BioThrax® (Anthrax) Vaccine in Pregnancy Registry
|Pregnancy Complications Pregnancy Outcome Congenital Abnormalities||Biological: Observational Intervention|
|Study Design:||Observational Model: Case-Control
Time Perspective: Prospective
|Official Title:||BioThrax® (Anthrax) Vaccine in Pregnancy Registry|
- Pregnancy Outcomes [ Time Frame: 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 [ Time Frame: Up to 44 weeks ]Maternal outcomes measured include maternal death, pre-eclampsia/eclampsia, preterm labor, and gestational diabetes.
- Infant Outcomes [ Time Frame: Up to 1 year of age ]Infant outcomes measured include birth defects, infant sex ratios, preterm birth, and birth weight.
|Study Start Date:||July 2012|
|Estimated Study Completion Date:||June 2022|
|Estimated Primary Completion Date:||June 2022 (Final data collection date for primary outcome measure)|
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.
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01653392
|Contact: Susan Farrish||619-553-9255||NHRC-VaccineRegistry@mail.mil|
|United States, California|
|Naval Health Research Center||Recruiting|
|San Diego, California, United States, 92106|
|Principal Investigator:||Susan Farrish||Naval Health Research Center|