Ignite Creation Date:
2025-12-24 @ 1:35 PM
Ignite Modification Date:
2025-12-30 @ 2:33 PM
Study NCT ID:
NCT04676295
Status:
UNKNOWN
Last Update Posted:
2020-12-21
First Post:
2020-12-07
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Pre-eclampsia and Future Cardiovascular Health: An Underused Opportunity to Improve Family Health
Sponsor:
Helsinki University Central Hospital
Organization:
Study Overview
Official Title:
Pre-eclampsia and Future Cardiovascular Health: An Underused Opportunity to Improve Family Health
Status:
UNKNOWN
Status Verified Date:
2020-12
Last Known Status:
RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
FINNCARE
Brief Summary:
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.
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.
Detailed 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 missing data, a sample of 148 women in the PE intervention group and 148 women in the PE control group is needed.
Specific objectives:
1. 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.
2. 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.
3. To assess the effectiveness of a lifestyle intervention on the awareness of CVD risk after a PE pregnancy.
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:
1. 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.
2. 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.
3. To assess the effectiveness of a lifestyle intervention on the awareness of CVD risk after a PE pregnancy.
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: