<?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>IRCT20181214041962N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2019-02-04</date_registration>
      <primary_sponsor>Gonabad University of Medical Sciences</primary_sponsor>
      <public_title>The effect of reflexology on postpartum pain and postpartum hemorrhage</public_title>
      <acronym></acronym>
      <scientific_title>The effect of foot reflexology in the fourth stage of labor on after pain and postpartum hemorrhage</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2019-01-21</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>80</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/36099</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Prevention, Randomization description: Sampling will be available (easy). Then, the research units will be assigned to two intervention and control groups using randomized systematic allocation and randomly assigned random numbers. How to use a random number table to allocate research units to study groups will be that the researcher will use the random number table to select the first number and then select the next number by up to 80 for the next five digits. The pair numbers represent the test group and the individual numbers representing the control group.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Postpartum hemorrhage,after pain.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: After leaving the placenta, without informing the mother, in the intervention group, 4 minutes of massage were performed on each leg of the mother, and then 2 minutes of specific reflexology in each of the uterus, pituitary, solar network is performed in rotational pressure. The time needed for both feet is 20 minutes. This operation is also repeated at the second hour after childbirth. Intervention 2: The control group received general massage on each foot for 4 min, followed  by rotational pressure on a neutral point on the lateral side  of the heel (placebo point).for 6 minutes.</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>No - There is not a plan to make this available</results_IPD_plan>
      <results_IPD_description>Justification or reason for not sharing IPD is For meet the confidentially of participants</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Narjes Bahri</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Asian Road Rim, Gonabad University of Medical Sciences</address>
        <city>Gonabad</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>۹۶۹۱۷۹۳۷۱۸</zip>
        <telephone>+98 57223028051</telephone>
        <email>nargesbahri@yahoo.com</email>
        <affiliation>Gonabad University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Narjes  Bahri</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Asian Road Rim, Gonabad University of Medical Sciences</address>
        <city>Gonabad</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>۹۶۹۱۷۹۷۸۵۲</zip>
        <telephone>+98 51 5722 3028</telephone>
        <email>Nargesbahri@yahoo.com</email>
        <affiliation>Gonabad University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Inclination to participate in research
Iranian race
Age 18 to 35 years old
Lack of uterus of fibroids (based on mother's statement or ultrasonography before giving birth)
Having no history of postpartum hemorrhage
Pregnancy second or third
The gestational age is 42-37 weeks of gestation (based on the first day of the last menstruation or first trimester ultrasound)
Singleton
Lack of high risk pregnancy (pregnancy hypertension, placental abnormalities such as dexamethasone, placenta perioia, placenta acetate, curium amnio nitis, gestational diabetes mellitus)
Unexplained erythematosus (polyhydramnios)
Cephalic presentation
No cuts, burns, fungal infections, varicose veins, warts, corns or numbness in the legs.
The absence of contagious skin diseases such as scabies, chicken pox, yellow wounds
Lack of deep venous thrombosis
Not having fast delivery
The second stage is less than an hour
No rupture or episiotomy
Non-use of non-pharmacological methods to accelerate the first stage of labor
Not taking anticoagulants (enoxaparin or heparin during pregnancy)
Do not use drugs that affect the nervous system
Vaginal delivery (no device)</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>35 years</agemax>
      <gender>Female</gender>
      <exclusion_criteria>Mother's reluctance to continue to work with a researcher
Exit manual pairs and embryonic curtains
Need additional treatment to control bleeding (prescribing oxytocin over 10 units, methergine, misoprostol, prostaglandin f2a, blood transfusion, surgical procedures, hand search for abdominal patches and curtains)
Baby weighs more than 4 kg
Postpartum urinary incontinence (according to the mother)
No bleeding more than 500 BC after delivery</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>Prevention</i_code>
      <i_code>Other</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group: After leaving the placenta, without informing the mother, in the intervention group, 4 minutes of massage were performed on each leg of the mother, and then 2 minutes of specific reflexology in each of the uterus, pituitary, solar network is performed in rotational pressure. The time needed for both feet is 20 minutes. This operation is also repeated at the second hour after childbirth.</i_keyword>
      <i_keyword>The control group received general massage on each foot for 4 min, followed  by rotational pressure on a neutral point on the lateral side  of the heel (placebo point).for 6 minutes.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Bleeding the fourth stage of labor. Timepoint: An hour and two hours after the intervention. Method of measurement: Bleeding measurement by disposable weighing method and pads, before and after use.</prim_outcome>
      <prim_outcome>Severity of  after pain. Timepoint: At first, second, third and fourth postpartum. Method of measurement: Visual Scale of Pain.</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>Gonabad University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2018-12-03</approval_date>
        <contact_name>Ethnical Committee of Gonabad University of Medical Sciences</contact_name>
        <contact_address>Asian Roadside Border,Gonabad University of Medical Sciences Gonabad Razavi Khorasan Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
