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As antiretroviral therapy (ART) expands in resource-limited settings, understanding the impact of ART on pregnancy outcomes is critical. We analyzed women who became pregnant on ART while enrolled in a clinical trial (HPTN 052, ACTG A5208, and ACTG A5175); the majority of women were from Africa, with a median age of 29 years. Eligible women were on ART at conception and had a documented date of a last menstrual period and a pregnancy outcome. The primary outcome was non-live birth (stillbirth; spontaneous abortion; elective termination; or ectopic pregnancy) versus live birth. Preterm birth (

Key Points: Question: Can novice clinicians accurately estimate gestational age using a low-cost, battery-powered ultrasonography probe with integrated artificial intelligence (AI) image interpretation? Findings: This prospective study enrolled 400 pregnant individuals with due dates confirmed by first-trimester ultrasonography. At follow-up visits randomly assigned throughout gestation, novice clinicians using an AI-enabled device estimated gestational age as accurately as credentialed sonographers using traditional ultrasonography devices (difference, 0.2 days). Meaning: Obstetrical care in low-resource settings may benefit from reliable gestational age assessment using AI integration with point-of-care ultrasonography. Importance: Accurate assessment of gestational age (GA) is essential to good pregnancy care but often requires ultrasonography, which may not be available in low-resource settings. This study developed a deep learning artificial intelligence (AI) model to estimate GA from blind ultrasonography sweeps and incorporated it into the software of a low-cost, battery-powered device. Objective: To evaluate GA estimation accuracy of an AI-enabled ultrasonography tool when used by novice users with no prior training in sonography. Design, Setting, and Participants: This prospective diagnostic accuracy study enrolled 400 individuals with viable, single, nonanomalous, first-trimester pregnancies in Lusaka, Zambia, and Chapel Hill, North Carolina. Credentialed sonographers established the "ground truth" GA via transvaginal crown-rump length measurement. At random follow-up visits throughout gestation, including a primary evaluation window from 14 0/7 weeks' to 27 6/7 weeks' gestation, novice users obtained blind sweeps of the maternal abdomen using the AI-enabled device (index test) and credentialed sonographers performed fetal biometry with a high-specification machine (study standard). Main Outcomes and Measures: The primary outcome was the mean absolute error (MAE) of the index test and study standard, which was calculated by comparing each method's estimate to the previously established GA and considered equivalent if the difference fell within a prespecified margin of ±2 days. Results: In the primary evaluation window, the AI-enabled device met criteria for equivalence to the study standard, with an MAE (SE) of 3.2 (0.1) days vs 3.0 (0.1) days (difference, 0.2 days [95% CI, −0.1 to 0.5]). Additionally, the percentage of assessments within 7 days of the ground truth GA was comparable (90.7% for the index test vs 92.5% for the study standard). Performance was consistent in prespecified subgroups, including the Zambia and North Carolina cohorts and those with high body mass index. Conclusions and Relevance: Between 14 and 27 weeks' gestation, novice users with no prior training in ultrasonography estimated GA as accurately with the low-cost, point-of-care AI tool as credentialed sonographers performing standard biometry on high-specification machines. These findings have immediate implications for obstetrical care in low-resource settings, advancing the World Health Organization goal of ultrasonography estimation of GA for all pregnant people. Trial Registration: ClinicalTrials.gov Identifier: NCT05433519 This prospective diagnostic study examines the accuracy of an AI-enabled ultrasonography tool in estimating gestational age when used by those with no prior training in sonography. [ABSTRACT FROM AUTHOR]

