An observational study in Pregnancy Complications, Pregnancy Outcome and Congenital Abnormalities, sponsored by Emergent BioSolutions. Completed at 1 site in United States. Open to female participants, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-03-15.
Sponsored by Emergent BioSolutions · Observational
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.
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.
411 studies on the registry are indexed under Pregnancy Complications; 113 are open to participants now.
This study's enrollment of 98 is below the median of 400 across 198 observational studies indexed under Pregnancy Complications.
Browse Pregnancy Complications studies →Emergent BioSolutions is the lead sponsor of 47 studies on the registry; 7 are open to participants now.
Of its 11 completed or terminated interventional studies of FDA-regulated products, 7 (64%) have results posted.
Counted across the registry records on this site, refreshed daily.
Active duty female service members 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 (LMP) All live born infants born to women who join the registry.
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Exclusion Criteria:
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.
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.
Time frame: Up to 44 weeks
Maternal Outcomes
Maternal outcomes measured include maternal death, pre-eclampsia/eclampsia, preterm labor, and gestational diabetes.
Time frame: Up to 44 weeks
Infant Outcomes
Infant outcomes measured include birth defects, infant sex ratios, preterm birth, and birth weight.
Time frame: Up to 1 year of age
Plan to share: No
No publications or documents are linked to this record.
This study is completed, as verified in Mar 2024. You cannot join it, but the record below documents what was studied.
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