Clinical trial NCT05883761: Birth Outcomes In Eswatini After Transition To Dolutegravir-Based Treatment
Official title: Assessment of Birth Outcomes in Eswatini After Transition to Dolutegravir-based Treatment
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Neural Tube Defects
Congenital Abnormalities
Teratogens
Lead sponsor: Elizabeth Glaser Pediatric AIDS Foundation
Sponsor class: OTHER
Collaborators: name: Ministry of Health Eswatini
name: George Washington University
First posted: 2023-06-01
Enrollment: 50075
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
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

Brief 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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Proportion of neural tube defects (NTDs) among live and stillborn infants delivered by HIV-positive women on DTG at conception.
timeFrame: 24 months
measure: Proportion of neural tube defects (NTDs) among live and stillborn infants delivered by HIV-negative women
timeFrame: 24 months
measure: Proportion of neural tube defects (NTDs) among live and stillborn infants delivered by HIV-positive women on non-DTG ARV at conception
timeFrame: 24 months
Secondary outcomes:
measure: Prevalence of major external birth defects among all live and stillborn infants regardless of maternal HIV or ART status.
timeFrame: 24 months
measure: Proportion of other pregnancy outcomes
timeFrame: 24 months
Other outcomes:
Locations:
city: Lubombo
country: Swaziland
facility: Good Shepherd Hospital
city: Manzini
country: Swaziland
facility: Mankayane Government Hospital
city: Manzini
country: Swaziland
facility: Raleigh Fitkin Memorial Hospital
city: Mbabane
country: Swaziland
facility: Mbabane Government Hospital
city: Shiselweni
country: Swaziland
facility: Hlathikhulu Hospital
Study officials:
affiliation: Elizabeth Glaser Pediatric AIDS Foundation
name: Michelle Gill, PhD
role: PRINCIPAL_INVESTIGATOR
References: