Preeclampsia Clinical Trial
— PreeclampBIOOfficial title:
Cardiac Biomarkers in Preeclampsia: Prediction of Disease and the Risk of Future Cardiovascular Events in Survivors
Verified date | January 2020 |
Source | Babcock University |
Contact | Dr |
Phone | +2348067857419 |
imaralujohn[@]yahoo.co.uk | |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
SUMMARY Background: Improvements in the management and prevention of obstetric haemorrhage
and sepsis, in addition to magnesium sulphate for preeclampsia have led to significant
reduction in global maternal mortality rates; thus leaving increasing number of survivors of
preeclampsia than previously. Preeclampsia is associated with inflammatory changes that alter
vascular integrity - an effect which may persist beyond pregnancy, resulting in
atherosclerosis which predisposes to myocardial ischemia, myocardial infarction and stroke.
Aim: To predict preeclampsia early in pregnancy and detect preeclampsia survivors at risk for
future cardiovascular disease and events using cardiac and gene markers.
Methods: a cohort study design with recruitment of participants at 3 stages; in the first
trimester of pregnancy, second half and the puerperium. Serum levels of fibrinogen, hsCRP,
apoA/apoB, triglycerides and other lipids, in addition to genetic studies would be compared
between those with preeclampsia and normal pregnancies, delivered mothers would be followed
up from puerperium, upto 5 years.
Data Analysis: would be performed using the Statistical Package for Social Sciences (SPSS)
software version 21.0. Numerical data would be expressed as mean ± standard deviation (SD).
Results from the two groups of women would be compared using the independent T-test, Analysis
of Variance (ANOVA) and the chi-square test while the Mantel Haenszel statistics would be
used to determine risks. The level of statistical significance would be set at p-value less
than 0.05.
Conclusion: Myocardial ischemia, myocardial infarction and stroke are major causes of sudden
death because their precursors; atherosclerosis and hypertension are asymptomatic.
Under-utilization of routine health care check further increases the risk of sudden death
from these conditions. Preeclampsia is a recognized risk factor and screening of survivors
would help to detect women at risk for cardiovascular diseases and offer early preventive
care.
Status | Recruiting |
Enrollment | 263 |
Est. completion date | November 30, 2025 |
Est. primary completion date | November 30, 2020 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Female |
Age group | 18 Years to 45 Years |
Eligibility |
Inclusion Criteria: - Healthy pregnant women at gestational age less than 20 weeks - Women with diagnosis of preeclampsia at gestational age 20-41 weeks - Healthy pregnant women without preeclampsia at gestational age 20-41 weeks - Women less than one year postpartum with history of preeclampsia or eclampsia in index pregnancy - Healthy women less than 1 year postpartum with no previous history of preeclampsia or eclampsia Exclusion Criteria: - History of chronic hypertension or hypertension before pregnancy - Patients with cardiac disease - Patients with renal disease - Patients with diabetes mellitus - Patients with connective tissue disorders |
Country | Name | City | State |
---|---|---|---|
Nigeria | Babcock University Teaching Hospital | Sagamu | Ogun |
Lead Sponsor | Collaborator |
---|---|
Babcock University |
Nigeria,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Serum levels of cardiac biomarkers | Serum concentrations of hsCRP, fibrinogen, apoB, lipid profile in mg/dL | Baseline | |
Secondary | Development of cardiovascular events | Incidence of hypertension (blood pressure >/=140/90 mmHg), Incidence of stroke (clinical, CT or MRI) and Incidence of myocardial infarction (clinical or ECG) in participants with elevated biomarkers | Year 1, Year 2 and Year 5 |
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