Quality and Content Concordance of International Clinical Guidelines on Hypertensive Disorders of Pregnancy Using the AGREE II Instrument: An Updated Systematic Review.

Utilization of high-quality clinical practice guidelines has the potential to positively impact health outcomes. This study aimed to assess the quality and content concordance of national and international recommendations on hypertensive disorders of pregnancy (HDPs). Searches were conducted of the MEDLINE database and reference lists generated from national and international agencies. Covidence software was used for the management of the systematic review process, the Appraisal of Guidelines for Research and Evaluation II (AGREE II) tool was used to assess guidelines for quality, and three reviewers independently screened records. The research team identified and screened a total of 399 records of which 10 were deemed high quality. Guidelines were assessed and compared regarding the treatment, prevention, and categorization of disorders. The quality of guidelines varied across different domains, with significant variation in domain scores even within individual guidelines. Not all recommendations showed a high level of methodologic rigor, and the highest-rated guidelines were from the American Heart Association, the World Health Organization, and South Africa national guidelines. Classification of hypertension differed among the guidelines, particularly in defining chronic hypertension, severe hypertension, and preeclampsia. Prevention modalities varied across guidelines, with recommendations for aspirin, calcium supplementation, and against the use of certain approaches. Treatment modalities highlighted the importance of delivery as the definitive way to terminate hypertensive disorders of pregnancy, with other management strategies provided for symptom control. The variability in guidelines and consensus statements across different contexts may reflect regional differences in healthcare practices, available resources, and research evidence. There is potential to harmonize guidelines for HDP globally while considering the unique needs of individual countries. Where guidelines may be synthesized and condensed into an accessible format, doing so could improve their use in clinical decision-making.

Yoga and Mindfulness for Social-Emotional Development and Resilience in 3-5 Year-Old Children: Non-Randomized, Controlled Intervention.

Background: Early childhood is the key life course period for development of social-emotional skills, providing the foundation for school readiness and resilience in later life. Age-appropriate yoga and mindfulness programs may contribute to the development of critical skills in children. Young children from minoritized communities that face structural racism and health disparities may benefit from programs that support social-emotional development and contribute to future academic success. Systematic reviews of yoga interventions for young children have indicated the potential for effectiveness in supporting social-emotional development, executive function, and physical activity. However, studies of yoga and mindfulness with non-White children are sparse and, overall, the evidence base to date for such programs remains limited by non-controlled studies and the variable quality of studies evaluating programs in early childhood settings. Methods: The analysis of data from a non-randomized, controlled intervention aimed to assess the effect of exposure to a yoga and mindfulness program for early childhood development of social-emotional skills in a majority Black/African American urban preschool setting in southeastern US. Children in the intervention received group yoga and mindfulness led by a certified children's yoga teacher who also had training and experience as a school teacher. Intervention participants engaged in activities for 20 minutes once per week for 32 weeks, while the control group had no yoga. The final sample included 579 in the historical control group and 122 in the intervention group. Results: Results indicated that children who participated in the yoga and mindfulness program had higher total protective factor (TPF) subscores on the Devereux Early Childhood Assessment over time than children who did not receive yoga and mindfulness programming, and that the difference was statistically significant (P<0.05). Participation in the intervention group significantly predicted increases in initiative score, self-control score, and TPF score, as well as a decrease in the behavioral concerns. Discussion: School based yoga and mindfulness programming can support social-emotional skills and resilience in young children. Additional studies with larger sample sizes and randomization are needed on use of yoga and mindfulness in young children for social-emotional development, particularly for Black/African American children and others from minoritized communities.

Effect of Yoga and Mindfulness Intervention on Symptoms of Anxiety and Depression in Young Adolescents Attending Middle School: A Pragmatic Community-Based Cluster Randomized Controlled Trial in a Racially Diverse Urban Setting.

