American College of Obstetricians and Gynecologists
1168 VOL. 114, NO. 6, DECEMBER 2009
Is Contraception Advisable?
Current guidelines from the Centers for Disease Control and Prevention
recommend prophylactic quadrivalent human papillomavirus
(HPV) types 6/11/16/18 vaccination of women up to the age of 26 years,
a population with childbearing potential. While the vaccine is not
recommended for use in pregnant women, inadvertent exposures during
pregnancy do occur. Therefore, clinicians and patients will be interested
in two articles in this issue of Obstetrics & Gynecology that report pregnancy
outcomes among women who received HPV vaccination within 30 days
of conception, at any time during pregnancy, or at any time during phase
III vaccine trials.
The article by Dana et al1 (see p. 1170) presents data from the first 2
years of the Pregnancy Registry established by Merck and Co., Inc.
(Whitehouse Station, NJ) at the time of vaccine licensure to monitor
postmarketing vaccine exposures during pregnancy. There were 517
evaluable prospective reports with known pregnancy outcomes after
exposures occurring within 1 month before the last menstrual period or at
any time during pregnancy. In these women, the rate of spontaneous
abortion was comparable to published data. The rate of fetal death was
slightly higher than that in the general population, but the total number of
fetal deaths in the registry was small. The rate of major birth defects was
similar to that in the general population. Regarding congenital anomalies,
there were two cases of schizencephaly, a rare central nervous system
malformation with an estimated population prevalence of 1.5 in 100,000
births; one case was reported prospectively (before the pregnancy outcome
was known) and one retrospectively (after the pregnancy outcome
was known). Two cases of anencephaly were reported, one prospectively
and one retrospectively. Anencephaly is a rare neural tube defect with an
estimated population prevalence of 1.1 cases in 10,000 births. The significance of the findings is severely limited due to the potential reporting bias for retrospective cases and absence of an optimal unexposed comparison group. The ongoing registry will continue to monitor the occurrence of these and other defects.
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