<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT02985385</url>
  </required_header>
  <id_info>
    <org_study_id>SFH</org_study_id>
    <nct_id>NCT02985385</nct_id>
  </id_info>
  <brief_title>Lethal Congenital Malformations: Palliative Therapy From An Islamic Point of View</brief_title>
  <acronym>LCM</acronym>
  <official_title>Palliative Therapy For Lethal Congenital Malformations: An Islamic Perspective</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Security Forces Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Security Forces Hospital</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      To prove that palliative therapy can be practised for congenital lethal malformations within&#xD;
      the Islamic Code of Ethics.&#xD;
&#xD;
      After defining lethal malformation no respiratory support is offered and newborns are&#xD;
      provided with compassionate care.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This is a prospective observational study where all abnormal antenatal ultrasounds are&#xD;
      discussed in a weekly prenatal meeting and plans are drawn for management of these abnormal&#xD;
      fetal findings. Lethal malformations are defined as conditions which will end in death&#xD;
      regardless of supportive care. Cases are discussed extensively and parents are involved in&#xD;
      management decisions. When a decision of non- intervention is reached for a lethal&#xD;
      malformation consent of the family is obtained and a plan of non monitoring for the mother is&#xD;
      documented together with no resuscitation for the newborn. Families who do not consent to&#xD;
      such plan are offered full support for the pregnant mother and her newborn. A record of all&#xD;
      cases is kept available together with the management plan so that the appropriate action is&#xD;
      taken when the the pregnant lady presents for admission. All babies with lethal malformations&#xD;
      are recorded whether stillborn or live born and their diagnosis is confirmed. Survival time&#xD;
      is recorded for each case.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>June 2001</start_date>
  <completion_date type="Actual">December 2005</completion_date>
  <primary_completion_date type="Actual">December 2005</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Effective Palliative therapy in lethal malformations</measure>
    <time_frame>Time of death in days for a baby with lethal malformation</time_frame>
    <description>Provide palliative care only to those babies born with lethal congenital malformations in the form of oxygen and feeding</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Survival of babies with lethal malformations</measure>
    <time_frame>Time of survival in hours or days</time_frame>
    <description>Record of the time of survival for each group of lethal malformations</description>
  </secondary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Actual">25958</enrollment>
  <condition>Congenital Malformations</condition>
  <arm_group>
    <arm_group_label>Abnormal Fetal Ultrasounds</arm_group_label>
    <description>Abnormal fetal ultrasounds:&#xD;
Those consistent with lethal malformations are provided with palliative management without providing respiratory support. Are given feeding and oxygen&#xD;
Those compatible with life are managed by full investigation and given standard care for each case</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Normal Fetal Ultrasounds</arm_group_label>
    <description>Given normal care</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Palliative management</intervention_name>
    <description>Diagnostic studies for abnormal fetal ultrasounds</description>
    <arm_group_label>Abnormal Fetal Ultrasounds</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Babies with abnormal fetal ultrasounds and who fall into the definition of lethal&#xD;
        congenital malformation according to the groups in our study&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:All babies with abnormal fetal ultrasounds -&#xD;
&#xD;
        Exclusion Criteria: Normal babies who die in the neonatal period because of other causes&#xD;
        not associated with lethal malformations&#xD;
&#xD;
        -&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>1 Hour</minimum_age>
