NCT05091827

Cardiovascular Risk in Infants Exposed to Pre-eclampsia in Utero

Status unknown Last updated 25 October 2021

What this trial tests

trial in Offspring of Pre-eclamptic Mothers in 234 participants. Status unknown.

Timeline

30 November 2021

Primary endpoint
30 December 2022

30 December 2023

Quick facts

Lead sponsor	Walter Sisulu University
Status	Status unknown
Study type	OBSERVATIONAL
Enrollment	234
Start date	30 November 2021
Primary completion	30 December 2022
Estimated completion	30 December 2023

Conditions studied

• Offspring of Pre-eclamptic Mothers — all drugs for Offspring of Pre-eclamptic Mothers →

Sponsor

Walter Sisulu University

Who can join

Eligibility, female only, with Offspring of Pre-eclamptic Mothers. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

An increasing number of scientific publications show that high blood pressure is being described in younger and younger children of African ancestry. It therefore makes sense to seek for the causes of this raised blood pressure in the in utero events. Recent studies have attributed and increased risk to cardiovascular disease (CVD) risk factors to the gestational environment. Pre-eclampsia (PE) is associated with endothelial dysfunction and oxidative stress in the mother which may influence how the developing foetus interacts with the external environment later on in life. Indeed scientific literature suggests that the foeto-placental vascular endothelial dysfunction may cause epigenetic alteration in the intrauterine environment of the foetus which may be at the origin of chronic diseases in children, thus predisposing them to risk factors of CVD. However, very few studies in women of African ancestry have been carried out to investigate whether or not children born of pre-eclamptic mothers of African ancestry are at risk of developing CVDs. Hence, the aim of this study is to investigate the relationship between pre-eclampsia and cardiovascular risk in children born to pre-eclampsic mothers in a rural South African population. A prospective case-control control design recruiting pre-eclamptic and normotensive pregnant women and their offspring subsequently will be used. CVD risk will be accessed in the pregnant women at 30 weeks of gestation and in the offspring at birth and then six weeks later. The difference in CVD risk between children born to these two groups of women will be assessed and the correlation between maternal and offspring risks for CVDs determined. It is expected that results obtained from this project will provide information on the cardiovascular effect of in utero exposure to PE in a population of African ancestry. This knowledge will advise policy on the management of women with pre-eclampsia with a view of preventing cardiovascular diseases in the offspring. Furthermore, the project will afford the opportunity for scientific research capacity building in students in Walter Sisulu University and foster collaboration between clinical and fundamental researchers.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Assessment of the Cardiovascular Risk Profile of Infants Exposed to Pre-eclampsia <i>in-utero</i>: A Prospective Case-Control Study in South African Children of African Ancestry.
   Nkeh-Chungag BN, Engwa GA, Businge C, Kutllovci-Hasani K, et al · · 2021 · cited 1× · PMID 34888368 · DOI 10.3389/fcvm.2021.773841