Mental health conditions in childhood and adolescence are increasing in the U.S. population and require early intervention, as highlighted by a recent Surgeon General's Advisory on Protecting Youth Mental Health. These health issues, which have been exacerbated by the COVID-19 pandemic, impair functioning, and may lead to longer term reductions in quality of life. Young adolescents are likely to experience stressors including academic pressure, feelings of loneliness and isolation, and excessive exposure to social media, all of which have been made worse by the pandemic and associated disruptions. Universal preventive programs at school serve as an important strategy for equipping youth with coping skills to address current and future social and emotional challenges. Yoga and mindfulness programs have emerged as a promising preventive approach for schools and have proven feasible and acceptable. The current study evaluated a universal, school-based mindfulness and yoga program among youth aged 11-14 in a racially diverse, urban setting in the United States. Outcomes of interest included symptoms of anxiety and depression. Anxiety and depression symptoms decreased in the intervention group, although these differences were not statistically significant. In the control group, anxiety symptoms decreased but depression symptoms increased. The resulting time effect indicated a significant decrease in anxiety symptoms, while the time by group effect revealed a strong trend in depression symptoms. Future research should investigate the utility of yoga and mindfulness interventions for early adolescents in a larger population, and the differences in intervention effect among subgroups, with attention to longer term outcomes.

Prenatal Symptom Cluster of Psychopathology and Associations With Mindfulness and Rumination: A Network Analysis.

ABSTRACT: The present study aimed to examine the interrelationships of prenatal psychopathology (specifically symptom cluster), dispositional mindfulness, and rumination using network analysis. Network analysis estimates the links between symptoms and can evaluate the presence and strength of the links. A total of 1122 pregnant women were recruited from a tertiary hospital in China. Psychopathology symptoms (including anxiety, depression, stress, fatigue, sleep, fear of childbirth [FOC], and memory problems) were assessed and used along with mindfulness and rumination to construct networks of association using R. Results illustrated five communities within the network. Anxiety resulted in the highest strength of centrality followed by two symptoms: FOC and retrospective memory. Paths showed that mindfulness was directly connected to depression, prospective memory, retrospective memory, and lack of positive anticipation in FOC, whereas mindfulness was connected indirectly through rumination to anxiety, fatigue, stress, and sleep problems. The findings reinforce that anxiety is a key symptom of prenatal psychopathology and requires priority consideration. The direct associations between mindfulness and prenatal psychopathology symptoms provide potential targets for future mindfulness-based interventions, and mindfulness reducing rumination thus in turn decrease anxiety, suggesting potential mediating mechanism of mindfulness.

Yoga and Mindfulness Interventions for Preschool-Aged Children in Educational Settings: A Systematic Review.

Early childhood and the pre-school stage of development constitute a dynamic period for acquisition of social-emotional competencies. Yoga and mindfulness practices (YMP) have become increasingly used in schools for social emotional learning, but less is known about their utility in early childhood settings. A systematic review using PRISMA guidelines was undertaken to explore the effect of YMP on social emotional function among preschool-aged children (3-5 years). The review resulted in identification of 1115 records, of which 80 full text articles were screened, with final inclusion of 16 studies. Included studies evaluated the effect of YMP on social-emotional functioning, and identified the potential for YMP to improve regulatory skills such as behavioral self-regulation and executive function. Among studies reviewed, 13 reported improvements in these domains, but quality appraisal indicated significant variability in risk of bias across studies, and heterogeneity of outcome measurements hindered comparison. Programs appeared to produce better results when implemented for at least 6 weeks and among children who had lower baseline social-emotional functioning. YMP constitute a promising strategy for social emotional development in early childhood settings, but additional rigorously designed studies are needed to expand understanding of how and why these programs are effective.

Effectiveness of Smartphone-Based Mindfulness Training on Maternal Perinatal Depression: Randomized Controlled Trial.

