<?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>IRCT2017070934981N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2017-07-16</date_registration>
      <primary_sponsor>Vice chancellor for research, Zahedan University of Medical Sciences</primary_sponsor>
      <public_title>The effect of estrogen and misoprostol on abortion</public_title>
      <acronym></acronym>
      <scientific_title>Comparison of induction of abortion in the first trimester using misoprostol and misoprostol with estrogen priming</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2017-07-23</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>100</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/26580</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Abortion.</hc_freetext>
      <i_freetext>In this study, the aim of this study was to examine the induction of abortion in the first trimester using misoprostol and misoprostol with estrogen priming, randomly divided into two groups receiving misoprostol and misoprostol with estrogen priming. In the misoprostol-containing group, this medication at 800 μg every 8 hours (4 pills 200 μg) will be placed vaginal in the posterior foreskin (up to a maximum dose of 2400 μg), followed by side effects of fever, sweating, fatigue, Nausea, vomiting, abdominal pain ... and the time taken to remove tissue and will be recorded in the patient's case. Four hours after the removal of the tissue, ultrasound is performed for the patient and if the pregnancy remains below 10 mm, the abortion is considered successful and if the remains are more than 10 mm, the curettage will be performed for the patient. . In the misoprostol group with estrogen priming, we will also work on the misoprostol group, with the exception that in this group, the first dosage of misoprostol will be given to the patient with oral estrogen valerima with a dose of 2 mg and the study will continue to be similar to that of the previous group. were..</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></results_IPD_plan>
      <results_IPD_description></results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Maryam Esmaeilpour</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>University Street, Dr Hasabe Square</address>
        <city>Zahedan</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip></zip>
        <telephone>+98 543329557185</telephone>
        <email>esmailpoorm2@yahoo.com</email>
        <affiliation>Zahedan University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Batoul Teymouri</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Ali ebn Abi Taleb Hop</address>
        <city>Zahedan</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip></zip>
        <telephone>+98 543329557185</telephone>
        <email>teimoorib@yahoo.com</email>
        <affiliation>Zahedan University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Entry Criteria: Pregnant women aged 6 weeks to 14 weeks have two Missed Abortion ultrasounds. &#13;
Exit criteria: history of cesarean section, history of adrenal, kidney or liver disease, pulmonary disease, coagulation disorders, evidence of thromboembolic events, prostaglandin sensitivity, smoking, water repellent, vaginal bleeding, history of thromboembolism, estrogen dependent cancers Breast and genital system), intrauterine device, any normal amount of blood. Pre-treatment blood tests include CBC, liver and kidney function tests including blood urea, creatinine, albumin, globulin, liver enzymes, electrolytes, severe anemia, disorders Uncontrolled seizures</inclusion_criteria>
      <agemin>no limit</agemin>
      <agemax>no limit</agemax>
      <gender>Female</gender>
      <exclusion_criteria></exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>O02.1</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Early fetal death with retention of dead fetus</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Treatment - Drugs</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>In this study, the aim of this study was to examine the induction of abortion in the first trimester using misoprostol and misoprostol with estrogen priming, randomly divided into two groups receiving misoprostol and misoprostol with estrogen priming. In the misoprostol-containing group, this medication at 800 μg every 8 hours (4 pills 200 μg) will be placed vaginal in the posterior foreskin (up to a maximum dose of 2400 μg), followed by side effects of fever, sweating, fatigue, Nausea, vomiting, abdominal pain ... and the time taken to remove tissue and will be recorded in the patient's case. Four hours after the removal of the tissue, ultrasound is performed for the patient and if the pregnancy remains below 10 mm, the abortion is considered successful and if the remains are more than 10 mm, the curettage will be performed for the patient. . In the misoprostol group with estrogen priming, we will also work on the misoprostol group, with the exception that in this group, the first dosage of misoprostol will be given to the patient with oral estrogen valerima with a dose of 2 mg and the study will continue to be similar to that of the previous group. were.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Successful abortion. Timepoint: 4 hours after disposal of pregnancy. Method of measurement: Based on the amount of pregnancy residues in ultrasound after excretion of pregnancy products.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Misoprostol side effects. Timepoint: Immediately after starting treatment. Method of measurement: Based on completed patient questionnaire.</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 for research, Zahedan University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2017-05-21</approval_date>
        <contact_name>Ethics Committee of Zahedan University of Medical Sciences</contact_name>
        <contact_address>University Street, Dr Hasabe Square Zahedan  Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
