BioThrax® (Anthrax) Vaccine in Pregnancy Registry

Study Overview
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Brief Summary
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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
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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.

Official Title
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BioThrax® (Anthrax) Vaccine in Pregnancy Registry

Conditions
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Pregnancy Complications, Pregnancy Outcome, Congenital Abnormalities

Intervention / Treatment
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* Biological: Observational Intervention


Participation Criteria
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Eligibility Criteria
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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.
Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Anthrax Vaccine Adsorbed<br>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<br>* This is an observational study, therefore no interventions are specified.<br>|

What is the study measuring?
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Primary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Maternal Mortality, Obstetric Labor, Premature, Eclampsia, Pre-Eclampsia, Abortion, Spontaneous, Diabetes, Gestational, Pregnancy, Ectopic, Hydatidiform Mole, Fetal death, Live birth, Still birth, Premature Birth, Sex ratio, Birth weight