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A community-based cluster randomized controlled trial (cRCT) to evaluate the impact and operational assessment of "safe motherhood and newborn health promotion package": study protocol.

ABSTRACT: BACKGROUND:Despite considerable progress in reduction of both under-five and maternal mortality in recent decades, Bangladesh is still one of the low and middle income countries with high burden of maternal and neonatal mortality. The primary objective of the current study is to measure the impact of a comprehensive package of interventions on maternal and neonatal mortality. In addition, changes in coverage, quality and utilization of maternal and newborn health (MNH) services, social capital, and cost effectiveness of the interventions will be measured. METHODS:A community-based, cluster randomized controlled trial design will be adopted and implemented in 30 unions of three sub-districts of Chandpur district of Bangladesh. Every union, the lowest administrative unit of the local government with population of around 20,000-30,000, will be considered a cluster. Based on the baseline estimates, 15 clusters will be paired for random assignment as intervention and comparison clusters. The primary outcome measure is neonatal mortality, and secondary outcomes are coverage of key interventions like ANC, PNC, facility and skilled provider delivery. Baseline, midterm and endline household survey will be conducted to assess the key coverage of interventions. Health facility assessment surveys will be conducted periodically to assess facility readiness and utilization of MNH services in the participating health facilities. DISCUSSION:The current study is expected to provide essential strong evidences on the impact of a comprehensive package of interventions to the Bangladesh government, and other developmental partners. The study results may help in prioritizing, planning, and scaling-up of Safe Motherhood Promotional interventions in other geographical areas of Bangladesh as well as to inform other developing countries of similar settings. TRIAL REGISTRATION:NCT03032276 .

SUBMITTER: Hoque DME

PROVIDER: S-EPMC5934824 | biostudies-literature | 2018 May

REPOSITORIES: biostudies-literature

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A community-based cluster randomized controlled trial (cRCT) to evaluate the impact and operational assessment of "safe motherhood and newborn health promotion package": study protocol.

Hoque Dewan Md Emdadul DME Chowdhury Mohiuddin Ahsanul Kabir MAK Rahman Ahmed Ehsanur AE Billah Sk Masum SM Bari Sanwarul S Tahsina Tazeen T Hasan Mohammad Mehedi MM Islam Sajia S Islam Tajul T Mori Rintaro R Arifeen Shams El SE

BMC public health 20180503 1

<h4>Background</h4>Despite considerable progress in reduction of both under-five and maternal mortality in recent decades, Bangladesh is still one of the low and middle income countries with high burden of maternal and neonatal mortality. The primary objective of the current study is to measure the impact of a comprehensive package of interventions on maternal and neonatal mortality. In addition, changes in coverage, quality and utilization of maternal and newborn health (MNH) services, social c ...[more]

PMID: 29724194

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Project description:BACKGROUND:To evaluate a delivery strategy for newborn interventions in rural Bangladesh. METHODS:A cluster-randomized controlled trial was conducted in Mirzapur, Bangladesh. Twelve unions were randomized to intervention or comparison arm. All women of reproductive age were eligible to participate. In the intervention arm, community health workers identified pregnant women; made two antenatal home visits to promote birth and newborn care preparedness; made four postnatal home visits to negotiate preventive care practices and to assess newborns for illness; and referred sick neonates to a hospital and facilitated compliance. Primary outcome measures were antenatal and immediate newborn care behaviours, knowledge of danger signs, care seeking for neonatal complications, and neonatal mortality. FINDINGS:A total of 4616 and 5241 live births were recorded from 9987 and 11153 participants in the intervention and comparison arm, respectively. High coverage of antenatal (91% visited twice) and postnatal (69% visited on days 0 or 1) home visitations was achieved. Indicators of care practices and knowledge of maternal and neonatal danger signs improved. Adjusted mortality hazard ratio in the intervention arm, compared to the comparison arm, was 1.02 (95% CI: 0.80-1.30) at baseline and 0.87 (95% CI: 0.68-1.12) at endline. Primary causes of death were birth asphyxia (49%) and prematurity (26%). No adverse events associated with interventions were reported. CONCLUSION:Lack of evidence for mortality impact despite high program coverage and quality assurance of implementation, and improvements in targeted newborn care practices suggests the intervention did not adequately address risk factors for mortality. The level and cause-structure of neonatal mortality in the local population must be considered in developing interventions. Programs must ensure skilled care during childbirth, including management of birth asphyxia and prematurity, and curative postnatal care during the first two days of life, in addition to essential newborn care and infection prevention and management. TRIAL REGISTRATION:Clinicaltrials.gov NCT00198627.