: Introduction: Postpartum depression (PPD) is a prevalent and debilitating disease that may affect medication adherence and thus maternal health and vertical transmission among women with HIV. We assessed the feasibility of a trial of interpersonal psychotherapy (IPT) versus antidepressant medication (ADM) to treat PPD and/or anxiety among postpartum women with HIV in Lusaka, Zambia. Methods: Between 29 October 2019 and 8 September 2020, we pre‐screened women 6–8 weeks after delivery with the Edinburgh Postnatal Depression Scale (EPDS) and diagnosed PPD or anxiety with the Mini International Neuropsychiatric Interview. Consenting participants were randomized 1:1 to up to 11 sessions of IPT or daily self‐administered sertraline and followed for 24 weeks. We assessed EPDS score, Clinical Global Impression‐Severity of Illness (CGI‐S) and medication side effects at each visit and measured maternal HIV viral load at baseline and final study visit. Retention, visit adherence, change in EPDS, CGI‐S and log viral load were compared between groups with t‐tests and Wilcoxon signed rank tests; we report mean differences, relative risks and 95% confidence intervals. A participant satisfaction survey assessed trial acceptability. Results: 78/80 (98%) participants were retained at the final study visit. In the context of the COVID‐19 pandemic, visit adherence was greater among women allocated to ADM (9.9 visits, SD 2.2) versus IPT (8.9 visits, SD 2.4; p = 0.06). EPDS scores decreased from baseline to final visit overall, though mean change was greater in the IPT group (−13.8 points, SD 4.7) compared to the ADM group (−11.4 points, SD 5.5; p = 0.04). Both groups showed similar changes in mean log viral load from baseline to final study visit (mean difference −0.43, 95% CI −0.32, 1.18; p = 0.48). In the IPT group, viral load decreased significantly from baseline (0.9 log copies/ml, SD 1.7) to final visit (0.2 log copies/ml, SD 0.9; p = 0.01). Conclusions: This pilot study demonstrates that a trial of two forms of PPD treatment is feasible and acceptable among women with HIV in Zambia. IPT and ADM both improved measures of depression severity; however, a full‐scale trial is required to determine whether treatment of PPD and anxiety improves maternal–infant HIV outcomes., INTRODUCTION Depression is a leading global cause of disability [1, 2]. Peripartum depression, defined as an episode of moderate or severe depression beginning during pregnancy or within 4 weeks of [...]

Objectives To estimate the rate of pregnancy-associated emergency care visits and identify maternal and pregnancy characteristics associated with high utilization of emergency care among pregnant Medicaid recipients in North Carolina. Methods A retrospective cohort study using linked Medicaid hospital claims and birth records of 107,207 pregnant Medicaid recipients who delivered a live-born infant in North Carolina between January 1, 2008 and December 31, 2009. Rates were estimated per 1000 member months of Medicaid coverage. High utilization was defined as [greater than or equal to] 4 visits. Emergency care visits included encounters in the emergency department or obstetric triage unit during pregnancy that did not result in hospital admission. Results During the study period, 57.5% of pregnant Medicaid recipients sought emergency care at least once during pregnancy. There were 171,909 emergency care visits with an overall rate of 202.3 visits per 1000 member months. Among the subset of pregnant women with Medicaid coverage for the majority of their pregnancy (n = 75,157), 18.1% were high utilizers. High emergency care utilization was associated with young age, black race, lower education, tobacco use, late preterm delivery, multifetal gestation, and having [greater than or equal to] 1 comorbidity. Threatened labor and abdominal pain were the leading indications for visits. Conclusion Utilization of hospital-based emergency care services was common in this cohort of pregnant Medicaid recipients. Additional research is needed to assess the drivers for accessing care through the emergency department, and to examine differences in pregnancy outcomes and health care costs between high and low utilizers., Author(s): Catherine J. Vladutiu [sup.1] [sup.2] , Elizabeth M. Stringer [sup.2] , Veni Kandasamy [sup.3] , Jill Ruppenkamp [sup.4] , M. Kathryn Menard [sup.2] Author Affiliations: (Aff1) 0000 0004 0405 [...]

