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

NCT04468763 | Unknown DMC

• 2 other identifiers: BUHREC014/19OOUTH/HREC/248/2019AP
• Study Type: observational
• Target: 263
• Locations: 1 country
• Sites: 1

Brief 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

Preeclampsia; Eclampsia

Keywords

Cardiac biomarkers; Prediction; Preeclampsia; Stroke

Outcome Measures

Primary Outcomes (1)

• Serum levels of cardiac biomarkers

  Serum concentrations of hsCRP, fibrinogen, apoB, lipid profile in mg/dL

  Baseline

Secondary Outcomes (1)

• Development of cardiovascular events

  Year 1, Year 2 and Year 5

Eligibility Criteria

• Age: 18 Years - 45 Years
• Gender Eligibility Details: Women aged 18-45 years, pregnant after 20 weeks gestational age, or within puerperium, with or treated for preeclampsia or eclampsia.
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

The participants would include 3 groups of women all aged between 18-45 years, recruited from the study sites who give a written informed consent. 1. Group 1: Pregnant women within the first 20 weeks of gestation who come to register for antenatal care. 2. Group 2: Pregnant women diagnosed with preeclampsia or eclampsia whose pregnancies are between 20 and 41 weeks. 3. Group 3: Delivered mothers who are within 1 year post-delivery.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Babcock University: lead

Study Sites (1)

Babcock University Teaching Hospital

Sagamu, Ogun State, 121103, Nigeria

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

After explaining the procedure with the aid of the subject information form, obtaining consent and completing the history segments of the proforma, 10ml of venous blood samples would be obtained from the participants prior to the commencement of any intravenous therapy. This sample would be collected from the contra-lateral upper limb of patients who are already on intravenous infusion. The venous blood would be aspirated from the participant's ante-cubital vein and placed in a lithium heparin vacuum tube (5mls) and a plain anticoagulant-free bottle (5mls). At the time of blood collection, a drop of blood would be made on a filter paper for genetic analysis.

MeSH Terms

Conditions

Pre-Eclampsia; Eclampsia; Stroke

Condition Hierarchy (Ancestors)

Hypertension, Pregnancy-Induced; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Study Officials

• Oladapo Walker, MBBS,PhD

  Babcock University

  STUDY CHAIR

Central Study Contacts

Dr

CONTACT

+2348067857419; imaralujohn@yahoo.co.uk

Atinuke Olaleye, MBChB, MPH

CONTACT

+2348033511909; tinukeolaleye@gmail.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 27, 2020
• First Posted: July 13, 2020
• Study Start: December 16, 2019
• Primary Completion: November 30, 2020
• Study Completion: November 30, 2025
• Last Updated: July 13, 2020

Record last verified: 2020-01

Locations

NG (1)