The following CDE items should be collected for each live or stillborn infant from the reported pregnancy.
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 |
|---|---|---|---|---|---|---|---|
| Gestational timing of live/stillborn offspring | Whether a live birth or stillbirth was preterm, full term, or post-term infant | Options: a) Pre-term, b) Full term, c) Post-term, d) Unknown | Yes | Yes | Directly reported Derived (gestational age at end of pregnancy) Derived (date of end of pregnancy and date of LMP or date of EDD) |
Report statistics Sub-setting |
The directly reported value may be based on the date of LMP or on assessments from prenatal ultrasound scans. Preterm is <37 weeks (<259 days), full-term is ≥37 to <42 weeks (≥259 and <294 days), and post-term is ≥42 weeks (≥294 days). Sub-categories of preterm birth may also be used - Moderate to late preterm birth is delivery on or after 32 weeks (224 days) but <37 weeks (<259 days), very preterm birth is delivery on or after 28 weeks (196 days) but <32 weeks (<223 days), and extremely preterm birth is deluvery <28 weeks (<196 days). |
| Infant birth weight | Weight of the offspring at delivery (in grams) | Integer | Yes | Yes | Directly reported |
Report statistic Derivation (SGA and LGA) Risk factor (longer term outcomes) |
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| Infant sex | Sex of the offspring at birth | Options: a) Male, b) Female, c) Undetermined, d) Unknown | Yes | Yes | Directly reported | Report statistics Derivation (SGA and LGA) Sub-setting Risk factor (longer term outcomes) |
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| 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 | Integer (in centimeters) | Yes | No* | Directly reported | Report statistics | *Not essential but highly recommended as an important co-variable risk factor. Microcephaly has been associated with a number of congenital infections and medication teratogens. Additionally, microcephaly is classified as a major malformation as per the EUROCAT guidelines. Therefore, this variable, although may not be routinely available, is considered essential for pregnancy/infant outcomes and highly recommended for childhood outcomes. |
| Infant birth length | Heel to crown (knees flat) measurement of recumbent infant length - to be recorded in cms | Integer (in centimeters) | No | No* | Directly reported | Report statistics | *Not essential but highly recommended as an important co-variable risk factor. |
| 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 | Options: a) Yes, b) No, c) Unknown | Yes | Yes | Directly reported Derived (birth weight, gestational age at delivery, infant sex, national birth weight charts) |
Report statistics | Birth weight for gestational age charts may be customised for various factors including gestational age at delivery as a minimum and additionally maternal BMI, parity and ethnicity, and infant sex. Note, that when extracting data, this outcome detail might be collected as adverse events in the baby. |
| 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 | Options: a) Yes, b) No, c) Unknown | Yes | Yes | Directly reported Derived (birth weight, gestational age at delivery, infant sex, national birth weight charts) |
Report statistics | Birth weight for gestational age charts may be customised for various factors including gestational age at delivery as a minimum and additionally maternal BMI, parity and ethnicity, and infant sex. Alternatively, a resource such as the WHO growth charts or Intergrowth-21 may be utilized, occasionally these are available with local standardisations applied. Note, that when extracting data, this outcome detail might be collected as adverse events in the baby. |
| Apgar score | Apgar score at set time intervals post-delivery | 1-Min Score: Value 1 - Options: a) Known, b) Unknown If "Known", Value 2 (Apgar score, 0-10): Integer 5-Min Score: Value 1 - Options: a) Known, b) Unknown If "Known", Value 2 (Apgar score, 0-10): Integer 10-Min Score: Value 1 - Options: a) Known, b) Unknown If "Known", Value 2 (Apgar score, 0-10): Integer 15-Min Score: Value 1 - Options: a) Known, b) Unknown If "Known", Value 2 (Apgar score, 0-10): Integer 20-Min Score: Value 1 - Options: a) Known, b) Unknown If "Known", Value 2 (Apgar score, 0-10): Integer |
No | No | Directly reported | Report statistics | Not relevant for stillbirth outcomes (using the definition of stillbirth in these recommendations). Apgar is a clinical scoring system used to establish the clinical status of the newborn at one and five minutes post-delivery, and every additional five minutes until 20 minutes in infants with ongoing Apgar scores <7. The scoring system comprises five components investigating: Appearance (skin colour), Pulse (heart rate), Grimace (reflexes), Activity (muscle tone) and Respiration (respiration rate). Scores of between 0 and 2 are provided for each component depending on the clinical features of the newborn, providing summary scores of between 0 and 10. Scores of 7-10 are reassuring, 4-6 moderately abnormal, and 0-3 as low. Whilst these scores are important early markers of neonatal status, there is no clear association with longer term outcomes. |