<?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>IRCT20210305050583N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2021-03-23</date_registration>
      <primary_sponsor>Mashhad University of Medical Sciences</primary_sponsor>
      <public_title>Evaluation of intrauterine gel of mazo aqueous extract on postpartum hemorrhage</public_title>
      <acronym></acronym>
      <scientific_title>Effect Intrauterin Gel of aqueous extract of Quercus Infectoria gall on the early postpartum hemorrhage</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2021-05-05</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>68</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/54914</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Triple blinded, Placebo: Used, Assignment: Parallel, Purpose: Prevention, Randomization description: Sampling in the maternity ward of Umm AL-Banin Hospital is performed by purposive sampling method based on inclusion and exclusion criteria .Research units are assigned to two groups of intervention and control using random allocation with the sequence created in the randomization website; Mazo and placebo aqueous extract gel has been prepared and packaged in the same way by the pharmacist consulting professor at the Pharmacological  Research Center of Medicinal Plants of Mashhad University of Medical Sciences, and the pharmacist consulting professor assigns acode to each group(only the pharmacology consultant is aware ).Based on codes A and B assigned to the two groups, the sequence is created AABAB; to hide the allocation, the method of opaque and sealed envelopes, which are numbered in order, will be used, Blinding description: For blinding, aqueous extract gel gel of Mazo and placebo  in similar forms and the same applicators are provided to the researcher. Each applicator has a code that only a pharmacist consultant knows. Individuals with inclusion criteria are grouped according to the codes based on the sequence created and until the end of the study, the research unite, researcher, statistical analyst and delivery agent will not know the codes related to aqueous extract of mazo  and placebo.</study_design>
      <phase>3</phase>
      <hc_freetext>postpartum hemorrhage.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: In addition to receiving routine oxytocin, immediately after placenta abruption and utrerine massage  an interauterine gel applicator containing 700 mg  of aqueous extract of mazo is inserted  into uterus through the inner hole of cervix. Intervention 2: Control group:: In addition to receiving routine oxytocin, immediately after placenta abruption and utrerine massage  an interauterine gel applicatoris  containing placebo gel is inserted  into uterus through the inner hole of cervix.</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>Yes - There is a plan to make this available</results_IPD_plan>
      <results_IPD_description>What will be shared:
The data will be shared after it becomes unrecognizable

When:
6 months after recording the results

To whom:
Allresearchers

Conditions:
The reduce postpartum hemorrhage

Where to obtain:
Email: MollazadehT982@mums.ac.ir, Library of Mashhad School of Nursing  to Mashhad Daneshgah  Street.

How to obtain:
First, send a requested email and if you do not respond within a week, you  can refer to the library of mashhad school of nursing

Comments:
</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Tayebeh Mollazadeh</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>University St., PhD. Intersection, Ibn Sina St., Mashhad School of Nursing and Midwifery</address>
        <city>Mashhad</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>9137913199</zip>
        <telephone>+98 51 3859 1151</telephone>
        <email>MollazadehT982@mums.ac.ir</email>
        <affiliation>Mashhad University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Mahboubeh Firoozi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>University St., Ph.D. Intersection, Ibn Sina St., Mashhad School of Nursing and Midwifery</address>
        <city>Mashhad</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>9137913199</zip>
        <telephone>+98 51 3859 1511</telephone>
        <email>FirooziM@mums.ac.ir</email>
        <affiliation>Mashhad University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Persian has informed consent to participate in the study .
Tends to have a normal delivery.
Have a singleton pregnancy with a display of the peak of the head
Maternal body mass index is less than 30
Mathers have no history of anemia HB&lt;7
Has no history of allergies to herbal medicines.
Has no history of medical and obstetric diseases.
Has no history of cesarean section and uterine surgery.
Has a history of giving birth less than 5 times .
Gestational age is between 37-42 weeks and in the active phase labore (4-6cm)
Fetal weight should be estimated between 2500-4000
Water bag rupture should not be more than 12 hours and temperature should not be more than 38</inclusion_criteria>
      <agemin>15 years</agemin>
      <agemax>44 years</agemax>
      <gender>Female</gender>
      <exclusion_criteria>Persion dose not want to continue participating in the study.
Delivery by cesarean section.
Grade 3or 4 perineal rupture or rupture of uterus and cervix occur.
Quick deliveries.
Have delivery with the device.
Have  postpartum hemorrhage more than 500cc.
Placenta out by hand</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>Prevention</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group: In addition to receiving routine oxytocin, immediately after placenta abruption and utrerine massage  an interauterine gel applicator containing 700 mg  of aqueous extract of mazo is inserted  into uterus through the inner hole of cervix.</i_keyword>
      <i_keyword>Control group:: In addition to receiving routine oxytocin, immediately after placenta abruption and utrerine massage  an interauterine gel applicatoris  containing placebo gel is inserted  into uterus through the inner hole of cervix.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Postpartum   hemorrhage. Timepoint: At the beginning of the intervention, at the end of the first, second, third, fourth and first four hours after delivery. Method of measurement: By weighing the method of collecting blood bags and disposable drums and pads.</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>Mashhad University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2021-03-08</approval_date>
        <contact_name>Ethics Committee of Mashhad University of Medical Sciences</contact_name>
        <contact_address>Qureshi Building University Street, Mashhad, Iran Mashhad Razavi Khorasan Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
