Stillbirths including intrapartum timing: EN-BIRTH multi-country validation study.

BACKGROUND: An estimated >2 million babies stillborn around the world each year lack visibility. Low- and middle-income countries carry 84% of the burden yet have the least data. Most births are now in facilities, hence routine register-recording presents an opportunity to improve counting of stillbirths, but research is limited, particularly regarding accuracy. This paper evaluates register-recorded measurement of hospital stillbirths, classification accuracy, and barriers and enablers to routine recording. METHODS: The EN-BIRTH mixed-methods, observational study took place in five hospitals in Bangladesh, Nepal and Tanzania (2017-2018). Clinical observers collected time-stamped data on perinatal care and birth outcomes as gold standard. To assess accuracy of routine register-recorded stillbirth rates, we compared birth outcomes recorded in labour ward registers to observation data. We calculated absolute rate differences and individual-level validation metrics (sensitivity, specificity, percent agreement). We assessed misclassification of stillbirths with neonatal deaths. To examine stillbirth appearance (fresh/macerated) as a proxy for timing of death, we compared appearance to observed timing of intrauterine death based on heart rate at admission. RESULTS: 23,072 births were observed including 550 stillbirths. Register-recorded completeness of birth outcomes was > 90%. The observed study stillbirth rate ranged from 3.8 (95%CI = 2.0,7.0) to 50.3 (95%CI = 43.6,58.0)/1000 total births and was under-estimated in routine registers by 1.1 to 7.3 /1000 total births (register: observed ratio 0.9-0.7). Specificity of register-recorded birth outcomes was > 99% and sensitivity varied between hospitals, ranging from 77.7-86.1%. Percent agreement between observer-assessed birth outcome and register-recorded birth outcome was very high across all hospitals and all modes of birth (> 98%). Fresh or macerated stillbirth appearance was a poor proxy for timing of stillbirth. While there were similar numbers of stillbirths misclassified as neonatal deaths (17/430) and neonatal deaths misclassified as stillbirths (21/36), neonatal deaths were proportionately more likely to be misclassified as stillbirths (58.3% vs 4.0%). Enablers to more accurate register-recording of birth outcome included supervision and data use. CONCLUSIONS: Our results show these routine registers accurately recorded stillbirths. Fresh/macerated appearance was a poor proxy for intrapartum stillbirths, hence more focus on measuring fetal heart rate is crucial to classification and importantly reduction in these preventable deaths.

Immediate newborn care and breastfeeding: EN-BIRTH multi-country validation study.

BACKGROUND: Immediate newborn care (INC) practices, notably early initiation of breastfeeding (EIBF), are fundamental for newborn health. However, coverage tracking currently relies on household survey data in many settings. "Every Newborn Birth Indicators Research Tracking in Hospitals" (EN-BIRTH) was an observational study validating selected maternal and newborn health indicators. This paper reports results for EIBF. METHODS: The EN-BIRTH study was conducted in five public hospitals in Bangladesh, Nepal, and Tanzania, from July 2017 to July 2018. Clinical observers collected tablet-based, time-stamped data on EIBF and INC practices (skin-to-skin within 1 h of birth, drying, and delayed cord clamping). To assess validity of EIBF measurement, we compared observation as gold standard to register records and women's exit-interview survey reports. Percent agreement was used to assess agreement between EIBF and INC practices. Kaplan Meier survival curves showed timing. Qualitative interviews were conducted to explore barriers/enablers to register recording. RESULTS: Coverage of EIBF among 7802 newborns observed for ≥1 h was low (10.9, 95% CI 3.8-21.0). Survey-reported (53.2, 95% CI 39.4-66.8) and register-recorded results (85.9, 95% CI 58.1-99.6) overestimated coverage compared to observed levels across all hospitals. Registers did not capture other INC practices apart from breastfeeding. Agreement of EIBF with other INC practices was high for skin-to-skin (69.5-93.9%) at four sites, but fair/poor for delayed cord-clamping (47.3-73.5%) and drying (7.3-29.0%). EIBF and skin-to-skin were the most delayed and EIBF rarely happened after caesarean section (0.5-3.6%). Qualitative findings suggested that focusing on accuracy, as well as completeness, contributes to higher quality with register reporting. CONCLUSIONS: Our study highlights the importance of tracking EIBF despite measurement challenges and found low coverage levels, particularly after caesarean births. Both survey-reported and register-recorded data over-estimated coverage. EIBF had a strong agreement with skin-to-skin but is not a simple tracer for other INC indicators. Other INC practices are challenging to measure in surveys, not included in registers, and are likely to require special studies or audits. Continued focus on EIBF is crucial to inform efforts to improve provider practices and increase coverage. Investment and innovation are required to improve measurement.

