<?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>IRCT20101130005280N43</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2021-11-30</date_registration>
      <primary_sponsor>Mashhad University of Medical Sciences</primary_sponsor>
      <public_title>Comparison of the maternal and neonatal fate</public_title>
      <acronym></acronym>
      <scientific_title>Comparison of the maternal and neonatal fate of head removal between three methods of removing the head by the cephalic, breech, and anterior shoulder in the head deeply stuck in the pelvis</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2021-11-22</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>111</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/60044</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Not randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Diagnostic.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Three methods of delivery.</hc_freetext>
      <i_freetext>Intervention 1: In group one, the fetus is removed by pushing the head and cephalic. Neonatal trauma, the need for hospitalization at the NICU, and the length of time the mother and baby are hospitalized are compared and compared. Intervention 2: In group two, we remove the embryos by pulling the legs and breeches. The duration of surgery from skin incision to skin suturing, the amount of bleeding during cesarean section, intraoperative complications including enlarged incision, bladder trauma, uterine artery rupture, neonatal apical Neonatal trauma, the need for NICU hospitalization, and the length of time the mother and baby are hospitalized are compared and compared. Intervention 3: Intervention group: In the third group, we remove the fetus by removing the anterior shoulder. The amount of surgery from skin incision to suturing the skin, the amount of bleeding during cesarean section, intraoperative complications including enlarged incision, bladder trauma, uterine artery rupture, Infant apnea, neonatal trauma, the need for NICU hospitalization, and the length of time the mother and baby are hospitalized are compared and compared.</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 After finishing work, consult with colleagues and it will be published if all members</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Farideh Akhlaghi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Razavi Khorasan Province, Mashhad, Ayatolah Bahjat St</address>
        <city>Mashhad</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>91447 34756</zip>
        <telephone>+98 51 3223 1061</telephone>
        <email>AkhlaghiF@mums.ac.ir</email>
        <affiliation>Mashhad University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Farideh Akhlaghi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Razavi Khorasan Province, Mashhad, Ayatolah Bahjat St,</address>
        <city>Mashhad</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>91447 34756</zip>
        <telephone>+98 51 3223 1061</telephone>
        <email>AkhlaghiF@mums.ac.ir</email>
        <affiliation>Mashhad University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Complete Cervical effacement and Stop childbirth
The head is stuck in the birth canal
Station 1- or more</inclusion_criteria>
      <agemin>no limit</agemin>
      <agemax>no limit</agemax>
      <gender>Female</gender>
      <exclusion_criteria>Fetal head does not come out of the birth canal in one of three ways</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code></hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword></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>In group one, the fetus is removed by pushing the head and cephalic. Neonatal trauma, the need for hospitalization at the NICU, and the length of time the mother and baby are hospitalized are compared and compared.</i_keyword>
      <i_keyword>In group two, we remove the embryos by pulling the legs and breeches. The duration of surgery from skin incision to skin suturing, the amount of bleeding during cesarean section, intraoperative complications including enlarged incision, bladder trauma, uterine artery rupture, neonatal apical Neonatal trauma, the need for NICU hospitalization, and the length of time the mother and baby are hospitalized are compared and compared.</i_keyword>
      <i_keyword>Intervention group: In the third group, we remove the fetus by removing the anterior shoulder. The amount of surgery from skin incision to suturing the skin, the amount of bleeding during cesarean section, intraoperative complications including enlarged incision, bladder trauma, uterine artery rupture, Infant apnea, neonatal trauma, the need for NICU hospitalization, and the length of time the mother and baby are hospitalized are compared and compared.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Duration of surgery. Timepoint: During surgery. Method of measurement: The duration of surgery is taken in three groups.</prim_outcome>
      <prim_outcome>The rate of bladder trauma. Timepoint: During the operation. Method of measurement: Trauma to the bladder is measured during surgery from skin incision to suturing.</prim_outcome>
      <prim_outcome>The degree of trauma to the pelvic organs. Timepoint: During the operation. Method of measurement: During surgery, from the incision of the skin to the suturing of the skin, the amount of trauma to the pelvic organs is measured.</prim_outcome>
      <prim_outcome>Bleeding volume during cesarean section. Timepoint: During the operation. Method of measurement: Bleeding is measured during surgery from skin incision to suturing.</prim_outcome>
      <prim_outcome>Extension of uterine incision. Timepoint: During the operation. Method of measurement: During surgery, from the incision of the skin to the suturing of the skin, the extent of extension of the uterine incision is measured.</prim_outcome>
      <prim_outcome>Uterine vascular involvement. Timepoint: During the operation. Method of measurement: Uterine vascular involvement is measured during surgery from skin incision to suturing.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Duration of hospitalization. Timepoint: After surgery. Method of measurement: The length of hospital stay is taken.</sec_outcome>
      <sec_outcome>Trauma to the baby's limbs. Timepoint: After surgery. Method of measurement: The extent of trauma to the baby's limbs is assessed.</sec_outcome>
      <sec_outcome>Duration of hospitalization of the baby. Timepoint: After surgery. Method of measurement: The length of the baby's hospital stay is taken.</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>2020-07-15</approval_date>
        <contact_name>Ethics committee of Mashhad University of Medical Science</contact_name>
        <contact_address>Central Building of Mashhad University of Medical Sciences (Ghorshi), Daneshgah 16, Daneshgah Street mashhad Razavi Khorasan Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
