Cardiovascular Risk in Infants Exposed to Pre-eclampsia in Utero

NCT05091827 | Unknown

• 1 other identifier: 070/2021
• Study Type: observational
• Target: 234
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Offspring of Pre-eclamptic Mothers

Outcome Measures

Primary Outcomes (1)

• Cardiovascular risk outcomes of children exposed to pre-eclampsia in vitro.

  The study will monitor both biochemical and physical risks of cardiovascular risk in exposed children during the second and third trimesters and pregnancy and up to one year after birth.

  January 2022 to December 2023

Study Arms (4)

Pregnant women with pre-eclampsia

Pre-eclamptic pregnant women with singleton uncomplicated ≥ 20 week old pregnancies will be recruited in this group of the study.

Normotensive pregnant women

Normotensive pregnant women with singleton uncomplicated ≥ 20 week old pregnancies will be recruited in this group of the study

Offspring of pre-eclamptic women

Both male and female offspring of pre-eclamptic women recruited in this study will be recruited into this study group.

Offspring of normotensive pregnant women

Both male and female offspring of from normotensive pregnant women recruited in this study will be recruited into this study group.

Eligibility Criteria

• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Pre-eclamptic and normotensive pregnant women and their offspring.

You may qualify if:

• Pre-eclamptic or normotensive pregnant women with singleton uncomplicated ≥ 20 week old pregnancies and their offspring will be recruited for the study.

You may not qualify if:

• Pregnant women with chronic hypertension, type 2 diabetes, gestational diabetes, renal and cardiovascular diseases or any critical health condition will be excluded from the study.

Sponsors & Collaborators

• Walter Sisulu University: lead
• Medical Research Council, South Africa: collaborator
• Medical University of Graz: collaborator

Related Publications (28)

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Central Study Contacts

Benedicta Nkeh-Chungag, PhD

CONTACT

+27475021989; bnkehchungag@wsu.ac.za

Wilson Akpan, PhD

CONTACT

+27475022044; wakpan@wsu.ac.za

Study Design

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

Study Record Dates

• First Submitted: October 12, 2021
• First Posted: October 25, 2021
• Study Start: November 30, 2021
• Primary Completion: December 30, 2022
• Study Completion: December 30, 2023
• Last Updated: October 25, 2021

Record last verified: 2021-10

Data Sharing

• IPD Sharing: Will not share