Birth Outcomes In Eswatini After Transition To Dolutegravir-Based Treatment

Congenital Abnormalities Clinical Trial

Official title:

Assessment of Birth Outcomes in Eswatini After Transition to Dolutegravir-based Treatment

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05883761
• Other study ID #: EG0259
• Status: Completed
• Start date: September 7, 2021
• Est. completion date: September 30, 2023

Study information

• Verified date: May 2023
• Source: Elizabeth Glaser Pediatric AIDS Foundation
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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. 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50075
• Est. completion date: September 30, 2023
• Est. primary completion date: September 30, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Congenital Abnormalities
• Neural Tube Defects
• Spinal Dysraphism
• Teratogens

Locations

Country	Name	City	State
Swaziland	Good Shepherd Hospital	Lubombo
Swaziland	Mankayane Government Hospital	Manzini
Swaziland	Raleigh Fitkin Memorial Hospital	Manzini
Swaziland	Mbabane Government Hospital	Mbabane
Swaziland	Hlathikhulu Hospital	Shiselweni

Sponsors (3)

Lead Sponsor	Collaborator
Elizabeth Glaser Pediatric AIDS Foundation	George Washington University, Ministry of Health Eswatini

Country where clinical trial is conducted

Swaziland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	24 months
Primary	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	24 months
Primary	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	24 months
Secondary	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	24 months
Secondary	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	24 months