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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02985385
Other study ID # SFH
Secondary ID
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


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
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