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

December 7, 2016 updated by: OMER B ABDELBASIT, Security Forces Hospital

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Actual)

25958

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Saudi Arabia
    • Central
      • Riyadh, Central, Saudi Arabia, 11481
        • Security Forces Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

1 hour to 1 hour (CHILD)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability 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

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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
Diagnostic studies for abnormal fetal ultrasounds
Normal Fetal Ultrasounds
Given normal care

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Time of death in days for a baby with lethal malformation

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Survival of babies with lethal malformations
Time Frame: Time of survival in hours or days
Record of the time of survival for each group of lethal malformations
Time of survival in hours or days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Security Forces Hospital

Investigators

  • Study Chair: KHALID A ALHUUSEIN, CABP, Security Forces Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2001

Primary Completion (ACTUAL)

December 1, 2005

Study Completion (ACTUAL)

December 1, 2005

Study Registration Dates

First Submitted

November 17, 2016

First Submitted That Met QC Criteria

December 2, 2016

First Posted (ESTIMATE)

December 7, 2016

Study Record Updates

Last Update Posted (ESTIMATE)

December 8, 2016

Last Update Submitted That Met QC Criteria

December 7, 2016

Last Verified

December 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SFH

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

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.

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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