HyperAldosteronism in Pregnancy Predicted Impacts
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 200
- 试验地点
- 2
- 主要终点
- Primary hyperaldosteronism (PHA) prevalence in pregnant women with hypertensive disorders of pregnancy.
研究概览
简要总结
Primary hyperaldosteronism confers a higher risk of cardiovascular complications compared to essential hypertension. Preliminary data is controversial in regards of excessive maternal fetal and neonatal excessive risks in pregnancy.
This study aims at establishing the prevalence of PHA in an population with a recent episode of hypertensive disorder of pregnancy (HDP). The goal is to determine if a universal screening for PHA after a HDP is worthed. The investigators also wish to evaluate the complication rate in pregnant women with PHA compared to women without PHA.
This is a prospective cohort study where all eligible women will be screened for PHA after a HDP episode in the last pregnancy. We will then compare PHA women to non PHA women according to pregnancy complications.
详细描述
This is a pilot study to evaluate feasibility and proof of concept. This is a prospective multicenter cohort study. Two university centers will participate (Sherbrooke and Montreal).
Participants will be recruited from post-partum Obstetric Medicine clinic in two tertiary care centers. They will be included if they presented a hypertensive disorder of preganncy (HDP) in their last pregnacy (from 4 weeks to 24 months after delivery). Women with pheochromocytoma, Cushing syndrome, secondary hyperaldosteronism, and those who are currently pregnant will be excluded.
All participants will be screened for PHA (with an aldosterone/renin ratio) and if the screening test is positive, they will be referred to a specialist to confirm the diagnosis.
Data will be collected from the participants and their babies' charts. Demographic data, obstetrical data, delivery data, maternal/fetal/neonatal complications, and diagnostic of PHA data will be collected.
A convenient sample size of 200 women will be used. If the prevalence of HPA is 5% or more, this would justify a larger study.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Between 4 and 24 weeks post-partum women who had a hypertensive disorder during their latest pregnancy.
排除标准
- •Ongoing pregnancy
- •Diagnosed pheochromocytoma
- •Diagnosed Cushing syndrome
- •Diagnosed secondary hyperaldosteronism
结局指标
主要结局
Primary hyperaldosteronism (PHA) prevalence in pregnant women with hypertensive disorders of pregnancy.
时间窗: Screening done between 4 and 24 weeks post-partum
Prevalence of PHA in women with a hypertensive disorder of pregnancy in last pregnancy
次要结局
- Prevalence of PHA for each hypertensive disorder of pregnancy(During last pregnancy and 6 weeks postpartum)
- Maternal and fetal impacts of PHA on hypertensive disorders of pregnancy(During last pregnancy and 6 weeks postpartum)
- Impact of the timing of PHA on hypertensive disorders of pregnancy(During last pregnancy and 6 weeks postpartum)
研究者
Nadine Sauvé
Principal investigator
Université de Sherbrooke