Determinants of teenage pregnancy in Malawi: a community-based case-control study.

BACKGROUND: Teenage pregnancies are a global concern. Malawi is one of the countries with the highest teenage pregnancy rates despite government efforts to reverse the situation and yet studies on determinants of teenage pregnancy are rare with some factors remaining unexplored. Therefore, this study aimed to identify factors associated with teenage pregnancies in Malawi. METHODS: This was a community-based case-control study that used secondary data from the 2015-16 Malawi Demographic and Health Survey from all 28 districts of Malawi. The study population comprised women aged 20-24 who participated in the survey. The study ran from September 2021 to October 2022 and used a sample size of 3,435 participants who were all women aged 20-24 in the dataset who met the inclusion criteria. Data were analysed using Stata 16 software. Logistic regression analyses were used to determine factors. Variables with a P value of < 0.1 in the univariable analysis were included in the multivariable analyses, where statistical significance was obtained at a P value < 0. 05. RESULTS: Data on 3435 participants were analysed. In multivariable analyses: no teenage marriage (AOR 0.13); secondary education (AOR 0.26); higher education (AOR 0.39); richest category of wealth index (AOR 0.51), use of contraception (AOR 3.08), domestic violence by father or mother (AOR 0.37) were found to be significant factors. CONCLUSION: This study identified determinants of teenage pregnancy. The government has to sustain and expand initiatives that increase protection from teenage pregnancy, reinforce the implementation of amended marriage legislation, introduce policies to improve the socioeconomic status of vulnerable girls and increase contraceptive use among adolescent girls before their first pregnancy. Further research is also recommended to resolve inconclusive results.

Does maternal health voucher scheme have association with distance inequality in maternal and newborn care utilization? Evidence from rural Bangladesh.

BACKGROUND: Bangladesh has made substantial progress in maternal health. However, persistent inequities in service use undermine the achievements at the national level. In 2007, the government introduced a Maternal Health Voucher Scheme (MHVS) to reduce barriers to service utilization. The current study explores the impact of MHVS on reducing distance inequality in utilization across the maternal and newborn continuum of care (MNCoC). METHODS: A cross-sectional survey was conducted from October'2017 to April'2018 in four selected MHVS sub-districts of Chattogram and Sylhet Divisions of Bangladesh. 2,400 women with at-least one child aged below two years were randomly selected. Both bivariate and multivariate analyses were carried out to explore the absolute and relative influence of the voucher scheme and chi-square test was used for hypothesis testing. RESULTS: Nineteen percent of the women were MHVS beneficiaries and 23% of them lived within 5 km of the health facility. Among the beneficiaries no significant differences were observed in the utilization of at-least 4 antenatal visits, skilled-assistance at delivery, postnatal care, and MNCoC between those living closer to the health facility and those living far away. However, a higher facility delivery rate was observed among beneficiary women living closer. By contrast, for non-beneficiaries, a significant difference was found in service use between women living closer to health facilities compared to those living further away. CONCLUSION: The study found the use of MNCoC to be similar for all MHVS beneficiaries irrespective of their distance to health facilities whereas non-beneficiary women living further away had lower utilization rates. MHVS could have potentially reduced distance-related inequality for its beneficiaries. However, despite the provision of transport incentives under MHVS the reduction in inequality in facility delivery was limited. We propose a revision of the transportation incentive adjusting for distance, geographical remoteness, road condition, and transport cost to enhance the impact of MHVS.

Exploring a framework for demandable services from antenatal to postnatal care: a deep-dive dialogue with mothers, health workers and psychologists.

