<?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>IRCT20230610058438N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2023-07-21</date_registration>
      <primary_sponsor>Yasouj University of Medical Sciences</primary_sponsor>
      <public_title>Investigating the effect of yarrow on bleeding and pain after childbirth</public_title>
      <acronym></acronym>
      <scientific_title>The effect of Achillea millefolium rectal suppositories on the prevention of postpartum hemorrhage and after pain</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2023-07-12</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>100</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/70618</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Triple blinded, Placebo: Used, Assignment: Parallel, Purpose: Prevention, Randomization description: Excell software is used to create a random sequence. To create a sequence in a column, study groups (A, B) are entered as follows. In the other column, the number of samples is entered from 1 to 100 (each group has 50 people). Random numbers are generated in the opposite column with the RAND command. Then, by executing the Sort command, the generated random numbers are sorted from small to large. In this way, the assignment of people to groups A and B is done randomly. Finally, based on the random numbers created in the software, cards are created, on one end of which a number is written based on the random sequence created in the software, and on the other side is one of the letters A/B. . Samples choose cards based on the numbers on the cards. Allocation to intervention and control groups is done based on the letters written on the other end of the card and should not be visible to mother and the researcher, Blinding description: Based on the random numbers created in the software, cards are created, on one end of which a number is written based on the random sequence created in the software, and on the other side is one of the letters A/B. Samples choose cards based on the numbers on the cards. Allocation to intervention and control groups is done based on the letters that are written on the other end of the card and should not be visible to Zao and the researcher. Also, the researcher, the participants, the monitoring committee, the health care workers, the outcome assessor, and the analyst. Data do not know which suppositories contain yarrow or placebo.</study_design>
      <phase>3</phase>
      <hc_freetext>postpartum hemorrhage,after pain.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: After removal of the placenta and fetal membranes and uterine massage, a yarrow rectal suppository with the scientific name of Achillea millefolium at a dose of 250 mg is prescribed to mothers by the researcher. Then every 6 hours the administration of these drugs is repeated. Intervention 2: Control group: After removal of the placenta and fetal membranes and uterine massage, a placebo suppository that looks like Yarrow suppository is prescribed by the researcher to the mothers. Then every 6 hours the administration of these drugs is repeated.</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 further information</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Azita Raeisi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Unit3,Bldg kosar,Second alley,Seven street,Amirie street</address>
        <city>Isfahan</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>8174954584</zip>
        <telephone>+98 31 3781 7248</telephone>
        <email>a.raeisi68@gmail.com</email>
        <affiliation>Yasouj University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Azita Raeisi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Unit3,Bldg kosar,Second alley,Seven street,Amirie street</address>
        <city>Isfahan</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>8174954584</zip>
        <telephone>+98 31 3781 7248</telephone>
        <email>a.raeisi68@gmail.com</email>
        <affiliation>Yasouj University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Entry criteria: written consent to participate in the study, being Iranian, reading and writing, mother's age range between 15-50, desire to have natural childbirth, cephalic presentation, singleton pregnancy,
Term pregnancy (38 to 42 full weeks based on LMP or first trimester ultrasound)
Obtaining a score equal to or greater than 10% of the nemogram is the prevention of postpartum hemorrhage</inclusion_criteria>
      <agemin>55 years</agemin>
      <agemax>15 years</agemax>
      <gender>Female</gender>
      <exclusion_criteria>Exclusion criteria include: allergy to yarrow, unwillingness to continue participating in the study, cesarean delivery, history of uterine surgery, use of herbal or chemical drugs before delivery and during labor and delivery.
The occurrence of serious complications after childbirth (higher temperature equal to 38 degrees Celsius and higher blood pressure equal to 140/90) contracting a medical disease
Heavy bleeding during childbirth, 3rd and 4th degree tears, uterine and cervical tears, use of epidural anesthesia, shoulder dystocia, decollement, require invasive measures or drugs.</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code></hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword></hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Prevention</i_code>
      <i_code>Placebo</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group: After removal of the placenta and fetal membranes and uterine massage, a yarrow rectal suppository with the scientific name of Achillea millefolium at a dose of 250 mg is prescribed to mothers by the researcher. Then every 6 hours the administration of these drugs is repeated.</i_keyword>
      <i_keyword>Control group: After removal of the placenta and fetal membranes and uterine massage, a placebo suppository that looks like Yarrow suppository is prescribed by the researcher to the mothers. Then every 6 hours the administration of these drugs is repeated</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Postpartum bleeding is considered to be the difference greater than equal to 500 grams before and after use between the weight of the bag used to collect blood and caused by the blood collected in it. Timepoint: Bleeding volume is measured in the first, second, third and fourth hours after placental discharge. Method of measurement: Blood collection bag, sheet and pad.</prim_outcome>
      <prim_outcome>Hemoglobin. Timepoint: Before delivery, 6 and 24 hours after delivery. Method of measurement: Laboratory measurement.</prim_outcome>
      <prim_outcome>After pain. Timepoint: The amount of after pain at 2, 6, 12, 18, and 24 hours after delivery. Method of measurement: Based on visual pain scale.</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>Yasouj University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2023-06-10</approval_date>
        <contact_name>Ethics Committee of Yasouj University of Medical Sciences</contact_name>
        <contact_address>Amirieh St. 7th St. second branch of Kausar  building Isfahan Isfehan Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
