Pre-eclampsia and Future Cardiovascular Health: An Underused Opportunity to Improve Family Health
Last updated on July 2021Recruitment
- Recruitment Status
- Recruiting
- Estimated Enrollment
- Same as current
Summary
- Conditions
- Cardiovascular Diseases
- Cardiovascular Risk Factor
- Gestational Hypertension
- Pre Eclampsia
- Type
- Interventional
- Phase
- Not Applicable
- Design
- Allocation: RandomizedIntervention Model: Parallel AssignmentMasking: None (Open Label)Primary Purpose: Prevention
Participation Requirements
- Age
- Younger than 125 years
- Gender
- Both males and females
Description
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 mis...
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.
Tracking Information
- NCT #
- NCT04676295
- Collaborators
- University of Helsinki
- Investigators
- Principal Investigator: Tiina Jääskeläinen, PhD University of Helsinki Study Chair: Hannele Laivuori, Prof, MD University of Helsinki and University of Tampere Study Director: Taisto Sarkola, PhD, MD Helsinki University Central Hospital
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