Table 1: Database administrative 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
Pregnancy exposure The report relates to a confirmed pregnancy (where a woman was carrying a fertilised oocyte, developing embryo or fetus, irrespective of the outcome) with exposure to a medical product Values: a) Yes, b) No Yes* Yes* Directly reported Dataset creation *This may only be relevant for datasets collecting reports of exposures and clinical outcomes in groups which are not necessarily pregnant. For example, in pregnancy registries all cases are exposed but this is not the case in drug registries and spontaneous adverse drug reaction datasets.
Mother case identifier Unique database identifier for the pregnant woman Text NA NA Internally generated Database functionality

Dataset creation
Maternal identifiers (e.g. name, date of birth, healthcare system number) and contact details (e.g. address, email, telephone number) will be required for follow-up purposes in prospective data collection systems.
Baby case identifier Unique database identifier for each offspring record Text NA NA Internally generated Database functionality

Dataset creation
Infant identifiers (e.g. name, date of birth, healthcare system number) and parental contact details (e.g. name, address, email, telephone number) will be required for follow-up purposes in longer-term prospective data collection systems.
Mother-Baby case link identifier Common unique identifier linking mother with fetus/fetuses or child/children (same identifier located on both maternal and fetal/offspring records) Text NA NA Internally generated Database functionality

Dataset creation
Primary reporter type Type of reporter providing the information Values: a) Healthcare professional, b) Other Yes Yes Directly reported Follow-up/case queries

Sub-setting
The primary reporter is assumed to collect information from evolving sources during pregnancy. Additional detail about the type of non-healthcare professional reporter may be required in some data collection instances (example, it may be useful to specifically identify reports from medication users - parents of affected children - or individuals which believe to have been affected by in utero medication exposure).
Primary reporter contact details Name and contact details for the primary reporter Value 1: Title

Value 2: Name

Value 3: Address

Value 4 Telephone number

Value 5: Email address
Yes Yes Directly reported Follow-up/case queries Contact details may include postal and/or email address and telephone number.
Initial report date Date when pregnancy is initially reported to the data collection system Date (dd/mm/yyyy) Yes Yes Directly reported or internally generated Derivation (pro/retrospective reporting status)

Sub-setting
Prospective status Whether the pregnancy was reported prospectively or retrospectively Values: a) Prospective, b) Retrospective, c) Unknown Yes Yes Directly reported

Derived (see notes)
Sub-setting Prospective - Report of a drug-exposed pregnancy (either during pregnancy or prior to conception) whilst the patient is still pregnant

Retrospective - Report of a drug-exposed pregnancy (either during pregnancy or prior to conception) after the pregnancy has ended.

Where required, alternative definitions of pro/retrospective can be constructed from the information collected about prenatal tests together with the Initial report date and date of end of pregnancy.

The collection of additional information (e.g., timing of, type of and findings from prenatal screening) is generally recommended to enable refinement of the prospective definition (e.g., in line with EMA/FDA definitions of pro/retrospective) according to the needs of the research activity.

Definitions of prospective status are likely to be different for studies investigating longer-term health and neurodevelopmental outcomes.