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Does dolutegravir raise the risk of birth defects? eswatini study investigates

NCT ID NCT05883761

Knowledge-focused Sponsor: Elizabeth Glaser Pediatric AIDS Foundation Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 11, 2026 · Updated 1 time

Summary

Researchers are tracking birth outcomes for infants born in Eswatini to mothers who took dolutegravir or other HIV drugs around the time of conception. The study compares rates of neural tube defects and other birth defects among babies born to HIV-positive women on dolutegravir, HIV-positive women on other HIV drugs, and HIV-negative women. About 50,000 deliveries are included, with detailed interviews and medical record reviews for a smaller group. The goal is to understand whether dolutegravir is linked to a higher risk of birth defects.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
dolutegravir, an HIV drug
What this could lead to
If dolutegravir turns out to be as safe for developing babies as other HIV drugs, this could reassure women and doctors about using it during pregnancy.
What could go wrong
This observational study cannot prove cause and effect, and birth defects have many possible causes. The findings may not apply to other countries or populations.

This is an AI summary of the original study and may miss details. Read our disclaimer.

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

More trials for these conditions

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