BACKGROUND: One of the factors affecting quality of care is that clients do not demand care practises during antenatal, intrapartum and postnatal care. This study aimed to identify care practices that can be demanded by the mother in the continuum of care from antenatal to postnatal. METHODS: The study respondents included 122 mothers, 31 health workers and 4 psychologists. The researchers conducted 9 Key Informant Interviews with service providers and psychologists, 8 Focus Group Discussions with 8 mothers per group, and 26 vignettes with mothers and service providers. Data was analysed using Interpretative Phenomenological Analysis (IPA) where themes were identified and categorised. RESULTS: During antenatal and postnatal care, mothers demanded all recommended services presented to them. Some services seen as demandable during labour and delivery included 4-hourly assessments of vital signs and blood pressure, emptying of the bladder, swabbing, delivery counselling, administration of oxytocin, post-delivery palpation, and vaginal examination. For the child mothers demanded head to toe assessment, assessment of vital signs, weighing, cord stamp and eye antiseptics, and vaccines. Women observed that they could demand birth registration even though it was not among the recommended services. Respondents proposed empowerment of mothers with cognitive, behavioural and interpersonal skills to demand services e.g., knowledge of service standards and health benefits in addition to improved self-confidence and assertiveness. In addition, efforts have to be made to address perceived or real health worker attitudes, mental health for the client and the service provider, service provider workload, and availability of supplies. CONCLUSION: The study found that if a mother is informed in simple language about services that she is supposed to receive, she can demand numerous services in the continuum of care from antenatal to postnatal. However, demand cannot be a standalone solution for improving quality of care. What the mother can ask for is a step in the guidelines, but she cannot probe deeper to influence quality of the procedure. In addition, empowerment of mothers needs to be coupled with services and systems strengthening in support of health workers.

Metrics for maternity unit staffing in low resource settings: Scoping review and proposed core indicator.

Background: The lack of usable indicators and benchmarks for staffing of maternity units in health facilities has constrained planning and effective program implementation for emergency obstetric and newborn care (EmONC) globally. Objectives: To identify potential indicator(s) and benchmarks for EmONC facility staffing that might be applicable in low resource settings, we undertook a scoping review before proceeding to develop a proposed set of indicators. Eligibility criteria: Population: women attending health facilities for care around the time of delivery and their newborns. Concept: reports of mandated norms or actual staffing levels in health facilities. Context: studies conducted in healthcare facilities of any type that undertake delivery and newborn care and those from any geographic setting in both public and private sector facilities. Sources of evidence and charting: Searches were limited to material published since 2000 in English or French, using Pubmed and a purposive search of national Ministry of Health, non-governmental organization and UN agency websites for relevant documents. A template for data extraction was designed. Results: Data extraction was undertaken from 59 papers and reports including 29 descriptive journal articles, 17 national Ministry of Health documents, 5 Health Care Professional Association (HCPA) documents, two each of journal policy recommendation and comparative studies, one UN Agency document and 3 systematic reviews. Calculation or modelling of staffing ratios was based on delivery, admission or inpatient numbers in 34 reports, with 15 using facility designation as the basis for staffing norms. Other ratios were based on bed numbers or population metrics. Conclusions: Taken together, the findings point to a need for staffing norms for delivery and newborn care that reflect numbers and competencies of staff physically present on each shift. A Core indicator is proposed, "Monthly mean delivery unit staffing ratio" calculated as number of annual births/365/monthly average shift staff census.

Ferric carboxymaltose versus standard-of-care oral iron to treat second-trimester anaemia in Malawian pregnant women: a randomised controlled trial.

BACKGROUND: Anaemia affects 46% of pregnancies in Africa; oral iron is recommended by WHO but uptake and adherence are suboptimal. We tested a single dose of a modern intravenous iron formulation, ferric carboxymaltose, for anaemia treatment in Malawian pregnant women. METHODS: In this open-label, individually randomised controlled trial, we enrolled women with a singleton pregnancy of 13-26 weeks' gestation in primary care and outpatient settings across two regions in southern Malawi. Women were eligible if they had capillary haemoglobin of less than 10·0 g/dL and negative malaria rapid diagnostic test. Participants were randomised by sealed envelope 1:1. Assessors for efficacy outcomes (laboratory parameters and birthweight) were masked to intervention; participants and study nurses were not masked. Participants were given ferric carboxymaltose up to 1000 mg (given once at enrolment in an outpatient primary care setting), or standard of care (60 mg elemental iron twice daily for 90 days), along with intermittent preventive malaria treatment. The primary maternal outcome was anaemia at 36 weeks' gestation. The primary neonatal outcome was birthweight. Analyses were performed in the intention-to-treat population for mothers and liveborn neonates, according to their randomisation group. Safety outcomes included incidence of adverse events during infusion and all adverse events from randomisation to 4 weeks' post partum. The trial is registered with ANZCTR, ACTRN12618001268235. The trial has completed follow-up. FINDINGS: Between Nov 12, 2018, and March 2, 2021, 21 258 women were screened, and 862 randomly assigned to ferric carboxymaltose (n=430) or standard of care (n=432). Ferric carboxymaltose did not reduce anaemia prevalence at 36 weeks' gestation compared with standard of care (179 [52%] of 341 in the ferric carboxymaltose group vs 189 [57%] of 333 in the standard of care group; prevalence ratio [PR] 0·92, 95% CI 0·81 to 1·06; p=0·27). Anaemia prevalence was numerically lower in mothers randomly assigned to ferric carboxymaltose compared with standard of care at all timepoints, although significance was only observed at 4 weeks' post-treatment (PR 0·91 [0·85 to 0·97]). Birthweight did not differ between groups (mean difference -3·1 g [-75·0 to 68·9, p=0·93). There were no infusion-related serious adverse events or differences in adverse events by any organ class (including malaria; ≥1 adverse event: ferric carboxymaltose 183 [43%] of 430 vs standard of care 170 [39%] of 432; risk ratio 1·08 [0·92 to 1·27]; p=0·34). INTERPRETATION: In this malaria-endemic sub-Saharan African setting, treatment of anaemic pregnant women with ferric carboxymaltose was safe but did not reduce anaemia prevalence at 36 weeks' gestation or increase birthweight. FUNDING: Bill & Melinda Gates Foundation (INV-010612).