Objective: To measure maternal/fetal SARS‐CoV‐2 antibody levels. Methods: A prospective observational study of eligible parturients admitted to the hospital for infant delivery was conducted between April and September 2020. SARS‐CoV‐2 antibody levels were measured in maternal and umbilical cord specimens using an in‐house ELISA based on the receptor‐binding domain (RBD) of the spike protein. Among SARS‐CoV‐2 seropositive patients, spike RBD antibody isotypes (IgG, IgM, and IgA) and ACE2 inhibiting antibodies were measured. Results: In total, 402 mothers were enrolled and spike RBD antibodies in 388 pregnancies were measured (336 maternal and 52 cord specimens). Of them, 19 were positive (15 maternal, 4 cord) resulting in a seroprevalence estimate of 4.8% (95% confidence interval 2.9–7.4). Of the 15 positive maternal specimens, all had cord blood tested. Of the 15 paired specimens, 14 (93.3%) were concordant. Four of the 15 pairs were from symptomatic mothers, and all four showed high spike‐ACE2 blocking antibody levels, compared to only 3 of 11 (27.3%) from asymptomatic mothers. Conclusion: A variable antibody response to SARS‐CoV‐2 in pregnancy among asymptomatic infections compared to symptomatic infections was found, the significance of which is unknown. Although transfer of transplacental neutralizing antibodies occurred, additional research is needed to determine how long maternal antibodies can protect the infant against SARS‐CoV‐2 infection. Synopsis: Among pregnant women infected with COVID‐19, transfer of transplacental neutralizing antibodies was efficient in participants with high levels of RBD IgG. [ABSTRACT FROM AUTHOR]

Objective To evaluate if a pilot programme to prevent mother-to-child transmission (PMTCT) of the human immunodeficiency virus (HIV) was associated with changes in early childhood survival at the population level in rural Zambia. Methods Combination antiretroviral regimens were offered to pregnant and breastfeeding, HIV-infected women, irrespective of immunological status, at four rural health facilities. Twenty-four-month HIV-free survival among children born to HIV- infected mothers was determined before and after PMTCT programme implementation using community surveys. Households were randomly selected and women who had given birth in the previous 24 months were asked to participate. Mothers were tested for HIV antibodies and children born to HIV-infected mothers were tested for viral deoxyribonucleic acid. Multivariable models were used to determine factors associated with child HIV infection or death. Findings In the first survey (2008-2009), 335 of 1778 women (18.8%) tested positive for HIV. In the second (2011), 390 of 2386 (16.3%) tested positive. The 24-month HIV-free survival in HIV-exposed children was 0.66 (95% confidence interval, CI: 0.63- 0.76) in the first survey and 0.89 (95% CI: 0.83-0.94) in the second. Combination antiretroviral regimen use was associated with a lower risk of HIV infection or death in children (adjusted hazard ratio: 0.33,95% CI: 0.15-0.73). Maternal knowledge of HIV status, use of HIV tests and use of combination regimens during pregnancy increased between the surveys. Conclusion The PMTCT programme was associated with an increased HIV-free survival in children born to HIV-infected mothers. Maternal utilization of HIV testing and treatment in the community also increased. Objectit Lvaluer si un programme pilote pour prevenir la transmission mere-enfant (PTME) du virus de l'immunodeficience humaine (VIH) est associe a des changements en matiere de survie du jeune enfant au sein de la population dans les regions rurales de la Zambie. Methodes Des therapies antiretrovirales combinees ont ete proposees a des femmes infectees par le VIH, enceintes et allanantes, independamment de leur statut immunologique, dans quatre centres de sante ruraux. La survie sans VIH a 24 mois chez les enfants nes de meres infectees par leVIH aetedetermineeavantetapres la mise en ceuvredu programme PTME a l'aide d'enquetes communautaires. Les