Status:
UNKNOWN
Cardiometabolic Health of Children Exposed to Anti-retroviral Therapy (ART) in Utero
Lead Sponsor:
Walter Sisulu University
Collaborating Sponsors:
Nelson Mandela Academic Hospital
Umtata General Hospital
Conditions:
In Utero Drug Exposure
Eligibility:
FEMALE
Brief Summary
The Human Immunodeficiency Virus (HIV) has been recently linked to increased risk for cardiovascular diseases (CVDs). The prevalence of cardiovascular diseases and its risk factor, hypertension, are v...
Detailed Description
I. Sample size calculation The number of participants required to show statistical significance is based on previously published studies in which vascular function was assessed in HIV patients (Agu et...
Eligibility Criteria
Inclusion
- Cases: sub-Saharan women with singleton uncomplicated 11-14 week old pregnancies, be HIV positive and have been on ARTs for at least four months before pregnancy.
- Controls: 11-14 week old pregnant HIV negative women.
Exclusion
- Pregnant women with type 2 diabetes, gestational diabetes, renal and cardiovascular diseases or any critical health.
Key Trial Info
Start Date :
May 20 2021
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
December 31 2023
Estimated Enrollment :
320 Patients enrolled
Trial Details
Trial ID
NCT04763668
Start Date
May 20 2021
End Date
December 31 2023
Last Update
May 6 2021
Active Locations (1)
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1
Umtata General Hospital
Mthatha, Eastern Cape, South Africa, 5099