Birth Outcomes In Eswatini After Transition To Dolutegravir-Based Treatment

NCT05883761 | Completed

• 1 other identifier: EG0259
• Study Type: observational
• Target: 50,075
• Locations: 1 country
• Sites: 5

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.

Conditions

Neural Tube Defects; Congenital Abnormalities; Teratogens

Outcome Measures

Primary Outcomes (3)

• 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

• 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

• 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 Outcomes (2)

• Prevalence of major external birth defects among all live and stillborn infants regardless of maternal HIV or ART status.

  24 months

• Proportion of other pregnancy outcomes

  24 months

Study Arms (3)

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).

Eligibility Criteria

• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• 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

You may not qualify if:

• unable to provide informed consent

Sponsors & Collaborators

• Elizabeth Glaser Pediatric AIDS Foundation: lead
• Ministry of Health Eswatini: collaborator
• George Washington University: collaborator

Study Sites (5)

Good Shepherd Hospital

Lubombo, Lubombo Region, Eswatini

Location

Hlathikhulu Hospital

Shiselweni, Shiselweni District, Eswatini

Location

Mankayane Government Hospital

Manzini, Eswatini

Location

Raleigh Fitkin Memorial Hospital

Manzini, Eswatini

Location

Mbabane Government Hospital

Mbabane, Eswatini

Location

MeSH Terms

Conditions

Neural Tube Defects; Congenital Abnormalities

Condition Hierarchy (Ancestors)

Nervous System Malformations; Nervous System Diseases; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Officials

• Michelle Gill, PhD

  Elizabeth Glaser Pediatric AIDS Foundation

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 22, 2023
• First Posted: June 1, 2023
• Study Start: September 7, 2021
• Primary Completion: September 30, 2023
• Study Completion: September 30, 2023
• Last Updated: April 4, 2024

Record last verified: 2023-05

Data Sharing

• IPD Sharing: Will not share

Locations

ES (5)