Chlorhexidine for facility-based umbilical cord care: EN-BIRTH multi-country validation study.

BACKGROUND: Umbilical cord hygiene prevents sepsis, a leading cause of neonatal mortality. The World Health Organization recommends 7.1% chlorhexidine digluconate (CHX) application to the umbilicus after home birth in high mortality contexts. In Bangladesh and Nepal, national policies recommend CHX use for all facility births. Population-based household surveys include optional questions on CHX use, but indicator validation studies are lacking. The Every Newborn Birth Indicators Research Tracking in Hospitals (EN-BIRTH) was an observational study assessing measurement validity for maternal and newborn indicators. This paper reports results regarding CHX. METHODS: The EN-BIRTH study (July 2017-July 2018) included three public hospitals in Bangladesh and Nepal where CHX cord application is routine. Clinical-observers collected tablet-based, time-stamped data regarding cord care during admission to labour and delivery wards as the gold standard to assess accuracy of women's report at exit survey, and of routine-register data. We calculated validity ratios and individual-level validation metrics; analysed coverage, quality and measurement gaps. We conducted qualitative interviews to assess barriers and enablers to routine register-recording. RESULTS: Umbilical cord care was observed for 12,379 live births. Observer-assessed CHX coverage was very high at 89.3-99.4% in all 3 hospitals, although slightly lower after caesarean births in Azimpur (86.8%), Bangladesh. Exit survey-reported coverage (0.4-45.9%) underestimated the observed coverage with substantial "don't know" responses (55.5-79.4%). Survey-reported validity ratios were all poor (0.01 to 0.38). Register-recorded coverage in the specific column in Bangladesh was underestimated by 0.2% in Kushtia but overestimated by 9.0% in Azimpur. Register-recorded validity ratios were good (0.9 to 1.1) in Bangladesh, and poor (0.8) in Nepal. The non-specific register column in Pokhara, Nepal substantially underestimated coverage (20.7%). CONCLUSIONS: Exit survey-report highly underestimated observed CHX coverage in all three hospitals. Routine register-recorded coverage was closer to observer-assessed coverage than survey reports in all hospitals, including for caesarean births, and was more accurately captured in hospitals with a specific register column. Inclusion of CHX cord care into registers, and tallied into health management information system platforms, is justified in countries with national policies for facility-based use, but requires implementation research to assess register design and data flow within health information systems.

Electronic data collection for multi-country, hospital-based, clinical observation of maternal and newborn care: EN-BIRTH study experiences.

