Congenital MalformationsLCMNCT02985385
Lethal Congenital Malformations: Palliative Therapy From An Islamic Point of View
An observational study of Congenital Malformations, run by Security Forces Hospital at 1 site in Saudi Arabia.
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. Read more about this study
- Who is it for?
- Ages 1 to 1 hour
- Conditions the study is for
- Congenital Malformations
- What is being tested?
- Palliative management
- How many people
- 25,958 participants
- Where
- 1 siteSaudi Arabia
- Study dates
- Jun 2001to Dec 2005
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 to 1 hour
- All sexes
- No healthy volunteers
- Child
Study population: Babies with abnormal fetal ultrasounds and who fall into the definition of lethal congenital malformation according to the groups in our study
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
-
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Palliative Therapy For Lethal Congenital Malformations: An Islamic Perspective
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.
Read the 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.
- Conditions
- Congenital Malformations
- Being tested
- Palliative management
- Keywords
- Congenital Lethal Malformations
- Medical subject headings
- Congenital Abnormalities
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Palliative managementOther
Diagnostic studies for abnormal fetal ultrasounds
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Other: Palliative management | |
| Normal Fetal Ultrasounds | Given normal care |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Time of death in days for a baby with lethal malformation
Secondary outcomes (1)
Survival of babies with lethal malformations
Record of the time of survival for each group of lethal malformations
Measured: Time of survival in hours or days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Dec 2016 (estimated)
- Study startJun 2001
- Primary completionDec 2005
- Study completionDec 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for Congenital MalformationsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 25,958 participants (actual)
Sponsor and investigators
- Lead sponsor
- Security Forces Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, OMER B ABDELBASIT, Security Forces Hospital
- Investigators
- KHALID A ALHUUSEIN, CABP, Study chair, Security Forces Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02985385
- Sponsor's protocol ID
- SFH
- Acronym
- LCM
- Status last verified
- Dec 2016
- First submitted
- 17 Nov 2016
- Last updated
- 8 Dec 2016
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Yes: 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.
Publications
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.
PubMed 22827258El-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.
PubMed 18060202Al-Aqeel AI. Ethical guidelines in genetics and genomics. An Islamic perspective. Saudi Med J. 2005 Dec;26(12):1862-70.
PubMed 16380763Islamic Figh Council of Moslim World League. Website: www.themwl.org/resolutions and recommendations of the council of the Islamic Figh Academy
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.
PubMed 12696785de 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.
PubMed 12696783Strong 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.
PubMed 12696790Leuthner SR. Fetal palliative care. Clin Perinatol. 2004 Sep;31(3):649-65. doi: 10.1016/j.clp.2004.04.018.
PubMed 15325543
Study at a glance
From the registry record, last updated by the sponsor on 8 Dec 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Palliative Therapy For Lethal Congenital Malformations: An Islamic Perspective
- ClinicalTrials.gov ID
- NCT02985385
- Acronym / sponsor ID
- LCM / SFH
- Conditions
- Congenital Malformations
- Keywords
- Congenital Lethal Malformations
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 25,958 participants (actual)
- Lead sponsor
- Security Forces HospitalUniversity, hospital or other
- Study start
- Jun 2001
- Primary completion
- Dec 2005 (actual)
- Study completion
- Dec 2005 (actual)
- First posted
- 7 Dec 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Abnormal Fetal Ultrasounds | – | Other: Palliative managementAbnormal 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 |
| Normal Fetal Ultrasounds | – | –Given normal care |
Who may qualify
- Ages
- 1 to 1 hour
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- Babies with abnormal fetal ultrasounds and who fall into the definition of lethal congenital malformation according to the groups in our study
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Palliative managementDiagnostic studies for abnormal fetal ultrasounds | Other | Abnormal Fetal Ultrasounds |
Primary outcome
Effective Palliative therapy in lethal malformations
Time frame: 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
1 secondary outcome
Survival of babies with lethal malformations
Time frame: Time of survival in hours or days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Dec 2016.
- Background: PubMed 22827258Wilkinson 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.
- Background: PubMed 18060202El-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.
- Background: PubMed 16380763Al-Aqeel AI. Ethical guidelines in genetics and genomics. An Islamic perspective. Saudi Med J. 2005 Dec;26(12):1862-70.
- BackgroundIslamic Figh Council of Moslim World League. Website: www.themwl.org/resolutions and recommendations of the council of the Islamic Figh Academy
- Background: PubMed 12696785Schenker JG. Codes of perinatal ethics: an international perspective. Clin Perinatol. 2003 Mar;30(1):45-65. doi: 10.1016/s0095-5108(02)00081-7.
- Background: PubMed 12696783de 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.
- Background: PubMed 12696790Strong 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.
- Background: PubMed 15325543Leuthner SR. Fetal palliative care. Clin Perinatol. 2004 Sep;31(3):649-65. doi: 10.1016/j.clp.2004.04.018.
- Individual participant dataSharing planned: Yes. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
KHALID A ALHUUSEIN, CABP study chair
Security Forces Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Congenital Malformations, run by Security Forces Hospital at 1 site in Saudi Arabia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Dec 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Saudi Arabia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Effective Palliative therapy in lethal malformations (time frame: Time of death in days for a baby with lethal malformation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02985385, which also lists 8 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Dec 2016.