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COMPLETED
NCT05883761

Birth Outcomes In Eswatini After Transition To Dolutegravir-Based Treatment

Sponsor: Elizabeth Glaser Pediatric AIDS Foundation

View on ClinicalTrials.gov

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