    <maximum_age>1 Hour</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>KHALID A ALHUUSEIN, CABP</last_name>
    <role>Study Chair</role>
    <affiliation>Security Forces Hospital</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Security Forces Hospital</name>
      <address>
        <city>Riyadh</city>
        <state>Central</state>
        <zip>11481</zip>
        <country>Saudi Arabia</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Saudi Arabia</country>
  </location_countries>
  <reference>
    <citation>Wilkinson DJ, Thiele P, Watkins A, De Crespigny L. Fatally flawed? A review and ethical analysis of lethal congenital malformations. BJOG. 2012 Oct;119(11):1302-8. doi: 10.1111/j.1471-0528.2012.03450.x. Epub 2012 Jul 25.</citation>
    <PMID>22827258</PMID>
  </reference>
  <reference>
    <citation>El-Hazmi MA. Islamic teachings of bioethics in relation to the practice of medical genetics. Saudi Med J. 2007 Dec;28(12):1781-7. No abstract available.</citation>
    <PMID>18060202</PMID>
  </reference>
  <reference>
    <citation>Al-Aqeel AI. Ethical guidelines in genetics and genomics. An Islamic perspective. Saudi Med J. 2005 Dec;26(12):1862-70.</citation>
    <PMID>16380763</PMID>
  </reference>
  <reference>
    <citation>Islamic Figh Council of Moslim World League. Website: www.themwl.org/resolutions and recommendations of the council of the Islamic Figh Academy</citation>
  </reference>
  <reference>
    <citation>Schenker JG. Codes of perinatal ethics: an international perspective. Clin Perinatol. 2003 Mar;30(1):45-65. doi: 10.1016/s0095-5108(02)00081-7.</citation>
    <PMID>12696785</PMID>
  </reference>
  <reference>
    <citation>de Crespigny L. Words matter: nomenclature and communication in perinatal medicine. Clin Perinatol. 2003 Mar;30(1):17-25. doi: 10.1016/s0095-5108(02)00088-x.</citation>
    <PMID>12696783</PMID>
  </reference>
  <reference>
    <citation>Strong C. Fetal anomalies: ethical and legal considerations in screening, detection, and management. Clin Perinatol. 2003 Mar;30(1):113-26. doi: 10.1016/s0095-5108(02)00083-0.</citation>
    <PMID>12696790</PMID>
  </reference>
  <reference>
    <citation>Leuthner SR. Fetal palliative care. Clin Perinatol. 2004 Sep;31(3):649-65. doi: 10.1016/j.clp.2004.04.018.</citation>
    <PMID>15325543</PMID>
  </reference>
  <verification_date>December 2016</verification_date>
  <study_first_submitted>November 17, 2016</study_first_submitted>
  <study_first_submitted_qc>December 2, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">December 7, 2016</study_first_posted>
  <last_update_submitted>December 7, 2016</last_update_submitted>
  <last_update_submitted_qc>December 7, 2016</last_update_submitted_qc>
  <last_update_posted type="Estimate">December 8, 2016</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Security Forces Hospital</investigator_affiliation>
    <investigator_full_name>OMER B ABDELBASIT</investigator_full_name>
    <investigator_title>Principal Investigator</investigator_title>
  </responsible_party>
  <keyword>Congenital Lethal Malformations</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Congenital Abnormalities</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Yes</sharing_ipd>
    <ipd_description>All the results of lethal malformations are discussed with participants and the management planned approved. The outcome is explained in terms of mortality and length of survival. The feasibility of applying palliative therapy to lethal congenital malformations will enable muslim doctors to take the decision to withhold respiratory support to these cases.&#xD;
The results of the study have been sent to the Muslim Scholarly Council to review and evaluate them in relation to Islamic guidelines and hence share on the decision of withholding treatment for terminally sick patients. This will add weight to our decision to apply palliative therapy to babies with lethal congenital malformations.</ipd_description>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT02985385
org study id: SFH
nct id: NCT02985385
lead sponsor: 
has dmc: Yes
To prove that palliative therapy can be practised for congenital lethal malformations within
      the Islamic Code of Ethics.

      After defining lethal malformation no respiratory support is offered and newborns are
      provided with compassionate care.
