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BACKGROUND: As utilization of individual antenatal care (I-ANC) has increased throughout sub-Saharan Africa, questions have arisen about whether individual versus group-based care might yield better outcomes. We implemented a trial of group-based antenatal care (G-ANC) to determine its impact on birth preparedness and complication readiness (BPCR) among pregnant women in Ghana. METHODS: We conducted a cluster randomized controlled trial comparing G-ANC to routine antenatal care in 14 health facilities in the Eastern Region of Ghana. We recruited women in their first trimester to participate in eight two-hour interactive group sessions throughout their pregnancies. Meetings were facilitated by midwives trained in G-ANC methods, and clinical assessments were conducted in addition to group discussions and activities. Data were collected at five timepoints, and results are presented comparing baseline (T0) to 34 weeks' gestation to 3 weeks post-delivery (T1) for danger sign recognition, an 11-point additive scale of BPCR, as well as individual items comprising the scale. RESULTS: 1285 participants completed T0 and T1 assessments (N = 668 I-ANC, N = 617, G-ANC). At T1, G-ANC participants were able to identify significantly more pregnancy danger signs than I-ANC participants (mean increase from 1.8 to 3.4 in G-ANC vs. 1.7 to 2.2 in I-ANC, p < 0.0001). Overall BPCR scores were significantly greater in the G-ANC group than the I-ANC group. The elements of BPCR that showed the greatest increases included arranging for emergency transport (I-ANC increased from 1.5 to 11.5% vs. G-ANC increasing from 2 to 41% (p < 0.0001)) and saving money for transportation (19-32% in the I-ANC group vs. 19-73% in the G-ANC group (p < 0.0001)). Identifying someone to accompany the woman to the facility rose from 1 to 3% in the I-ANC group vs. 2-20% in the G-ANC group (p < 0.001). CONCLUSIONS: G-ANC significantly increased BPCR among women in rural Eastern Region of Ghana when compared to routine antenatal care. Given the success of this intervention, future efforts that prioritize the implementation of G-ANC are warranted. TRIAL REGISTRATION: ClinicalTrials.gov Identifier: NCT04033003 (25/07/2019). PROTOCOL AVAILABLE: Protocol Available at: https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9508671/ .

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Intimate partner violence (IPV) impacts women of reproductive age globally and can lead to significant negative consequences during pregnancy. This study describes an exploratory aim of a cluster randomised controlled trial designed to assess the outcomes of Group Antenatal Care (ANC) in Ghana. The purpose was to understand the effect of a healthy relationship Group ANC module on experiences of IPV and safety planning as well as to explore the relationship between self-efficacy on the experiences of IPV and safety planning. Data were collected at baseline and at 11-14 months postpartum (post). Survey measures captured reported experiences of violence, self-efficacy, and safety. The chi-square test was used to compare baseline and post scores, and a logistic regression was performed to ascertain the effects of self-efficacy on the experiences of IPV in both groups. The sample included 1,751 participants, of whom 27.9% reported IPV at baseline. Between baseline and postpartum, there was a small increase in reported emotional (6.2% vs. 4.6%) and sexual (5.4% vs. 3.2%) violence in the intervention group compared to the control group. Logistic regression demonstrated that an increasing self-efficacy score was associated with an increased likelihood of experiencing IPV. There were no changes in safety knowledge. This study found higher rates of reported sexual and emotional violence post-intervention among the intervention group. Group ANC may be just one part of a portfolio of interventions needed to address IPV at all socio-ecological levels.Paper ContextMain findings: There was no reduction in experiences of intimate partner violence or increases in safety planning among Ghanaian pregnant women participating in a Group Antenatal Care session focused on healthy relationships and safety planning.Added knowledge: Group Antenatal Care has been identified as an effective modality for providing antenatal care and facilitating conversations about sensitive topics such as intimate partner violence and safety. However, this study highlights the importance of developing multifaceted approaches to decrease the risk of intimate partner violence among women, especially during the critical times of pregnancy and postpartum.Global health impact for policy and action: Effective global health action and policy must extend beyond educational efforts, incorporating multifaceted strategies that include healthcare provider training, robust community engagement, and legislation aimed at preventing intimate partner violence, with a special focus on safeguarding the well-being of women during pregnancy and the postpartum period.

