Table 6: Pregnancy medication exposure details

Each of the following CDE items are to be collected for each maternal medication exposure considered relevant to the reported pregnancy (including preconception exposures up to 6 months prior to pregnancy as standard or longer if relevant; e.g. medications with very long half-lives/conservative labeling recommendations). Multiple start/stop dates should be collected for all medications that are stopped and then restarted.


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
Drug name(s) International non-proprietary drug name (i.e. active ingredient(s) of the medicinal product) Value 1 (name): Text

Value 2: ATC code

Date (dd/mm/yyyy)

Yes Yes Directly reported Dataset creation

Sub-setting/risk factor

Derivation (period of exposure: Preconception / Peri-LMP / Trimester 1 / Trimester 2 / Trimester 3)
Includes the drug(s) targeted for investigation and concomitant drugs.



Multiple start/stop dates should be collected for all medications that are stopped and then restarted.
Drug start date Date at which the medication used during pregnancy was started Date (dd/mm/yyyy) Yes Yes Directly reported Derivation (period of exposure: Preconception / Peri-LMP / Trimester 1 / Trimester 2 / Trimester 3)

Derivation (gestational age at exposure)

Dataset creation

Sub-setting

Risk factor
Multiple start/stop dates should be collected for all medications that are stopped and then restarted.

Start dates are to be recorded for each separate period of use of the drug in the pregnancy under the same record (e.g. Start 1: dd/mm/yyyy, Start 2: dd/mm/yyyy).

Missing dates should be entered as "missing".
Drug stop date Date at which the medication used during pregnancy was stopped Date (dd/mm/yyyy) Yes Yes Directly reported Derivation (period of exposure: Preconception / Peri-LMP / Trimester 1 / Trimester 2 / Trimester 3)

Derivation (gestational age at exposure)

Dataset creation

Sub-setting

Risk factor
Stop dates are to be recorded for each separate period of use of the drug in the pregnancy under the same record (e.g. Stop 1: dd/mm/yyyy, Stop 2: dd/mm/yyyy).

Missing dates should be entered as "missing".

Drug indication(s) Specific indication for which the medication was used Value 1: Text

Value 2 (MedDRA/ICD diagnosis code): Text

Value 3 (Coding system) - Options: a) MedDRA, b) ICD10, c) Other (detail) - Text
Yes Yes Directly reported Dataset creation

Sub-setting

Risk factor
Peri-LMP exposure Exposure before LMP in a time period considered relevant to the half-life of the medication under investigation and other concomitant medications (e.g. five half-lives) and/or a time period defined clinically relevant given the expected length of time the medication can produce pharmacodynamics effects Options: a) Yes, b) No



Yes Yes Directly reported

Derived (Drug start/stop dates, Date of LMP)
Dataset creation

Sub-setting

Risk factor

Report statistics
"Exposure" relates to the timing when the medication was administered.

Exposure during this period may be reported directly or defined during data analysis using medication start and stop dates.
Trimester 1 exposure Exposure occurring in the first trimester (from date of LMP to date of LMP+90 days) Options: a) Yes, b) No Yes Yes Directly reported

Derived (Drug start/stop dates, Date of LMP/EDD)

Dataset creation

Sub-setting

Risk factor

Report statistics
"Exposure" relates to the timing when the medication was administered.

Varying definitions of the pregnancy trimesters are available. This document aligns with the UK RCOG definitions. Consequently, trimester 1 is defined to start at the date of LMP, approximately 14 days before conception and therefore covers a period when the fetus may not be exposed directly.

Depending on the medication exposure under study, the proposed definition of “first trimester exposure” may be too broad to be considered scientifically relevant for examining malformation risks following in utero medication exposure. For example, medications which are not used to treat a chronic medical condition and may only be used for short time periods may be discontinued between the LMP date and the date of conception. Provided these medications have a short half-life, pre-conception exposures probably have limited relevance with regards to malformation risks in the developing fetus. In such cases, the exposure period of interest may need to be adapted so that it more accurately overlaps with the expected period of organogenesis (e.g. from conception - approximately 2 weeks post-LMP - until the end of the tenth week gestational age)
Trimester 2 exposure Exposure occurring in the second trimester (from date of LMP+91 days to date of LMP+188) Options: a) Yes, b) No Yes Yes Directly reported

Derived (Drug start/stop dates, Date of LMP/EDD)
Dataset creation

Sub-setting

Risk factor

Report statistics
"Exposure" relates to the timing when the medication was administered.

Varying definitions of the pregnancy trimesters are available. This document aligns with the UK RCOG definitions.
Trimester 3 exposure Exposure occurring in the third trimester (from date of LMP+189 days onwards) Options: a) Yes, b) No Yes Yes Directly reported

Derived (Drug start/stop dates, Date of LMP/EDD)
Dataset creation

Sub-setting

Risk factor

Report statistics
"Exposure" relates to the timing when the medication was administered.

Varying definitions of the pregnancy trimesters are available. This document aligns with the UK RCOG definitions.
Route of exposure Route by which the medication is administered Options: a) Aural, b) Inhalation, c) Ocular, d) Oral, e) IV, f) IM, g) Rectal, h) Topical, i) Vaginal, j) Other (detail) - Text Yes Yes Directly reported

Dataset creation

Sub-setting
Dose per use Amount of medication administered per use Value 1: Integer

Value 2: Unit (g / mg / mcg / IUs etc.)
Yes Yes Directly reported

Dataset creation

Sub-setting

Risk factor
This detail in combination with time period of use and frequency of use details may be useful for assessing risks associated with daily or cumulative doses.
Frequency of use Number of times the medication is taken per unit of time Value 1 (Times taken): Integer

Value 2 (Unit of time) - Options: a) day, b) 2-days, c) 3-days, d) week, e) 2-weeks, f) 3-weeks, g) 4-weeks, h) month, i) 2-months, j) 3-months, k) 6-months, l) year, m) Other (detail) - Text
Yes Yes Directly reported Dataset creation

Sub-setting

Risk factor
This detail in combination with time period of use and dose per use details may be useful for assessing risks associated with daily or cumulative doses.