BioThrax® (Anthrax) Vaccine in Pregnancy Registry
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 98
- 试验地点
- 1
- 主要终点
- Pregnancy Outcomes
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Prospective
入排标准
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •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.
排除标准
- •Non-service member, non-active duty pregnant female.
结局指标
主要结局
Pregnancy Outcomes
时间窗: 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
时间窗: Up to 44 weeks
Maternal outcomes measured include maternal death, pre-eclampsia/eclampsia, preterm labor, and gestational diabetes.
Infant Outcomes
时间窗: Up to 1 year of age
Infant outcomes measured include birth defects, infant sex ratios, preterm birth, and birth weight.
次要结局
未报告次要终点