Project description:BackgroundAppropriate facility-based care at birth is a key determinant of safe motherhood but geographical access remains poor in many high burden regions. Despite its importance, geographical access is rarely audited systematically, preventing integration in national-level maternal health system assessment and planning. In this study, we develop a uniquely detailed set of spatially-linked data and a calibrated geospatial model to undertake a national-scale audit of geographical access to maternity care at birth in Ghana, a high-burden country typical of many in sub-Saharan Africa.MethodsWe assembled detailed spatial data on the population, health facilities, and landscape features influencing journeys. These were used in a geospatial model to estimate journey-time for all women of childbearing age (WoCBA) to their nearest health facility offering differing levels of care at birth, taking into account different transport types and availability. We calibrated the model using data on actual journeys made by women seeking care.ResultsWe found that a third of women (34%) in Ghana live beyond the clinically significant two-hour threshold from facilities likely to offer emergency obstetric and neonatal care (EmONC) classed at the 'partial' standard or better. Nearly half (45%) live that distance or further from 'comprehensive' EmONC facilities, offering life-saving blood transfusion and surgery. In the most remote regions these figures rose to 63% and 81%, respectively. Poor levels of access were found in many regions that meet international targets based on facilities-per-capita ratios.ConclusionsDetailed data assembly combined with geospatial modelling can provide nation-wide audits of geographical access to care at birth to support systemic maternal health planning, human resource deployment, and strategic targeting. Current international benchmarks of maternal health care provision are inadequate for these purposes because they fail to take account of the location and accessibility of services relative to the women they serve.

Project description:BACKGROUND:A community-based intervention known as Safe Motherhood Action Groups (SMAGs) was implemented to increase coverage of maternal and neonatal health (MNH) services among the poorest and most remote populations in Zambia. While the outcome evaluation demonstrated statistically significant improvement in the MNH indicators, targets for key indicators were not achieved, and reasons for this shortfall were not known. This study was aimed at understanding why the targeted key indicators for MNH services were not achieved. METHODS:A process evaluation, in accordance with the Medical Research Council (MRC) framework, was conducted in two selected rural districts of Zambia using qualitative approaches. Focus group discussions were conducted with SMAGs, volunteer community health workers, and mothers and in-depth interviews with healthcare providers. Content analysis was done. RESULTS:We found that SMAGs implemented much of the intervention as was intended, particularly in the area of women's education and referral to health facilities for skilled MNH services. The SMAGs went beyond their prescribed roles to assist women with household chores and personal problems and used their own resources to enhance the success of the intervention. Deficiencies in the intervention were reported and included poor ongoing support, inadequate supplies and lack of effective transportation such as bicycles needed for the SMAGs to facilitate their work. Factors external to the intervention, such as inadequacy of health services and skilled healthcare providers in facilities where SMAGs referred mothers and poor geographical access, may have led SMAGs to engage in the unintended role of conducting deliveries, thus compromising the outcome of the intervention. CONCLUSION:We found evidence suggesting that although SMAGs continue to play pivotal roles in contribution towards accelerated coverage of MNH services among hard-to-reach populations, they are unable to meet some of the critical sets of MNH service-targeted indicators. The complexities of the implementation mechanisms coupled with the presence of setting specific socio-cultural and geographical contextual factors could partially explain this failure. This suggests a need for innovating existing implementation strategies so as to help SMAGs and any other community health system champions to effectively respond to MNH needs of most-at-risk women and promote universal health coverage targeting hard-to-reach groups.