BACKGROUND: Despite potential for benefit, mindfulness remains an emergent area in perinatal mental health care, and evidence of smartphone-based mindfulness training for perinatal depression is especially limited. OBJECTIVE: The objective of this study was to evaluate the effectiveness of a smartphone-based mindfulness training intervention during pregnancy on perinatal depression and other mental health problems with a randomized controlled design. METHODS: Pregnant adult women who were potentially at risk of perinatal depression were recruited from an obstetrics clinic and randomized to a self-guided 8-week smartphone-based mindfulness training during pregnancy group or attention control group. Mental health indicators were surveyed over five time points through the postpartum period by online self-assessment. The assessor who collected the follow-up data was blind to the assignment. The primary outcome was depression as measured by symptoms, and secondary outcomes were anxiety, stress, affect, sleep, fatigue, memory, and fear. RESULTS: A total of 168 participants were randomly allocated to the mindfulness training (n=84) or attention control (n=84) group. The overall dropout rate was 34.5%, and 52.4% of the participants completed the intervention. Mindfulness training participants reported significant improvement of depression (group × time interaction χ24=16.2, P=.003) and secondary outcomes (χ24=13.1, P=.01 for anxiety; χ24=8.4, P=.04 for positive affect) compared to attention control group participants. Medium between-group effect sizes were found on depression and positive affect at postintervention, and on anxiety in late pregnancy (Cohen d=0.47, -0.49, and 0.46, respectively). Mindfulness training participants reported a decreased risk of positive depressive symptom (Edinburgh Postnatal Depression Scale [EPDS] score>9) compared to attention control participants postintervention (odds ratio [OR] 0.391, 95% CI 0.164-0.930) and significantly higher depression symptom remission with different EPDS reduction scores from preintervention to postintervention (OR 3.471-27.986). Parity did not show a significant moderating effect; however, for nulliparous women, mindfulness training participants had significantly improved depression symptoms compared to nulliparous attention control group participants (group × time interaction χ24=18.1, P=.001). CONCLUSIONS: Smartphone-based mindfulness training is an effective intervention in improving maternal perinatal depression for those who are potentially at risk of perinatal depression in early pregnancy. Nulliparous women are a promising subgroup who may benefit more from mindfulness training. TRIAL REGISTRATION: Chinese Clinical Trial Registry ChiCTR1900028521; http://www.chictr.org.cn/showproj.aspx?proj=33474.

Predictors of relapse of acute malnutrition following exit from community-based management program in Amhara region, Northwest Ethiopia: An unmatched case-control study.

BACKGROUND: Community-based management of acute malnutrition (CMAM) is an effective program to manage children with acute malnutrition, including both severe and moderate acute malnutrition. However, little is known about continued child nutritional status after discharge from community based management of acute malnutrition programs in Ethiopia. OBJECTIVE: The study aimed to identify factors associated with relapse of acute malnutrition among children 6-59 months after been discharged recovered from community based management program in South Gondar Zone, Northwest Ethiopia. METHODS: A case-control study was conducted in three districts of South Gondar Zone by tracing children age 6-59 months who were reported as recovered from the community based management program. Sample size calculated for the first objective of assessing prevalence of severe acute malnutrition among children following discharge as recovery using Epi- Info version 7.1.3.3 StatCalc taking 95% CL, 17.8% post discharge relapse (Ashraf H, et al. (2012), 3% margin of error, design effect of 2 and adding 5% non-response rate was the largest sample size and used to this study. Children with Mid Upper Arm Circumference (MUAC) <12.5cm constituted cases and children with > = 12.5cm served as controls. Data were collected from 10 November 2017 to 30 January 2018 using a survey questionnaire and families were asked to bring children to a health facility for anthropometric measurements, following which data were entered and analyzed. Bivariate and multivariable logistic regression models were utilized to measure association between the risk factors and acute malnutrition. RESULTS: Overall, 1,273 participants were interviewed. The mean age in months of children was 23.1 (±9.1 SD) for cases and 23.1 (±8.9 SD) for controls. About 40% of the cases and 50% of the controls were female children. The factors associated with acute malnutrition were: male children (AOR = 1.84, 95% CI: 1.42-2.39), living in a food insecure household (AOR = 1.67, 95% CI:1.15-2.44), non-receipt of Vitamin A supplement (AOR = 1.76, 95% CI: 1.28-2.41), prelacteal feeding (AOR = 2.81 (95%CI, 1.57-5.05), distance to water source more than 15 walk (AOR = 1.88, 95% CI:1.32-2.71), less frequent self-reported hand washing (AOR = 1.35, 95% CI:1.05-1.75), mother not having consumed extra food during this pregnancy/lactation (AOR = 1.36, 95% CI: 1.03-1.78), and respondent age above 30 years (AOR = 1.43, 95% CI:1.10-1.87). CONCLUSION: The key factors contributing to relapse of acute malnutrition were related to childcare and feeding practices. Social and behavior change communication strategies targeting families at risk of undernutrition, along with improved food security and integrated programming are recommended to prevent relapse of acute malnutrition.

