed in the intervention or control group according to the words removed. The letter A indicates the intervention group and the letter B indicates the control group. Any envelopes removed by the mother will be removed from the original envelope box.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Postpartum hemorrhage.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: In addition to receiving routine care, the intervention group will also receive auricular therapy intervention. To perform uriculotherapy intervention, the researcher first cleansed the mother's ears with an alcohol swab and then stimulated the Oxytocin(posterior pituitary), Uterus and Shenmen points in left ear and Thalamic, Lung1 and 2 points in right ear with the help of Vakaria herbal seeds.These seeds are placed on the mother's ear at the mentioned points in the dilatation stage of ten centimeters. In the ten-centimeter dilatation phase,  immediately after the exit of fetus and one hour after the exit of placenta, each seed will be pressed for one minute. This technique will be performed by the researcher for all samples. After 24 hours from the time of delivery, the previous seeds are removed and new seeds are placed in the same places. The mother is taught to press each point for one minute at least 6 to 8 times and utmost every one hour for ten days. Meanwhile, mothers are told that there is no need to press the seeds at nights. Intervention 2: Control group: The control group will receive only routine care during delivery and postpartum period.</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 There is no more information.</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Mahboobeh Valliani</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Isfahan University of Medical Sciences, Hezar Jarib St.</address>
        <city>Isfahan</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>81746-73461</zip>
        <telephone>+98 31 3668 0048</telephone>
        <email>valiani@nm.mui.ac.ir</email>
        <affiliation>Esfahan University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Mahboobeh Valiani</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Isfahan University of Medical Sciences, Hezar Jerib St.</address>
        <city>Isfahan</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>81746-73461</zip>
        <telephone>+98 31 3668 0048</telephone>
        <email>valiani@nm.mui.ac.ir</email>
        <affiliation>Esfahan University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Having a term pregnancy
Normal delivery
No history of bleeding before and during delivery
Having normal hemoglobin (11 and above)
Having the consent to participate in the study
No sores or lesions in the ear
No gravid 4 or higher
Live fetus
Ultrasound-confirmed single pregnancy
Not weighing more than 4000 grams of fetus on ultrasound</inclusion_criteria>
      <agemin>no limit</agemin>
      <agemax>no limit</agemax>
      <gender>Female</gender>
      <exclusion_criteria>history of coagulation disorders and use of anticoagulants
endocrine and vascular diseases
high-risk pregnancy (Gestational hypertension, gestational diabetes, etc.)
history of infertility
history of mental disorders ( Mother self report)
recent emotional stress (death of a close family member in the current pregnancy, divorce, etc.)</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>O72</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Postpartum hemorrhage</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Treatment - Devices</i_code>
      <i_code>Treatment - Other</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group: In addition to receiving routine care, the intervention group will also receive auricular therapy intervention. To perform uriculotherapy intervention, the researcher first cleansed the mother's ears with an alcohol swab and then stimulated the Oxytocin(posterior pituitary), Uterus and Shenmen points in left ear and Thalamic, Lung1 and 2 points in right ear with the help of Vakaria herbal seeds.These seeds are placed on the mother's ear at the mentioned points in the dilatation stage of ten centimeters. In the ten-centimeter dilatation phase,  immediately after the exit of fetus and one hour after the exit of placenta, each seed will be pressed for one minute. This technique will be performed by the researcher for all samples. After 24 hours from the time of delivery, the previous seeds are removed and new seeds are placed in the same places. The mother is taught to press each point for one minute at least 6 to 8 times and utmost every one hour for ten days. Meanwhile, mothers are told that there is no need to press the seeds at nights.</i_keyword>
      <i_keyword>Control group: The control group will receive only routine care during delivery and postpartum period.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Postpartum hemorrhage. Timepoint: One hour and 24 hours after delivery. Method of measurement: Plastic graded shan, number and weight of pads used by mother, hemoglobin and hematocrit level.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Postpartum blues. Timepoint: One day and ten days after delivery. Method of measurement: Edinburgh Postnatal Depression Scale.</sec_outcome>
      <sec_outcome>Postnatal Attachment. Timepoint: One day and ten days after delivery. Method of measurement: Maternal Postnatal Attachment Scale.</sec_outcome>
      <sec_outcome>Postpartum Pain. Timepoint: One day and ten days after delivery. Method of measurement: Visual Analog Scale.</sec_outcome>
      <sec_outcome>Breastfeeding pattern. Timepoint: One day and ten days after delivery. Method of measurement: Interview with mother.</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>Isfahan University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2021-10-30</approval_date>
        <contact_name>Ethics Committee of Isfahan University of Medical Sciences</contact_name>
        <contact_address>Hezar Jarib Street، Isfahan university of Medical sciences Isfahan Isfehan Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
