Neural Tube DefectsNCT05883761
Birth Outcomes In Eswatini After Transition To Dolutegravir-Based Treatment
An observational study of Neural Tube Defects and Congenital Abnormalities, run by Elizabeth Glaser Pediatric AIDS Foundation at 5 sites in Eswatini.
Trial 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. Read more about this study
- Who is it for?
- Any age, women onlyHealthy volunteers can take part
- Conditions the study is for
- Neural Tube Defects, Congenital Abnormalities, Teratogens
- How many people
- 50,075 participants
- Where
- 5 sitesEswatini
- Study dates
- 7 Sep 2021to 30 Sep 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- Women only
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: 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
Who may be able to join
- 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
Who cannot join
- unable to provide informed consent
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
Eswatini5 sites
Hlathikhulu Hospital
Hlatikulu, Shiselweni
Mankayane Government Hospital
Manzini
Raleigh Fitkin Memorial Hospital
Manzini
Mbabane Government Hospital
Mbabane
Good Shepherd Hospital
Siteki, Lubombo Region
About this study
Official title: Assessment of Birth Outcomes in Eswatini After Transition to Dolutegravir-based Treatment
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.
Read the detailed description
This is an observational study conducted at five high volume hospitals in Eswatini, in which birth defect and other data will be collected at the time of delivery (or hospital admission for miscarriages and medical abortions) for all women. The overall aim of this study is to evaluate the birth outcomes of HIV-positive women who are receiving DTG or other ARV drug regimens. The primary research objectives are to: 1) determine the proportion of neural tube defects among live and stillborn infants delivered by HIV-positive women on DTG at conception; 2) determine the proportion of neural tube defects among live and stillborn infants delivered by HIV-negative women; and 3) determine the proportion of neural tube defects among live and stillborn infants delivered by HIV-positive women on non-DTG ART at conception. Secondary objectives are to determine overall general prevalence of major external birth defects and other pregnancy outcomes and any associations with other factors (e.g., maternal age, gravida). Data on mothers' pregnancy history, birth outcomes, and HIV and ARV information (as applicable) are collected from patient charts, registers, reporting forms and databases for all women. Women of live or stillborn infants with birth defects are consented for interviews capturing detailed history and exposure data and photographs of newborns' birth defects. Data collection will be for approximately 24 months. Blinded interview data and photographs are reviewed by a medical geneticist for confirmatory defect diagnosis. We will describe rates and 95% confidence intervals (CI) for birth defects among infants by maternal HIV and ART status.
- Conditions
- Neural Tube Defects, Congenital Abnormalities, Teratogens
- Medical subject headings
- Neural Tube Defects, Congenital Abnormalities
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| HIV-positive DTG preconception | HIV status defined as a documented positive result in the perinatal and/or maternity register or other clinical source record. Preconception drug exposure determined using date of DTG initiation and LMP date or gestational age at delivery (if LMP not available). ART at conception is defined as maternal ART that started up to 8 weeks after the calculated LMP date, which would be up to 6 weeks after the estimated date of conception. As this is the group of interest, sample size target was determined as 10,000. | |
| HIV-negative | Women with the last HIV test result recorded during pregnancy or labor and delivery as negative. | |
| HIV-positive on non-DTG ARV preconception | HIV status defined as a documented positive result in the perinatal and/or maternity register or other clinical source record. Preconception drug exposure determined using date of ARV initiation (e.g., efavirenz) and LMP date or gestational age at delivery (if LMP not available). ART at conception is defined as maternal ART that started up to 8 weeks after the calculated LMP date, which would be up to 6 weeks after the estimated date of conception. Other groups to be included as informed by the data (e.g., HIV+ not on ART a conception, unknown ART at conception, etc). |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of neural tube defects (NTDs) among live and stillborn infants delivered by HIV-positive women on DTG at conception.
Number of live and stillborn infants with NTDs divided by the total number of live and stillborn infants of HIV-positive women on DTG at conception
Measured: 24 months
Proportion of neural tube defects (NTDs) among live and stillborn infants delivered by HIV-negative women
Number of live and stillborn infants with NTDs divided by the total number of live and stillborn infants of HIV-negative women
Measured: 24 months
Proportion of neural tube defects (NTDs) among live and stillborn infants delivered by HIV-positive women on non-DTG ARV at conception
Number of live and stillborn infants with NTDs divided by the total number of live and stillborn infants of HIV-positive women on non-DTG ARV at conception
Measured: 24 months
Secondary outcomes (2)
Prevalence of major external birth defects among all live and stillborn infants regardless of maternal HIV or ART status.
