BioThrax® (Anthrax) Vaccine in Pregnancy Registry

Completed

• Conditions: Pregnancy Complications; Congenital Abnormalities; Pregnancy Outcome
• Interventions: Biological: Observational Intervention

• Registration Number: NCT01653392
• Lead Sponsor: Emergent BioSolutions

Brief 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.

Study Timeline

• Study Start: 2012-07
• Study First Submitted: 2012-07-16
• Study First Submitted QC: 2012-07-30
• Study First Posted: 2012-07-31
• Primary Completion: 2020-02
• Study Completion: 2020-02
• Status Verified: 2024-03
• Last Update Submitted: 2024-03-14
• Last Update Posted: 2024-03-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 98

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Anthrax Vaccine Adsorbed	Observational Intervention	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.

Primary Outcome Measures

Name	Time	Method
Pregnancy Outcomes	Up to 44 weeks	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.
Maternal Outcomes	Up to 44 weeks	Maternal outcomes measured include maternal death, pre-eclampsia/eclampsia, preterm labor, and gestational diabetes.
Infant Outcomes	Up to 1 year of age	Infant outcomes measured include birth defects, infant sex ratios, preterm birth, and birth weight.

Trial Locations

Locations (1)

Naval Health Research Center; 🇺🇸 San Diego, California, United States