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BACKGROUND: Computerized decision support systems (CDSS) and performance-based incentives (PBIs) can improve health-worker performance. However, there is minimal evidence on the combined effects of these interventions or perceived effects among maternal and child healthcare providers in low-resource settings. We thus aimed to explore the perceptions of maternal and child healthcare providers of CDSS support in the context of a combined CDSS-PBI intervention on performance in twelve primary care facilities in Ghana's Upper East Region. METHODS: We conducted a qualitative study drawing on semi-structured key informant interviews with 24 nurses and midwives, 12 health facility managers, and 6 district-level staff familiar with the intervention. We analysed data thematically using deductive and inductive coding in NVivo 10 software. RESULTS: Interviewees suggested the combined CDSS-PBI intervention improved their performance, through enhancing knowledge of maternal health issues, facilitating diagnoses and prescribing, prompting actions for complications, and improving management. Some interviewees reported improved morbidity and mortality. However, challenges described in patient care included CDSS software inflexibility (e.g. requiring administration of only one intermittent preventive malaria treatment to pregnant women), faulty electronic partograph leading to unnecessary referrals, increased workload for nurses and midwives who still had to complete facility forms, and power fluctuations affecting software. CONCLUSION: Combining CDSS and PBI interventions has potential to improve maternal and child healthcare provision in low-income settings. However, user perspectives and context must be considered, along with allowance for revisions, when designing and implementing CDSS and PBIs interventions.

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BACKGROUND: While group antenatal care (ANC) has been delivered and studied in high-income countries for over a decade, it has only recently been introduced as an alternative to individual care in sub-Saharan Africa. Although the experimental design of the studies from high-resource countries have been scientifically rigorous, findings cannot be generalized to low-resource countries with low literacy rates and high rates of maternal and newborn morbidity and mortality. The Group Antenatal Care Delivery Project (GRAND) is a collaboration between the University of Michigan in the United States and the Dodowa Health Research Centre in Ghana. GRAND is a 5-year, cluster randomized controlled trial (RCT). Our intervention-group ANC-consists of grouping women by similar gestational ages of pregnancy into small groups at the first ANC visit. They then meet with the same group and the same midwife at the recommended intervals for care. OBJECTIVE: This study aims to improve health literacy, increase birth preparedness and complication readiness, and optimize maternal and newborn outcomes among women attending ANC at seven rural health facilities in the Eastern Region of Ghana. METHODS: Quantitative data will be collected at four time points using a secure web application for data collection and a database management tool. Data will be analyzed on an intention-to-treat basis to test the differences between the two arms: women randomized to group-based ANC and women randomized to routine individual ANC. We will conduct a process evaluation concurrently to identify and document patient, provider, and system barriers and facilitators to program implementation. RESULTS: The study was funded in September 2018. Recruitment and enrollment of participants and data collection started in July 2019. In November 2021, we completed participant enrollment in the study (n=1761), and we completed data collection at the third trimester in May 2022 (n=1284). Data collection at the additional three time points is ongoing: 6 weeks postpartum, 6 months postpartum, and 1 year postpartum. CONCLUSIONS: This study is significant and timely because it is among the first RCTs to be conducted to examine the effects of group ANC among low-literacy and nonliterate participants. Our findings have the potential to impact how clinical care is delivered to low-literacy populations, both globally and domestically, to improve maternal and newborn outcomes. TRIAL REGISTRATION: ClinicalTrials.gov NCT04033003; https://clinicaltrials.gov/ct2/show/NCT04033003. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): DERR1-10.2196/40828.

