Manchester Antenatal Vascular Service
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 750
- 试验地点
- 1
- 主要终点
- Blood Pressure
研究概览
简要总结
25-30% of women with preexisting vascular disease (chronic hypertension/diabetes/obesity) will develop pre-eclampsia and or growth restriction. In addition, the frequency of stillbirths in this group is dramatically increased over the general population. Pregnancy complications in this very heterogeneous group are likely to be a combination of a failure of the maternal vasculature to adapt to pregnancy and/or a failure of placental development. The relative contribution of these two mechanisms is poorly understood and current preventative strategies (aspirin) in this group only prevent a small number of adverse outcomes. This important and complex group have been inadequately investigated to date mainly because of the diversity of their underlying disease complicating prospective research studies.
The evolution of tools which allow more detailed assessments of both uteroplacental blood flow and maternal vascular function will enable us to perform prospective studies in these women and to develop targeted preventative measures. Recent biomarker studies have also identified a number of biomarkers which have not yet been assessed in these high risk groups.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Women with preexisting vascular disease:
- •chronic hypertension BP ≥140/90 at ≤14 weeks
- •chronic hypertension requiring antihypertensive treatment ≤ 14 weeks
- •pre gestational diabetes with evidence of vascular complications (hypertension, nephropathy)
- •history of ischemic heart disease
- •previous early onset pre-eclampsia (delivery < 32 weeks)
- •Obesity (BMI ≥ 40) with any history of hypertension or booking BP≥130/80
排除标准
- •Women who do not meet the inclusion criteria
结局指标
主要结局
Blood Pressure
时间窗: At recruitment (<14 weeks gestation) and at 16-18 weeks, 22-26 weeks & 30-34 weeks gestation
次要结局
- Vascular compliance(At recruitment (<14 weeks gestation) and at 16-18 weeks, 22-26 weeks & 30-34 weeks gestation)
- Uteroplacental assessment(At recruitment (<14 weeks gestation) and at 16-18 weeks, 22-26 weeks & 30-34 weeks gestation)