This is a prospective observational study where all abnormal antenatal ultrasounds are
      discussed in a weekly prenatal meeting and plans are drawn for management of these abnormal
      fetal findings. Lethal malformations are defined as conditions which will end in death
      regardless of supportive care. Cases are discussed extensively and parents are involved in
      management decisions. When a decision of non- intervention is reached for a lethal
      malformation consent of the family is obtained and a plan of non monitoring for the mother is
      documented together with no resuscitation for the newborn. Families who do not consent to
      such plan are offered full support for the pregnant mother and her newborn. A record of all
      cases is kept available together with the management plan so that the appropriate action is
      taken when the the pregnant lady presents for admission. All babies with lethal malformations
      are recorded whether stillborn or live born and their diagnosis is confirmed. Survival time
      is recorded for each case.
observational model: Cohort
time perspective: Prospective
measure: Effective Palliative therapy in lethal malformations
time frame: Time of death in days for a baby with lethal malformation
description: Provide palliative care only to those babies born with lethal congenital malformations in the form of oxygen and feeding
measure: Survival of babies with lethal malformations
time frame: Time of survival in hours or days
description: Record of the time of survival for each group of lethal malformations
arm group label: Abnormal Fetal Ultrasounds
description: Abnormal fetal ultrasounds:
Those consistent with lethal malformations are provided with palliative management without providing respiratory support. Are given feeding and oxygen
Those compatible with life are managed by full investigation and given standard care for each case
arm group label: Normal Fetal Ultrasounds
description: Given normal care
intervention type: Other
intervention name: Palliative management
description: Diagnostic studies for abnormal fetal ultrasounds
arm group label: Abnormal Fetal Ultrasounds
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 1 Hour
maximum age: 1 Hour
healthy volunteers: No
last name: KHALID A ALHUUSEIN, CABP
role: Study Chair
affiliation: Security Forces Hospital
facility: 
country: Saudi Arabia
citation: Wilkinson DJ, Thiele P, Watkins A, De Crespigny L. Fatally flawed? A review and ethical analysis of lethal congenital malformations. BJOG. 2012 Oct;119(11):1302-8. doi: 10.1111/j.1471-0528.2012.03450.x. Epub 2012 Jul 25.
PMID: 22827258
citation: El-Hazmi MA. Islamic teachings of bioethics in relation to the practice of medical genetics. Saudi Med J. 2007 Dec;28(12):1781-7. No abstract available.
PMID: 18060202
citation: Al-Aqeel AI. Ethical guidelines in genetics and genomics. An Islamic perspective. Saudi Med J. 2005 Dec;26(12):1862-70.
PMID: 16380763
citation: Islamic Figh Council of Moslim World League. Website: www.themwl.org/resolutions and recommendations of the council of the Islamic Figh Academy
citation: Schenker JG. Codes of perinatal ethics: an international perspective. Clin Perinatol. 2003 Mar;30(1):45-65. doi: 10.1016/s0095-5108(02)00081-7.
PMID: 12696785
citation: de Crespigny L. Words matter: nomenclature and communication in perinatal medicine. Clin Perinatol. 2003 Mar;30(1):17-25. doi: 10.1016/s0095-5108(02)00088-x.
PMID: 12696783
citation: Strong C. Fetal anomalies: ethical and legal considerations in screening, detection, and management. Clin Perinatol. 2003 Mar;30(1):113-26. doi: 10.1016/s0095-5108(02)00083-0.
PMID: 12696790
citation: Leuthner SR. Fetal palliative care. Clin Perinatol. 2004 Sep;31(3):649-65. doi: 10.1016/j.clp.2004.04.018.
PMID: 15325543
responsible party type: Principal Investigator
investigator affiliation: Security Forces Hospital
investigator full name: OMER B ABDELBASIT
investigator title: Principal Investigator
mesh term: Congenital Abnormalities
sharing ipd: Yes
ipd description: All the results of lethal malformations are discussed with participants and the management planned approved. The outcome is explained in terms of mortality and length of survival. The feasibility of applying palliative therapy to lethal congenital malformations will enable muslim doctors to take the decision to withhold respiratory support to these cases.
The results of the study have been sent to the Muslim Scholarly Council to review and evaluate them in relation to Islamic guidelines and hence share on the decision of withholding treatment for terminally sick patients. This will add weight to our decision to apply palliative therapy to babies with lethal congenital malformations.