<?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>IRCT20210607051505N2</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2021-10-31</date_registration>
      <primary_sponsor>Vice Chancellor of Guilan University of Medical Sciences</primary_sponsor>
      <public_title>Survey of the effect of date fruit consumption on amount of postpartum hemorrhage.</public_title>
      <acronym></acronym>
      <scientific_title>Survey of the effect of date fruit consumption on amount of postpartum hemorrhage in women hospitalized.</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2021-11-11</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>98</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/59197</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Prevention, Randomization description: The type of randomization is blocking and will be divided into two groups of date consumer and control using the block randomization method with the size of 4 and 6 blocks. The method used to generate the random allocation sequence is from the online randomization service Sealed Envelope Ltd. 2019 will be used (https://www.sealedenvelope.com/simple-randomiser/v1/lists). 
The method of concealing the allocation is to use sealed envelopes.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Postpartum hemorrhage.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: Two hours after delivery and stability of the samples 100 gr of Bam Mazafati dates which are weighed and packaged by the researcher, should be given to them to eat within a maximum time of 2 hours. A pack of sanitary pads will be given. Pictorial Blood loss Assessment Chart (PBAC) will be given to them and it should be completed within first 24 hours after delivery based on amount of bleeding. Intervention 2: Control group: In this group, only routine care will be performed. Also a package of sanitary pads and PBAC will be given to them.</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 After sampling</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Maryam Farash</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Daneshjoo St., Rasht - Shahid Beheshti Highway, Rasht Town</address>
        <city>Rasht</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>39841-41469</zip>
        <telephone>+98 13 3355 5058</telephone>
        <email>farimah.farash98@gmail.com</email>
        <affiliation>Rasht University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Maryam Niknami</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Daneshjoo St., Shahid Beheshti Highway, Rasht Town</address>
        <city>Rasht</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>39841-41469</zip>
        <telephone>+98 13 3355 5058</telephone>
        <email>niknami@gums.ac.ir</email>
        <affiliation>Rasht University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Age between 18 and 35 years
Having minimum of primary education
History of childbirth less than 5 times ( not being grandmultipara)
Body Mass Index (BMI) between 18/5 to 29/9 kg/m2
Lack of history and absence of medical disorders and pregnancy complications
Not receiving herbal remedies during pregnancy
Estimated fetal weight between 2500 to 4500 gr
Term and singleton pregnancy
Vertex presentation
Normal amniotic fluid index in third trimester sonography
Normal length of the first, second and third stages based on birth partograph
Breastfeeding begins less than two hours after delivery</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>35 years</agemax>
      <gender>Female</gender>
      <exclusion_criteria>Rupture of embryonic membranes more than 12 hours
Precipitous delivery
Operative delivery
Grade 3 or 4 tear
Retention of placenta
Remove placenta with courage
Severe bleeding in fourth stage of birth
Receive oxytocin more than routine dosage of hospital</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>O72.1</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Other immediate postpartum haemorrhage</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Prevention</i_code>
      <i_code>N/A</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group: Two hours after delivery and stability of the samples 100 gr of Bam Mazafati dates which are weighed and packaged by the researcher, should be given to them to eat within a maximum time of 2 hours. A pack of sanitary pads will be given. Pictorial Blood loss Assessment Chart (PBAC) will be given to them and it should be completed within first 24 hours after delivery based on amount of bleeding.</i_keyword>
      <i_keyword>Control group: In this group, only routine care will be performed. Also a package of sanitary pads and PBAC will be given to them</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Postpartum hemorrhage scores within first 24 hours ( primary Postpartum hemorrhage) in pictorial blood loss assessment chart. Timepoint: First 24 hours after intervention. Method of measurement: The method of measuring the Postpartum hemorrhage is the standard pictorial blood loss assessment chart. This tool is a table that shows the days of bleeding in horizontal and bloodstain pads or tampons or clots in vertical rows. Bloody pads or tampons divide to three degrees: mild with 1 score, moderate with 5 score and severe with 20 score. Small and large clots gain 1 and 5 scores, respectively. Women mark table after changing their pads every time within 24 hours after birth. At the end of 24 hours the final scores will be calculated. The cut-off score of severe bleeding is 100 and more. The validity and reliability of PBAC have been proven in numerous studies.</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>Vice Chancellor of Guilan University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2021-09-29</approval_date>
        <contact_name>Ethics Committee of Guilan University of Medical Sciences</contact_name>
        <contact_address>Daneshjoo St, Rasht - Shahid Beheshti Highway, Rasht Town Rasht Guilan Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
