Lethal Congenital Malformations: Palliative Therapy From An Islamic Point of View

Congenital Malformations Clinical Trial

— LCM  

Official title:

Palliative Therapy For Lethal Congenital Malformations: An Islamic Perspective

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02985385
• Other study ID #: SFH
• Status: Completed
• Phase: N/A
• First received: November 17, 2016
• Last updated: December 7, 2016
• Start date: June 2001
• Est. completion date: December 2005

Study information

• Verified date: December 2016
• Source: Security Forces Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Saudi Arabia: Ethics CommitteeSaudi Arabia: Research Advisory Council
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 25958
• Est. completion date: December 2005
• Est. primary completion date: December 2005
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A to 1 Hour

Eligibility

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

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Congenital Abnormalities
• Congenital Malformations

Intervention

Other:
• Palliative management
Diagnostic studies for abnormal fetal ultrasounds

Locations

Country	Name	City	State
Saudi Arabia	Security Forces Hospital	Riyadh	Central

Sponsors (1)

Lead Sponsor	Collaborator
Security Forces Hospital

Country where clinical trial is conducted

Saudi Arabia, 

References & Publications (8)

Al-Aqeel AI. Ethical guidelines in genetics and genomics. An Islamic perspective. Saudi Med J. 2005 Dec;26(12):1862-70. Review. — View Citation

de Crespigny L. Words matter: nomenclature and communication in perinatal medicine. Clin Perinatol. 2003 Mar;30(1):17-25. — View 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. — View Citation

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. — View Citation

Schenker JG. Codes of perinatal ethics: an international perspective. Clin Perinatol. 2003 Mar;30(1):45-65. — View Citation

Strong C. Fetal anomalies: ethical and legal considerations in screening, detection, and management. Clin Perinatol. 2003 Mar;30(1):113-26. — View 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. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Effective Palliative therapy in lethal malformations	Provide palliative care only to those babies born with lethal congenital malformations in the form of oxygen and feeding	Time of death in days for a baby with lethal malformation	No
Secondary	Survival of babies with lethal malformations	Record of the time of survival for each group of lethal malformations	Time of survival in hours or days	No