<?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>IRCT20230101057014N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2023-02-04</date_registration>
      <primary_sponsor>Yasouj University of Medical Sciences</primary_sponsor>
      <public_title>Bilateral hypogastric artery occlusion on the volume of bleeding in patients with abnormal placental adhesion</public_title>
      <acronym></acronym>
      <scientific_title>Evaluation of bilateral hypogastric artery occlusion on the volume of bleeding in patients with abnormal placental adhesions</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2021-10-23</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>40</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/67826</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: In order to randomly select the treatment method using the kitset.ir website  patients were divided into two groups and placed in their own group at the beginning of the study. In this way, first a number is considered for each patient and the first and last number and the desired number of numbers are entered in the relevant part of the mentioned site and by clicking on the number generation option, the numbers are given to us selectively and randomly.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Abnormal placental adhesion.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: In the hypo-gastric artery ligation group, first 10 units of oxytocin are used to eutronicize the uterus, and in case of high suspicion of placental adhesion, the patient's bleeding is controlled by bilateral hypogastric artery ligation. An oncologist starts the surgery by opening the posterior peritoneum that covers the bifurcation of the common iliac vessels. Then, bilateral hypo-gastric artery ligation steps are carefully performed. Before performing this surgery and also after closing the hypogastric artery, checking the femoral pulse on both sides is done. Intervention 2: Intervention group: In the hypo-gastric artery group without ligation, cesarean surgery and hysterectomy are performed. The cesarean surgery starts by cutting the skin from the mid-line until exposing the uterus, and the fetus is delivered through the classical upper section. The umbilical cord is cut and closed by using a Kokher clip.</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 It has not been decided yet.</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Parvin Ghaffari</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Yasuj University of Medical Sciences, Shahid Motahari boulvared, Yasuj city, Kohgiluyeh and Boyer-Ahmad Province, Iran.</address>
        <city>Yasuj</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>7591741417</zip>
        <telephone>+98 71 3837 0829</telephone>
        <email>pari.ghaffari@gmail.com</email>
        <affiliation>Yasouj University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Parvin Ghaffari</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Yasuj University of Medical Sciences, Shahid Motahari boulvared, Yasuj city, Kohgiluyeh and Boyer-Ahmad Province, Iran.</address>
        <city>Yasuj</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>7591741417</zip>
        <telephone>+98 71 3837 0829</telephone>
        <email>pari.ghaffari@gmail.com</email>
        <affiliation>Yasouj University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Patients with abnormal placental adhesion with Multiple Lacuna
Patients with abnormal placental adhesion due to loss of the retroplacental region
Patients with abnormal placental adhesion that abnormalities of the serous connection of the bladder and uterus, which will be identified through trans-abdominal and trans-vaginal ultrasonography by referring to the sonographist.</inclusion_criteria>
      <agemin>no limit</agemin>
      <agemax>no limit</agemax>
      <gender>Female</gender>
      <exclusion_criteria>Cases that have a high risk for bleeding during surgery include bleeding disorders (such as hemoglobinopathies, and thrombocytopenia)
Cases receiving anticoagulant treatment, etc
Cases of abnormal invasive placenta that require quick termination of pregnancy, such as heavy bleeding in the emergency department of people who have underlying diseases such as diabetes, blood pressure disorders, heart diseases, etc.
Those who refused to participate in the study</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>O00.0</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Abdominal pregnancy</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Treatment - Surgery</i_code>
      <i_code>Treatment - Surgery</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group: In the hypo-gastric artery ligation group, first 10 units of oxytocin are used to eutronicize the uterus, and in case of high suspicion of placental adhesion, the patient's bleeding is controlled by bilateral hypogastric artery ligation. An oncologist starts the surgery by opening the posterior peritoneum that covers the bifurcation of the common iliac vessels. Then, bilateral hypo-gastric artery ligation steps are carefully performed. Before performing this surgery and also after closing the hypogastric artery, checking the femoral pulse on both sides is done.</i_keyword>
      <i_keyword>Intervention group: In the hypo-gastric artery group without ligation, cesarean surgery and hysterectomy are performed. The cesarean surgery starts by cutting the skin from the mid-line until exposing the uterus, and the fetus is delivered through the classical upper section. The umbilical cord is cut and closed by using a Kokher clip.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>The amount of bleeding volume during the surgery. Timepoint: During the surgery. Method of measurement: In order to estimate the volume of blood lost during the surgery, the volume of liquid collected in the suction device, the difference in the weight of  clean and soaked in blood gauze and lung gauze and the number of towels used to control the bleeding were used.</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>2021-10-16</approval_date>
        <contact_name>Ethics committee of Yasuj University of Medical Sciences</contact_name>
        <contact_address>Deputy of research and technology of Yasuj University of Medical Sciences, Shahid Motahari boulvared, Yasuj city, Kohgiluyeh and Boyer-Ahmad Province, Iran. Yasuj Kohgilouyeh-va-Boyrahmad Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