BACKGROUND: Observation of care at birth is challenging with multiple, rapid and potentially concurrent events occurring for mother, newborn and placenta. Design of electronic data (E-data) collection needs to account for these challenges. The Every Newborn Birth Indicators Research Tracking in Hospitals (EN-BIRTH) was an observational study to assess measurement of indicators for priority maternal and newborn interventions and took place in five hospitals in Bangladesh, Nepal and Tanzania (July 2017-July 2018). E-data tools were required to capture individually-linked, timed observation of care, data extraction from hospital register-records or case-notes, and exit-survey data from women. METHODS: To evaluate this process for EN-BIRTH, we employed a framework organised around five steps for E-data design, data collection and implementation. Using this framework, a mixed methods evaluation synthesised evidence from study documentation, standard operating procedures, stakeholder meetings and design workshops. We undertook focus group discussions with EN-BIRTH researchers to explore experiences from the three different country teams (November-December 2019). Results were organised according to the five a priori steps. RESULTS: In accordance with the five-step framework, we found: 1) Selection of data collection approach and software: user-centred design principles were applied to meet the challenges for observation of rapid, concurrent events around the time of birth with time-stamping. 2) Design of data collection tools and programming: required extensive pilot testing of tools to be user-focused and to include in-built error messages and data quality alerts. 3) Recruitment and training of data collectors: standardised with an interactive training package including pre/post-course assessment. 4) Data collection, quality assurance, and management: real-time quality assessments with a tracking dashboard and double observation/data extraction for a 5% case subset, were incorporated as part of quality assurance. Internet-based synchronisation during data collection posed intermittent challenges. 5) Data management, cleaning and analysis: E-data collection was perceived to improve data quality and reduce time cleaning. CONCLUSIONS: The E-Data system, custom-built for EN-BIRTH, was valued by the site teams, particularly for time-stamped clinical observation of complex multiple simultaneous events at birth, without which the study objectives could not have been met. However before selection of a custom-built E-data tool, the development time, higher training and IT support needs, and connectivity challenges need to be considered against the proposed study or programme's purpose, and currently available E-data tool options.

Uterotonics for prevention of postpartum haemorrhage: EN-BIRTH multi-country validation study.

BACKGROUND: Postpartum haemorrhage (PPH) is a leading cause of preventable maternal mortality worldwide. The World Health Organization (WHO) recommends uterotonic administration for every woman after birth to prevent PPH. There are no standardised data collected in large-scale measurement platforms. The Every Newborn Birth Indicators Research Tracking in Hospitals (EN-BIRTH) is an observational study to assess the validity of measurement of maternal and newborn indicators, and this paper reports findings regarding measurement of coverage and quality for uterotonics. METHODS: The EN-BIRTH study took place in five hospitals in Bangladesh, Nepal and Tanzania, from July 2017 to July 2018. Clinical observers collected tablet-based, time-stamped data. We compared observation data for uterotonics to routine hospital register-records and women's report at exit-interview survey. We analysed the coverage and quality gap for timing and dose of administration. The register design was evaluated against gap analyses and qualitative interview data assessing the barriers and enablers to data recording and use. RESULTS: Observed uterotonic coverage was high in all five hospitals (> 99%, 95% CI 98.7-99.8%). Survey-report underestimated coverage (79.5 to 91.7%). "Don't know" replies varied (2.1 to 14.4%) and were higher after caesarean (3.7 to 59.3%). Overall, there was low accuracy in survey data for details of uterotonic administration (type and timing). Register-recorded coverage varied in four hospitals capturing uterotonics in a specific column (21.6, 64.5, 97.6, 99.4%). The average coverage measurement gap was 18.1% for register-recorded and 6.0% for survey-reported coverage. Uterotonics were given to 15.9% of women within the "right time" (1 min) and 69.8% within 3 min. Women's report of knowing the purpose of uterotonics after birth ranged from 0.4 to 64.9% between hospitals. Enabling register design and adequate staffing were reported to improve routine recording. CONCLUSIONS: Routine registers have potential to track uterotonic coverage - register data were highly accurate in two EN-BIRTH hospitals, compared to consistently underestimated coverage by survey-report. Although uterotonic coverage was high, there were gaps in observed quality for timing and dose. Standardisation of register design and implementation could improve data quality and data flow from registers into health management information reporting systems, and requires further assessment.

Antibiotic use for inpatient newborn care with suspected infection: EN-BIRTH multi-country validation study.

