Effectiveness of Echocardiographic Screening of Pregnant Women During Antenatal Care
概览
- 阶段
- 不适用
- 干预措施
- 未指定
- 疾病 / 适应症
- Valvular Heart Disease
- 发起方
- Thomas Pilgrim
- 入组人数
- 9000
- 试验地点
- 2
- 主要终点
- Composite endpoint
- 状态
- 进行中（未招募）
- 最后更新
- 3个月前
概览
简要总结
Non-obstetrical drivers of adverse pregnancy outcomes are underappreciated. Latent structural heart disease may account for a substantial proportion of adverse pregnancy outcomes in low-resource settings.
Pregnant women presenting to B.P. Koirala Institute of Health Sciences will be prospectively included into a registry upon their visit for antenatal care. Women will be followed until 6 weeks after the time of delivery. Nested within this registry, the investigators will perform a registry-based adaptive cluster randomized crossover trial. The trial compares an experimental condition (echocardiographic screening) and a control condition (routine antenatal care).
详细描述
Latent structural heart disease may result in complications during pregnancy and delivery. Echocardiographic screening of pregnant women allows for timely detection of structural heart disease in women that may complicate delivery and jeopardize the health and well-being of both the mother and the newborn. In a setting of high rates of latent rheumatic heart disease, with particular high prevalence among women, systematic echocardiographic screening may be a pragmatic approach to prevent adverse clinical outcome related to valvular heart failure. Systematic echocardiographic screening proved to be effective among children in endemic regions. The present study is a registry-based, adaptive cluster randomized crossover trial. The trial will be nested into a registry of pregnant women presenting for routine antenatal care. The experimental condition will be echocardiographic screening. The control condition will be no echocardiographic screening. In the experimental condition, all pregnant women presenting for routine antenatal care will be offered transthoracic echocardiographic screening for the detection of latent structural heart disease. In the control condition, pregnant women will undergo routine antenatal care with echocardiography only when clinically indicated. Ascertainment of the primary endpoint will be performed at hospital discharge after delivery and will rely on routinely collected data. All events will be independently adjudicated by an expert panel of pediatricians, cardiologists and gynecologists. The randomization relates solely to the detection of rheumatic heart disease, while treatment follows guideline recommendations. It is important to note, that all women both in the experimental arm and the control arm detected to have heart disease will undergo optimal medical management during pregnancy and delivery according to the most recent guidelines.
研究者
Thomas Pilgrim
Deputy Physician-in-Chief
Insel Gruppe AG, University Hospital Bern
入排标准
入选标准
- •Pregnant women ≥18 years presenting for routine antenatal care.
- •Written informed consent.
排除标准
- •Women presenting to the hospital after delivery.
- •Women presenting directly for delivery without previous antenatal care.
结局指标
主要结局
Composite endpoint
时间窗: For APGAR Score: 10 minutes after birth. For all other components of the composite endpoint: Hospital discharge after delivery (on an average of 4 days after delivery) or 7 days after delivery (whatever takes first).
Incidence rate of the composite of maternal death, fetal/neonatal death, maternal heart failure, maternal hospitalization for cardiovascular reasons or an APGAR Score \<7.
次要结局
- Incidence of fetal/neonatal adverse events(6 weeks after delivery)
- Incidence of maternal adverse events(6 weeks after delivery)