BioThrax® (Anthrax) Vaccine in Pregnancy Registry

Pregnancy Complications Clinical Trial

Official title: BioThrax® (Anthrax) Vaccine in Pregnancy Registry

Status Completed

Clinical Trial 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.

Clinical Trial 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. ;

Related Conditions & MeSH terms

• Anthrax
• Congenital Abnormalities
• Pregnancy Complications
• Pregnancy Outcome

• NCT number: NCT01653392
• Study type: Observational
• Source: Emergent BioSolutions
• Status: Completed
• Start date: July 2012
• Completion date: February 2020