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Clinical trialNCT05883761CompletedObservational

Birth Outcomes In Eswatini After Transition To Dolutegravir-Based Treatment

SponsorElizabeth Glaser Pediatric AIDS FoundationEnrollment50,075Congenital AbnormalitiesNeural Tube DefectsTeratogens
View the registry record on ClinicalTrials.gov

Summary

The lay summary the sponsor registered on ClinicalTrials.gov.

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.
clinicaltrials.gov ↗

Investigators

The overall officials registered on this study. Names that resolve to a FindMyKOL profile link to it; the rest are shown as registered.

A profile link is shown only when the registered name resolves to a person record with a confident, namesake-checked match; ambiguous names stay unlinked.

Sites

5 registered facilities, with the per-site recruitment status where the registry publishes one. ClinicalTrials.gov does not publish per-site enrollment counts.

Eswatini
  • Good Shepherd Hospital

    Lubombo, Lubombo Region, Eswatini

  • Hlathikhulu Hospital

    Shiselweni, Shiselweni, Eswatini

  • Mankayane Government Hospital

    Manzini, Eswatini

  • Raleigh Fitkin Memorial Hospital

    Manzini, Eswatini

  • Mbabane Government Hospital

    Mbabane, Eswatini

Site investigator names are published by ClinicalTrials.gov only while a study recruits, so completed studies list sites without them.

Drugs studied

No drug or biological interventions are in our data for this study. It may test a procedure, device or behavioral intervention, or the intervention list isn't in our current snapshot. See the registry record ↗. Why? →

Registration & key dates

Registry attributes as recorded on the ClinicalTrials.gov study record.

Start
7 Sept 2021
Primary completion
30 Sept 2023
Completion
30 Sept 2023
Last update posted
4 Apr 2024
Registered enrollment
50,075
Registry id
NCT05883761
clinicaltrials.gov ↗

Source: ClinicalTrials.gov, via the CTTI AACT database, data as of 24 Aug 2026. Registry facts are shown as registered by the study sponsor; FindMyKOL does not interpret them.