LCM: Lethal Congenital Malformations: Palliative Therapy From An Islamic Point of View
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
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.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Abnormal Fetal Ultrasounds 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 |
Other: Palliative management
Diagnostic studies for abnormal fetal ultrasounds
|
| Normal Fetal Ultrasounds Given normal care |
Outcome Measures
Primary Outcome Measures
- Effective Palliative therapy in lethal malformations [Time of death in days for a baby with lethal malformation]
Provide palliative care only to those babies born with lethal congenital malformations in the form of oxygen and feeding
Secondary Outcome Measures
- Survival of babies with lethal malformations [Time of survival in hours or days]
Record of the time of survival for each group of lethal malformations
Eligibility Criteria
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
-
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Security Forces Hospital | Riyadh | Central | Saudi Arabia | 11481 |
Sponsors and Collaborators
- Security Forces Hospital
Investigators
- Study Chair: KHALID A ALHUUSEIN, CABP, Security Forces Hospital
Study Documents (Full-Text)
None provided.More Information
Publications
- Al-Aqeel AI. Ethical guidelines in genetics and genomics. An Islamic perspective. Saudi Med J. 2005 Dec;26(12):1862-70. Review.
- de Crespigny L. Words matter: nomenclature and communication in perinatal medicine. Clin Perinatol. 2003 Mar;30(1):17-25.
- El-Hazmi MA. Islamic teachings of bioethics in relation to the practice of medical genetics. Saudi Med J. 2007 Dec;28(12):1781-7.
- Islamic Figh Council of Moslim World League. Website: www.themwl.org/resolutions and recommendations of the council of the Islamic Figh Academy
- Leuthner SR. Fetal palliative care. Clin Perinatol. 2004 Sep;31(3):649-65. Review.
- Schenker JG. Codes of perinatal ethics: an international perspective. Clin Perinatol. 2003 Mar;30(1):45-65.
- Strong C. Fetal anomalies: ethical and legal considerations in screening, detection, and management. Clin Perinatol. 2003 Mar;30(1):113-26.
- 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. Review.
- SFH