Table 3: Pregnancy 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
Date of LMP Date of the first day of the last menstrual period prior to conception Date (dd/mm/yyyy) Yes Yes Directly reported Derivation (Pro-/retrospective reporting status)

Derivation (exposure timing)

Derivation (gestational age at pregnancy outcome)
This refers to the LMP associated with this pregnancy (not with earlier cycles).

LMP is derived as EDD-280 days (please note in early pregnancy, the EDD is derived from LMP, whereas in later pregnancy the EDD can be defined from ultrasound fetal crown-rump length measurements) or (where EDD is unknown) the date of end of pregnancy minus the gestational age at end of pregnancy (in days).

International variations exist with regards to updating the EDD (based on ultrasound fetal crown-rump length measurements) during prenatal care. In some locations, these updates may always be applied, whereas in others they may only be appliedd if the EDD is altered by >5 days.
Expected date of delivery (EDD) Expected date of delivery Date (dd/mm/yyyy) Yes Yes Directly reported Derivation (Pro-/retrospective reporting status)

Derivation (exposure timing)

Derivation (gestational age at pregnancy outcome)
The directly reported value may have been based on (e.g.) the date of LMP, results from ultra-sound examinations, the date of embryo transfer (assisted fertilisation).

Alternatively, it could be derived from entered dates of LMP based on 280 day gestation length (using the LMP date) or 266 day gestation length (using estimated date of conception from fetal ultrasound measurements).
Source of directly reported EDD The final method used to establish the estimated date of delivery Value 1 - Options: a) LMP, b) Date of embryo transfer, c) Ultrasound results, d) Other (detail) - Text Yes Yes Directly reported Database management

Sub-setting
The EDD may change over the course of the pregnancy (e.g. those based on date of LMP are potentially inaccurate and can be improved upon by ultrasound measurements performed at the end of the first trimester). This detail may be requested during peer-review of study publications, and is a useful statement to add to methods sections to show that any estimated exposure periods are accurate.

Clinical calculation of EDD could be based on LMP, Date of embryo transfer (assisted fertilisation), Ultrasound Measurement, or any other obstetric evaluation.
Assisted conception Assisted conception technique utilised for this pregnancy Options: a) Yes, b) No, c) Unknown No No Directly reported Risk factor
Plurality Number of fetuses in current pregnancy Integer Yes Yes Directly reported Sub-setting Multiple fetus pregnancies are considered to be at higher risk of several adverse pregnancy/fetal outcomes. Researchers may decide to exclude multiple fetus pregnancies from primary analyses, or conduct sensitivity analyses using the information collected in this variable.

Details about the type of multiple pregnancy (e.g. mono-/dichorionic or mono-/diamniotic) my also be valuable when assessing case specific risk factors for adverse pregnancy outcome.
Prenatal test(s) Details of any medical prenatal examination or test performed to investigate fetal wellbeing/medical conditions Value 1: Date test performed (dd/mm/yyyy)

Value 2 (approx. gestational age in days when test was performed): Text

Value 3 (Type of prenatal test (see notes): Text

Value 4 (Were any congenital anomalies identified) - Options: a) Yes, b) No, c) Unknown

If "Yes", Value 5 (Congenital anomaly details/ findings/ diagnosis): Text

If "Yes", Value 6 (MedDRA/ICD diagnosis code): Text

If "Yes", Value 7 (Coding system) - Options: a) MedDRA, b) ICD10, c) Other (detail) - Text
Yes Yes Directly reported Derivation (Pro-/retrospective status)

Derivation (Congenital anomaly status)
Values to be reported for each prenatal test performed.

Tests to be reported here are only those that have been conducted in a medical setting, social or non-clinical prenatal ultrasound scans should not be described.

Value 3 example options for tests include: a) Chorionic Villous Biopsy, b) Amniocentesis, c) Cordocentesis, d) 2d USS, e) 4d USS, f) Maternal blood tests, g) Nuchal translucency, h) Maternal serum (alpha fetal protein etc.), i) Other