BioThrax® (Anthrax) Vaccine in Pregnancy Registry
Status: | Active, not recruiting |
---|---|
Conditions: | Infectious Disease, Women's Studies |
Therapuetic Areas: | Immunology / Infectious Diseases, Reproductive |
Healthy: | No |
Age Range: | Any |
Updated: | 4/6/2019 |
Start Date: | July 2012 |
End Date: | February 2020 |
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.
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.
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.
Inclusion Criteria:
- Female active duty service member
- Received one or more dose of BioThrax while pregnant, with the onset of pregnancy
defined as the first day of the last menstrual period.
Exclusion Criteria:
- Non-service member, non-active duty pregnant female.
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