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Subject: search.filters.subject.Pregnant women

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    The moral obligation to include pregnant women in clinical trials
    (University of the Witwatersrand, Johannesburg, 2024) Ramtahal, Kieara-Lee; Behrens, Kevin
    Many pregnancies are complicated by serious medical conditions that require treatment, and despite the need to use medication during pregnancy, the majority of clinical trials do not include the pregnant population, which leaves pregnant women with limited “robust” data regarding the safety and effectiveness of medications that they may require during pregnancy (Little & Wickremsinhe, 2017, p.1). In this report, I examine the reasons provided for the exclusion of pregnant women from clinical trials and the ethical reasons for their inclusion. I argue that, 1. the exclusion of pregnant women as participants in clinical trials could potentially expose future pregnant women to significant harms, 2. the benefits arising out of the inclusion of pregnant women in clinical trials far exceeds the possible harms to the pregnant women trial participants and their fetuses and 3. pregnant women deserve fair access to research trials where their participation will involve access to potential benefits. I also discuss objections to my arguments and provide a response. In conclusion, I contend that pregnant women should be included in clinical trials unless there are compelling reasons for exclusion.
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    Routine laboratory and clinical monitoring of HIV-positive pregnant women on antiretroviral therapy
    (2024) Khulu, Kwano Mahlako Kgwerano
    Background Developments in South Africa’s prevention of mother-to-child transmission of HIV (PMTCT) programme show a decline in AIDS-related paediatric deaths. In 2015, PMTCT guidelines were updated, with revised protocols for clinical and laboratory monitoring for patients on antiretroviral therapy (ART). The aim of this study was to assess adherence to monitoring guidelines for HIV-positive pregnant women on ART. Methods This was a clinical audit of 185 HIV-positive pregnant women, on pre-pregnancy ART, or initiated during the index pregnancy and delivered at Charlotte Maxeke Johannesburg Academic Hospital (CMJAH) in the period January to June 2017. Data were collected on timing of HIV diagnosis and ART initiation, clinical and laboratory monitoring, and initiation of prophylaxis for opportunistic infections. Results Of the 185 patients, 64.9% (120/185) were known with HIV infection prior to the index pregnancy, and 85.8% (103/120) were initiated on ART pre-pregnancy, with 64/103 (62.1%) virally suppressed (<50 copies/ml)d t baseline. Overall, 179/185 women accessed antenatal care. A total of 82 patients were initiated on ART in the index pregnancy, and of these 60/82 (73.2%) had a 3-month viral load done, and 22/82 (26.8%) were suppressed. A total of 153/185 (82.7%) patients had CD4 counts done, and of these, 63/153 (41.2%) were ≤350 cells/dl, with 7/63 (11.1%) patients receiving cotrimoxazole prophylaxis. Tuberculosis (TB) screening was documented for 35/179 (19.6%) patients, with 6/35 (17.1%) receiving TB preventative therapy. Birth HIV PCR tests were available for 175/185 (94.6%) neonates, and all were negative. Conclusion There were gaps identified in laboratory and clinical monitoring. ART initiation was however high, with no cases of MTCT reported.