Pregnancy Outcomes From the Pregnancy Registry of a Human Papillomavirus Type6/11/16/18 Vaccine
| Autor: | Richard M. Haupt, Margaret M. Seminack, Karyn M. Buchanan, Kristine E. Shields, Scott Korn, Michael L. Cunningham, Adrian Dana, Mary Ann Goss |
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| Rok vydání: | 2009 |
| Předmět: |
Adult
Canada medicine.medical_specialty Adolescent Abortion Young Adult Human Papillomavirus Recombinant Vaccine Quadrivalent Types 6 11 16 18 Pregnancy Epidemiology Product Surveillance Postmarketing Humans Medicine Papillomavirus Vaccines Registries Young adult Human papillomavirus Child Adverse effect Fetal Death business.industry Obstetrics Pregnancy Outcome Abnormalities Drug-Induced Obstetrics and Gynecology General Medicine medicine.disease United States Abortion Spontaneous Vaccination Gestation Female France business |
| Zdroj: | Obstetrics & Gynecology. 114:1170-1178 |
| ISSN: | 0029-7844 |
| DOI: | 10.1097/aog.0b013e3181c2a122 |
| Popis: | To better describe the safety profile of pregnancy exposures to the human papillomavirus (HPV) type 6/11/16/18 vaccine by acquiring and analyzing postmarketing data on pregnancy outcomes (ie, live births, abortions, fetal deaths, and congenital anomalies).Enrollment criteria included an identifiable patient and health care provider from the United States, France, or Canada and exposure within 1 month before the date of onset of the last menstrual period or at any time during pregnancy. Outcomes of interest were pregnancy outcomes and birth defects. Prospectively reported cases (reported before the outcome of the pregnancy was known) were used for rate calculations.For the 517 prospective reports with known outcome, 451 (87.2%) were live births, including three sets of twins. Of 454 neonates, 439 (96.7%) were normal. The overall rate of spontaneous abortion was 6.9 per 100 outcomes (95% confidence interval [CI] 4.8-9.6). The prevalence of major birth defects was 2.2 per 100 liveborn neonates (95% CI 1.05-4.05). There were seven fetal deaths (1.5 per 100 outcomes, 95% CI 0.60-3.09).Rates of spontaneous abortions and major birth defects were not greater than the unexposed population rates. Although no adverse signals have been identified to date, the HPV6/11/16/18 vaccine is not recommended for use in pregnant women.III. |
| Databáze: | OpenAIRE |
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