<?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>IRCT20200122046221N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2020-05-11</date_registration>
      <primary_sponsor>Jahrom University of Medical Sciences</primary_sponsor>
      <public_title>The efficacy and side effects of oxytocin, methyl ergonovine (metergin) and misoprostol in the excretion of pregnancy products.</public_title>
      <acronym></acronym>
      <scientific_title>Comparison of the efficacy and side effects of oxytocin + misoprostol with methyl ergonovine (metergin) + misoprostol and misoprostol alone in the excretion of pregnancy products.</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2020-04-02</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>90</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/45240</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Diagnostic, Randomization description: In this study, simple randomization method will be used, the randomization unit will be individualized and we will use random number table method to generate random sequence.People are divided into three groups (two case and one control group) . They also pack medication based on codes and another person who is unaware of the randomization process gives the drugs to the patients according to the mentioned codes .This randomization and allocation will be remained hidden from researchers and participants until the statistical analysis is completed, Blinding description: despite obtaining written consent from patients to participate in the study, they only knew that they would participate in the study to find the best way to get rid of pregnancy products after first trimester abortion, but they did not know which group of drugs was included in the drug coding (one-way blinding).the ampoules and tablets were presented to the researchers in similar syringes and covers respectively (with special codes ) so that it could not be identified for the researchers.  Accordingly, the researchers who assisted patients in prescribing the drug, although they knew what the drug's content was in each package, were unaware of the research hypotheses, so they did not know which intervention group and which control group to use , It should be noted that the participants in each group were unaware of the drug regime of the opposite group.(double-blinding). And because the drugs were prescribed to patients with a coding system, the researcher did not know when the data was analyzed until the final calculations were performed. Because the researcher knew about the coding system and the researchers did not know about this system, but the data reached the researcher with numbers 1, 2 and 3, so the researcher did not know until the end of the analysis and before generalizing the calculations to the groups that the numbers one and Two or three belong to which codes A, B and C. It is obvious that the researcher's help wrote down the numbers belonging to the codes somewhere and gave them to the researcher after analyzing the data. In this research, three-way blinding technique was found.
Coding system: control group: a, second group: b, third group: c (when delivering drug envelopes coded by the researcher with the help of the researcher)
Group naming system with numbers: control group: 1, second group: 2, third group: 3 (when delivering data on therapeutic effects and side effects by the researcher to the researcher)
Note: Research Assistant for Researcher after Data Analysis: Control Group: A-1, Second Group: B-2, Third Group C-3.</study_design>
      <phase>3</phase>
      <hc_freetext>incomplete abortion in first trimester.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group:  How to prescribe the drugs in the first intervention group: Oxytocin 1 amp (dose of amp: 10 unit) in the morning, 1 amp in the afternoon and 1 amp in the evening(IM injection) + misoprostol at a dose of 200 mg every 6 hours up to 3 days.An ultrasound is then performed to examine the remaining tissue And if the products are not passed, this diet will be repeated for another two periods. Intervention 2: Intervention group: How to administer the drugs in the second intervention group:1 amp metergin every 8 hour IM and tab misoprostol at a dose of 200 mg every 6 hours up to 3 days.An ultrasound is then performed to examine the remaining tissue And if the products are not passed, this diet will be repeated for another two periods. Intervention 3: Control group:  This group will only receive Misoprostol 200mg sublingual tablets every 6 hours up to 3 days.An ultrasound is then performed to examine the remaining tissue And if the products are not passed, this diet will be repeated for another two periods.</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:
data would be presented according to the jahrom university of medical sciences protocols

When:
according to the jahrom university of medical sciences protocols

To whom:
according to the jahrom university of medical sciences protocols

Conditions:
according to the jahrom university of medical sciences protocols

Where to obtain:
jahrom university of medical sciences

How to obtain:
according to the jahrom university of medical sciences protocols

Comments:
</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>athar rasekhjahromi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Jahrom-Ostad Motahari Street-After School of Nursing-Jahrom University of Medical Sciences-Pardis site.</address>
        <city>jahrom</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>۷۴۱۴۸-۴۶۱۹۹</zip>
        <telephone>+98 71 5433 1521</telephone>
        <email>drrasekh@yahoo.com</email>
        <affiliation>Jahrom University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>athar rasekhjahromi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Jahrom-Ostad Motahari Street-After School of Nursing-Jahrom University of Medical Sciences-Pardis site.</address>
        <city>jahrom</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>۷۴۱۴۸-۴۶۱۹۹</zip>
        <telephone>+98 71 5433 1521</telephone>
        <email>drrasekh@yahoo.com</email>
        <affiliation>Jahrom University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>tendency toward outpatient treatment
gestational age less than 14 week
not presence of high risk disease</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>45 years</agemax>
      <gender>Female</gender>
      <exclusion_criteria>presence of a major disease
the patients who can not tolerate drugs
those who get tired from the process of treatment</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>O03.4</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Incomplete spontaneous abortion without complication</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Diagnosis</i_code>
      <i_code>Diagnosis</i_code>
      <i_code>Diagnosis</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group:  How to prescribe the drugs in the first intervention group: Oxytocin 1 amp (dose of amp: 10 unit) in the morning, 1 amp in the afternoon and 1 amp in the evening(IM injection) + misoprostol at a dose of 200 mg every 6 hours up to 3 days.An ultrasound is then performed to examine the remaining tissue And if the products are not passed, this diet will be repeated for another two periods.</i_keyword>
      <i_keyword>Intervention group: How to administer the drugs in the second intervention group:1 amp metergin every 8 hour IM and tab misoprostol at a dose of 200 mg every 6 hours up to 3 days.An ultrasound is then performed to examine the remaining tissue And if the products are not passed, this diet will be repeated for another two periods.</i_keyword>
      <i_keyword>Control group:  This group will only receive Misoprostol 200mg sublingual tablets every 6 hours up to 3 days.An ultrasound is then performed to examine the remaining tissue And if the products are not passed, this diet will be repeated for another two periods</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Time of disposal of pregnancy products. Timepoint: Before starting the study . 3-6-9 days after starting the drug regimen. Method of measurement: The time from partial abortion to complete disposal of pregnancy products was measured.</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>Jahrom University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2017-06-03</approval_date>
        <contact_name>jahrom university of medical science ethic comitte</contact_name>
        <contact_address>jahrom,motahari street,jahrom university of medical science jahrom Fars Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
