Clinical trial · Observational
BioThrax® (Anthrax) Vaccine in Pregnancy Registry
NCT01653392CI-TRIAL-00075088completedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Congenital Abnormalities | — | UNRESOLVED | — |
| Pregnancy Complications | — | UNRESOLVED | — |
| Pregnancy Outcome | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Observational Intervention | Biological | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- label
- Anthrax Vaccine Adsorbed
- description
- 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.
- interventionNames
- Biological: Observational Intervention
Primary outcomes (3)
- measure
- Pregnancy Outcomes
- timeFrame
- Up to 44 weeks
- description
- 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.
- measure
- Maternal Outcomes
- timeFrame
- Up to 44 weeks
- description
- Maternal outcomes measured include maternal death, pre-eclampsia/eclampsia, preterm labor, and gestational diabetes.
Eligibility
Eligibility (as posted)
- Sex
- Female
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available
No reference posted for this study.