Weekly 17 alpha-hydroxyprogesterone caproate to prevent preterm birth among women living with HIV: a randomised, double-blind, placebo-controlled trial

Background: Women with HIV face an increased risk of preterm birth. 17 alpha-hydroxyprogesterone caproate (17P) has been shown in some trials to reduce early delivery among women with a history of spontaneous preterm birth. We investigated whether 17P would reduce this risk among women with HIV. Methods: We did a randomised, double-blind, placebo-controlled trial in pregnant women with HIV at the University Teaching Hospital and Kamwala District Health Centre in Lusaka, Zambia. Eligible patients were women aged 18 years or older with confirmed HIV-1 infection, viable intrauterine singleton pregnancy at less than 24 weeks of gestation, and were receiving or intending to commence antiretroviral therapy during pregnancy. Exclusion criteria were major uterine or fetal anomaly; planned or in situ cervical cerclage; evidence of threatened miscarriage, preterm labour, or ruptured membranes at screening; medical contraindication to 17P; previous participation in the trial; or history of spontaneous preterm birth. Eligible participants provided written informed consent and were randomly assigned (1:1) to receive 250 mg intramuscular 17P or placebo once per week, starting between 16 and 24 weeks of gestation until delivery, stillbirth, or reaching term (37 weeks). Participants and study staff were masked to assignment, except for pharmacy staff who did random assignment and prepared injections but did not interact with participants. The primary outcome was a composite of delivery before 37 weeks or stillbirth at any gestational age. Patients attended weekly visits for study drug injections and antenatal care. We estimated the absolute and relative difference in risk of the primary outcome and safety events between treatment groups by intention to treat. This trial is registered with ClinicalTrials.gov, NCT03297216, and is complete. Findings: Between Feb 7, 2018 and Jan 13, 2020, we assessed 1042 women for inclusion into the study. 242 women were excluded after additional assessments, and 800 eligible patients were enrolled and randomly assigned to receive intramuscular 17P (n=399) or placebo (n=401). Baseline characteristics were similar between groups. Adherence to study drug injections was 98% in both groups, no patients were lost to follow-up, and the final post-partum visit was on Aug 6, 2020. 36 (9%) of 399 participants assigned to 17P had preterm birth or stillbirth, compared with 36 (9%) of 401 patients assigned to placebo (risk difference 0·1, 95% CI −3·9 to 4·0; relative risk 1·0, 95% CI 0·6 to 1·6; p=0·98). Intervention-related adverse events were reported by 140 (18%) of 800 participants and occurred in similar proportions in both randomisation groups. No serious adverse events were reported. Interpretation: Although 17P seems to be safe and acceptable to participants, available data do not support the use of the drug to prevent preterm birth among women whose risk derives solely from HIV infection. The low risk of preterm birth in both randomisation groups warrants further investigation. Funding: US National Institutes of Health and the Bill and Melinda Gates Foundation

The lunar effect on delivery and other birth outcomes in rural Zambia

Objective: It is a widely held belief that the period of a full moon is associated with higher birth rates compared to periods when the moon is not full. We investigated whether more births occurred during a full moon in a rural African population.Design: Data collected from 42 clinical sites in rural Zambia associated with the Better Health Outcomes through Mentoring and Assessment (BHOMA) Study were evaluated. We compared the proportion of pregnancies born during a full moon to theproportion that would be expected if there were no association.Main outcomes: Proportion of births during the full moon.Measures: Demographics and birth outcomes.Results: A total of 10,127 women delivered at a participating site between 8  December 2010 and 19 August 2015. Mean maternal age was 25.1 years (standard deviation [SD] 6.4 years), mean maternal weight 62.7 kg (SD 13.9 kg), 14.4% were HIV seropositive, and 3.7% were syphilis positive. The mean birth weight was 3032 g (SD 0.5 g); 49.6% newborns were female, and 1.48% were stillborn. There was a full moon during 70 of the 1715 days under observation. In the absence of an association, we would expect 70 / 1715 (4.08%) of births to occur on these days. We observed a total of 434deliveries (4.29%; 95% Confidence Interval [CI]: 3.89%, 4.68%) during these 24-hour periods. Thus, an association between the full moon and higher delivery rates was not observed (p=0.87). An additional analysis, where the entire lunar cycle was divided into 8 equal bins, also yielded no association. Finally, we did not identify any other birth outcomes that were  associated with lunar cycle (birthweight, stillbirth, gender, or congenital malformation).Conclusions: In this large, rural population, we found no evidence of a lunar effect on delivery or adverse birth outcomes. These results refute a common belief and should provide assurance to managers who opt to ignore lunar cycle when scheduling midwife staffing of rural clinics

Sliding Mode Idle Speed Ignition Control Strategies for Automotive Engines 1.0 Introduction

In recent years it has become apparent that control system design based on conventional linear transfer function or state-variable feedback suffers from several serious disadvantages including

UNITY:A low-field magnetic resonance neuroimaging initiative to characterize neurodevelopment in low and middle-income settings

Measures of physical growth, such as weight and height have long been the predominant outcomes for monitoring child health and evaluating interventional outcomes in public health studies, including those that may impact neurodevelopment. While physical growth generally reflects overall health and nutritional status, it lacks sensitivity and specificity to brain growth and developing cognitive skills and abilities. Psychometric tools, e.g., the Bayley Scales of Infant and Toddler Development, may afford more direct assessment of cognitive development but they require language translation, cultural adaptation, and population norming. Further, they are not always reliable predictors of future outcomes when assessed within the first 12–18 months of a child's life. Neuroimaging may provide more objective, sensitive, and predictive measures of neurodevelopment but tools such as magnetic resonance (MR) imaging are not readily available in many low and middle-income countries (LMICs). MRI systems that operate at lower magnetic fields (&lt; 100mT) may offer increased accessibility, but their use for global health studies remains nascent. The UNITY project is envisaged as a global partnership to advance neuroimaging in global health studies. Here we describe the UNITY project, its goals, methods, operating procedures, and expected outcomes in characterizing neurodevelopment in sub-Saharan Africa and South Asia.</p

UNITY: A low-field magnetic resonance neuroimaging initiative to characterize neurodevelopment in low and middle-income settings

Measures of physical growth, such as weight and height have long been the predominant outcomes for monitoring child health and evaluating interventional outcomes in public health studies, including those that may impact neurodevelopment. While physical growth generally reflects overall health and nutritional status, it lacks sensitivity and specificity to brain growth and developing cognitive skills and abilities. Psychometric tools, e.g., the Bayley Scales of Infant and Toddler Development, may afford more direct assessment of cognitive development but they require language translation, cultural adaptation, and population norming. Further, they are not always reliable predictors of future outcomes when assessed within the first 12-18 months of a child’s life. Neuroimaging may provide more objective, sensitive, and predictive measures of neurodevelopment but tools such as magnetic resonance (MR) imaging are not readily available in many low and middle-income countries (LMICs). MRI systems that operate at lower magnetic fields (< 100mT) may offer increased accessibility, but their use for global health studies remains nascent. The UNITY project is envisaged as a global partnership to advance neuroimaging in global health studies. Here we describe the UNITY project, its goals, methods, operating procedures, and expected outcomes in characterizing neurodevelopment in sub-Saharan Africa and South Asia