Table 5: Family medical history and obstetric history details


Display only CDE items recommended as ESSENTIAL when studying: Pregnancy and infant outcomes Longer term childhood outcomes

CDE Item Definition Recommended data format and suggested values Essential to collect when studying pregnancy and infant outcomes Essential to collect when studying longer term childhood outcomes Source Purpose Notes
Family history of congenital anomalies The presence of any congenital anomaly (major or minor) in any sibling (live born, stillborn or terminated), or the mother or the father of the reference pregnancy, or their immediate/ first degree relatives (grandparents, aunts or uncles of the reference pregnancy) Value 1 - Options: a) Yes, b) No, c) Unknown

If "Yes", Value 2 (MedDRA/ICD diagnosis code): Text

If "Yes", Value 3 (Coding system) - Options: a) MedDRA, b) ICD10, c) Other (detail) - Text

If "Yes", Value 4 (record details of anomaly, and relationship to the affected family member): Text
No* No* Directly reported Sub-setting

Risk factor

Derivation (number of previous pregnancies with congenital anomalies)
*Not essential but highly recommended as an important co-variable risk factor.

Only the categorical response can be used in data sub-setting or as a risk factor statistic.

May be useful to improve analysis of infant congenital anomaly data.
Relevant family history of genetic conditions The presence of any genetic condition in a relative thought to be the explanation or of relevance to the abnormalities reported in the reference pregnancy Value 1 - Options: a) Yes, b) No, c) Unknown

If "Yes", Value 2 (MedDRA/ICD diagnosis code): Text

If "Yes", Value 3 (Coding system) - Options: a) MedDRA, b) ICD10, c) Other (detail) - Text

If "Yes", Value 4 (record details of the condition(s), and relationship to the affected family member): Text
No* No* Directly reported Sub-setting

Risk factor
*Not essential but highly recommended as an important co-variable risk factor.

Only the categorical response can be used in data sub-setting or as a risk factor statistic. May be useful to improve analysis of infant congenital anomaly data.

Relevant family history of learning disability or of neurodevelopmental disorders The presence of a learning disability or neurodevelopmental disorder (e.g. attention deficit hyperactivity disorder or autistic spectrum disorder) in a sibling, mother, father or their immediate / first degree relatively (grandparents, aunts or uncles of the reference pregnancy) Value 1 - Options: a) Yes, b) No, c) Unknown

If "Yes", Value 2 (MedDRA/ICD diagnosis code): Text

If "Yes", Value 3 (Coding system) - Options: a) MedDRA, b) ICD10, c) Other (detail) - Text

If "Yes", Value 4 (record details of the condition(s), and relationship to the affected family member): Text
No No* Directly reported Sub-setting

Risk factor
*Not essential but highly recommended as an important co-variable risk factor.

Only the categorical response can be used in data sub-setting or as a risk factor statistic.

History of learning disability or neurodevelopmental disorders may be relevant to neurodevelopmental outcomes but less essential for certain childhood health variables.
Relevant family history of diseases with onset in childhood The present of a health condition which onsets in childhood (<18 years of age) Value 1 - Options: a) Yes, b) No, c) Unknown

If "Yes", Value 2 (MedDRA/ICD diagnosis code): Text

If "Yes", Value 3 (Coding system) - Options: a) MedDRA, b) ICD10, c) Other (detail) - Text

If "Yes", Value 4 (record details of the condition(s), and relationship to the affected family member): Text
No No* Directly reported Risk factor *Not essential but highly recommended as an important co-variable risk factor.

Only the categorical response can be used in data sub-setting or as a risk factor statistic.

History of health conditions may be relevant to child health conditions but less so to other longer term outcomes (e.g. neurodevelopmental outcomes)
Number of previous pregnancies Number of previous pregnancies (including non-live births) experienced by the mother only Integer No No Directly reported Risk factor
Number of previous live births Number of previous live births Integer No* No* Directly reported Sub-setting

Risk factor
*Not essential but highly recommended as an important co-variable risk factor.

May be useful to improve analysis of infant birth weight data

Birth order may be particularly relevant for certain developmental outcomes
Number of previous spontaneous abortions Number of previous spontaneous abortions Integer No* No Directly reported Sub-setting

Risk factor
*Not essential but highly recommended as an important co-variable risk factor.

May be useful to improve analysis of miscarriage data
Number of previous induced terminations Number of previous induced terminations (for any reason) Integer No No Directly reported Sub-setting

Risk factor
Number of previous stillbirths Number of previous stillbirths Integer No* No Directly reported Sub-setting

Risk factor
*Not essential but highly recommended as an important co-variable risk factor.

May be useful to improve analysis of stillbirth data
Number of previous pregnancies with congenital anomalies Number of previous pregnancies (including non-live births) experienced by the mother which resulted in a fetus or child with congenital anomalies Integer No* No Directly reported Sub-setting

Risk factor
*Not essential but highly recommended as an important co-variable risk factor.

May be useful to improve analysis of infant congenital anomaly data