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Objective: This paper describes sexual behaviours and their associated factors among young people. Design: The study design is cross-sectional. Setting: Dodowa Health and Demographic Surveillance Site (DHDSS) in Ghana's Shai-Osudoku and Ningo Prampram districts. Participants: Young people aged 10 to 24 years, median age 17 years. Outcome measures: Self-reported to have ever had sex, non-use of a condom at last sex, and ever been pregnant or gotten someone pregnant. Results: Of the 1689 young people; 42% reported having ever had sex, not using a condom at last sexual activity (64%), and ever been pregnant or gotten someone pregnant (41%). The proportion of non-use of condoms at last sex was high across all age groups but was highest (93%) in a small proportion of 10 to 14-year-olds who have ever had sex. Higher proportions of females than males; were reported to have ever had sex (46%), not using a condom at their last sex (66%) and ever been pregnant or getting someone pregnant (56%). Age group (20 to 24), females, primary or junior high school, living alone and lower household socio-economic status were risk factors associated with all three outcome measures. Conclusion: Risky sexual behaviour is high among young people in the Dodowa HDSS. Therefore, interventions that promote safer sexual practices and help young people make timely decisions on their sexual and reproductive health care needs are required.

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Objective: This paper describes sexual behaviours and their associated factors among young people. Design: The study design is cross-sectional. Setting: Dodowa Health and Demographic Surveillance Site (DHDSS) in Ghana's Shai-Osudoku and Ningo Prampram districts. Participants: Young people aged 10 to 24 years, median age 17 years. Outcome measures: Self-reported to have ever had sex, non-use of a condom at last sex, and ever been pregnant or gotten someone pregnant. Results: Of the 1689 young people; 42% reported having ever had sex, not using a condom at last sexual activity (64%), and ever been pregnant or gotten someone pregnant (41%). The proportion of non-use of condoms at last sex was high across all age groups but was highest (93%) in a small proportion of 10 to 14-year-olds who have ever had sex. Higher proportions of females than males; were reported to have ever had sex (46%), not using a condom at their last sex (66%) and ever been pregnant or getting someone pregnant (56%). Age group (20 to 24), females, primary or junior high school, living alone and lower household socio-economic status were risk factors associated with all three outcome measures. Conclusion: Risky sexual behaviour is high among young people in the Dodowa HDSS. Therefore, interventions that promote safer sexual practices and help young people make timely decisions on their sexual and reproductive health care needs are required. Funding: No funding was obtained for this paper.

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OBJECTIVE: The Three Delays Model outlines, three common delays that lead to poor newborn outcomes: (i) recognising symptoms and deciding to seek care; (ii) getting to care and; (iii) receiving timely, high-quality care. We gathered data for all newborn deaths within four districts in Ghana to explore how well the Three Delays Model explains outcomes. METHODS: In this cross-sectional, observational study, trained field workers conducted verbal and social autopsies with the closest surviving relative (typically mothers) of all neonatal deaths across four districts in northern Ghana from September 2015 until April 2017. Data were collected using Survey CTO and analysed using StataSE 15.0. Frequencies and descriptive statistics were calculated for key variables. RESULTS: 247 newborn deaths were identified. Nearly 77% (190) of newborns who died were born at a health facility, and 48.9% (93) of those who died before discharge. Of the 149 newborns who were discharged or born at home, 71.8% (107) sought care at a facility for illness, and 72.9% (N = 78) of those did so within the same day of illness recognition. Of the 83 respondents who arranged for transportation, 82% (68) did so within 1 h. Newborns received prompt care but insufficient interventions - 25% or fewer received IV fluids, oral medications, antibiotics or oxygen. CONCLUSIONS: These data suggest that women are following recommendations for safe delivery and prompt care-seeking. In rural northern Ghana, behaviour change interventions focused on mothers and families may not be as pressing as interventions focused on the Third Delay - obtaining timely, high-quality care.

