Pre-eclampsia and Future Cardiovascular Health: An Underused Opportunity to Improve Family Health
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 400
- 试验地点
- 2
- 主要终点
- Blood pressure (mothers)
研究概览
简要总结
Background: PE (pre-eclampsia) is a common pregnancy-specific vascular hypertensive disease affecting 3-5% of pregnancies. PE independently increases the risk for premature cardiovascular disease (CVD) in mothers and their offspring long-term. PE provides a unique window for early risk profiling and CVD prevention. However, the efficacy of a family oriented lifestyle intervention to lower CVD risk in families with history of PE has not previously been evaluated.
Aim: This study will explore the impact of PE on CVD progression 8-12 years from delivery in mothers and their children, and assess whether a lifestyle intervention is useful for lowering mother and child blood pressure and improving the CVD risk profile overall in families with a history of PE.
Hypothesis: PE is related with CVD progression mediated by elevated blood pressure. Blood pressure and the CVD risk profile overall is modifiable in mothers and children by a 12-month behavioral lifestyle intervention in families with a history of PE.
Study design: Randomized controlled behavioral lifestyle intervention trial where families (mother, child and father from the FINNPEC study) are offered the opportunity to participate in a lifestyle intervention program 8-12 years after a PE pregnancy. 300 PE families will be randomized 1:1 to a 12-month lifestyle intervention program or to a control group. A parallel group of 100 non-PE control families will be assessed at baseline and follow-up.
Main outcome: 24 hour mean blood pressure change between baseline and follow-up in mother and child.
Significance: This study will provide information on CVD progression in mothers and children 8-12 years from a PE pregnancy. Furthermore, the study assess the effect of a 12-month lifestyle intervention on blood pressure and CVD risk profile overall following a PE pregnancy. Potentially, the study provides the opportunity to identify PE families at highest risk of CVD progression and families amenable to blood pressure and CVD risk profile improvement.
详细描述
Power analysis:
Power calculations were performed in order to detect 5.5 mmHg reduction in maternal systolic blood pressure with a power of 80% and a 2-sided p-value of 0.05 for the difference between the groups (intervention and control PE) (NICE 2011). Accounting for a 20% loss to follow-up or missing data, a sample of 148 women in the PE intervention group and 148 women in the PE control group is needed.
Specific objectives:
- To assess cardiovascular health and CVD progression in families (mother, child and father) 8-12 years following a PE pregnancy compared with non-PE control families.
- To assess the effectiveness of a behavioral 12-month lifestyle intervention in mothers and their children 8-12 years following a PE pregnancy to lower blood pressure and improve their CVD risk profile overall.
- To assess the effectiveness of a lifestyle intervention on the awareness of CVD risk after a PE pregnancy.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Families are recruited from the FINNPEC cohort. In FINNPEC, PE was defined as hypertension and proteinuria occurring after 20 weeks gestation (American College of Obstetricians and Gynecologists 2002 criteria). Hypertension was defined as systolic blood pressure ≥140 mm Hg or diastolic blood pressure ≥90 mm Hg. Proteinuria was defined as urinary excretion of ≥0.3 g protein in a 24-hour specimen, or 0.3 g/L, or two ≥1+ readings on a dipstick in a random urine determination with no evidence of a urinary tract infection. Each PE diagnosis was ascertained based on hospital records and confirmed independently by a research nurse and a study physician in the original FINNPEC case-control study including 1450 nulliparous or multiparous women with a singleton pregnancy with PE and 1065 pregnant control women without PE (aged 18-47 years) from all 5 university hospitals in Finland during 2008-
- •Exclusion criteria in the FINNPEC: multiple pregnancy, inability to speak Finnish or Swedish.
- •Exclusion Criteria in the FINNCARE:
- •Pregnancy and/or lactation (for all mothers)
- •Pre-eclampsia in any previous or subsequent pregnancies (for all non-PE mothers)
排除标准
- 未提供
结局指标
主要结局
Blood pressure (mothers)
时间窗: baseline -12 months
mean 24 hour ambulatory systolic BP and diastolic BP; mmHg
Blood pressure (children)
时间窗: baseline -12 months
mean 24 hour ambulatory systolic BP and diastolic BP; mmHg
次要结局
- Heart rate variability (mothers)(baseline -12 months)
- Arterial stiffness (mothers)(baseline -12 months)
- Smoking (mothers)(baseline -12 months)
- Blood pressure 24 hour variability (mothers)(baseline -12 months)
- Blood pressure 24 hour variability (children)(baseline -12 months)
- Awareness of later life morbidity (mothers)(baseline -12 months)
- Arterial stiffness (children)(baseline -12 months)
- Dietary intake (children)(baseline -12 months)
- Physical activity and sedentary behavior (children)(baseline -12 months)
- Laboratory assessment of cardiovascular risk (children)(baseline -12 months)
- Process evaluation: reach(baseline)
- Process evaluation: compliance(baseline -12 months)
- Process evaluation: acceptability(baseline -12 months)
- Adiposity (mothers)(baseline -12 months)
- Dietary intake (mothers)(baseline -12 months)
- Physical activity and sedentary behavior (mothers)(baseline -12 months)
- Laboratory assessment of cardiovascular risk (mothers)(baseline -12 months)
- Adiposity (children)(baseline -12 months)
研究者
Tiina Jääskeläinen
Principal Investigator
University of Helsinki