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临床试验/NCT04936815
NCT04936815进行中(未招募)不适用

Effectiveness of Echocardiographic Screening of Pregnant Women During Antenatal Care

Thomas Pilgrim4 个研究点 分布在 2 个国家目标入组 9,000 人开始时间: 2021年12月1日最近更新:
适应症

试验速览

阶段
不适用
状态
进行中(未招募)
发起方
入组人数
9,000
试验地点
4
主要终点
Composite endpoint

研究概览

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Crossover
主要目的
Prevention
盲法
Single (Outcomes Assessor)

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
Female
接受健康志愿者

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)

研究者

发起方
Thomas Pilgrim
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Thomas Pilgrim

Deputy Physician-in-Chief

Insel Gruppe AG, University Hospital Bern

研究点 (4)

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