Effectiveness of sodium-glucose co-transporter-2 inhibitors on ischaemic heart disease.

AIM: To compare the cardiovascular risks between users and non-users of sodium-glucose co-transporter-2 (SGLT2) inhibitors based on electronic medical record data from a large integrated healthcare system in South Louisiana. MATERIALS AND METHODS: Demographic, anthropometric, laboratory and medication prescription information for patients with type 2 diabetes who were new users of SGLT2 inhibitors, either as initial treatments or as add-on treatments, were obtained from electronic health records. Mediation analysis was performed to evaluate the association of use of SGLT2 inhibitors and changes of metabolic risk factors with the risk of incident ischaemic heart disease. RESULTS: A total of 5338 new users of SGLT2 inhibitors were matched with 13 821 non-users. During a mean follow-up of 3.26 years, 2302 incident cases of ischaemic heart disease were defined. After adjusting for multiple confounding factors, patients using SGLT2 inhibitors had a lower risk of incident ischaemic heart disease compared to patients not using SGLT2 inhibitors (hazard ratio [HR] 0.63, 95% confidence interval [CI] 0.54-0.73). Patients using SGLT2 inhibitors also had a lower risk of incident ischaemic heart disease within 6 months (HR 0.36, 95% CI 0.25-0.44), 12 months (HR 0.40, 95% CI 0.32-0.49), 24 months (HR 0.53, 95% CI 0.43-0.60) and 36 months (HR 0.65, 95% CI 0.54-0.73), respectively. Reductions in systolic blood pressure partly mediated lowering risk of ischaemic heart disease among patients using SGLT2 inhibitors. CONCLUSIONS: The real-world data in the present study show the contribution of SGLT2 inhibitors to reducing risk of ischaemic heart disease, and their benefits beyond glucose-lowering.

Clinical Effectiveness of Decision Support for Prescribing Opioids for Chronic Noncancer Pain: A Prospective Cohort Study.

OBJECTIVES: This prospective cohort study examines the clinical effectiveness of electronic medical record clinical decision support (EMR CDS) for opioid prescribing. METHODS: Data analysis included primary care patients with chronic opioid therapy for noncancer pain seen within an integrated health delivery system in Louisiana between January 2017 and October 2018. EMR CDS incorporated an opioid health maintenance tool to display the status of risk mitigation, and the medication order embedded the morphine equivalent daily dose (MEDD) calculator and a hyperlink to the Louisiana pharmacy drug monitoring program. Outcome measures included change in the average MEDD and rates of opioid risk mitigation, hospitalization, and emergency department use. RESULTS: Among 14 221 patients, 9% had prescriptions with an average MEDD ≥90 mg. There were no significant changes in MEDD after EMR CDS implementation. Increasing age, Charlson Comorbidity Index score, female sex, black non-Hispanic race, non-opioid pain medication co-prescriptions, and specialty referrals were associated with a lower odds of MEDD ≥90 (high-dose threshold). Medicare or self-pay, substance abuse history, and pain agreements were associated with increased odds of prescribing above this high-dose threshold. After incorporation of EMR CDS, patients had higher rates of urine drug screens (17% vs 7%) and naloxone prescriptions (3% vs 1%, all P < .001). In addition, specialty referrals to physical or occupational therapy, orthopedics, neurology, and psychiatry or psychology increased in the postintervention period. Although emergency department use decreased (rate ratio 0.92; 95% confidence interval 0.89-0.95), hospitalization rates did not change. CONCLUSIONS: EMR CDS improved adherence to opioid risk mitigation strategies. Further research examining which practice redesign interventions effectively reduce high-dose opioid prescribing is needed.