menages ont ete choisis de maniere aleatoire, et il a ete demande aux femmes qul avaient accouche au cours des 24derniers mois, d'y participen On a teste la presence d'anticorps antl-VIH chez les meres et d'acide desoxyribonucleique viral chez les enfants nes de meres infectees par le VIH. Des modeles a variables multiples ont ete utilises pour determiner lesfacteurs associes a l'infection par le VIH ou au deces de l'enfant. Resultats Dansla premiere etude (2008-2009), 335 femmes parmi 1778 (18,8%) ont ete testees positives a l'infection par leVIH. Dans la deuxieme etude (2011), 390 femmes parmi 2386 (16,3%) ont ete testees positives. La survie sans VIH a 24 mois chez les enfants exposes au VIH etait de 0,66 (intervalle de confiance de 95%, IC: 0,63-0,76) dans la premiere etude et de 0,89 (IC de 95%: 0,83-0,94) dans la seconde. La combinalson de la therapie antiretrovirale etait associeea un risque inferieurd'infection par le VIH ou de deces chez les enfants (rapport de risques ajuste: 0,33, IC de 95%: 0,15-0,73). La connaissance du statut VIH des meres, l'utilisation des tests de depistage du VIH et des traitements combines pendant la grossesse ont augmente entre les etudes. Conclusion Le programme PTME etait associe a une augmentation de la survie sans VIH chez les enfants nes de meres infectees par leVIH. L'utilisation par les meres du depistage et du traitement contre leVIH a egalement augmente au sein de la communaute. Objetivo Evaluar si un programa piloto para prevenir la transmision maternoinfantil (PTMI) del virus de la inmunodeficiencia humana (VIH) esta asociado a cambios en la supervivencia en la primera infancia a nivel de poblacion en las zonas rurales de Zambia. Metodos Se ofrecio una combinacion de tratamientos antirretroviraies a mujeres embarazadas y lactantes infectadas por el VIH, independientemente de su estado inmunologico, en cuatro centros de salud rurales. Mediante encuestas en la comunidad se determino una supervivencia sin VIH de veinticuatro meses entre los ninos nacidos de madres infectadas por el VIH antes y despues de la implementacion del programa PTMI. Los hogares se seleccionaron al azar y se pidio que participaran las mujeres que habian dado a luz en los 24 meses anteriores. Las madres se sometieron a una prueba para detectar los anticuerpos contra el VIH y se realizo una prueba del acido desoxirribonucleico viral a los ninos nacidos de madres infectadas con VIH. Se utilizaron modelos multivariables para determinar los factores asociados con la infeccion o muerte por VIH del nino. Resultados En la primera encuesta (2008-2009), 335 de 1778 mujeres (18,8%) dieron positivo en el VIH. En la segunda (2011), dieron positivo 390 de 2386 (16,3%). La supervivencia sin VIH de 24 meses en los ninos expuestos al VIH fue del 0,66 (intervalo de confianza del 95 %, IC: 0,63-0,76) en la primera encuesta y del 0,89 (IC del 95 %: 0,83-0,94) en la segunda. La combinacion de un tratamiento antirretroviral se asocio con un menor riesgo de infeccion por VIH o muerte en los ninos (razon de riesgo ajustada: 0,33,1C del 95 %: 0,15-0,73). El conocimiento de las madres de su estado serologico, el uso de pruebas para el VIH y los tratamientos combinados durante el embarazo aumentaron en el tiempo transcurrido entre las encuestas. Conclusion El programa PTMI estuvo asociado a un aumento de la supervivencia sin VIH en los ninos nacidos de madres infectadas por el VIH. La utilizacion materna de la prueba y el tratamiento del VIH en la comunidad tambien aumento., Introduction In recent years, studies have shown unequivocally that the use of combination antiretroviral regimens, for either treatment or prophylaxis, during the antenatal, intrapartum and breastfeeding periods in women with [...]

A study was conducted to evaluate and investigate the coverage of nevirapine-based services to help prevent the spread of mother-to-child HIV transmission in 4 African countries. Results indicated that only 51% of HIV-exposed infants received the required dosage of nevirapine in these countries.