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Methods of gestational age assessment influence the observed association between antiretroviral therapy exposure, preterm delivery, and small-for-gestational age infants: a prospective study in Cape Town, South Africa.

ABSTRACT: PURPOSE:Heterogeneous findings exist on antiretroviral therapy (ART) use in pregnancy and preterm delivery (PTD) or infants born small-for-gestational age (SGA). Whether reported differences may be explained by methods used to ascertain gestational age (GA) has not been explored. METHODS:We enrolled consecutive pregnant women attending a large primary care antenatal clinic in South Africa. Public-sector midwives assessed GA by last menstrual period (LMP) and symphysis-fundal height (SFH). Separately, if clinical GA was less than 24 weeks, ultrasound (US) was performed by a research sonographer blinded to midwife assessments. In analysis, the impact of measurement error on the association between HIV/ART status and birth outcome by GA method was assessed, and factors associated with clinical GA underestimation or overestimation identified. RESULTS:In 1787 women included overall, estimated PTD incidence was 36% by LMP, 17% by SFH, and 11% by US. PTD risk was higher for HIV-infected than HIV-uninfected women using US-GA (adjusted odds ratio [aOR] 1.95; 95% CI 1.10-3.46); for LMP/SFH-GA, the associations were smaller and not significant. These findings persisted after adjustment for age, parity, height, and previous PTD. PTD risk did not vary by timing of ART initiation (before or during pregnancy) for any method. Elevated BMI and older age were associated with decreased risk of underestimation by both LMP and SFH; HIV status and obesity were associated with increased risk of overestimation by SFH. There were no differences in SGA incidence across GA methods. CONCLUSIONS:Findings for an association between HIV/ART and birth outcomes are substantially influenced by GA assessment method. With growing public health interest in this association, future research efforts should seek to standardize optimal measures of gestation.

SUBMITTER: Malaba TR

PROVIDER: S-EPMC6286247 | biostudies-literature | 2018 Dec

REPOSITORIES: biostudies-literature

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Methods of gestational age assessment influence the observed association between antiretroviral therapy exposure, preterm delivery, and small-for-gestational age infants: a prospective study in Cape Town, South Africa.

Malaba Thokozile Rosemary TR Newell Marie-Louise ML Madlala Hlengiwe H Perez Alexander A Gray Clive C Myer Landon L

Annals of epidemiology 20180829 12

<h4>Purpose</h4>Heterogeneous findings exist on antiretroviral therapy (ART) use in pregnancy and preterm delivery (PTD) or infants born small-for-gestational age (SGA). Whether reported differences may be explained by methods used to ascertain gestational age (GA) has not been explored.<h4>Methods</h4>We enrolled consecutive pregnant women attending a large primary care antenatal clinic in South Africa. Public-sector midwives assessed GA by last menstrual period (LMP) and symphysis-fundal heigh ...[more]

PMID: 30293920

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Project description:Background: The numbers of women initiating lifelong antiretroviral therapy (ART) during pregnancy and postpartum is increasing rapidly, presenting a burden on health systems and an urgent need for scalable models of care for this population. In a pilot project, we referred postpartum women who initiated ART during pregnancy to a community-based model of differentiated ART services.Methods: Eligible women (on ART for at least 3 months with viral load (VL)<1000 copies/mL) were offered a choice of two ART models of care: (i) referral to an existing system of community-based 'adherence clubs', operated by lay counsellors with medication collection every 2-4 months; or (ii) referral to local primary healthcare clinics (PHC) with services provided by clinicians and medication collection every 1-2 months (local standard of care for postpartum ART). For evaluation, women were followed through 6-months postpartum with VL testing separate from either ART service.Results: Through September 2015, n = 129 women were enrolled (median age, 28 years; median time postpartum, 10 days). Overall, 65% (n = 84) chose adherence clubs and 35% (n = 45) chose PHCs; there were no demographic or clinical predictors of this choice. Location of service delivery was commonly cited as a reason for choice by women selecting either model of care; shorter waiting times, ability to receive ART from lay counsellors and less frequent appointments were motivations for choosing adherence clubs. Among women choosing adherence clubs, 15% never attended the service and another 11% attended the service but were not retained through six months postpartum. Overall, 86% of women (n = 111) remained in the evaluation through 6 months postpartum; in this group, there were no differences in VL<1000 copies/mL at six months postpartum between women choosing PHCs (88%) vs. adherence clubs (92%; p = 0.483), but women who were not retained in adherence clubs were more likely to have VL?1000 copies/mL compared to those who remained (p = 0.002).Discussion: Adherence clubs may be a valuable model for postpartum women initiating ART in pregnancy, with good short-term outcomes observed during this critical period. To support optimal implementation, further research is needed into patient preferences for models of care, with consideration of integration of maternal and child health services, while ART adherence and retention require ongoing consideration in this population.