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OBJECTIVE: This study explored providers' perspectives and behavior regarding respectful maternity care, including knowledge, attitudes, and practices. DESIGN: Mixed-methods cross-sectional study combining quantitative survey data, qualitative interviews, and observations of labor and delivery across four health facilities SETTING: Government health facilities in rural northern Ghana PARTICIPANTS: 43 front-line maternity care providers completed a survey of practice patterns before a quality of care training. We then used purposive and convenience sampling to recruit a sub-sample for in-depth interviews (N=17), and convenience sampling and self-selection to observe approximately half (N=8) providing clinical care. MEASUREMENTS AND FINDINGS: We calculated descriptive statistics from quantitative data and used the framework approach for qualitative analysis. Observational data were examined using the CHANGE Project's Assessment Tools for Caring Providers. We utilized split frame methodology to make comparisons across data sources. Quantitative survey results (N=43) indicate most providers report explaining procedures to women (89.5%), involving women and families in care decisions (84.1%), and covering or screening women for privacy (81.5%). At the same time, 38.9% reported they have shouted at, scolded, insulted, threatened, or talked rudely to a woman, and 26.4% said they have treated a woman differently because of her personal attributes. Qualitative interview data (N=17) suggested that providers can articulate a vision of respectful care, aspire to offer respectful care, and recognize they do not always meet those aspirations. Among those (N=8) volunteering to be observed, introductions and explanations for procedures were rare, privacy screening was infrequent, and participants were observed slapping, scolding, and restraining women in labor, often associated with patient non-compliance to provider instructions. KEY CONCLUSIONS: Even among providers knowledgeable about respectful maternity care and who agreed to be observed providing delivery care, disrespect and abuse were present. IMPLICATIONS FOR PRACTICE: Further research and programmatic efforts are needed to address the gap between knowledge and behavior.

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Plasmodium falciparum in pregnancy is a major cause of adverse pregnancy outcomes. We combine performance estimates of standard rapid diagnostic tests (RDT) from trials of intermittent screening and treatment in pregnancy (ISTp) with modelling to assess whether screening at antenatal visits improves upon current intermittent preventative therapy with sulphadoxine-pyrimethamine (IPTp-SP). We estimate that RDTs in primigravidae at first antenatal visit are substantially more sensitive than in non-pregnant adults (OR = 17.2, 95% Cr.I. 13.8-21.6), and that sensitivity declines in subsequent visits and with gravidity, likely driven by declining susceptibility to placental infection. Monthly ISTp with standard RDTs, even with highly effective drugs, is not superior to monthly IPTp-SP. However, a hybrid strategy, recently adopted in Tanzania, combining testing and treatment at first visit with IPTp-SP may offer benefit, especially in areas with high-grade SP resistance. Screening and treatment in the first trimester, when IPTp-SP is contraindicated, could substantially improve pregnancy outcomes.

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BACKGROUND: The health benefits of exclusive breastfeeding practices in both the short and long term accrue to breastfed infants, mothers, families and the society at large. Despite the evidence of these benefits and adoption of various World Health Organization (WHO) strategies on promotion of exclusive breastfeeding by Ghana, the increase in the rate of exclusive breastfeeding has been very slow in the country. This study aimed to estimate the rate and investigate socio-economic and demographic determinants of 6 months exclusive breastfeeding in two rural districts in Southern Ghana. METHODS: Pregnancy, childbirth, breastfeeding, demographic and socioeconomic information of 1870 women who were prospectively registered by the Dodowa Health and Demographic Surveillance System and gave birth between 1 January 2011 and 31 December 2013 was extracted. The proportion of 6 months exclusive breastfeeding among the study participants was estimated and the relationship between the dependent and the independent variables were explored using logistics regression model at 95% confidence level. RESULTS: The proportion of mothers who exclusive breastfed for 6 months in the study was 71.0%. Mothers aged 25-29 and 30 + years are 93 and 91% respectively more likely to practice 6 months exclusive breastfeeding compared to those aged < 20 years (OR 1.93, 95% CI 1.25, 2.99, OR 1.91, 95% CI 1.91, 3.08). The odds of artisan mothers practicing 6 months exclusive breastfeeding is 36% less likely compared to those unemployed (OR 0.64, 95% CI 0.43, 0.96). There is a higher chance that 45% of mothers with a household size of more than five members to practice exclusive breastfeeding compared to those with household size of less than six (OR 1.45, 95% CI 1.16, 1.81). Women in the fishing district were 85% less likely to practice 6 months exclusive breastfeeding compared to those in farming district (OR 0.15, 95% CI 0.12, 0.20). CONCLUSION: There is high rate of exclusive breastfeeding in the study area. Maternal age, type of occupation, household size and district of residence are determinants of 6 months exclusive breastfeeding among the study participants.