BACKGROUND: An estimated 30 million neonates require inpatient care annually, many with life-threatening infections. Appropriate antibiotic management is crucial, yet there is no routine measurement of coverage. The Every Newborn Birth Indicators Research Tracking in Hospitals (EN-BIRTH) study aimed to validate maternal and newborn indicators to inform measurement of coverage and quality of care. This paper reports validation of reported antibiotic coverage by exit survey of mothers for hospitalized newborns with clinically-defined infections, including sepsis, meningitis, and pneumonia. METHODS: EN-BIRTH study was conducted in five hospitals in Bangladesh, Nepal, and Tanzania (July 2017-July 2018). Neonates were included based on case definitions to focus on term/near-term, clinically-defined infection syndromes (sepsis, meningitis, and pneumonia), excluding major congenital abnormalities. Clinical management was abstracted from hospital inpatient case notes (verification) which was considered as the gold standard against which to validate accuracy of women's report. Exit surveys were conducted using questions similar to The Demographic and Health Surveys (DHS) approach for coverage of childhood pneumonia treatment. We compared survey-report to case note verified, pooled across the five sites using random effects meta-analysis. RESULTS: A total of 1015 inpatient neonates admitted in the five hospitals met inclusion criteria with clinically-defined infection syndromes. According to case note verification, 96.7% received an injectable antibiotic, although only 14.5% of them received the recommended course of at least 7 days. Among women surveyed (n = 910), 98.8% (95% CI: 97.8-99.5%) correctly reported their baby was admitted to a neonatal ward. Only 47.1% (30.1-64.5%) reported their baby's diagnosis in terms of sepsis, meningitis, or pneumonia. Around three-quarters of women reported their baby received an injection whilst in hospital, but 12.3% reported the correct antibiotic name. Only 10.6% of the babies had a blood culture and less than 1% had a lumbar puncture. CONCLUSIONS: Women's report during exit survey consistently underestimated the denominator (reporting the baby had an infection), and even more so the numerator (reporting known injectable antibiotics). Admission to the neonatal ward was accurately reported and may have potential as a contact point indicator for use in household surveys, similar to institutional births. Strengthening capacity and use of laboratory diagnostics including blood culture are essential to promote appropriate use of antibiotics. To track quality of neonatal infection management, we recommend using inpatient records to measure specifics, requiring more research on standardised inpatient records.

Survey of women's report for 33 maternal and newborn indicators: EN-BIRTH multi-country validation study.

BACKGROUND: Population-based household surveys, notably the Demographic and Health Surveys (DHS) and Multiple Indicator Cluster Surveys (MICS), remain the main source of maternal and newborn health data for many low- and middle-income countries. As part of the Every Newborn Birth Indicators Research Tracking in Hospitals (EN-BIRTH) study, this paper focuses on testing validity of measurement of maternal and newborn indicators around the time of birth (intrapartum and postnatal) in survey-report. METHODS: EN-BIRTH was an observational study testing the validity of measurement for selected maternal and newborn indicators in five secondary/tertiary hospitals in Bangladesh, Nepal and Tanzania, conducted from July 2017 to July 2018. We compared women's report at exit survey with the gold standard of direct observation or verification from clinical records for women with vaginal births. Population-level validity was assessed by validity ratios (survey-reported coverage: observer-assessed coverage). Individual-level accuracy was assessed by sensitivity, specificity and percent agreement. We tested indicators already in DHS/MICS as well as indicators with potential to be included in population-based surveys, notably the first validation for small and sick newborn care indicators. RESULTS: 33 maternal and newborn indicators were evaluated. Amongst nine indicators already present in DHS/MICS, validity ratios for baby dried or wiped, birthweight measured, low birthweight, and sex of baby (female) were between 0.90-1.10. Instrumental birth, skin-to-skin contact, and early initiation of breastfeeding were highly overestimated by survey-report (2.04-4.83) while umbilical cord care indicators were massively underestimated (0.14-0.22). Amongst 24 indicators not currently in DHS/MICS, two newborn contact indicators (kangaroo mother care 1.00, admission to neonatal unit 1.01) had high survey-reported coverage amongst admitted newborns and high sensitivity. The remaining indicators did not perform well and some had very high "don't know" responses. CONCLUSIONS: Our study revealed low validity for collecting many maternal and newborn indicators through an exit survey instrument, even with short recall periods among women with vaginal births. Household surveys are already at risk of overload, and some specific clinical care indicators do not perform well and may be under-powered. Given that approximately 80% of births worldwide occur in facilities, routine registers should also be explored to track coverage of key maternal and newborn health interventions, particularly for clinical care.

