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Assessment of birth outcomes in eswatini after transition to dolutegravir-based treatment

NCT ID NCT05883761

NEW Sponsor: Elizabeth Glaser Pediatric AIDS Foundation Source: ClinicalTrials.gov ↗

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Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Sep 10, 2026 · Last updated Sep 10, 2026

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.

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Study facts

What this study's own registry entry says, in plain language.

Participants

50,075 people

The number who actually took part.

Started

Sep 2021

Finished

Sep 2023

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Who is studied

Women delivering infants at selected hospitals in Eswatini, including women delivering stillborn infants and those admitted for miscarriages or medical abortions due to identified congenital defects via diagnostic imaging

Ages

Children (under 18), adults (18 to 64) and older adults (65 and over)

Sex

Female participants only

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Surveillance component includes all deliveries/admissions as defined in study population description. For a subset of the population recruited for additional data collection: Inclusion Criteria: * women whose live or stillborn infant has birth defect as identified by a midwife or other clinician at the study hospital * willing to provide informed consent Exclusion Criteria: * unable to provide informed consent

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Conditions

The condition(s) this trial relates to.

Congenital Abnormalities neural tube defect neural tube defects, susceptibility to

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Congenital abnormalities Neural tube defects Teratogens

Contacts and locations

Locations

  • Good Shepherd Hospital

    Siteki, Lubombo Region, Eswatini

  • Hlathikhulu Hospital

    Hlatikulu, Shiselweni, Eswatini

  • Mankayane Government Hospital

    Manzini, Eswatini

  • Mbabane Government Hospital

    Mbabane, Eswatini

  • Raleigh Fitkin Memorial Hospital

    Manzini, Eswatini

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