Congenital Abnormalities, Pregnancy Complications, Pregnancy Outcome
Conditions
Keywords
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
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.
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.
Interventions
BIOLOGICALObservational Intervention
This is an observational study, therefore no interventions are specified.
Sponsors
Naval Health Research Center
Emergent BioSolutions
Study design
Observational model
CASE_CONTROL
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
FEMALE
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.
Exclusion criteria
* Non-service member, non-active duty pregnant female.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
United States
Outcome results
None listed