Prospective pregnancy reports with a known pregnancy outcome, for women exposed to HPV-16/18 vaccine within the pre-defined risk period* (N = 226)
Trimester of exposure | Outcome classified with no congenital abnormality | Outcome classified with a congenital abnormality | Total | ||||||
---|---|---|---|---|---|---|---|---|---|
Live birth | Stillbirth | Elective termination | Spontaneous abortion | Live birth | Stillbirth | Elective termination | Spontaneous abortion | ||
Within 60 days prior to pregnancy onset | 51† | 1 | 3 | 7 | 4 | 0 | 0 | 0 | 66 |
First trimester | 103† | 0 | 14 | 8 | 12 | 0 | 0 | 0 | 137 |
Second trimester | 9‡ | 0 | 0 | 1 | 1 | 0 | 0 | 0 | 11 |
Third trimester | 2‡ | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 2 |
Unknown trimester | 7 | 0 | 2 | 1 | 0 | 0 | 0 | 0 | 10 |
Total | 172 | 1 | 19 | 17 | 17§¶ | 0 | 0 | 0 | 226 |
Risk period defined as vaccination with Cervarix® within 60 days prior to pregnancy onset up to whole duration of pregnancy. Multi-exposures during pregnancy:
Three cases were identified as having been exposed to Cervarix® more than once within 60 days and during the first trimester.
One case was identified as having been exposed to Cervarix® more than once during the second and third trimesters.
For one case, the congenital anomaly was observed 1 year after birth.
Five were classified as major structural defects including cardiac (2), palate (1), abdominal wall (1) and genital (1) structural defects, and 12 were classified as minor or non-structural anomalies.