This study will assess the risk of spontaneous abortion during weeks 1-19 of gestation, and other pregnancy outcomes, in an Exposed vaccinated cohort, i.e. women with last menstrual period between 30 days before and 90 days after any dose of CERVARIX, when compared to a Non-exposed vaccinated cohort, i.e. women with last menstrual period between 120 days and 18 months after the last CERVARIX or GARDASIL dose.
The present study will be conducted by the OTIS (Organization of Teratology Information Specialists) network. OTIS is a non-profit organization specialised to assess exposures during pregnancy and dedicated to providing accurate evidence-based, clinical information to patients and health care professionals about exposures during pregnancy and lactation. OTIS is based on voluntary phone calls. Women call when they have questions and concerns about risks potentially associated with any kind of exposure during pregnancy or breastfeeding, including medications, chemicals, pesticides, diseases, infections, and vaccinations.
Study Type
OBSERVATIONAL
Enrollment
2
Data collection from hard copy interview forms routinely used by the Organization of Teratology Information Specialists (OTIS).
GSK Investigational Site
San Diego, California, United States
Occurrence of spontaneous abortion during weeks 1-19 of gestation
Time frame: This outcome measure will be recorded between zero and six weeks after end of pregnancy
Occurrence of other adverse pregnancy outcomes
Time frame: This outcome measure will be recorded between zero and six weeks after end of pregnancy
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