The incidence of subsequent pregnancies in women enrolled in the DolPHIN 2 studies
type: CreativeWork
description: Background Inadequate safety and efficacy data for medications during pregnancy, particularly for antiretroviral therapy (ART) regimens, stems from the exclusion of pregnant and postpartum women from clinical trials. Despite global efforts, challenges persist in enrolling this population. In the context of antiretroviral therapy, (ART) the shift from efavirenz (EFV) to dolutegravir (DTG) as the World Health Organization-recommended (first-line regimen) occurred with limited pregnancy data. In some clinical trials, becoming pregnant resulted from withdrawal from the trial, emphasizing the ongoing challenges in including pregnant women in trials. Furthermore, longer term follow-up beyond the duration of trials has been lacking. The objective of this secondary analysis is to provide an interim pathway, of retaining women who subsequently become pregnant and obtaining comprehensive pregnancy data, allowing pregnant women to continue participating in clinical trials. However, evidence on the incidence of subsequent pregnancies among women in such trials is limited and thus we aim to describe it. Methodology This secondary analysis included data from the 250 women (South Africa n=114, Uganda n=135) who met the intention to treat (ITT) criteria in the DolPHIN-2 study and were actively followed up over time. This study focuses on describing the incidence of subsequent pregnancies in a cohort of women enrolled in the DoLPHIN-2 randomized trial and its observational extension study D2 TRIO. The aim of this trial was to explore the safety and efficacy of DTG in pregnant women aged ≥18 years of age, presenting late (≥28 weeks gestational age) for antenatal care. Women were randomised 1:1 to receive DTG or EFV. Data from South Africa and Uganda collected between January 22, 2018, and September 5, 2023, were analysed descriptively. Results This secondary analysis included data from the 250 women (South Africa n=114, Uganda n=135) who met the intention to treat (ITT) criteria in t…
abstract: Background Inadequate safety and efficacy data for medications during pregnancy, particularly for antiretroviral therapy (ART) regimens, stems from the exclusion of pregnant and postpartum women from clinical trials. Despite global efforts, challenges persist in enrolling this population. In the context of antiretroviral therapy, (ART) the shift from efavirenz (EFV) to dolutegravir (DTG) as the World Health Organization-recommended (first-line regimen) occurred with limited pregnancy data. In some clinical trials, becoming pregnant resulted from withdrawal from the trial, emphasizing the ongoing challenges in including pregnant women in trials. Furthermore, longer term follow-up beyond the duration of trials has been lacking. The objective of this secondary analysis is to provide an interim pathway, of retaining women who subsequently become pregnant and obtaining comprehensive pregnancy data, allowing pregnant women to continue participating in clinical trials. However, evidence on the incidence of subsequent pregnancies among women in such trials is limited and thus we aim to describe it. Methodology This secondary analysis included data from the 250 women (South Africa n=114, Uganda n=135) who met the intention to treat (ITT) criteria in the DolPHIN-2 study and were actively followed up over time. This study focuses on describing the incidence of subsequent pregnancies in a cohort of women enrolled in the DoLPHIN-2 randomized trial and its observational extension study D2 TRIO. The aim of this trial was to explore the safety and efficacy of DTG in pregnant women aged ≥18 years of age, presenting late (≥28 weeks gestational age) for antenatal care. Women were randomised 1:1 to receive DTG or EFV. Data from South Africa and Uganda collected between January 22, 2018, and September 5, 2023, were analysed descriptively. Results This secondary analysis included data from the 250 women (South Africa n=114, Uganda n=135) who met the intention to treat (ITT) criteria in t…
author: Marshall, Amanda
keywords: Medicine
date published: 2024
date modified: 2026-07-22T22:23:38Z
provider: University of Cape Town
publisher: Networked Digital Library of Theses and Dissertations
type: WebPage
source organization: Department of Public Health and Family Medicine

PropertyValue
property ID: Handle
value: http://hdl.handle.net/11427/41121