Project description:BackgroundImmigrant women have low rates of physical activity (PA), placing them at risk for chronic diseases. Some research suggests that strategies targeting this group must be culturally-safe and community-based. This study aimed to identify the design (i.e. characteristics) and impact of culturally-safe community-based PA promotion for immigrant women.MethodsWe conducted a descriptive review by searching MEDLINE, EMBASE, SPORTDiscus, CINAHL, SCOPUS, Cochrane Library and Joanna Briggs Institute Database of Systematic Reviews from inception to June 9, 2021 for English language studies that assessed community-based PA promotion strategies targeting adult immigrants and involved at least 50% women. We compiled findings in a preliminary context-mechanisms-outcomes conceptual framework.ResultsWe included 13 studies published from 2004 to 2020. Three included women-only; the remainder included a median of 63% women (range 50 to 98%). Studies included immigrants from Brazil, Dominican, Columbian, Haiti, Mexico, China, Vietnam, Bangladesh, India, Pakistan, Somalia, Sudan and Turkey. All but one study (89%) significantly improved one or more outcomes: PA knowledge, PA participation and anthropometric measures (e.g. weight, BMI, blood pressure). Most (89%) strategies were multi-faceted: in-person group educational sessions reinforced by take-home educational material and/or follow-up reminder phone calls. Single strategies (e.g. mailed educational material, group educational session) also achieved beneficial outcomes. We identified 17 culturally-safe characteristics of PA promotion strategies: language of choice, based in community settings or organizations, led by lay health workers, reflected ethno-cultural linguistic expressions and PA norms, and recognized and offered solutions to barriers of PA. Findings were captured in a preliminary theory of how contextual factors (gender, intersectionality) and mechanism (culturally-safe PA promotion) may influence PA-related outcomes (PA knowledge, self-efficacy and participation; anthropometric measures, quality of life).ConclusionsThis study revealed the characteristics of PA promotion strategies that significantly improved PA-related outcomes among immigrants. Given that few studies focused solely on immigrant women or reported sub-analyses, the conceptual framework generated by this study can be used in future research to more definitively establish the design and impact of culturally-safe, community-based PA promotion for immigrant women.

Project description:ObjectivesThe primary objective of this cluster randomised controlled trial was to compare the effectiveness of the three experimental continence promotion interventions against a control intervention on urinary symptom improvement in older women with untreated incontinence recruited from community organisations. A second objective was to determine whether changes in incontinence-related knowledge and new uptake of risk-modifying behaviours explain these improvements.Setting71 community organisations across the UK.Participants259 women aged 60 years and older with untreated incontinence entered the trial; 88% completed the 3-month follow-up.InterventionsThe three active interventions consisted of a single 60 min group workshop on (1) continence education (20 clusters, 64 women); (2) evidence-based self-management (17 clusters, 70 women); or (3) combined continence education and self-management (17 clusters, 61 women). The control intervention was a single 60 min educational group workshop on memory loss, polypharmacy and osteoporosis (17 clusters, 64 women).Primary and secondary outcome measuresThe primary outcome was self-reported improvement in incontinence 3 months postintervention at the level of the individual. The secondary outcome was change in the International Consultation on Incontinence Questionnaire (ICIQ) from baseline to 3-month follow-up. Changes in incontinence-related knowledge and behaviours were also assessed.ResultsThe highest rate of urinary symptom improvement occurred in the combined intervention group (66% vs 11% of the control group, prevalence difference 55%, 95% CI 43% to 67%, intracluster correlation 0). 30% versus 6% of participants reported significant improvement respectively (prevalence difference 23%, 95% CI 10% to 36%, intracluster correlation 0). The number-needed-to-treat was 2 to achieve any improvement in incontinence symptoms, and 5 to attain significant improvement. Compared to controls, participants in the combined intervention reported an adjusted mean 2.05 point (95% CI 0.87 to 3.24) greater improvement on the ICIQ from baseline to 3-month follow-up. Changes in knowledge and self-reported risk-reduction behaviours paralleled rates of improvement in all intervention arms.ConclusionsContinence education combined with evidence-based self-management improves symptoms of incontinence among untreated older women. Community organisations represent an untapped vector for delivering effective continence promotion interventions.Trial registrationClinicalTrials.gov ID number NCT01239836.