Project description:BackgroundWith an increasing number of countries implementing Option B+ guidelines of lifelong antiretroviral therapy (ART) for all pregnant and breastfeeding women, there is urgent need to identify effective approaches for retaining this growing and highly vulnerable population in ART care.MethodsNewly postpartum, breastfeeding women who initiated ART in pregnancy and met eligibility criteria were enrolled, and offered the choice of two options for postpartum ART care: (i) referral to existing network of community-based adherence clubs or (ii) referral to local primary health care clinic (PHC). Women were followed at study measurement visits conducted separately from either service. Primary outcome was a composite endpoint of retention in ART services and viral suppression [VS < 50 copies/mL based on viral load (VL) testing at measurement visits] at 12 months postpartum. Outcomes were compared across postpartum services using chi-square, Fisher's exact tests and Poisson regression models. The primary outcome was compared across services where women were receiving care at 12 months postpartum in exploratory analyses.ResultsBetween February and September 2015, 129 women (median age: 28.9 years; median time postpartum: 10 days) were enrolled with 65% opting to receive postpartum HIV care through an adherence club. Among 110 women retained at study measurement visits, 91 (83%) achieved the composite endpoint, with no difference between those who originally chose clubs versus those who chose PHC services. Movement from an adherence club to PHC services was common: 31% of women who originally chose clubs and were engaged in care at 12 months postpartum were attending a PHC service. Further, levels of VS differed significantly by where women were accessing ART care at 12 months postpartum, regardless of initial choice: 98% of women receiving care in an adherence club and 76% receiving care at PHC had VS < 50 copies/mL at 12 months postpartum (p = 0.001).ConclusionThis study found comparable outcomes related to retention and VS at 12 months postpartum between women choosing adherence clubs and those choosing PHC. However, movement between postpartum services among those who originally chose adherence clubs was common, with poorer VS outcomes among women leaving clubs and returning to PHC services.Trial registrationClinicalTrials.gov NCT02417675 , April 16, 2015 (retrospectively registered).

Project description:BackgroundInfants born HIV-exposed yet remain uninfected (HEU) are at increased risk of poorer growth and health compared to infants born HIV-unexposed (HU). Whether maternal antiretroviral treatment (ART) in pregnancy ameliorates this risk of poorer growth is not well understood. Furthermore, whether risks are similar across high burden HIV settings has not been extensively explored.MethodsWe harmonized data from two prospective observational studies conducted in Cape Town, South Africa, and Lusaka, Zambia, to compare weight-for-age (WAZ), length-for-age (LAZ) and weight-for-length (WLZ) Z-scores between infants who were HEU and HU, converting infant anthropometric measures using World Health Organisation Growth Standards adjusted for age and sex. Linear mixed effects models were fit to identify risk factors for differences in anthropometrics at 6-10 weeks and 6 months by infant HIV exposures status and by timing of exposure to maternal ART, either from conception or later in gestation.ResultsOverall 773 mother-infant pairs were included across two countries: women living with HIV (WLHIV), 51% (n = 395) with 65% on ART at conception and 35% initiating treatment in pregnancy. In linear mixed effects models, WAZ and WLZ at 6-10 weeks were lower among infants who were HEU vs HU [β = - 0.29 (95% CI: - 0.46, - 0.12) and [β = - 0.42 (95% CI: - 0.68, - 0.16)] respectively after adjusting for maternal characteristics and infant feeding with a random intercept for country. At 6 months, LAZ was lower [β = - 0.28 CI: - 0.50, - 0.06)] among infants who were HEU, adjusting for the same variables, with no differences in WAZ and WLZ. Within cohort evaluations identified different results with higher LAZ among infants who were HEU from Zambia at 6-10 weeks, [β = + 0.34 CI: + 0.01, + 0.68)] and lower LAZ among infants who were HEU from South Africa [β = - 0.30 CI: - 0.59, - 0.01)] at 6 months, without other anthropometric differences at either site.ConclusionInfant growth trajectories differed by country, highlighting the importance of studying contextual influences on outcomes of infants who were HEU.

