Cardiac Biomarkers in Preeclampsia: Prediction of Disease and the Risk of Future Cardiovascular Events in Survivors

Status: Recruiting
Location: See location...
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.

Eligibility
Participation Requirements
Sex: Female
Minimum Age: 18
Maximum Age: 45
Healthy Volunteers: t
View:

• 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

Locations
Other Locations
Nigeria
Babcock University Teaching Hospital
RECRUITING
Sagamu
Contact Information
Primary
Dr
imaralujohn@yahoo.co.uk
+2348067857419
Backup
Atinuke Olaleye, MBChB, MPH
tinukeolaleye@gmail.com
+2348033511909
Time Frame
Start Date: 2019-12-16
Estimated Completion Date: 2025-11-30
Participants
Target number of participants: 263
Sponsors
Leads: Babcock University

This content was sourced from clinicaltrials.gov