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Birth Outcomes In Eswatini After Transition To Dolutegravir-Based Treatment

NCT05883761 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 50075

Last updated 2024-04-04

No results posted yet for this study

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.

Conditions

  • Neural Tube Defects
  • Congenital Abnormalities
  • Teratogens

Sponsors & Collaborators

  • Ministry of Health Eswatini

    collaborator UNKNOWN

  • George Washington University

    collaborator OTHER

  • Elizabeth Glaser Pediatric AIDS Foundation

    lead OTHER

Principal Investigators

  • Michelle Gill, PhD · Elizabeth Glaser Pediatric AIDS Foundation

Eligibility

Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2021-09-07
Primary Completion
2023-09-30
Completion
2023-09-30

Countries

  • Eswatini

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05883761 on ClinicalTrials.gov