Number of live and stillborn infants with major external birth defects divided by the total number of live and stillborn infants among all women regardless of HIV or ART status
Measured: 24 months
Proportion of other pregnancy outcomes
Number of live and stillborn infants with low birthweight and pre-term delivery divided by the total number of live infants among women (overall and by HIV/ART status); number of stillborn infants among all pregnancies, including miscarriages
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jun 2023
- Study start7 Sep 2021
- Primary completion30 Sep 2023
- Study completion30 Sep 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Neural Tube DefectsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 50,075 participants (actual)
Sponsor and investigators
- Lead sponsor
- Elizabeth Glaser Pediatric AIDS Foundation
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Michelle Gill, PhD, Principal investigator, Elizabeth Glaser Pediatric AIDS Foundation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05883761
- Sponsor's protocol ID
- EG0259
- Status last verified
- Sep 2026
- First submitted
- 22 May 2023
- Last updated
- 10 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of Birth Outcomes in Eswatini After Transition to Dolutegravir-based Treatment
- ClinicalTrials.gov ID
- NCT05883761
- Acronym / sponsor ID
- EG0259
- Conditions
- Neural Tube Defects, Congenital Abnormalities, Teratogens
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 50,075 participants (actual)
- Lead sponsor
- Elizabeth Glaser Pediatric AIDS FoundationUniversity, hospital or other
- Study start
- 7 Sep 2021 (actual)
- Primary completion
- 30 Sep 2023 (actual)
- Study completion
- 30 Sep 2023 (actual)
- First posted
- 1 Jun 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
This is an observational study conducted at five high volume hospitals in Eswatini, in which birth defect and other data will be collected at the time of delivery (or hospital admission for miscarriages and medical abortions) for all women. The overall aim of this study is to evaluate the birth outcomes of HIV-positive women who are receiving DTG or other ARV drug regimens. The primary research objectives are to: 1) determine the proportion of neural tube defects among live and stillborn infants delivered by HIV-positive women on DTG at conception; 2) determine the proportion of neural tube defects among live and stillborn infants delivered by HIV-negative women; and 3) determine the proportion of neural tube defects among live and stillborn infants delivered by HIV-positive women on non-DTG ART at conception. Secondary objectives are to determine overall general prevalence of major external birth defects and other pregnancy outcomes and any associations with other factors (e.g., maternal age, gravida). Data on mothers' pregnancy history, birth outcomes, and HIV and ARV information (as applicable) are collected from patient charts, registers, reporting forms and databases for all women. Women of live or stillborn infants with birth defects are consented for interviews capturing detailed history and exposure data and photographs of newborns' birth defects. Data collection will be for approximately 24 months. Blinded interview data and photographs are reviewed by a medical geneticist for confirmatory defect diagnosis. We will describe rates and 95% confidence intervals (CI) for birth defects among infants by maternal HIV and ART status.
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| HIV-positive DTG preconception | – | –HIV status defined as a documented positive result in the perinatal and/or maternity register or other clinical source record. Preconception drug exposure determined using date of DTG initiation and LMP date or gestational age at delivery (if LMP not available). ART at conception is defined as maternal ART that started up to 8 weeks after the calculated LMP date, which would be up to 6 weeks after the estimated date of conception. As this is the group of interest, sample size target was determined as 10,000. |
| HIV-negative | – | –Women with the last HIV test result recorded during pregnancy or labor and delivery as negative. |
| HIV-positive on non-DTG ARV preconception | – | –HIV status defined as a documented positive result in the perinatal and/or maternity register or other clinical source record. Preconception drug exposure determined using date of ARV initiation (e.g., efavirenz) and LMP date or gestational age at delivery (if LMP not available). ART at conception is defined as maternal ART that started up to 8 weeks after the calculated LMP date, which would be up to 6 weeks after the estimated date of conception. Other groups to be included as informed by the data (e.g., HIV+ not on ART a conception, unknown ART at conception, etc). |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- 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
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (1 listed)
- unable to provide informed consent
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Proportion of neural tube defects (NTDs) among live and stillborn infants delivered by HIV-positive women on DTG at conception.
Time frame: 24 months
Number of live and stillborn infants with NTDs divided by the total number of live and stillborn infants of HIV-positive women on DTG at conception
Proportion of neural tube defects (NTDs) among live and stillborn infants delivered by HIV-negative women
Time frame: 24 months
Number of live and stillborn infants with NTDs divided by the total number of live and stillborn infants of HIV-negative women
Proportion of neural tube defects (NTDs) among live and stillborn infants delivered by HIV-positive women on non-DTG ARV at conception
Time frame: 24 months
Number of live and stillborn infants with NTDs divided by the total number of live and stillborn infants of HIV-positive women on non-DTG ARV at conception
2 secondary outcomes
Prevalence of major external birth defects among all live and stillborn infants regardless of maternal HIV or ART status.
Time frame: 24 months
Proportion of other pregnancy outcomes
Time frame: 24 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Sep 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Michelle Gill, PhD principal investigator
Elizabeth Glaser Pediatric AIDS Foundation
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Neural Tube Defects and Congenital Abnormalities, run by Elizabeth Glaser Pediatric AIDS Foundation at 5 sites in Eswatini.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in Eswatini. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of neural tube defects (NTDs) among live and stillborn infants delivered by HIV-positive women on DTG at conception. (time frame: 24 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Sep 2026.