Shonjibon cash and counselling: a community-based cluster randomised controlled trial to measure the effectiveness of unconditional cash transfers and mobile behaviour change communications to reduce child undernutrition in rural Bangladesh.

BACKGROUND: Undernutrition is strongly associated with poverty - levels of undernutrition are higher in poor countries than in better-off countries. Social protection especially cash transfer is increasingly recognized as an important strategy to accelerate progress in improving maternal and child nutrition. A critical method to improve nutrition knowledge and influence feeding practices is through behaviour change communication intervention. The Shonjibon Cash and Counselling study aims to assess the effectiveness of unconditional cash transfers combined with a mobile application on nutrition counselling and direct counselling through mobile phone in reducing the prevalence of stunting in children at 18 months. METHOD: The study is a longitudinal cluster randomised controlled trial, with two parallel groups, and cluster assignment by groups of villages. The cohort of mother-child dyads will be followed-up over the intervention period of approximately 24 months, starting from recruitment to 18 months of the child's age. The study will take place in north-central Bangladesh. The primary trial outcome will be the percentage of stunted children at 18 m as measured in follow up assessments starting from birth. The secondary trial outcomes will include differences between treatment arms in (1) Mean birthweight, percentage with low birthweight and small for gestational age (2) Mean child length-for age, weight for age and weight-for-length Z scores (3) Prevalence of child wasting (4) Percentage of women exclusively breastfeeding and mean duration of exclusive breastfeeding (5) Percentage of children consuming > 4 food groups (6) Mean child intake of energy, protein, carbohydrate, fat and micronutrients (7) Percentage of women at risk of inadequate nutrient intakes in all three trimesters (8) Maternal weight gain (9) Household food security (10) Number of events for child suffering from diarrhoea, acute respiratory illness and fever (11) Average costs of mobile phone BCC and cash transfer, and benefit-cost ratio for primary and secondary outcomes. DISCUSSION: The proposed trial will provide high-level evidence of the efficacy and cost-effectiveness of mobile phone nutrition behavior change communication, combined with unconditional cash transfers in reducing child undernutrition in rural Bangladesh. TRIAL REGISTRATION: The study has been registered in the Australian New Zealand Clinical Trials Registry ( ACTRN12618001975280 ).

Labour and delivery ward register data availability, quality, and utility - Every Newborn - birth indicators research tracking in hospitals (EN-BIRTH) study baseline analysis in three countries.

BACKGROUND: Countries with the highest burden of maternal and newborn deaths and stillbirths often have little information on these deaths. Since over 81% of births worldwide now occur in facilities, using routine facility data could reduce this data gap. We assessed the availability, quality, and utility of routine labour and delivery ward register data in five hospitals in Bangladesh, Nepal, and Tanzania. This paper forms the baseline register assessment for the Every Newborn-Birth Indicators Research Tracking in Hospitals (EN-BIRTH) study. METHODS: We extracted 21 data elements from routine hospital labour ward registers, useful to calculate selected maternal and newborn health (MNH) indicators. The study sites were five public hospitals during a one-year period (2016-17). We measured 1) availability: completeness of data elements by register design, 2) data quality: implausibility, internal consistency, and heaping of birthweight and explored 3) utility by calculating selected MNH indicators using the available data. RESULTS: Data were extracted for 20,075 births. Register design was different between the five hospitals with 10-17 of the 21 selected MNH data elements available. More data were available for health outcomes than interventions. Nearly all available data elements were > 95% complete in four of the five hospitals and implausible values were rare. Data elements captured in specific columns were 85.2% highly complete compared to 25.0% captured in non-specific columns. Birthweight data were less complete for stillbirths than live births at two hospitals, and significant heaping was found in all sites, especially at 2500g and 3000g. All five hospitals recorded count data required to calculate impact indicators including; stillbirth rate, low birthweight rate, Caesarean section rate, and mortality rates. CONCLUSIONS: Data needed to calculate MNH indicators are mostly available and highly complete in EN-BIRTH study hospital routine labour ward registers in Bangladesh, Nepal and Tanzania. Register designs need to include interventions for coverage measurement. There is potential to improve data quality if Health Management Information Systems utilization with feedback loops can be strengthened. Routine health facility data could contribute to reduce the coverage and impact data gap around the time of birth.

