BioThrax® (Anthrax) Vaccine in Pregnancy Registry

Pregnancy Complications Clinical Trial

Official title:

BioThrax® (Anthrax) Vaccine in Pregnancy Registry

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01653392
• Other study ID #: EBS.AVA.010 / NHRC.2012.0003
• Status: Completed
• Start date: July 2012
• Est. completion date: February 2020

Study information

• Verified date: March 2024
• Source: Emergent BioSolutions
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 98
• Est. completion date: February 2020
• Est. primary completion date: February 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: N/A and older

Eligibility

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.

Related Conditions & MeSH terms

• Anthrax
• Congenital Abnormalities
• Pregnancy Complications
• Pregnancy Outcome

Intervention

Biological:
• Observational Intervention
This is an observational study, therefore no interventions are specified.

Locations

Country	Name	City	State
United States	Naval Health Research Center	San Diego	California

Sponsors (2)

Lead Sponsor	Collaborator
Emergent BioSolutions	Naval Health Research Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pregnancy Outcomes	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.	Up to 44 weeks
Primary	Maternal Outcomes	Maternal outcomes measured include maternal death, pre-eclampsia/eclampsia, preterm labor, and gestational diabetes.	Up to 44 weeks
Primary	Infant Outcomes	Infant outcomes measured include birth defects, infant sex ratios, preterm birth, and birth weight.	Up to 1 year of age