Rural children remain more at risk of acute malnutrition following exit from community based management of acute malnutrition program in South Gondar Zone, Amhara Region, Ethiopia: a comparative cross-sectional study.

BACKGROUND: Community-based management of acute malnutrition has been reported effective in terms of recovery rate, but recovered children may be at increased risk of developing acute malnutrition after returning to the same household (HH) environment. OBJECTIVE: Compare the magnitude and factors associated with acute malnutrition among recovered and never treated children in South Gondar Zone, Amhara Region, Ethiopia. METHOD: A comparative cross-sectional study was conducted in three districts of South Gondar Zone by tracing 720 recovered and an equal number of age matched children who were never treated for acute malnutrition. Parents were asked to bring children to health post for survey data collection, anthropometric measurements, and edema assessment. Data were collected using a survey questionnaire, entered in to EpiData and analyzed using SPSS v20. Anthropometric indices were generated according to the WHO's 2006 Child Growth Standards using WHO Anthro software version 3.2.2. Bivariate and multivariable logistic regression was utilized. Values with P < 0.05 were considered statistically significant and Odds Ratio with 95% CI was used to measure strength of association. RESULT: A total of 1,440 parents were invited, of which 1,414 participated (98.2% response rate). Mean age in months of children (±SD) was 23.7 (±10.4) for recovered and 23.3 (±10.8) for comparison group. About 49% of recovered and 46% of comparison children were females. A significant difference was observed on magnitude of acute malnutrition between recovered (34.2% (95% CI [30.9-38.0]) and comparison groups (26.7% (95% CI [23.5-30.2]), P = 0.002. Factors associated with acute malnutrition among recovered were district of Ebnat (AOR = 3.7; 95% CI [1.9-7.2]), Tach-Gayint (AOR = 2.4; 95% CI [1.2-4.7]); male child (AOR = 1.4; 95% CI [1.0-2.0]); prelactal feeding (AOR = 2.6; 95% CI [1.3 -5.1]); not feeding colostrum (AOR = 1.5; 95% CI [1.1-2.3]); not consuming additional food during pregnancy/lactation (AOR = 1.6; 95% CI [1.1-2.3]); not given Vitamin A supplement (AOR = 2.1; 95% CI [1.4-3.2]); and safe child feces disposal practice (AOR = 1.7; 95% CI [1.2-2.5]) while district of Tach-Gayint (AOR = 2.5; 95% CI [1.3-4.8]); male child (AOR = 1.5; 95% CI [1.1-2.1]), not feeding colostrum (AOR = 1.7; 95% CI [1.2-2.5]), poor hand washing practice (AOR = 1.6; 95% CI [1.1-2.2]); food insecure HH (AOR = 1.6; 95% CI [1.1-2.4]), birth interval <24 months (AOR = 1.9; 95% CI [1.2-3.2]), and poor access to health facility (AOR = 1.7; 95% CI [1.2-2.4]) were factors associated with acute malnutrition among comparison group. CONCLUSION: Recovered children were more at risk of acute malnutrition than the comparison group. Nutrition programs should invest in improving nutrition counseling and education; as well as the hygienic practices to protect children against post-discharge relapse of acute malnutrition.

Warming the postpartum body as a form of postnatal care: An ethnographic study of medical injections and traditional health practices in Cambodia.

Postpartum care is a critical element for ensuring survival and health of mothers and newborns but is often inadequate in low- and middle-income countries due to barriers to access and resource constraints. Newly delivered mothers and their families often rely on traditional forms of postnatal care rooted in social and cultural customs or may blend modern and traditional forms of care. This ethnographic study sought to explore use of biomedical and traditional forms of postnatal care. Data were collected through unstructured observation and in-depth interviews with 15 mothers. Participants reported embracing traditional understandings of health and illness in the post-partum period centered on heating the body through diet, steaming, and other applications of heat, yet also seeking injections from private health care providers. Thematic analysis explored concepts related to transitioning forms of postnatal care, valuing of care through different lenses, and diverse sources of advice on postnatal care. Mothers also described concurrent use of both traditional medicine and biomedical postnatal care, and the importance of adhering to cultural traditions of postnatal care for future health. Maternal and newborn health are closely associated with postnatal care, so ensuring culturally appropriate and high-quality care must be an important priority for stakeholders including understand health practices that are evolving to include injections.

