NCT01653392

BioThrax® (Anthrax) Vaccine in Pregnancy Registry

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 98 (actual)
• Sponsor: Emergent BioSolutions · Industry
• Sex: Female
• Age: —
• Healthy volunteers: Accepted

Summary

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.

Detailed description

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

• Pregnancy Complications
• Pregnancy Outcome
• Congenital Abnormalities

Interventions

Type	Name	Description
BIOLOGICAL	Observational Intervention	This is an observational study, therefore no interventions are specified.

Timeline

• Start date: 2012-07-01
• Primary completion: 2020-02-01
• Completion: 2020-02-01
• First posted: 2012-07-31
• Last updated: 2024-03-15

Locations

1 site across 1 country: United States