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

NCT ID: NCT02985385

Last Updated: 2016-12-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

25958 participants

Study Classification

OBSERVATIONAL

Study Start Date

2001-06-30

Study Completion Date

2005-12-31

Brief Summary

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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

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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.

Conditions

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Congenital Malformations

Keywords

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Congenital Lethal Malformations

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Abnormal Fetal Ultrasounds

Abnormal fetal ultrasounds:

1. Those consistent with lethal malformations are provided with palliative management without providing respiratory support. Are given feeding and oxygen
2. Those compatible with life are managed by full investigation and given standard care for each case

Palliative management

Intervention Type OTHER

Diagnostic studies for abnormal fetal ultrasounds

Normal Fetal Ultrasounds

Given normal care

No interventions assigned to this group

Interventions

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Palliative management

Diagnostic studies for abnormal fetal ultrasounds

Intervention Type OTHER

Eligibility Criteria

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Exclusion Criteria

\-
Minimum Eligible Age

1 Hour

Maximum Eligible Age

1 Hour

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Security Forces Hospital

OTHER

Sponsor Role lead

Responsible Party

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OMER B ABDELBASIT

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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KHALID A ALHUUSEIN, CABP

Role: STUDY_CHAIR

Security Forces Hospital

Locations

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Security Forces Hospital

Riyadh, Central, Saudi Arabia

Site Status

Countries

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Saudi Arabia

References

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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.

Reference Type BACKGROUND
PMID: 22827258 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 18060202 (View on PubMed)

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

Reference Type BACKGROUND
PMID: 16380763 (View on PubMed)

Islamic Figh Council of Moslim World League. Website: www.themwl.org/resolutions and recommendations of the council of the Islamic Figh Academy

Reference Type BACKGROUND

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.

Reference Type BACKGROUND
PMID: 12696785 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 12696783 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 12696790 (View on PubMed)

Leuthner SR. Fetal palliative care. Clin Perinatol. 2004 Sep;31(3):649-65. doi: 10.1016/j.clp.2004.04.018.

Reference Type BACKGROUND
PMID: 15325543 (View on PubMed)

Other Identifiers

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SFH

Identifier Type: -

Identifier Source: org_study_id