Factors associated with low utilisation of cervical cancer screening among urban women in Lilongwe, Malawi: a cross sectional study.

BACKGROUND: In 2012, more than half a million women (528,000) were diagnosed with cervical cancer around the world. More than 80% of cervical cancer occurs in developing nations, such as Malawi, where estimates of the disease's burden show an incidence of 75.9 per 100,000 women and a mortality rate of 49.8 per 100,000 women (both age-adjusted). Despite its case fatality rate, cervical cancer can be avoided through immunization, early detection and screening. Malawi however, has low immunization and screening rates with coverage as low as 9% and 15%, respectively. Here our aim is to uncover factors that contribute to low utilization of cervical cancer screening services among women in Lilongwe, a large urban center. METHODS: This was a qualitative cross-sectional study. Participants were chosen at random from a big metropolitan health center. In-depth interviews and two observations were undertaken by the researchers. Interviews were taped, transcribed verbatim, and content assessed. RESULTS: A total of 24 women and 5 health workers, with an average age of 34.8 years, were questioned. 50% of women had completed secondary school, 33.3% had completed primary school, and 4% had completed no formal education. The majority of the women were housewives and entrepreneurs. 62.5% of the respondents had fewer than four children, 25% had four to six children, and 8.3% had more than six children. 91 - 6% of those surveyed were married, with 78% of Christians and 20% of Muslims. The majority of women were unaware of the importance of cervical cancer screening. Some people were concerned about marital troubles, pain during the process, "laziness," and the amount of time necessary. The majority of people would come for a test as a result of signs and symptoms. Male health personnel would be unable to screen Muslim women. All of the medical personnel had at least two years of experience. Women's low involvement in cervical cancer screening has been linked by health workers to a lack of resources and a lack of community awareness. CONCLUSION: Cervical cancer can be prevented by early detection and treatment. Women, on the other hand, are uninformed about cervical cancer. Myths, misconceptions, cultural and religious beliefs, as well as service restrictions and community sensitization, influence the use of cervical cancer screening services. Addressing these issues has the potential to boost cervical cancer screening rates.

Generalisability of fetal ultrasound deep learning models to low-resource imaging settings in five African countries.

Most artificial intelligence (AI) research and innovations have concentrated in high-income countries, where imaging data, IT infrastructures and clinical expertise are plentiful. However, slower progress has been made in limited-resource environments where medical imaging is needed. For example, in Sub-Saharan Africa, the rate of perinatal mortality is very high due to limited access to antenatal screening. In these countries, AI models could be implemented to help clinicians acquire fetal ultrasound planes for the diagnosis of fetal abnormalities. So far, deep learning models have been proposed to identify standard fetal planes, but there is no evidence of their ability to generalise in centres with low resources, i.e. with limited access to high-end ultrasound equipment and ultrasound data. This work investigates for the first time different strategies to reduce the domain-shift effect arising from a fetal plane classification model trained on one clinical centre with high-resource settings and transferred to a new centre with low-resource settings. To that end, a classifier trained with 1792 patients from Spain is first evaluated on a new centre in Denmark in optimal conditions with 1008 patients and is later optimised to reach the same performance in five African centres (Egypt, Algeria, Uganda, Ghana and Malawi) with 25 patients each. The results show that a transfer learning approach for domain adaptation can be a solution to integrate small-size African samples with existing large-scale databases in developed countries. In particular, the model can be re-aligned and optimised to boost the performance on African populations by increasing the recall to [Formula: see text] and at the same time maintaining a high precision across centres. This framework shows promise for building new AI models generalisable across clinical centres with limited data acquired in challenging and heterogeneous conditions and calls for further research to develop new solutions for the usability of AI in countries with fewer resources and, consequently, in higher need of clinical support.