Effect of mindfulness and yoga on quality of life for elementary school students and teachers: results of a randomized controlled school-based study.

OBJECTIVE: To assess the impact of a yoga curriculum in an elementary school on student quality of life, and to assess teacher and staff perception of potential barriers to, and benefits of, introducing yoga and mindfulness into the classroom. METHODS: A randomized controlled trial was utilized to assess the impact of a brief intervention on third-grade students who screened positive for symptoms of anxiety. Students were randomized to an intervention group of 20 students receiving small-group yoga/mindfulness activities for 8 weeks between October 2016 and February 2017, and a control group of 32 students receiving care as usual. The Brief Multidimensional Students' Life Satisfaction Scale-Peabody Treatment Progress Battery and the Pediatric Quality of Life Inventory (PedsQL) served as outcomes. Teachers were invited to participate in two professional development sessions about introducing yoga and mindfulness into the classroom, and completed a survey following each of the sessions. RESULTS: In generalized estimating equation models adjusted for time, the yoga-based intervention was associated with a 14.17 unit increase in student emotional PedsQL (p-value 0.001) and a 7.43 unit increase in psychosocial PedsQL (p-value 0.01). Results were not attenuated by adjustment. Teachers and staff reported using yoga more frequently in the classroom following the second of two professional development sessions (p-value <0.05). Perceived barriers to introducing yoga to the classroom were similar at two data collection time points, while perceived benefits remained high. CONCLUSION: The intervention was associated with a significant improvement in emotional and psychosocial quality of life in the intervention group when compared to the control group, suggesting that yoga/mindfulness interventions may improve symptoms of anxiety among students. Yoga/mindfulness activities may facilitate stress management among elementary school students and may be added as a complement to social and emotional learning activities.

The Life Course Implications of Ready to Use Therapeutic Food for Children in Low-Income Countries.

The development of ready-to-use therapeutic food (RUTF) for the treatment of uncomplicated cases of severe acute malnutrition in young children from 6 months to 5 years old has greatly improved survival through the ability to treat large numbers of malnourished children in the community setting rather than at health facilities during emergencies. This success has led to a surge in demand for RUTF in low income countries that are frequently food insecure due to environmental factors such as cyclical drought. Worldwide production capacity for the supply of RUTF has increased dramatically through the expansion and development of new manufacturing facilities in both low and high income countries, and new business ventures dedicated to ready-to-use foods have emerged not only for emergencies, but increasingly, for supplementing caloric intake of pregnant women and young children not experiencing acute undernutrition. Due to the lack of evidence on the long term health impact these products may have, in the midst of global nutrition transitions toward obesity and metabolic dysfunction, the increased use of manufactured, commercial products for treatment and prevention of undernutrition is of great concern. Using a framework built on the life course health development perspective, the current research presents several drawbacks and limitations of RUTF for nutrition of mothers and young children, especially in non-emergency situations. Recommendations follow for potential strategies to limit the use of these products to the treatment of acute undernutrition only, study the longer term health impacts of RUTF, prevent conflict of interests arising for social enterprises, and where possible, ensure that whole foods are supported for life-long health and nutrition, as well as environmental sustainability.

Use of Camphor and Essential Oil Balms for Infants in Cambodia.

Balms and oils containing terpenic compounds, such as camphor, menthol and eucalyptus, are potentially toxic, and numerous reports of adverse events stemming from their use in infants and young children have been published. During qualitative research on newborn practices in rural Cambodia, these products were found to be commonly applied to the skin of newborns and infants and available in most households. Parents and caregivers of infants in Cambodia and other settings where use of camphor- and menthol-containing products are common should be educated on the risks of these to prevent child morbidity and potential mortality.

A Review of Herbal and Pharmaceutical Galactagogues for Breast-Feeding.

