Status:
UNKNOWN
Pre-eclampsia and Future Cardiovascular Health: An Underused Opportunity to Improve Family Health
Lead Sponsor:
Helsinki University Central Hospital
Collaborating Sponsors:
University of Helsinki
Conditions:
Pre-Eclampsia
Cardiovascular Diseases
Eligibility:
All Genders
Phase:
NA
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...
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 betwee...
Eligibility Criteria
Inclusion
- Inclusion Criteria:
- 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 2008-2011.
- 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)
Exclusion
Key Trial Info
Start Date :
June 1 2019
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2024
Estimated Enrollment :
400 Patients enrolled
Trial Details
Trial ID
NCT04676295
Start Date
June 1 2019
End Date
December 1 2024
Last Update
December 21 2020
Active Locations (1)
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1
Helsinki University Hospital
Helsinki, Finland, 00029