Early initiation of breastfeeding and severe illness in the early newborn period: An observational study in rural Bangladesh.

BACKGROUND: In Bangladesh, neonatal sepsis is the cause of 24% of neonatal deaths, over 65% of which occur in the early-newborn stage (0-6 days). Only 50% of newborns in Bangladesh initiated breastfeeding within 1 hour of birth. The mechanism by which early initiation of breastfeeding reduces neonatal deaths is unclear, although the most likely pathway is by decreasing severe illnesses leading to sepsis. This study explores the effect of breastfeeding initiation time on early newborn danger signs and severe illness. METHODS AND FINDINGS: We used data from a community-based trial in Bangladesh in which we enrolled pregnant women from 2013 through 2015 covering 30,646 newborns. Severe illness was defined using newborn danger signs reported by The Young Infants Clinical Science Study Group. We categorized the timing of initiation as within 1 hour, 1 to 24 hours, 24 to 48 hours, ≥48 hours of birth, and never breastfed. The analysis includes descriptive statistics, risk attribution, and multivariable mixed-effects logistic regression while adjusting for the clustering effects of the trial design, and maternal/infant characteristics. In total, 29,873 live births had information on breastfeeding among whom 19,914 (66.7%) initiated within 1 hour of birth, and 4,437 (14.8%) neonates had a severe illness by the seventh day after birth. The mean time to initiation was 3.8 hours (SD 16.6 hours). The proportion of children with severe illness increased as the delay in initiation increased from 1 hour (12.0%), 24 hours (15.7%), 48 hours (27.7%), and more than 48 hours (36.7%) after birth. These observations would correspond to a possible reduction by 15.9% (95% CI 13.2-25.9, p < 0.001) of severe illness in a real world population in which all newborns had breastfeeding initiated within 1 hour of birth. Children who initiated after 48 hours (odds ratio [OR] 4.13, 95% CI 3.48-4.89, p < 0.001) and children who never initiated (OR 4.77, 95% CI 3.52-6.47, p < 0.001) had the highest odds of having severe illness. The main limitation of this study is the potential for misclassification because of using mothers' report of newborn danger signs. There could be a potential for recall bias for mothers of newborns who died after being born alive. CONCLUSIONS: Breastfeeding initiation within the first hour of birth is significantly associated with severe illness in the early newborn period. Interventions to promote early breastfeeding initiation should be tailored for populations in which newborns are delivered at home by unskilled attendants, the rate of low birth weight (LBW) is high, and postnatal care is limited. TRIAL REGISTRATION: Trial Registration number: anzctr.org.au ID ACTRN12612000588897.

Opting for home birth in rural Bangladesh: An assessment of the current status and reasons.

BACKGROUND: In Bangladesh, over half of women give birth at home, generally without the support of a skilled birth attendant. In this article, we examined the decision-making around birthplace and explored the reported reasons of preferring home birth over facility birth in a rural district of Bangladesh. METHODS: A cross-sectional household survey with 1367 women was conducted in Brahmanbaria district. Choice of birthplace and actual place of birth were the main outcomes of interest. Associations between the outcomes of interest and background characteristics were analyzed through binary logistic regression. Effects of the covariates and confounders were adjusted through multiple logistic regression. RESULTS: Sixty-four percent of women planned to give birth at home, and 62% gave birth at home. Planning to give birth at home was significantly associated with eventually giving birth at home (AOR [CI]: 4.93 [3.79-6.43]). Multiparous women and women from larger households were significantly more likely to give birth at home, whereas more educated and wealthier women and those attending antenatal care were significantly less likely to give birth at home. The main reported reasons for home birth were perceived lack of importance of facility birth, financial reasons, fear of cesarean section, and not being permitted by a husband of other family member to seek facility birth. CONCLUSIONS: Home is the preferred birthplace and main actual place of birth in rural Bangladesh. The maternal health program of Bangladesh should look critically at the preferences of women and reasons for those preferences for further promotion of skilled attendance at birth in rural settings.