BACKGROUND: Therapeutic approaches to addressing insufficient lactation are available but remain poorly understood. Current trends in maternal health, such as increasing rates of obesity, delayed age at childbearing, and high rates of cesarean section, may be associated with physiological challenges for lactation that cannot be managed by counseling alone. Women who have not had success with counseling alone, including adoptive mothers seeking to induce lactation, may use galactagogues (pharmaceutical and herbal compounds used to increase lactation). We present a review of selected studies of galactagogues and data indicating popular demand for such products. METHODS: A systematic search was conducted for published studies on the use of galactagogues for breast-feeding. The following databases were searched: MEDLINE (PubMed), EBSCO (Academic Search Complete), and EMBASE. The search was conducted between July 15, 2015, and August 18, 2015; only English language articles were included, and we imposed no restrictions on publication date. Two authors independently reviewed the studies and extracted data. RESULTS: Blinded, placebo-controlled clinical trials of 2 pharmaceutical galactagogues (domperidone and metoclopramide) and 5 popular herbal galactagogues (shatavari, fenugreek, silymarin, garlic, and malunggay) were identified. All of the studies identified for domperidone showed a significant difference in milk production between the treatment and placebo groups. Of the 6 trials of metoclopramide, only 1 study showed a significant difference in milk production compared to placebo. Results of the clinical trials on herbal galactagogues were mixed. Our review of the evidence for the efficacy of popular pharmaceutical and herbal galactagogues revealed a dearth of high-quality clinical trials and mixed results. CONCLUSION: Health providers face the challenge of prescribing or recommending galactagogues without the benefit of robust evidence. Given the suboptimal rates of exclusive breast-feeding worldwide and the availability and demand for medical and herbal lactation therapies, controlled trials and analyses investigating these medicines are urgently warranted.

Newborn Infection Control and Care Initiative for health facilities to accelerate reduction of newborn mortality (NICCI): study protocol for a randomized controlled trial.

BACKGROUND: Newborn health is a key issue in addressing the survival of children under five years old, particularly in low and middle income countries, and the evidence base for newborn health interventions continues to evolve. Over the last decade, maternal and under five-year-old mortality and morbidity rates have been successfully reduced in Cambodia, but newborn health has lagged behind. Evidence suggests that an important proportion of newborn mortality both globally and in Cambodia is attributable to infections and sepsis. While initiatives are being implemented to address some causes of newborn illness (related to pre-term birth and asphyxia), a country-level approach to reducing infections has not been formulated. The Newborn Infection Control and Care Initiative (NICCI) is a community and health facility linked intervention to improve health outcomes for newborns. METHODS/DESIGN: The present study applies a cluster randomized trial, using a stepped wedge design, to assess the impact of a package intervention on newborn health. The intervention components include addressing infection control in the perinatal period in health facilities, promoting infection prevention and control practices in health center and home environments, and improving the timeliness of referrals for newborns with suspected infections to appropriate health facilities, by linking families to the medical system through a network of community based volunteers who will make home visits to families in the first week of a newborn's life. DISCUSSION: The NICCI trial is designed to complement and enhance the Cambodian Ministry of Health strategies and objectives for maternal and newborn care. Results of the study will help to inform policy and the possible scale-up of newborn health interventions in the country. TRIAL REGISTRATION: This trial was registered with Clinicaltrials.gov (identifier: NCT02271737) on 5 October 2014.

Supplementation with vitamin B6 reduces side effects in Cambodian women using oral contraception.

UNLABELLED: Hormonal contraceptives may produce side effects that deter women from their use as a method of family planning. In nutritionally vulnerable populations these effects may be more pronounced due to micronutrient deficiencies and health status. Previous studies have been unable to resolve whether micronutrient supplementation may reduce such side effects. AIM: In a longitudinal study, 1011 women obtaining oral contraception through the public health system in rural Cambodia were allocated to either intervention or control groups, receiving either daily Vitamin B6 supplement or care as usual (without placebo). RESULTS: The intervention participants (n = 577) reported fewer side effects in three categories: nausea/no appetite, headache, and depression compared with control group participants (n = 434). CONCLUSION: Women taking Vitamin B6 supplement were less likely to report side effects in a nutritionally vulnerable population. Underlying nutrition status should be considered by clinicians and reproductive health policy makers in the context of providing contraceptive services. Further investigation into micronutrient supplementation, particularly with B6, in reproductive-aged women using hormonal contraception should be conducted in other settings to determine the potential for widespread adoption.

