BioThrax® (Anthrax) Vaccine in Pregnancy Registry

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

98 participants

Study Classification

OBSERVATIONAL

Study Start Date

2012-07-31

Study Completion Date

2020-02-29

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Pregnancy Complications Pregnancy Outcome Congenital Abnormalities

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

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Anthrax Vaccine Adsorbed

Active duty women who received one or more doses of BioThrax while pregnant, with the onset of pregnancy defined as the first day of the last menstrual period, and all live born infants born to women who join the registry.

Observational Intervention

Intervention Type BIOLOGICAL

This is an observational study, therefore no interventions are specified.

Interventions

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Observational Intervention

This is an observational study, therefore no interventions are specified.

Intervention Type BIOLOGICAL

Eligibility Criteria

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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.