Cohort profile: the Western Cape Pregnancy Exposure Registry (WCPER)

Kalk, Emma; Heekes, Alexa; Slogrove, Amy L.; Phelanyane, Florence; Davies, Mary‐Ann; Myer, Landon; Euvrard, Jonathan; Kroon, Max; Petro, Gregory; Fieggen, Karen; Stewart, Chantal; Rhoda, Natasha; Gebhardt, Stefan; Osman, Ayesha; Anderson, Kim; Boulle, Andrew; Mehta, Ushma

doi:10.1136/bmjopen-2021-060205

Cited by 5 publications

(4 citation statements)

References 28 publications

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“…23 Maternal mortality ranged between 43.6 and 66.8 per 100 000 live births at healthcare facilities in 2017–2019. 24 Khayelitsha is a peri-urban low resourced health subdistrict, with a mix of formal and informal housing. 25 It is serviced by a district hospital and 10 primary healthcare (PHC) facilities.…”

Section: Methodsmentioning

confidence: 99%

Association between tuberculosis and pregnancy outcomes: a retrospective cohort study of women in Cape Town, South Africa

Meehan,

Hesseling,

von Delft

et al. 2024

BMJ Open

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BackgroundTuberculosis (TB) remains a leading cause of mortality among women of childbearing age and a significant contributor to maternal mortality. Pregnant women with TB are at high risk of adverse pregnancy outcomes. This study aimed to determine risk factors for an adverse pregnancy outcome among pregnant women diagnosed with TB.MethodsUsing TB programmatic data, this retrospective cohort analysis included all women who were routinely diagnosed with TB in the public sector between October 2018 and March 2020 in two health subdistricts of Cape Town, and who were documented to be pregnant during their TB episode. Adverse pregnancy outcome was defined as either a live birth of an infant weighing <2500 g and/or with a gestation period <37 weeks or as stillbirth, miscarriage, termination of pregnancy, maternal or early neonatal death. Demographics, TB and pregnancy characteristics were described by HIV status. Logistic regression was used to determine risk factors for adverse pregnancy outcome.ResultsOf 248 pregnant women, half (52%) were living with HIV; all were on antiretroviral therapy at the time of their TB diagnosis. Pregnancy outcomes were documented in 215 (87%) women, of whom 74 (34%) had an adverse pregnancy outcome. Being older (35–44 years vs 25–34 years (adjusted OR (aOR): 3.99; 95% CI: 1.37 to 11.57), living with HIV (aOR: 2.72; 95% CI: 0.99 to 4.63), having an unfavourable TB outcome (aOR: 2.29; 95% CI: 1.03 to 5.08) and having presented to antenatal services ≤1 month prior to delivery (aOR: 10.57; 95% CI: 4.01 to 27.89) were associated with higher odds of an adverse pregnancy outcome.ConclusionsPregnancy outcomes among women with TB were poor, irrespective of HIV status. Pregnant women with TB are a complex population who need additional support prior to, during and after TB treatment to improve TB treatment and pregnancy outcomes. Pregnancy status should be considered for inclusion in TB registries.

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Section: Methodsmentioning

confidence: 99%

Association between tuberculosis and pregnancy outcomes: a retrospective cohort study of women in Cape Town, South Africa

Meehan,

Hesseling,

von Delft

et al. 2024

BMJ Open

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“…New pregnancy PV projects in LMICs may expand on existing structures, often bolstered by local or national governments, to become more robust and adapt to the needs of LMICs with changes in health patterns or disease burden. Such an example is the recent Western Cape Pregnancy Exposure Registry [63], which leverages electronic health records collected at the district level. Our findings may help guide future policy to address the gaps identified in existing PV structures, such as in quality and consistency of data collected or study designs utilized, as the limited existing evidence surrounding medication and vaccination use during pregnancy often shapes conservative guidelines that may negatively impact the health of pregnant people.…”

Section: Summary Of Evidencementioning

confidence: 99%

Pharmacovigilance in Pregnancy Studies, Exposures and Outcomes Ascertainment, and Findings from Low- and Middle-Income Countries: A Scoping Review

