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

NCT04468763 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 263

Last updated 2020-07-13

No results posted yet for this study

Summary

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.

Conditions

Sponsors & Collaborators

  • Babcock University

    lead OTHER

Principal Investigators

  • Oladapo Walker, MBBS,PhD · Babcock University

Eligibility

Min Age
18 Years
Max Age
45 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2019-12-16
Primary Completion
2020-11-30
Completion
2025-11-30

Countries

  • Nigeria

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04468763 on ClinicalTrials.gov