Table 4: Maternal medical 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
Maternal pre-pregnancy medical conditions (history) Maternal medical conditions present prior to 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 (Age (in years) at diagnosis): Integer
Yes Yes* Directly reported Study sample demographics

Sub-setting

Risk factor
Details regarding any pre-existing conditions which may act as risk factors for adverse pregnancy/fetal/infant/childhood outcomes are to be collected. Information may also come from drug indication or concomitant drugs.

Examples of important co-morbidities include asthma, autoimmune diseases, cancer, diabetes, epilepsy, hypertension, infection (cytomegalovirus, hepatitis, HIV, herpes simplex, sexually transmitted diseases etc.), neurological conditions (multiple sclerosis etc.), psychiatric illness, organ transplant and thyroid function disorders.

*Details regarding maternal mental health are valuable for studies investigating childhood health and neurodevelopmental outcomes, studies investigating these outcomes may benefit from adding separate variables to their data collection forms to ensure this important information is collected