A latent class approach to understanding patterns of emotional and behavioral problems among early adolescents across four low- and middle-income countries.

Early adolescents (ages 10-14) living in low- and middle-income countries have heightened vulnerability to psychosocial risks, but available evidence from these settings is limited. This study used data from the Global Early Adolescent Study to characterize prototypical patterns of emotional and behavioral problems among 10,437 early adolescents (51% female) living in the Democratic Republic of Congo (DRC), Malawi, Indonesia, and China, and explore the extent to which these patterns varied by country and sex. LCA was used to identify and classify patterns of emotional and behavioral problems separately by country. Within each country, measurement invariance by sex was evaluated. LCA supported a four-class solution in DRC, Malawi, and Indonesia, and a three-class solution in China. Across countries, early adolescents fell into the following subgroups: Well-Adjusted (40-62%), Emotional Problems (14-29%), Behavioral Problems (15-22%; not present in China), and Maladjusted (4-15%). Despite the consistency of these patterns, there were notable contextual differences. Further, tests of measurement invariance indicated that the prevalence and nature of these classes differed by sex. Findings can be used to support the tailoring of interventions targeting psychosocial adjustment, and suggest that such programs may have utility across diverse cross-national settings.

Protocol and statistical analysis plan for a randomized controlled trial of the effect of intravenous iron on anemia in Malawian pregnant women in their third trimester (REVAMP - TT).

Background: Anemia affects 40% of pregnant women globally, leading to maternal mortality, premature birth, low birth weight, and poor baby development. Iron deficiency causes over 40% of anemia cases in Africa. Oral iron supplementation is insufficient for Low-and-Middle-Income-Countries (LMICs) to meet current WHO targets. We hypothesized that a single intravenous dose of Ferric Carboxymaltose (FCM) may be more effective than oral iron treatment for anemia recovery, particularly in these settings where women present late for antenatal care. Methods: This is a two-arm parallel open-label individual-randomized controlled trial in third trimester, in malaria Rapid Diagnostic Test-negative pregnant women with moderate or severe anemia - capillary hemoglobin <10 g/dL - who are randomized to receive either parenteral iron - with FCM - or standard-of-care oral iron for the remainder of pregnancy. This is the sister trial to the second-trimester REVAMP trial, funded by the Bill and Melinda Gates Foundation (trial registration ACTRN12618001268235, Gates Grant number INV-010612). In REVAMP-TT, recruitment and treatment are performed within primary health centers. The trial will recruit 590 women across Zomba district, Malawi. The primary outcome is the proportion of anemic women - venous hemoglobin <11 g/dL - at 36 weeks' gestation or delivery (whichever occurs first). Other pre-specified key secondary clinical and safety outcomes include maternal iron-status and hypophosphatemia, neonate birth weight, infant growth and infant iron and hematological parameters. Discussion: This study will determine whether FCM, delivered within primary health centers, is effective, safe and feasible for treating moderate to severe anemia in third-trimester pregnant Malawian women. This intervention could have long-term benefits for maternal and child health, resulting in improved survival and child development.

The Integration of vertical and horizontal programmes for health systems strengthening in Malawi: a case study.

A challenge for the health system in Malawi is that funding allocation is heavily influenced by donor priorities. As a result, mandated routine elements of service delivery may not be fully offered owing to lack of resources or programmatic priority. Integration of currently active 'vertical' programmes (those focused on a specific priority disease entity) into existing 'horizontal' services (meaning provision across the range of clinical and public health need) has potential to improve access and quality of service delivery for Reproductive, Maternal, Newborn, Child and Adolescent Health (RMNCAH) in Malawi. We identified and tabulated the main vertical funding streams currently available in Malawi and identified where these could intersect with existing horizontal health sector programmes in order to strengthen RMNCAH. We have indicated how each of the main vertical programmatic components can be adapted and integrated to support broader system strengthening within RMNCAH focusing especially on drug and commodity procurement, supply chain logistics, health facility and equipment maintenance/upgrading, health service activity data systems, human resources for 'front line' RMNCAH provision, as well as community engagement and mobilization. By circumventing the various limitations of vertical programmes in the delivery of health services in the country, they would complement existing funding streams rather than operating in a vacuum as independent activities. We therefore recommend the integration of horizontal and existing vertical programmes in order to improve RMNCAH in Malawi.