Project description:The transformation of the BRAC MANOSHI programme from humanitarian to a social enterprise model, has made it increasingly urgent to enumerate the minimum number of door-to-door antenatal care (ANC) visits by community health workers (CHWs), for the purpose of effectively improving facility delivery. Thus prevent social exclusion of poor slum communities in Bangladesh with regard to safe motherhood and essential newborn care (ENC). This cross-sectional study was conducted, during March-July, 2015 in slums of Chittagong, Dhaka and Sylhet city corporations of Bangladesh. A census was conducted among 25,700 households covering 10 branch offices of MANOSHI to identify women with a delivery outcome in the preceding three years of the survey. A total of 1100 respondents were interviewed randomly through a structured questionnaire. These women were stratified into three categories-1, 2 & 3, consisting of 497, 205 and 398 women respectively. Women in category-1 did not receive any ANC checkup from the BRAC CHWs, while women in category-2 and category-3 received one to three and ≥four ANC checkups from BRAC CHWs respectively. Data was analysed using STATA Version 13 (Chicago Inc.). Findings revealed that women, who received ≥four ANC checkups from BRAC CHWs, are 25% more likely to avail facility delivery [adjusted Prevalence Ratio (aPR) 1.25; 95% confidence interval (CI) (1.01-1.54)] compared to the women who did not receive any ANC from BRAC CHWs. Women in category-2 [aPR3.64; 95% CI (1.76-7.54)] and in category-3 [aPR5.92; 95% CI (3.04-11.53)] respectively had four and six folds higher tendency to receive postnatal care (PNC) within 48 hours after delivery. Furthermore, facility delivery improved PNC assisted by medically trained providers (MTPs) within 48 hours after delivery and ENC in both categories 2 & 3. The evidence shows that at least four ANC visits of BRAC CHWs can increase institutional delivery, and which can further facilitate PNC and ENC visits. At present, the BRAC MANOSHI programme needs to implement feasible strategies to include pregnant women in the slums in receiving at least four ANC checkups by BRAC CHWs for ensuring safe motherhood and newborn care.

Project description:The authors tested the effectiveness of a community-based, tribally delivered oral health promotion (OHP) intervention (INT) at reducing caries increment in Navajo children attending Head Start. In a 3-y cluster-randomized trial, we developed an OHP INT with Navajo input that was delivered by trained Navajo lay health workers to children attending 52 Navajo Head Start classrooms (26 INT, 26 usual care [UC]). The INT was designed as a highly personalized set of oral health-focused interactions (5 for children and 4 for parents), along with 4 fluoride varnish applications delivered in Head Start during academic years of 2011 to 2012 and 2012 to 2013. The authors evaluated INT impact on decayed, missing, and filled tooth surfaces (dmfs) increment compared with UC. Other outcomes included caries prevalence and caregiver oral health-related knowledge and behaviors. Modified intention-to-treat and per-protocol analyses were conducted. The authors enrolled 1,016 caregiver-child dyads. Baseline mean dmfs/caries prevalence equaled 19.9/86.5% for the INT group and 22.8/90.1% for the UC group, respectively. INT adherence was 53% (i.e., ≥3 child OHP events, ≥1 caregiver OHP events, and ≥3 fluoride varnish). After 3 y, dmfs increased in both groups (+12.9 INT vs. +10.8 UC; P = 0.216), as did caries prevalence (86.5% to 96.6% INT vs. 90.1% to 98.2% UC; P = 0.808) in a modified intention-to-treat analysis of 897 caregiver-child dyads receiving 1 y of INT. Caregiver oral health knowledge scores improved in both groups (75.1% to 81.2% INT vs. 73.6% to 79.5% UC; P = 0.369). Caregiver oral health behavior scores improved more rapidly in the INT group versus the UC group (P = 0.006). The dmfs increment was smaller among adherent INT children (+8.9) than among UC children (+10.8; P = 0.028) in a per-protocol analysis. In conclusion, the severity of dental disease in Navajo Head Start children is extreme and difficult to improve. The authors argue that successful approaches to prevention may require even more highly personalized approaches shaped by cultural perspectives and attentive to the social determinants of oral health (ClinicalTrials.gov NCT01116739).

Dataset Information

A community-based cluster randomized controlled trial (cRCT) to evaluate the impact and operational assessment of "safe motherhood and newborn health promotion package": study protocol.

Publications

A community-based cluster randomized controlled trial (cRCT) to evaluate the impact and operational assessment of "safe motherhood and newborn health promotion package": study protocol.

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