Introducing home based skin-to-skin care for low birth weight newborns: a pilot approach to education and counseling in Ghana.

UNLABELLED: Skin-to-skin contact (STSC) for low birth weight newborns in community settings may greatly improve survival, especially where access to health facilities is limited. Community STSC has been implemented in large-scale trials in Asia and is recommended by WHO and UNICEF. In countries where the practice is entirely new, such as Ghana, STSC may need special educational approaches. OBJECTIVE: The dual aims of this study were to understand the acceptance and barriers to STSC in an African community setting and to use in-depth formative research to contribute to the success of a behavior-based health intervention. DESIGN: A rapid qualitative study with an intentionally small sample. SETTING: Kintampo, Ghana, a predominately rural, agrarian area in the center of the country with diverse ethnic groups in a forest-savannah transition zone. METHOD: Key informants were consulted through in-depth interviews and focus group discussions to develop the pilot. Five mothers participated in pilot instruction (four refused), which included counseling and used a trials-of-improved-practices methodology; data from group discussion with traditional birth attendants were also included. RESULTS: It was difficult to overcome barriers to the practice (post partum pain, fear of harming the umbilicus), and less intractable barriers (traditional carrying practices, fear of causing harm, lack of back support, time constraints, breast feeding issues) were reported. CONCLUSION: Some study participants tried STSC but none did it continuously. As promotion of STSC could be vital for improving newborn survival in low resource settings, tackling perceived barriers may be an important way to increase acceptability of this practice.

Social costs of skilled attendance at birth in rural Ghana.

OBJECTIVE: To examine the social costs to women of skilled attendance at birth in rural Ghana. METHOD: Ethnographic data were obtained through participant observation, interviews, case histories, and focus groups and were analyzed alongside data from a birth cohort of 2878 singletons born in the Kintampo study district between July 2003 and June 2004. RESULTS: Most women delivered at home. Home delivery raises a woman's status in her community, while seeking skilled attendance lowers it. Women feel that seeking assistance in childbirth wastes other people's time and they value secrecy in labor. Negative treatment by health providers and expensive supplies needed for delivery also act as barriers. CONCLUSION: The social costs of obtaining skilled attendance at birth must be offset by community level strategies such as mobilization of older women and husbands, and ensuring health providers extend professional, humane care to laboring women.

Beyond symptom recognition: care-seeking for ill newborns in rural Ghana.

OBJECTIVES: To assess newborn care-seeking practices in a rural area of Ghana where most births take place at home in order to inform potential strategies for reducing newborn mortality. METHODS: Qualitative, ethnographic study with quantitative data from a birth cohort collected as part of the surveillance system of an ongoing randomized controlled trial. Data collected comprised 84 h of participant observation (including following an ill newborn through a hospital visit), 14 in-depth interviews with key informants (older mothers and grandmothers), 45 semistructured interviews with mothers, 28 case histories from women who had recently given birth and 32 expert interviews with local health providers. Thirteen focus groups were held with men and women, and narrative histories of newborn deaths were taken from eight women. Birth cohort data came from 2878 singletons born alive in the study district within the year July 2003-June 2004. RESULTS: Significant delays in care seeking for ill newborns occur in Kintampo District, Ghana. 2.1% of 2878 newborns in the birth cohort had a serious illness during the first 4 weeks of life, but care was only sought outside the home for 61% of those and from a doctor or hospital for 39%. Barriers to prompt allopathic care seeking include sequential care-seeking practices, with often exclusive use of traditional medicine as first-line treatment for 7 days, previous negative experiences with health service facilities, financial constraints and remoteness from health facilities. CONCLUSIONS: Improvements in care seeking are urgently needed. Families should be urged to seek medical care for any symptom of illness in a newborn; financial and socio-cultural barriers to care seeking for newborns must be addressed in order to improve neonatal survival.