Clinical trial NCT02985385: Lethal Congenital Malformations: Palliative Therapy From An Islamic Point of View
Official title: Palliative Therapy For Lethal Congenital Malformations: An Islamic Perspective
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Congenital Malformations
Keywords: Congenital Lethal Malformations
Lead sponsor: Security Forces Hospital
Sponsor class: OTHER
First posted: 2016-12-07
Enrollment: 25958
Sex: ALL
Minimum age (years): 1
Maximum age (years): 1
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Babies with abnormal fetal ultrasounds and who fall into the definition of lethal congenital malformation according to the groups in our study

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:All babies with abnormal fetal ultrasounds -

Exclusion Criteria: Normal babies who die in the neonatal period because of other causes not associated with lethal malformations

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Primary outcomes:
measure: Effective Palliative therapy in lethal malformations
timeFrame: Time of death in days for a baby with lethal malformation
Secondary outcomes:
measure: Survival of babies with lethal malformations
timeFrame: Time of survival in hours or days
Other outcomes:
Locations:
city: Riyadh
country: Saudi Arabia
facility: Security Forces Hospital
state: Central
Study officials:
affiliation: Security Forces Hospital
name: KHALID A ALHUUSEIN, CABP
role: STUDY_CHAIR
References:
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: 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: Al-Aqeel AI. Ethical guidelines in genetics and genomics. An Islamic perspective. Saudi Med J. 2005 Dec;26(12):1862-70.
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.
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: 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: Leuthner SR. Fetal palliative care. Clin Perinatol. 2004 Sep;31(3):649-65. doi: 10.1016/j.clp.2004.04.018.