Preeclampsia prediction with blood pressure measurements: A global external validation of the ALSPAC models.

OBJECTIVE: The prediction of preeclampsia in pregnancy has resulted in a plethora of prognostic models. Yet, very few make it past the development stage and most fail to influence clinical practice. The timely identification of high-risk pregnant women could deliver a tailored antenatal care regimen, particularly in low-resource settings. This study externally validated and calibrated previously published models that predicted the risk of preeclampsia, based on blood pressure (BP) at multiple time points in pregnancy, in a geographically diverse population. METHODS: The prospective INTERBIO-21st Fetal Study included 3,391 singleton pregnancies from Brazil, Kenya, Pakistan, South Africa, Thailand and the UK, 2012-2018. Preeclampsia prediction was based on baseline characteristics, BP and deviation from the expected BP trajectory at multiple time points in pregnancy. The prediction rules from the Avon Longitudinal Study of Parents and Children (ALSPAC) were implemented in the INTERBIO-21st cohort. RESULTS: Model discrimination was similar to the development cohort. Performance was best with baseline characteristics and a BP measurement at 34 weeks' gestation (AUC 0.85, 95 % CI 0.80-0.90). The ALSPAC models largely overestimated the true risk of preeclampsia incidence in the INTERBIO-21st cohort. CONCLUSIONS: After recalibration, these prediction models could potentially serve as a risk stratifying tool to help identify women who might benefit from increased surveillance during pregnancy.

The Bangladesh Maternal Health Voucher Scheme: impact on completeness of antenatal care provision.

This study aimed to assess completeness of antenatal care coverage following implementation of a voucher scheme for maternal health in Bangladesh. The investigation used interview data from a survey conducted in Bangladesh in 2017 of 2400 randomly selected women aged 15-49 with children aged 0-23 months in four geographical areas where voucher scheme implementation was underway. Of these women, 1944 had attended at least one antenatal clinic visit so were included in the analysis. A 'completeness index' for antenatal visits was constructed as an outcome variable based on recall of thirteen elements of care. Bivariate analysis against independent variables of interest was carried out and multivariate linear regression models developed to examine the influence of voucher scheme participation on completeness of antenatal care adjusting for socio-demographic characteristics. Voucher scheme membership was associated with higher 'completeness index' scores, with a mean score of 185.2±101.0 for voucher recipients and 139.6 ± 93.3 for non-recipients (p<0.001). Scheme membership reduced the differentials associated with health facility type and socioeconomic status. Women from the lowest socioeconomic group who were voucher recipients received substantially more components of antenatal care (mean score: 159.6±82.1) compared with non-recipients (mean score: 115.7±83.0). This favourable effect of voucher scheme membership on the most vulnerable socioeconomic group remained significant after adjusting for educational status. The Bangladesh voucher scheme model has the potential to maximize gains in maternal and newborn health through enhancing the completeness of service provision.

Why do young people engage in dating relationships during early adolescence? An inter-generational qualitative analysis from Blantyre, Malawi.

Engagement in dating relationships plays an important role in the health trajectories of young people, particularly during the early adolescent period between ages 10-14. Yet little is known about such relationships among youth in low resource contexts. This study sought to contribute to the literature on this topic by exploring reasons why school-going young people aged 12-14 years engage in dating relationships in Blantyre, Malawi. A thematic analysis was used to code and analyse in-depth interview data from 23 young people and 19 caregivers. Against the backdrop of growing sexual desires and feelings of attraction, participants stressed harassment from boys and coercion from older men, peer pressure, social status attainment, financial deprivation and encouragement during initiation ceremonies as reasons for engaging in dating relationships. Girls were found to be subject to multiple power dynamics-including gender power relations, as well as power dynamics within same-gender peer groups-that influenced their sex and relationship involvement. These findings carry implications for the design and timing of sexual and reproductive health youth programmes in Sub-Saharan Africa and emphasise the need for multi-level interventions to address the multiple influences in young people's dating lives.

Assessing the relationship between agency and peer violence among adolescents aged 10 to 14 years in Kinshasa, Democratic Republic of Congo and Blantyre, Malawi: A cross-sectional study.

