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Birth Outcomes In Eswatini After Transition To Dolutegravir-Based Treatment
Sponsor: Elizabeth Glaser Pediatric AIDS Foundation
Summary
The goal of this observational study is to assess the birth outcomes of HIV-positive women delivering in hospitals in Eswatini who are receiving dolutegravir (DTG) or other anti-retroviral (ARV) drug regimens. The main question the study aims to answer is, what is the proportion of neural tube defects among live and stillborn infants delivered by: * HIV-positive women on DTG at conception * HIV-negative women * HIV-positive women on non-DTG ARV at conception Participants will be interviewed for information on HIV testing and antiretroviral therapy history, other medical history of selected conditions (e.g., diabetes, malaria, TB) and potential birth defect exposures. Photographs will be taken of the infants. Data on mothers' pregnancy history, birth outcomes, and HIV and ARV information (as applicable) will be collected from patient records.
Official title: Assessment of Birth Outcomes in Eswatini After Transition to Dolutegravir-based Treatment
Key Details
Gender
FEMALE
Age Range
Any - Any
Study Type
OBSERVATIONAL
Enrollment
50075
Start Date
2021-09-07
Completion Date
2023-09-30
Last Updated
2026-09-10
Healthy Volunteers
Yes
Locations (5)
Good Shepherd Hospital
Siteki, Lubombo Region, Eswatini
Hlathikhulu Hospital
Hlatikulu, Shiselweni, Eswatini
Mankayane Government Hospital
Manzini, Eswatini
Raleigh Fitkin Memorial Hospital
Manzini, Eswatini
Mbabane Government Hospital
Mbabane, Eswatini