CDE Index

Please search for desired core data element to locate the corresponding table.



CDE Item Definition Table location
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 Table 1: Database management details
Mother case identifier Unique database identifier for the pregnant woman Table 1: Database management details
Baby case identifier Unique database identifier for each offspring record Table 1: Database management details
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) Table 1: Database management details
Primary reporter type Type of reporter providing the information Table 1: Database management details
Primary reporter contact details Name and contact details for the primary reporter Table 1: Database management details
Initial report date Date when pregnancy is initially reported to the data collection system Table 1: Database management details
Prospective status Whether the pregnancy was reported prospectively or retrospectively Table 1: Database management details
Maternal date of birth Mother's date of birth Table 2: Maternal details
Maternal age at last menstrual period (LMP) Mother's age (in years) on the first day of the last menstrual period prior to the pregnancy Table 2: Maternal details
Household income The total annual household income (mother and partner before any tax or other deductions). Table 2: Maternal details
Maternal education Highest level of education achieved by the mother Table 2: Maternal details
Paternal education Highest level of education achieved by the father Table 2: Maternal details
Maternal IQ Intellectual ability of the mother Table 2: Maternal details
Maternal ethnicity The ethnicity of the mother Table 2: Maternal details
Consanguinity The father of the baby is a first or second degree relative of the mother Table 2: Maternal details
Maternal Height Height (cm) of the mother at the time of conception Table 2: Maternal details
Maternal Weight pre-pregnancy Actual or approximate weight (kg) of the mother at or around the time of conception Table 2: Maternal details
Maternal BMI pre-pregnancy Maternal BMI at the time of conception (kg/m2) Table 2: Maternal details
Maternal country of residence Country in which the mother resides at the time of reporting Table 2: Maternal details
Smoking in pregnancy Maternal smoking of tobacco during pregnancy Table 2: Maternal details
Alcohol in pregnancy Maternal alcohol consumption during pregnancy Table 2: Maternal details
Illicit drugs in pregnancy Maternal recreational drug use in pregnancy (details of drugs, approximate daily amount ingested, duration of use in pregnancy) Table 2: Maternal details
Folic acid use Maternal folic acid use in pregnancy Table 2: Maternal details
Date of LMP Date of the first day of the last menstrual period prior to conception Table 3: Pregnancy details
Expected date of delivery (EDD) Expected date of delivery Table 3: Pregnancy details
Source of directly reported EDD The final method used to establish the estimated date of delivery Table 3: Pregnancy details
Assisted conception Assisted conception technique utilised for this pregnancy Table 3: Pregnancy details
Plurality Number of fetuses in current pregnancy Table 3: Pregnancy details
Prenatal test(s) Details of any medical prenatal examination or test performed to investigate fetal wellbeing/medical conditions Table 3: Pregnancy details
Maternal pre-pregnancy medical conditions (history) Maternal medical conditions present prior to pregnancy Table 4: Maternal medical history details
Family history of congenital anomalies The presence of any congenital anomaly (major or minor) in any sibling (live born, stillborn or terminated), or the mother or the father of the reference pregnancy, or their immediate/ first degree relatives (grandparents, aunts or uncles of the reference pregnancy) Table 5: Family medical history and obstetric history details
Relevant family history of genetic conditions The presence of any genetic condition in a relative thought to be the explanation or of relevance to the abnormalities reported in the reference pregnancy Table 5: Family medical history and obstetric history details
Relevant family history of learning disability or of neurodevelopmental disorders The presence of a learning disability or neurodevelopmental disorder (e.g. attention deficit hyperactivity disorder or autistic spectrum disorder) in a sibling, mother, father or their immediate / first degree relatively (grandparents, aunts or uncles of the reference pregnancy) Table 5: Family medical history and obstetric history details
Relevant family history of diseases with onset in childhood The present of a health condition which onsets in childhood (<18 years of age) Table 5: Family medical history and obstetric history details
Number of previous pregnancies Number of previous pregnancies (including non-live births) experienced by the mother only Table 5: Family medical history and obstetric history details
Number of previous live births Number of previous live births Table 5: Family medical history and obstetric history details
