Heart Sounds at Home: Prospective Maternal Surveillance of SSA Positive Pregnancies Using a Hand-Held Fetal Heart Rate Monitor
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 700
- 试验地点
- 1
- 主要终点
- Development of Fetal AV (atrio-ventricular) heart block
研究概览
简要总结
The purpose of the research study "Heart Sounds at Home" is for pregnant SSA or SSA/SSB (Sjögren syndrome B) antibody positive mothers to use a Doppler fetal heart rate monitor to detect abnormal heart rates and rhythms in their babies before they are born.
详细描述
The study will enroll mothers during week 16-19 of gestation and will ask the mothers to use a hand-held Doppler monitor to listen to the baby's heart rate and rhythm twice daily from about week 16 to week 26 of the pregnancy. Pregnant mothers will be asked to keep a log of the heart rates and will undergo a fetal echocardiogram every 2 weeks during their study participation. In addition to these procedures, the study team will collect the mother's medical and obstetrical histories. Should irregular heart rhythms be detected at home, the mother will contact the investigator to be evaluated. After the baby is delivered, the study team will collect information about the baby's birth and heart rhythm evaluation (electrocardiogram).
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 50 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Pregnant women with positive SSA or SSA and SSB antibodies
- •Gestational age (GA) between 16 and 19 weeks
- •No signs of antibody-mediated fetal cardiac disease on pre-enrollment echo
排除标准
- •Subjects who are more than 19 weeks gestation
- •Subjects who have a fetus with an estimated fetal weight below the 10th percentile will also not be included
结局指标
主要结局
Development of Fetal AV (atrio-ventricular) heart block
时间窗: Date of randomization until the date of first documented progression, assessed up to 41 weeks.
Development of fetal AV heart block will be determined by the principal investigator's analysis of the fetal echocardiogram.
次要结局
未报告次要终点