Project description:BackgroundSuccessful scale-up of antiretroviral therapy (ART) during pregnancy has minimized infant HIV acquisition, and over 1 million infants are born HIV-exposed but uninfected (HEU), with an increasing proportion also exposed in utero to maternal ART. While benefits of ART in pregnancy outweigh risks, some studies have reported associations between in utero ART exposure and impaired fetal growth, highlighting the need to identify the safest ART regimens for use in pregnancy.MethodsWe compared birth anthropometrics of infants who were HEU with those HIV-unexposed (HU) in Cape Town, South Africa. Pregnant women had gestational age assessed by ultrasound at enrolment. Women living with HIV were on ART (predominately tenofovir-emtricitabine-efavirenz) either prior to conception or initiated during pregnancy. Birth weights and lengths were converted to weight-for-age (WAZ) and length-for-age (LAZ) z-scores using Intergrowth-21st software. Linear regression was used to compare mean z-scores adjusting for maternal and pregnancy characteristics.ResultsAmong 888 infants, 49% (n = 431) were HEU and 51% (n = 457) HU. Of 431 HEU infants, 62% (n = 268) were exposed to HIV and antiretrovirals (ARVs) from conception and 38% (n = 163) were exposed to ARVs during gestation but after conception (median fetal ARV exposure of 21 weeks [IQR; 17-26]). In univariable analysis, infants who were HEU had lower mean WAZ compared with HU [β = - 0.15 (95% Confidence Interval (CI): - 0.28, - 0.020)]. After adjustment for maternal age, gravidity, alcohol use, marital and employment status the effect remained [adjusted β - 0.14 (95%CI: - 0.28, - 0.01]. Similar differences were noted for mean LAZ in univariable [β - 0.20 (95%CI: - 0.42, - 0.01] but not multivariable analyses [adjusted β - 0.18 (95%CI: - 0.41, + 0.04] after adjusting for the same variables. Mean WAZ and LAZ did not vary by in utero ARV exposure duration among infants who were HEU.ConclusionIn a cohort with high prevalence of ART exposure in pregnancy, infants who were HEU had lower birth WAZ compared with those HU. Studies designed to identify the mechanisms and clinical significance of these disparities, and to establish the safest ART for use in pregnancy are urgently needed.

Project description:BackgroundThe diagnosis of gestational diabetes mellitus (GDM) may affect women's mental wellbeing, functioning and quality of life, with potentially negative effects on treatment adherence. Identifying and addressing the psychological and emotional needs of women with GDM, could have benefits for sustainable long-term behavioural change following the affected pregnancy. This study explored the lived experiences of women with GDM and the impact of GDM on their experience of pregnancy and sense of well-being.MethodsPurposive sampling was used to recruit women who had been diagnosed with GDM in their previous pregnancy and received antenatal care at a tertiary hospital in Cape Town, South Africa. This was a descriptive qualitative study using a combination of focus groups and in-depth interviews for an in- depth exploration of women's lived experiences of GDM, their context and perceived needs. Data analysis followed an iterative thematic analysis approach.ResultsThirty-five women participated in nine focus groups and five in-depth interviews. Women discussed the emotional and psychological burden of having GDM, highlighting (i) their initial emotional reactions to receiving a GDM diagnosis, (ii) their experience of adjusting to the constraints of living with GDM (iii) their feelings of apprehension about childbirth and their maternal role and (iv) their feelings of abandonment in the post-partum period once the intensive support from both health system and family ends.ConclusionsThe current biomedical model used in the management of GDM, is highly foetal-centric and fails to acknowledge important psychological factors that contribute to women's overall wellbeing and experience of pregnancy. These results demonstrate the importance of incorporating mental health support in the management and care for women with GDM in public health services, along with facilitating emotional support from partners and family members. Based on our findings, we recommend routine mental health and psychosocial vulnerability screening and monitoring for women diagnosed with GDM throughout pregnancy and postpartum to improve prognoses.

Dataset Information

Methods of gestational age assessment influence the observed association between antiretroviral therapy exposure, preterm delivery, and small-for-gestational age infants: a prospective study in Cape Town, South Africa.

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Methods of gestational age assessment influence the observed association between antiretroviral therapy exposure, preterm delivery, and small-for-gestational age infants: a prospective study in Cape Town, South Africa.

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