Number of previous spontaneous abortions Number of previous spontaneous abortions Table 5: Family medical history and obstetric history details
Number of previous induced terminations Number of previous induced terminations (for any reason) Table 5: Family medical history and obstetric history details
Number of previous stillbirths Number of previous stillbirths Table 5: Family medical history and obstetric history details
Number of previous pregnancies with congenital anomalies Number of previous pregnancies (including non-live births) experienced by the mother which resulted in a fetus or child with congenital anomalies Table 5: Family medical history and obstetric history details
Drug name(s) International non-proprietary drug name (i.e. active ingredient(s) of the medicinal product) Table 6: Pregnancy medication exposure details
Drug start date Date at which the medication used during pregnancy was started Table 6: Pregnancy medication exposure details
Drug stop date Date at which the medication used during pregnancy was stopped Table 6: Pregnancy medication exposure details
Drug indication(s) Specific indication for which the medication was used Table 6: Pregnancy medication exposure details
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 Table 6: Pregnancy medication exposure details
Trimester 1 exposure Exposure occurring in the first trimester (from date of LMP to date of LMP+90 days) Table 6: Pregnancy medication exposure details
Trimester 2 exposure Exposure occurring in the second trimester (from date of LMP+91 days to date of LMP+188) Table 6: Pregnancy medication exposure details
Trimester 3 exposure Exposure occurring in the third trimester (from date of LMP+189 days onwards) Table 6: Pregnancy medication exposure details
Route of exposure Route by which the medication is administered Table 6: Pregnancy medication exposure details
Dose per use Amount of medication administered per use Table 6: Pregnancy medication exposure details
Frequency of use Number of times the medication is taken per unit of time Table 6: Pregnancy medication exposure details
Maternal medical conditions arising in pregnancy Any maternal medical condition arising during pregnancy Table 7: Maternal illness and obstetric complication details
Maternal post-partum complications Any maternal complication occurring post-delivery Table 7: Maternal illness and obstetric complication details
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. Table 7: Maternal illness and obstetric complication details
Pregnancy outcome collection status Status of pregnancy outcome details reported to the system Table 8: Pregnancy outcome details
Date of end of pregnancy Date at which the pregnancy completes (for all outcomes). Table 8: Pregnancy outcome details
Gestational age at end of pregnancy Gestational age in days (post-LMP) at the time the pregnancy ended Table 8: Pregnancy outcome details
Induced termination Induced abortion (either medical or surgical) of a pregnancy for any reason Table 8: Pregnancy outcome details
Ectopic pregnancy Implantation outside of the endometrial cavity (including tubal, cervical, caesarean scar, interstitial, cornual, ovarian, abdominal, hetertopic or of unknown location) confirmed by transvaginal ultrasound. Table 8: Pregnancy outcome details
Stillbirth Death of a fetus prior to the complete expulsion or extraction from its mother, after the 22nd completed week post-LMP (≥154 days) of pregnancy; the death is indicated by the fact that after such separation the fetus does not breathe or show any other evidence of life, such as beating of the heart, pulsation of the umbilical cord or definite movement of voluntary muscles Table 8: Pregnancy outcome details
Spontaneous abortion Death of a fetus prior to the complete expulsion or extraction from its mother, before the 22nd completed week of pregnancy (≤153 days). Table 8: Pregnancy outcome details
Molar pregnancy A non-viable product of conception which can be either a 'complete mole' arising after single sperm fertilisation of an ovum lacking genetic material, or a 'partial mole' which arises as a consequence of multi-sperm fertilisation of a healthy ovum. An invasive mole (formerly known as chorioadenoma destruens) is a hydatidiform mole that has grown into the muscle layer of the uterus Table 8: Pregnancy outcome details
Labour onset How labour began Table 9: Delivery details
Mode of delivery The method by which the fetus was delivered from the mother Table 9: Delivery details
Maternal delivery complications Any maternal complications arising as a result of the delivery method during or after delivery Table 9: Delivery details
Gestational timing of live/stillborn offspring Whether a live birth or stillbirth was preterm, full term, or post-term infant Table 10: Live/stillborn birth outcome details
Infant birth weight Weight of the offspring at delivery (in grams) Table 10: Live/stillborn birth outcome details
Infant sex Sex of the offspring at birth Table 10: Live/stillborn birth outcome details