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PURPOSE: This study compared changes in imaging and in pain relief between patients with intraosseous, as opposed to extraosseous bone metastases. Both groups were treated palliatively with magnetic resonance-guided high-intensity-focused ultrasound (MRgHIFU). MATERIALS AND METHODS: A total of 21 patients were treated prospectively with MRgHIFU at 3 centers. Intraprocedural thermal changes measured using proton resonance frequency shift (PRFS) thermometry and gadolinium-enhanced T1-weighted (Gd-T1W) image appearances after treatment were compared for intra- and extraosseous metastases. Pain scores and use of analgesic therapy documented before and up to 90 days after treatment were used to classify responses and were compared between the intra- and extraosseous groups. Gd-T1W changes were compared between responders and nonresponders in each group. RESULTS: Thermal dose volumes were significantly larger in the extraosseous group (P = 0.039). Tumor diameter did not change after treatment in either group. At day 30, Gd-T1W images showed focal nonenhancement in 7 of 9 patients with intraosseous tumors; in patients with extraosseous tumors, changes were heterogeneous. Cohort reductions in worst-pain scores were seen for both groups, but differences from baseline at days 14, 30, 60, and 90 were only significant for the intraosseous group (P = 0.027, P = 0.013, P = 0.012, and P = 0.027, respectively). By day 30, 67% of patients (6 of 9) with intraosseous tumors were classified as responders, and the rate was 33% (4 of 12) for patients with extraosseous tumors. In neither group was pain response indicated by nonenhancement on Gd-T1W. CONCLUSIONS: Intraosseous tumors showed focal nonenhancement by day 30, and patients had better pain response to MRgHIFU than those with extraosseous tumors. In this small cohort, post-treatment imaging was not informative of treatment efficacy.

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The objective of this trial, Biomarkers in Autism of Aripiprazole and Risperidone Treatment (BAART), was to provide support and guidance for an evidence-based approach for the selection and monitoring of initial pharmacotherapy in patients with autism by assessing predictors of efficacy, tolerability, and safety. This randomized double-blind parallel-group study was conducted in three academic medical centers and a single private pediatric practice. Eighty children or adolescents (aged 6-17 yrs) with autistic disorder were enrolled, and 61 patients were randomized to the study drug. Of those patients, 51 completed the 10-week trial, and 31 completed an optional 12-week blinded extension phase. All patients were treated with 2 weeks of placebo before random assignment to receive aripiprazole (31 patients) or risperidone (30 patients) for 10 weeks. Sixteen placebo responders (20%) were excluded from further analysis. Drug dosing followed U.S. Food and Drug Administration (FDA) labeling, and weekly dosage adjustments were allowed until week 4; patients were then maintained on a fixed dose for 6 additional weeks. Safety, physical, and psychological assessments were recorded weekly or every 2 weeks. No significant differences in severity of illness between the aripiprazole and risperidone groups were noted at baseline. All patients significantly improved on the Aberrant Behavior Checklist-Irritability subscale after 1 week and continued for the remaining 9 weeks and the extension phase. Improvement was greatest in the risperidone group at every assessment period and was statistically significantly better than that in the aripiprazole group at weeks 3 and 6 (p<0.05). No dose-limiting adverse events occurred during the dose-titration period. Mean weight gain in the aripiprazole group was significantly less than that in the risperidone group at week 4 (0.62 vs 1.38 kg, p=0.033) and week 10 (1.61 vs 3.31 kg, p<0.001), but the difference became nonsignificant for the 31 patients completing the 3-month extension phase (4.36 vs 5.55 kg, p=0.26). Pharmacotherapy of patients with autism spectrum disorder resulted in behavioral improvement within 1 week and lasted at least 22 weeks. Weight gain occurred to a greater degree with risperidone than aripiprazole initially, but the differences became nonsignificant by the end of the trial. Our trial supports previous results of drug efficacy and safety in patients with autism spectrum disorder from other trials and extends the evidence-based support for choosing an FDA-approved drug for initial pharmacotherapy for autism spectrum disorder.

