Outcome
Type |
Measure |
Description |
Time frame |
Safety issue |
Primary |
Number of Infants With Major Congenital Malformations |
Major congenital malformations were defined as any codes within the Q-chapter of The Tenth Revision of the International Classification of Diseases (ICD-10), excluding certain minor anomalies. |
For 12 months after birth |
|
Secondary |
Number of Infants With Stillbirths |
Stillbirth was defined as death at a gestational age of greater than or equal to (>=) 22 weeks, with the exception that in Sweden prior to 2008 it was defined as death at a gestational age of >=28 weeks. |
At the time of birth |
|
Secondary |
Number of Infants Born Small for Gestational Age (SGA) |
An infant was defined as SGA if birth weight was below the 10th percentile of its sex-specific national distribution at the respective gestational week. Data on birth weight and gestational age from the medical birth registries were used to calculate the 10th percentiles for each sex based on all Danish and Swedish births during the study observation period. |
At the time of birth |
|
Secondary |
Number of Infants Born Preterm |
Preterm birth was defined as birth before the gestational age of 37 weeks. |
At the time of birth |
|
Secondary |
Number of Infants Born To Mothers Diagnosed With Premature Rupture of Membranes |
|
At the time of birth |
|
Secondary |
Number of Infants Diagnosed With Sudden Infant Death Syndrome (SIDS) |
Sudden Infant Death Syndrome (SIDS) was defined as a sudden unexplained death of an infant less than one year of age. |
For 12 months after birth |
|