<?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>IRCT20201022049108N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2020-11-05</date_registration>
      <primary_sponsor>Karaj University of Medical Sciences</primary_sponsor>
      <public_title>Evaluation of the effects of prophylactic misoprostol with oxytocin for postpartum hemorrhage in women with preeclampsia</public_title>
      <acronym></acronym>
      <scientific_title>Evaluation of the Efficacy of Rectal or Sub-linguinal Misoprostol concomitant with Oxytocin for Prevention of Postpartum Hemorrhage in women with preeclampsia</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2020-11-21</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>128</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/51799</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Prevention, Randomization description: Pocket shuffling, In this study for a total sample size of 128, the principle investigator write number 1 on 43 blanck cards, number 2 on 43 blanck cards, number 3 on 43 blanck cards. Then, she place them in non-transparent pockets, then give all of them to another person that will shuffle them and put them in a box and give the box back to PI. For every patients included in the study, the PI picks up one card and assign the patient to one of the 3 groups based on the information on that card.
The rest of the cards is then shuffled again and placed in a box to be used by another patient. This continues until the last patient, Blinding description: First, dark envelopes were prepared for the number of total sample size, the inside of which was not visible in the light, and a paper that the name of groups was written on them were placed in them and placed in the operating room. The surgeon picks up an envelope and gives it to the PI. Based on the information in the envelope, the PI prescribes the medication for the patient. The patients and data analyzer will not know what kind of tratment were prescribed.</study_design>
      <phase>3</phase>
      <hc_freetext>severe pre-eclampsia.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: Oral misoprostol manufactured in Aboorehyan pharmacy CO, Iran, give to patients sublingually after C-section it is in combination with conventional treatment that is infusion of 30 IU (3 X ampule 10 IU/mL) of same company. Intervention 2: Control group: Without Intervention: after C-section aconventional treatment that is infusion of 30 IU (3 X ampule 10 IU/mL) of Abooreyhan pharmacy CO. Iran. will give to patients. Intervention 3: Intervention  group: rectal misoprostol, Oral misoprostol manufactured in Aboorehyan pharmacy CO, iran, give to patients rectally after C-section it is in combination with conventional treatment that is infusion of 30 IU (3 X ampule 10 IU/mL) of same company.</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 Patients unsatisfication for sharing their information</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Mansooreh Sadeghi Afkham</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>خیابان شهید بهشتی - میدان شهداء - خیابان کمالی - مرکز آموزشی درمانی کمالی</address>
        <city>Karaj</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>3134877179</zip>
        <telephone>+98 26 3222 2021</telephone>
        <email>m.sadeh.2003@gmail.com</email>
        <affiliation>Karaj University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Mina Ataee</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>خیابان شهید بهشتی - میدان شهداء - خیابان کمالی -   مرکز آموزشی درمانی کمالی</address>
        <city>Karaj</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>3134877179</zip>
        <telephone>+98 26 3222 2021</telephone>
        <email>ataee.mina@yahoo.com</email>
        <affiliation>Karaj University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>ALL pregnant mothers with severe pre-eclampsia who referred to the Shahi Kamali educational center in the study period
Hospitalization for C-section
Gestational age over 35 weeks
Having a healthy and alive fetus
Cephalic fetus
A maximum of 2 previous cesarean sections
Complete removal of the placenta after cesarean section
The age of 18-45 years</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>45 years</agemax>
      <gender>Female</gender>
      <exclusion_criteria>Mothers with coagulation disorders
History of maternal blood disorders
Chronic hypertension
Placental adhesion such as placenta previa and ecrta
Placental abruption (overt and covert)
Complications or emergency during surgery
Eclampsia
Mild pre-eclampsia
Abnormal placenta
History of uterine rupture
High bleeding risk
Indication for hysterectomy or TL</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>O14.13</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Severe pre-eclampsia, third trimester</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Treatment - Drugs</i_code>
      <i_code>N/A</i_code>
      <i_code>Treatment - Drugs</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group: Oral misoprostol manufactured in Aboorehyan pharmacy CO, Iran, give to patients sublingually after C-section it is in combination with conventional treatment that is infusion of 30 IU (3 X ampule 10 IU/mL) of same company.</i_keyword>
      <i_keyword>Control group: Without Intervention: after C-section aconventional treatment that is infusion of 30 IU (3 X ampule 10 IU/mL) of Abooreyhan pharmacy CO. Iran. will give to patients.</i_keyword>
      <i_keyword>Intervention  group: rectal misoprostol, Oral misoprostol manufactured in Aboorehyan pharmacy CO, iran, give to patients rectally after C-section it is in combination with conventional treatment that is infusion of 30 IU (3 X ampule 10 IU/mL) of same company.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Bleeding volume with  gauze counting. Timepoint: Immediately, 1 hour, and 4 hours after C-section. Method of measurement: gauze counting.</prim_outcome>
      <prim_outcome>Hemoglobin and hematocrit changes. Timepoint: 24 hours after C-section. Method of measurement: Blood test.</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>Karaj University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2020-10-10</approval_date>
        <contact_name>lborz University of Medical Sciences</contact_name>
        <contact_address>Kamali St. Karaj Alborz Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