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With the increasing survival rate of people with developmental disabilities into adulthood and later life, nutritional support and feeding of these individuals frequently becomes a critical problem which must be addressed by their caregivers and healthcare providers. Problems surrounding mealtimes include difficulty with the mechanisms of feeding as well as medical complications including aspiration and gastrointestinal dysmotility. No comprehensive guidelines exist to aid caregivers and healthcare providers regarding the issues in feeding and nutrition in this population. We offer an algorithmic approach to the nutrition-related problems of aspiration, laborious meals and mealtime refusal, choosing the best route for tube feeding, and when to return patients with developmental disabilities back to oral feeding.

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The military's use of whole-blood transfusions is not new but has recently received new emphasis by the Tactical Combat Casualty Care Committee. US Army units are implementing a systematic approach to obtain and use whole blood on the battlefield. This case report reviews the care of the first patient to receive low titer group O whole blood (LTOWB) transfusion, using a new protocol.

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BACKGROUND: Lack of an adequate and well-performing health workforce has emerged as the biggest barrier to scaling up health services provision in sub-Saharan Africa. As the global community commits to the Sustainable Development Goals and universal health coverage, health workforce challenges are critical. In northern Ghana, performance-based incentives (PBIs) were introduced to improve health worker motivation and service quality. OBJECTIVE: The goal of this study was to determine the impact of PBIs on maternal health worker motivation in two districts in northern Ghana. DESIGN: A quasi-experimental study design with pre- and post-intervention measurement was used. PBIs were implemented for 2 years in six health facilities in Kassena-Nankana District with six health facilities in Builsa District serving as comparison sites. Fifty pre- and post-intervention structured interviews and 66 post-intervention in-depth interviews were conducted with health workers. Motivation was assessed using constructs for job satisfaction, pride, intrinsic motivation, timelines/attendance, and organisational commitment. Quantitative data were analysed to determine changes in motivation between intervention and comparison facilities pre- and post-intervention using STATA™ version 13. Qualitative data were analysed thematically using NVivo 10 to explore possible reasons for quantitative findings. RESULTS: PBIs were associated with slightly improved maternal health worker motivation. Mean values for overall motivation between intervention and comparison health workers were 0.6 versus 0.7 at baseline and 0.8 versus 0.7 at end line, respectively. Differences at baseline and end line were 0.1 (p=0.40 and p=0.50 respectively), with an overall 0.01 difference in difference (p=0.90). Qualitative interviews indicated that PBIs encouraged health workers to work harder and be more punctual, increasing reported pride and job satisfaction. CONCLUSIONS: The results contribute evidence on the effects of PBIs on motivational constructs among maternal health workers in primary care facilities in northern Ghana. PBIs appeared to improve motivation, but not dramatically, and the long-term and unintended effects of their introduction require additional study.

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BACKGROUND: Given the prevalence of untreated pain among cancer patients, there have been calls for more and better research in the domain. Increasingly, calls for less waste and more optimal use of trial data collected are being made. Waste of data includes non-optimal statistical analysis and non-presentation of interpretable effect size as a measure of effectiveness of an intervention which also enable comparisons across studies. METHODS: We reviewed the recent literature on randomised trials on longitudinal cancer pain to identify sources of loss of data information by collecting material on the nature of outcomes collected, analysed, the method of analysis and what was presented as a result of the trial. Illustrated with real data, we propose some guidelines on how to adequately analyse longitudinal data and report the results using mixed models. RESULTS: We identified some major source of data information loss, one of which is the transformation of a continuous pain outcome. Not adjusting for the collected outcome baseline value is moreover a source of bias. Multiple testing by analysing the data cross-sectionnally at each time-point leads to loss of information and power. Finally, effect sizes reflecting the effectiveness of the intervention were never reported. CONCLUSIONS: We identified several sources of information loss in the way longitudinal trials on pain were analysed and reported. However these problems could be easily solved by using regression methods like mixed models and presenting regression parameters to provide a concrete quantitative effect of the intervention.

