Due to the multiplicity of possible medical conditions and measurements of disease activity/severity, it was not considered feasible to provide specific recommendations around the collection of maternal medical conditions arising either during pregnancy or in the post-partum period.
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 medical conditions arising in pregnancy | Any maternal medical condition arising during pregnancy | Value 1 (detail): Text Value 2 (MedDRA/ICD diagnosis code): Text Value 3 (Coding system) - Options: a) MedDRA, b) ICD10, c) Other (detail) - Text Value 4 (gestational age when condition was diagnosed in days): Integer |
Yes | Yes* | Directly reported | Sub-setting Risk factor Report statistics |
Value 4 (gestational age when condition was diagnosed in days) is considered an important detail for this data element as it will allow researchers to perform analysis of events occurring at aetiologically relevant time points in the pregnancy. *The importance of maternal medical conditions arising during pregnancy as a co-variable risk factor for adverse pregnancy/infant outcome may vary by the outcome under analysis. *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 |
| Maternal post-partum complications | Any maternal complication occurring post-delivery | Value 1 - Options: a) Yes, b) No, c) Unknown Value 2 (MedDRA/ICD diagnosis code): Text Value 3 (Coding system) - Options: a) MedDRA, b) ICD10, c) Other (detail) - Text |
No | Yes | Directly reported | Sub-setting Risk factor Report statistics |
|
| Maternal death | Death of a woman while pregnant or ≤42 days of the end of the pregnancy (including live/stillbirth delivery, ectopic pregnancy, miscarriage or termination) from any cause related to or aggravated by the pregnancy or its management but not from accidental or incidental causes. | Value 1 - Options: a) Yes, b) No, c) Unknown If "Yes", Value 2 (date of death): Date (dd/mmm/yyyy) Values 3 (cause of death, MedDRA/ICD diagnosis code): Text Value 4 (Coding system) - Options: a) MedDRA, b) ICD10, c) Other (detail) - Text |
Yes | Yes | Directly reported | Sub-setting Risk factor Report statistics Follow-up |