The purpose of this study is to determine if inadvertent receipt of the BioThrax vaccine during pregnancy is independently associated with adverse maternal, pregnancy, or infant health outcomes.
This study will use a convenience sample and passive referral to enroll participants. For the maternal outcome portion of the study, pregnant active duty women who consent to join the registry are expected to complete several surveys over the course of their pregnancy, including an initial enrollment survey, a follow-up survey at or after the 20th week of pregnancy, and a post-delivery survey at two weeks after their delivery due date (unless a pregnancy loss is reported in the 20 week survey). Outcomes among infants born to women enrolled in the Registry whose pregnancies result in a livebirth will be assessed with a survey during the post-delivery contact, again at 4 months of age, with a final follow-up when the infant reaches one year of age.
Study Type
OBSERVATIONAL
Enrollment
98
This is an observational study, therefore no interventions are specified.
Naval Health Research Center
San Diego, California, United States
Pregnancy Outcomes
Pregnancy outcomes measured include live birth, still birth, spontaneous abortion, elective termination, ectopic pregnancy, or molar pregnancy Note: Twin or higher order multiple pregnancies may have more than one outcome.
Time frame: Up to 44 weeks
Maternal Outcomes
Maternal outcomes measured include maternal death, pre-eclampsia/eclampsia, preterm labor, and gestational diabetes.
Time frame: Up to 44 weeks
Infant Outcomes
Infant outcomes measured include birth defects, infant sex ratios, preterm birth, and birth weight.
Time frame: Up to 1 year of age
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