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This article examines a decade of demographic surveillance data from rural northern Ghana linked with prospective panel survey data recording respondents' reported fertility-regulation behavior. We assess the impact of access to community-based contraceptive services, reported fertility-regulation behavior, and their interaction on the risk of a conception that results in a birth. The effects of service exposure differ by marital status. Reported use of any method to delay or avoid pregnancy appears to be more effective in reducing the risk of conception among the unmarried in areas offering community-based contraceptive services, relative to those in areas where services are facility based. Among both married and unmarried survey respondents who state that they are not using contraception, the risk of conception is lower among women in areas with community-based services than among women in communities without these services. The lower risk of conception among women who are receiving community-based services and who report that they are regulating their fertility may be due to increased efficacy and duration of fertility regulation. Among women who report that they are not regulating their fertility, under-reporting of contraceptive use in experimental areas is likely to play a role in explaining these findings.

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BACKGROUND: Intermittent screening and treatment in pregnancy (ISTp) is a potential strategy for the control of malaria during pregnancy. However, the frequency and consequences of malaria infections missed by a rapid diagnostic test (RDT) for malaria are a concern. METHODS: Primigravidae and secundigravidae who participated in the ISTp arm of a noninferiority trial in 4 West African countries were screened with an HRP2/pLDH RDT on enrollment and, in Ghana, at subsequent antenatal clinic (ANC) visits. Blood samples were examined subsequently by microscopy and by a polymerase chain reaction (PCR) assay. RESULTS: The sensitivity of the RDT to detect peripheral blood infections confirmed by microscopy and/or PCR at enrollment ranged from 91% (95% confidence interval [CI], 88%, 94%) in Burkina Faso to 59% (95% CI, 48%, 70% in The Gambia. In Ghana, RDT sensitivity was 89% (95% CI, 85%, 92%), 83% (95% CI, 76%, 90%) and 77% (95% CI, 67%, 86%) at enrollment, second and third ANC visits respectively but only 49% (95% CI, 31%, 66%) at delivery. Screening at enrollment detected 56% of all infections detected throughout pregnancy. Seventy-five RDT negative PCR or microscopy positive infections were detected in 540 women; these were not associated with maternal anemia, placental malaria, or low birth weight. CONCLUSIONS: The sensitivity of an RDT to detect malaria in primigravidae and secundigravidae was high at enrollment in 3 of 4 countries and, in Ghana, at subsequent ANC visits. In Ghana, RDT negative malaria infections were not associated with adverse birth outcomes but missed infections were uncommon.

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BACKGROUND: Several studies have reported an association between malaria infection of the placenta and the risk of malaria in young children in the first year of life, but it is not known if this is causal, or influenced by malaria control measures during pregnancy. This paper compares the incidence of malaria in infants born to mothers who received either intermittent preventive treatment with sulfadoxine/pyrimethamine (IPTp-SP) or screening with a rapid diagnostic test and treatment with artemether-lumefantrine (ISTp-AL) during their pregnancy. METHODS: From July 2011 to April 2013, 988 infants of women enrolled in a trial of IPTp-SP versus ISTp-AL in the Kassena-Nankana districts of northern Ghana were followed to determine the risk of clinical malaria during early life, and their risk of parasitaemia and anaemia at 6 and 12 months of age. In addition, the incidence of clinical malaria in infants whose mothers had malaria infection of the placenta was compared with that in infants born to women free of placental malaria. RESULTS: The incidence of clinical malaria was 0.237 and 0.211 episodes per child year in infants whose mothers had received ISTp-AL or IPTp-SP, respectively. The adjusted incidence rate ratio and the adjusted rate difference were 0.94 (95% CI 0.68, 1.33) and 0.029 (95% CI -0.053, 0.110) cases per child year at risk respectively. The incidence of clinical malaria was similar in infants born to women with placental malaria (0.195 episodes per child year) and in infants of women without placental malaria (0.224 episodes per child year) (rate ratio = 0.86 [95% CI 0.54, 1.37]). CONCLUSION: Infants born to women managed with ISTp-AL during pregnancy were not at greatly increased risk of malaria compared with infants born to women who had received IPTp-SP. The incidence of malaria in infants was similar whether or not their mother had had placental malaria.

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