Shafi,

Virk,

Kalk

et al. 2024

Drug Saf

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Introduction Pharmacovigilance (PV), or the ongoing safety monitoring after a medication has been licensed, plays a crucial role in pregnancy, as clinical trials often exclude pregnant people. It is important to understand how pregnancy PV projects operate in low- and middle-income countries (LMICs), where there is a disproportionate lack of PV data yet a high burden of adverse pregnancy outcomes. We conducted a scoping review to assess how exposures and outcomes were measured in recently published pregnancy PV projects in LMICs. Methods We utilized a search string, secondary review, and team knowledge to review publications focusing on therapeutic or vaccine exposures among pregnant people in LMICs. We screened abstracts for relevance before conducting a full text review, and documented measurements of exposures and outcomes (categorized as maternal, birth, or neonatal/infant) among other factors, including study topic, setting, and design, comparator groups, and funding sources. Results We identified 31 PV publications spanning at least 24 LMICs, all focusing on therapeutics or vaccines for infectious diseases, including HIV ( n = 17), tuberculosis (TB; n = 9), malaria ( n = 7), pertussis, tetanus, and diphtheria ( n = 1), and influenza ( n = 3). As for outcomes, n = 15, n = 31, and n = 20 of the publications covered maternal, birth, and neonatal/infant outcomes, respectively. Among HIV-specific publications, the primary exposure-outcome relationship of focus was exposure to maternal antiretroviral therapy and adverse outcomes. For TB-specific publications, the main exposures of interest were second-line drug-resistant TB and isoniazid-based prevention therapeutics for pregnant people living with HIV. For malaria-specific publications, the primary exposure-outcome relationship of interest was antimalarial medication exposure during pregnancy and adverse outcomes. Among vaccine-focused publications, the exposure was assessed during a specific time during pregnancy, with an overall interest in vaccine safety and/or efficacy. The study settings were frequently from Africa, designs varied from cohort or cross-sectional studies to clinical trials, and funding sources were largely from high-income countries. Conclusion The published pregnancy PV projects were largely centered in Africa and concerned with infectious diseases. This may reflect the disease burden in LMICs but also funding priorities from high-income countries. As the prevalence of non-communicable diseases increases in LMICs, PV projects will have to broaden their scope. Birth and neonatal/infant outcomes were most reported, with fewer reporting on maternal outcomes and none on longer-term child outcomes; additionally, heterogeneity exist...

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“…With this approach, miscarriages, medical or elective abortions that occur after the first antenatal visit and stillbirths are less likely to be missed compared to hospital-based studies. An example of this is the Western Cape Pregnancy Exposure Registry linked to the UBOMI BUHLE pregnancy exposure registry project in South Africa ( 72 , 73 ).…”

Section: Approaches To Safety Surveillancementioning

confidence: 99%

Safety surveillance for PrEP in pregnant and breastfeeding women

Fairlie,

Lavies,

Kalk

et al. 2023

Front. Reprod. Health

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The risk of HIV acquisition is higher during pregnancy and postpartum than other times. Newly acquired maternal HIV infection associated with high primary viraemia, substantially increases the risk of vertical HIV transmission. Pre-exposure prophylaxis (PrEP) reduces the risk of HIV acquisition. Currently available products include oral tenofovir/emtricitabine (TDF/FTC) and tenofovir alafenamide (TAF)/FTC), long-acting cabotegravir (CAB-LA) and the dapivirine ring (DVR). All except oral TDF/FTC have limited safety data available for use in pregnant and breastfeeding women. The safety of new PrEP agents for pregnant women and the fetus, infant and child, either exposed in utero or during breastfeeding is an ongoing concern for health care workers and pregnant and breastfeeding women, particularly as the safety risk appetite for antiretroviral (ARV) agents used as PrEP is lower in pregnant and breastfeeding women who are HIV-uninfected, compared to women living with HIV taking ARVs as treatment. With the widespread rollout of TDF/FTC among pregnant women in South Africa and other low-middle income countries (LMIC) and the potential introduction of new PrEP agents for pregnant women, there is a need for safety surveillance systems to identify potential signals of risk to either the mother or fetus, measure the burden of such a risk, and where appropriate, provide specific reassurance to PrEP users. Safety data needs to be collected across the continuum of the product life cycle from pre-licensure into the post-marketing period, building a safety profile through both passive and active surveillance systems, recognising the strengths and limitations of each, and the potential for bias and confounding. Pharmacovigilance systems that aim to assess the risk of adverse birth outcomes in pregnant women exposed to PrEP and other agents need to consider the special requirements of pregnancy epidemiology to ensure that the data derived from surveillance are sufficiently robust to inform treatment policies. Here we review the known safety profiles of currently available PrEP candidates in women of child-bearing potential, pregnancy and breastfeeding and discuss pragmatic approaches for such surveillance in HIV-endemic LMICs.

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Cohort profile: the Western Cape Pregnancy Exposure Registry (WCPER)

Cited by 5 publications

References 28 publications

Association between tuberculosis and pregnancy outcomes: a retrospective cohort study of women in Cape Town, South Africa

Association between tuberculosis and pregnancy outcomes: a retrospective cohort study of women in Cape Town, South Africa

Pharmacovigilance in Pregnancy Studies, Exposures and Outcomes Ascertainment, and Findings from Low- and Middle-Income Countries: A Scoping Review

Safety surveillance for PrEP in pregnant and breastfeeding women

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