An observational study in Neural Tube Defects, Congenital Abnormalities and Teratogens, sponsored by Elizabeth Glaser Pediatric AIDS Foundation. Completed at 5 sites in Eswatini. Open to female participants, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-09-10.
Sponsored by Elizabeth Glaser Pediatric AIDS Foundation · Observational
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:
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.
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.
47 studies on the registry are indexed under Neural Tube Defects; 9 are open to participants now.
This study's enrollment of 50,075 is above the median of 90 across 20 observational studies indexed under Neural Tube Defects.
Browse Neural Tube Defects studies →Elizabeth Glaser Pediatric AIDS Foundation is the lead sponsor of 30 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
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
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
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:
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Women with the last HIV test result recorded during pregnancy or labor and delivery as negative.
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).
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
Time frame: 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
Time frame: 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
Time frame: 24 months
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
Time frame: 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
Time frame: 24 months
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: No
Ran from Sep 2021 to primary completion in Sep 2023, 24 months.
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This study is completed, as verified in Sep 2026. You cannot join it, but the record below documents what was studied.
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Elizabeth Glaser Pediatric AIDS Foundation