NCT02985385

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
25,958

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jun 2001

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2001

Completed
4.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2005

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2005

Completed
11 years until next milestone

First Submitted

Initial submission to the registry

November 17, 2016

Completed
20 days until next milestone

First Posted

Study publicly available on registry

December 7, 2016

Completed
Last Updated

December 8, 2016

Status Verified

December 1, 2016

Enrollment Period

4.5 years

First QC Date

November 17, 2016

Last Update Submit

December 7, 2016

Conditions

Congenital Malformations

Keywords

Congenital Lethal Malformations

Outcome Measures

Primary Outcomes (1)

  • 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

Secondary Outcomes (1)

  • Survival of babies with lethal malformations

    Time of survival in hours or days

Study Arms (2)

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

Other: Palliative management

Normal Fetal Ultrasounds

Given normal care

Interventions

Palliative managementOTHER

Diagnostic studies for abnormal fetal ultrasounds

Abnormal Fetal Ultrasounds

Eligibility Criteria

Age1 Hour - 1 Hour
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)
Sampling MethodProbability 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Security Forces Hospital

Riyadh, Central, 11481, Saudi Arabia

Location

Related Publications (8)

  • 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.

    PMID: 22827258BACKGROUND

  • 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.

    PMID: 18060202BACKGROUND

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

    PMID: 16380763BACKGROUND

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

    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.

    PMID: 12696785BACKGROUND

  • 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.

    PMID: 12696783BACKGROUND

  • 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.

    PMID: 12696790BACKGROUND

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

    PMID: 15325543BACKGROUND

MeSH Terms

Conditions

Congenital Abnormalities

Condition Hierarchy (Ancestors)

Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Officials

  • KHALID A ALHUUSEIN, CABP

    Security Forces Hospital

    STUDY CHAIR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

November 17, 2016

First Posted

December 7, 2016

Study Start

June 1, 2001

Primary Completion

December 1, 2005

Study Completion

December 1, 2005

Last Updated

December 8, 2016

Record last verified: 2016-12

Data Sharing

IPD Sharing
Will share

All the results of lethal malformations are discussed with participants and the management planned approved. The outcome is explained in terms of mortality and length of survival. The feasibility of applying palliative therapy to lethal congenital malformations will enable muslim doctors to take the decision to withhold respiratory support to these cases. The results of the study have been sent to the Muslim Scholarly Council to review and evaluate them in relation to Islamic guidelines and hence share on the decision of withholding treatment for terminally sick patients. This will add weight to our decision to apply palliative therapy to babies with lethal congenital malformations.

Locations

SA(1)