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Completed

NCT Number: NCT02985385

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

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.

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Key information

Conditions

Congenital Malformations Congenital Abnormalities Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Age range

1 hour–1 hour

Sex eligibility

All sexes

Study type

Observational

Primary location

Security Forces Hospital

Riyadh, Central, 11481, Saudi Arabia

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

-

Treatment and study plan

Palliative management

Other

Diagnostic studies for abnormal fetal ultrasounds

Primary outcomes

  1. 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

Secondary outcomes

  1. 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

Sponsors and collaborators

Lead sponsor

Security Forces Hospital

Other

Registry information

Official study title

Palliative Therapy For Lethal Congenital Malformations: An Islamic Perspective

Acronym: LCM

Important dates

Study start
2001
Primary completion
2005
Study completion
2005
First posted
Dec 7, 2016
Registry last updated
Dec 8, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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