BACKGROUND: Interpersonal violence has physical, emotional, educational, social, and economic implications. Although there is interest in empowering young people to challenge harmful norms, there is scant research on how individual agency, and, specifically, the "power to" resist or bring about an outcome relates to peer violence perpetration and victimization in early adolescence. This manuscript explores the relationship between individual agency and peer violence perpetration and victimization among very young adolescents (VYAs) living in two urban poor settings in sub-Saharan Africa (Kinshasa, Democratic Republic of Congo (DRC) and Blantyre, Malawi). METHODS AND FINDINGS: The study draws on two cross-sectional surveys including 2,540 adolescents 10 to 14 years from Kinshasa in 2017 (girls = 49.8% and boys = 50.2%) and 1,213 from Blantyre in 2020 (girls = 50.7% and boys = 49.3%). The sample was school based in Malawi but included in-school and out-of-school participants in Kinshasa due to higher levels of early school dropout. Peer violence in the last 6 months (dependent variable) was defined as a four categorical variable: (1) no victimization or perpetration; (2) victimization only; (3) perpetration only; and (4) both victimization and perpetration. Agency was operationalized using 3 scales: freedom of movement, voice, and decision-making, which were further divided into tertiles. Univariate analysis and multivariable multinomial logistic regressions were conducted to evaluate the relationships between each agency indicator and peer violence. The multivariable regression adjusted for individual, family, peer, and community level covariates. All analyses were stratified by gender and site. In both sites, adolescents had greater voice and decision-making power than freedom of movement, and boys had greater freedom of movement than girls. Boys in both settings were more likely to report peer violence in the last six months than girls (40% to 50% versus 32% to 40%, p < 0.001), mostly due to higher rates of a perpetration-victimization overlap (18% to 23% versus 10% to 15%, p < 0.001). Adolescents reporting the greatest freedom of movement (Tertile 3) (with the exception of girls in Kinshasa) had a greater relative risk ratio (RRR) of reporting a perpetrator-victim overlap (boys Kinshasa: RRR = 1.9 (1.2 to 2.8, p = 0.003); boys Blantyre: RRR = 3.8 (1.7 to 8.3, p = 0.001); and girls Blantyre: RRR = 2.4 (1.1 to 5.1, p = 0.03)). Adolescents with the highest decision-making power in Kinshasa also had greater RRR of reporting a perpetrator-victim overlap (boys: RRR = 3.0 (1.8 to 4.8, p < 0.001). Additionally, girls and boys in Kinshasa with intermediate decision-making power (tertile 2 versus 1) had a lower RRR of being victimized (Girls: RRR = 1.7 (1.02 to 2.7, p = 0.04); Boys: RRR = 0.6 (0.4 to 0.9, p = 0.01)). Higher voice among boys in Kinshasa (Tertile 2: RRR = 1.9 (1.2 to 2.9, p = 0.003) and Tertile 3: 1.8 (1.2 to 2.8, p = 0.009)) and girls in Blantyre (Tertile 2: 2.0 (1.01 to 3.9, p = 0.048)) was associated with a perpetrator-victim overlap, and girls with more voice in Blantyre had a greater RRR of being victimized (Tertile 2: RRR = 1.9 (1.1 to 3.1, p = 0.02)). Generally, associations were stronger for boys than girls, and associations often differed when victimization and perpetration occurred in isolation of each other. A main limitation of this study is that the cross-sectional nature of the data does not allow a causal interpretation of the findings, which need further longitudinal exploration to establish temporality. CONCLUSIONS: In this study, we observed that peer violence is a gendered experience that is related to young people's agency. This stresses the importance of addressing interpersonal violence in empowerment programs and of including boys who experience the greatest perpetration-victimization overlap.

Protocol for a multicentre, parallel-group, open-label randomised controlled trial comparing ferric carboxymaltose with the standard of care in anaemic Malawian pregnant women: the REVAMP trial.