Infant head circumference Occipito-frontal circumference (i.e. the widest circumference of the skull from the broadest part of the forehead (above the eyebrow and ears) to the most prominent part of the rear of the head), measured using a non-stretchable flexible tape - to be recorded in cms Table 10: Live/stillborn birth outcome details
Infant birth length Heel to crown (knees flat) measurement of recumbent infant length - to be recorded in cms Table 10: Live/stillborn birth outcome details
Small for Gestational Age at delivery An infant born with a birth weight less than the 10th centile on population-level infant birth weight charts Table 10: Live/stillborn birth outcome details
Large for Gestational Age at Delivery An infant born with a birth weight greater than the 90th centile on population-level infant birth weight charts Table 10: Live/stillborn birth outcome details
Apgar score Apgar score at set time intervals post-delivery Table 10: Live/stillborn birth outcome details
Complications in the first year of life Any complication experienced in the first year of life Table 11:Live born neonatal/infant outcome details
Postnatal death of live born infant Details of the death of a live born infant Table 11:Live born neonatal/infant outcome details
Product/disease-specific outcomes Offspring outcomes specific to the investigated medicinal product Table 11:Live born neonatal/infant outcome details
Congenital anomaly Presence of any structural/morphological, functional or biochemical anomaly(ies) in the fetus that occur during intrauterine life and can be identified prenatally, at birth or later in life Table 12: Malformation details
Details of all congenital anomaly(ies) Details of the anomaly(ies) present in the exposed fetus Table 12: Malformation details
Infant malformation case classification Classification of status of a fetus / infant case with an anomaly(ies) based on a hierarchy of observed events Table 12: Malformation details
Infant/child medical problems Has the child (infant @ge;1 year old) had any medical problems since birth. Table 13: Longer-term child health outcome details
Infant/child specialist visit Has the child required any specialist reviews? Table 13: Longer-term child health outcome details
Infant/child medication Child medication use. Table 13: Longer-term child health outcome details
Infant/child professional concerns Report of any developmental concerns raised by professionals. Table 13: Longer-term child health outcome details
Infant/child vision difficulties Difficulties with child vision. Table 13: Longer-term child health outcome details
Infant/child hearing difficulties Difficulties with child hearing. Table 13: Longer-term child health outcome details
Infant/child toileting difficulties Does the child have any frequent difficulties with the passing of urine or opening of their bowels? Table 13: Longer-term child health outcome details
Infant/child eczema/ skin conditions Diagnosis of eczema or other skin conditions. Table 13: Longer-term child health outcome details
Infant/child asthma/ respiratory conditions Diagnosis of asthma or other respiratory conditions. Table 13: Longer-term child health outcome details
Infant/child congenital heart disease Diagnosis of congenital heart disease. Table 13: Longer-term child health outcome details
Infant/child food allergies Diagnosis of food allergies. Table 13: Longer-term child health outcome details
Child Cognitive Functioning The expected developmental level within the area of cognitive functioning varies by the age of the child. This should be measured via age appropriate assessment using either 1. parental completed questionnaires 2. through direct research / clinical assessment of the child or 3. Diagnoses of deficits (e.g. intellectual disability). 4. Attainment of key milestones. Table 14: Longer-term child neurodevelopmental outcome details
Child Motor Functioning The expected developmental level within the area of motor functioning varies by the age of the child. This should be measured via age appropriate assessment using either 1. parental completed questionnaires 2. though direct researcher assessment of the child or 3. Diagnoses of deficits relating to motor development/ functioning (e.g. dyspraxia). 4. Attainment of key milestones. Table 14: Longer-term child neurodevelopmental outcome details
Child Language Functioning The expected developmental level within the area of language functioning varies by the age of the child. This should be measured via age appropriate assessment using either 1. parental completed questionnaires 2. through direct research / clinical assessment of the child or 3. Diagnoses of deficits (e.g. intellectual disability). 4. Attainment of key milestones. Table 14: Longer-term child neurodevelopmental outcome details
Child Social Functioning The expected level of social functioning varies by the age of the child. This should be measured via age appropriate assessment using either 1. parental completed questionnaires 2. though direct researcher assessment of the child or 3. Diagnoses of deficits relating to motor development/ functioning (e.g. dyspraxia). 4. Attainment of key milestones. Table 14: Longer-term child neurodevelopmental outcome details