BioThrax® (Anthrax) Vaccine in Pregnancy Registry

Sponsor

Emergent BioSolutions (Industry)

Overall Status

Completed

CT.gov ID

NCT01653392

Collaborator

Naval Health Research Center (U.S. Fed)

Enrollment

Location

Actual Duration (Months)

1.1

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Pregnancy Complications Pregnancy Outcome Congenital Abnormalities	Biological: Observational Intervention

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 Design

Study Type:

Observational

Actual Enrollment :

98 participants

Observational Model:

Case-Control

Time Perspective:

Prospective

Official Title:

BioThrax® (Anthrax) Vaccine in Pregnancy Registry

Actual Study Start Date :

Jul 1, 2012

Actual Primary Completion Date :

Feb 1, 2020

Actual Study Completion Date :

Feb 1, 2020

Arms and Interventions

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

Arm

Intervention/Treatment

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.

Biological: Observational Intervention

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

Outcome Measures

Primary Outcome Measures

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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

N/A and Older

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

Yes

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.