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 |