INTRODUCTION: Anaemia in pregnancy remains a critical global health problem, affecting 46% of pregnant women in Africa and 49% in Asia. Oral iron therapy requires extended adherence to achieve correction of anaemia and replenishment of iron stores. Ferric carboxymaltose (FCM) is a recently established intravenous iron formulation associated with substantial advantages in safety, speed of delivery and total dose deliverable in a single infusion. We aim to determine whether FCM given once during the second trimester of pregnancy compared with standard oral iron distributed through routine antenatal services is effective and safe for treatment of moderate to severe maternal anaemia in sub-Saharan Africa. METHODS AND ANALYSIS: The randomized controlled trial of the effect of intravenous iron on anaemia in Malawian pregnant women (REVAMP) is a two-arm confirmatory individually randomised trial set in Blantyre and Zomba districts in Malawi. The trial will randomise 862 women in the second trimester of pregnancy with a capillary haemoglobin concentration below 100.0 g/L. The study comprises two arms: (a) intravenous FCM (20 mg/kg up to 1000 mg) given once at randomisation, and (b) standard of care oral iron (65 mg elemental iron two times per day) for 90 days (or the duration of pregnancy, whichever is shorter) provided according to local healthcare practices. Both arms receive sulfadoxine-pyrimethamine as intermittent preventive treatment in pregnancy. The primary outcome is the prevalence of anaemia (Hb <110.0 g/L) at 36 weeks' gestation. Secondary outcomes include birth weight, gestation duration and safety outcomes, including clinical malaria, serious perinatal events and postpartum haematologic and health-related outcomes in the mother and child. ETHICS AND DISSEMINATION: Ethical approval was granted by the Research Ethics Committee (COMREC P.02/18/2357) in Malawi and the Human Research Ethics Committee (WEHI: 18/02), Melbourne, Australia. The protocol is registered with the Australian and New Zealand Clinical Trials Registry. The results will be shared with the local community that enabled the research, and also to the international fora. TRIAL REGISTRATION NUMBER: ACTRN12618001268235; Pre-results.

Impact of a maternal and newborn health results-based financing intervention (RBF4MNH) on stillbirth: a cross-sectional comparison in four districts in Malawi.

BACKGROUND: Malawi implemented a Results Based Financing (RBF) model for Maternal and Newborn Health, "RBF4MNH" at public hospitals in four Districts, with the aim of improving health outcomes. We used this context to seek evidence for the impact of this intervention on rates of antepartum and intrapartum stillbirth, taking women's risk factors into account. METHODS: We used maternity unit delivery registers at hospitals in four districts of Malawi to obtain information about stillbirths. We purposively selected two districts hosting the RBF4MNH intervention and two non-intervention districts for comparison. Data were extracted from the maternity registers and used to develop logistic regression models for variables associated with fresh and macerated stillbirth. RESULTS: We identified 67 stillbirths among 2772 deliveries representing 24.1 per 1000 live births of which 52% (n = 35) were fresh (intrapartum) stillbirths and 48% (n = 32) were macerated (antepartum) losses. Adjusted odds ratios (aOR) for fresh and macerated stillbirth at RBF versus non-RBF sites were 2.67 (95%CI 1.24 to 5.57, P = 0.01) and 7.27 (95%CI 2.74 to 19.25 P < 0.001) respectively. Among the risk factors examined, gestational age at delivery was significantly associated with increased odds of stillbirth. CONCLUSION: The study did not identify a positive impact of this RBF model on the risk of fresh or macerated stillbirth. Within the scientific limitations of this non-randomised study using routinely collected health service data, the findings point to a need for rigorously designed and tested interventions to strengthen service delivery with a focus on the elements needed to ensure quality of intrapartum care, in order to reduce the burden of stillbirths.

Don't forget eclampsia in the efforts to reduce maternal morbidity and mortality.

Hypertensive disorders are a leading cause of maternal morbidity and mortality worldwide. Despite advances in prevention and clinical management, women in low-resource countries continue to bear the burden of the sequelae of severe pre-eclampsia-eclampsia. Sustainable strategies to improve the care of women with hypertensive disease, to identify those at risk for hypertensive disease, and to reduce the risk of eclampsia will require partnerships between clinicians and health policy makers. Resources are needed to scale up healthcare access and infrastructure, establish evidence-based protocols for care, and ensure an adequate supply of equipment and drugs. Additionally, efforts for a sustained workforce of perinatal clinicians and staff trained in the assessment and management of hypertensive disease are needed. Effective postpartum care and monitoring are essential to prevent morbidity and mortality due to cardiovascular disease. Culturally appropriate strategies are needed to educate women and their families on the symptoms of pre-eclampsia to address delays in seeking care during pregnancy and postpartum. With targeted, sustained efforts and resources, eclampsia and its associated co-morbidities can be preventable.