Study protocol of a 4- parallel arm, superiority, community based cluster randomized controlled trial comparing paper and e-platform based interventions to improve accuracy of recall of last menstrual period (LMP) dates in rural Bangladesh.

BACKGROUND: Gestational age (GA) is a key determinant of newborn survival and long-term impairment. Accurate estimation of GA facilitates timely provision of essential interventions to improve maternal and newborn outcomes. Menstrual based dating, ultrasound based dating, and neonatal estimates are the primarily used methods for assessing GA; all of which have some strength and weaknesses that require critical consideration. Last menstrual period (LMP) is simple, low-cost self-reported information, recommended by the World Health Organization for estimating GA but has issues of recall mainly among poorer, less educated women and women with irregular menstruation, undiagnosed abortion, and spotting during early pregnancy. Several studies have noted that about 20-50% of women cannot accurately recall the date of LMP. The goal of this study is therefore to improve recall and reporting of LMP and by doing so increase the accuracy of LMP based GA assessment in a rural population of Bangladesh where antenatal care-seeking, availability and utilization of USG is low. METHOD: We propose to conduct a 4- parallel arm, superiority, community based cluster randomized controlled trial comparing three interventions to improve recall of GA with a no intervention arm. The interventions include (i) counselling and a paper based calendar (ii) counselling and a cell phone based SMS alert system (iii) counselling and smart-phone application. The trial is being conducted among 3360 adolescent girls and recently married women in Mirzapur sub-district of Bangladesh. DISCUSSION: Enrolment of study participants continued from January 24, 2017 to March 29, 2017. Data collection and intervention implementation is ongoing and will end by February, 2019. Data analysis will measure efficacy of interventions in improving the recall of LMP date among enrolled participants. Results will be reported following CONSORT guideline. The innovative conventional & e-platform based interventions, if successful, can provide substantial evidence to scale-up in a low resource setting where m-Health initiatives are proliferating with active support from all sectors in policy and implementation. TRIAL REGISTRATION: ClinicalTrials.gov NCT02944747 . The trial has been registered before starting enrolment on 24 October 2016.

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.

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 .

A community-based cluster randomised controlled trial in rural Bangladesh to evaluate the impact of the use of iron-folic acid supplements early in pregnancy on the risk of neonatal mortality: the Shonjibon trial.

BACKGROUND: Iron-deficiency is the most common nutritional deficiency globally. Due to the high iron requirements for pregnancy, it is highly prevalent and severe in pregnant women. There is strong evidence that maternal iron deficiency anaemia increases the risk of adverse perinatal outcomes. However, most of the evidence is from observational epidemiological studies except for a very few randomised controlled trials. IFA supplements have also been found to reduce the preterm delivery rate and neonatal mortality attributable to prematurity and birth asphyxia. These results combined indicate that IFA supplements in populations of iron-deficient pregnant women could lead to a decrease in the number of neonatal deaths mediated by reduced rates of preterm delivery. In this paper, we describe the protocol of a community-based cluster randomised controlled trial that aims to evaluate the impact of maternal antenatal IFA supplements on perinatal outcomes. METHODS/DESIGN: The effect of the early use of iron-folic acid supplements on neonatal mortality will be examined using a community based, cluster randomised controlled trial in five districts with 30,000 live births. In intervention clusters trained BRAC village volunteers will identify pregnant women & provide iron-folic acid supplements. Groundwater iron levels will be measured in all study households using a validated test kit. The analysis will follow the intention to treat principle. We will compare neonatal mortality rates & their 95% confidence intervals adjusted for clustering between treatment groups in each groundwater iron-level group. Cox proportional hazards mixed models will be used for mortality outcomes & will include groundwater iron level as an interaction term in the mortality model. DISCUSSION: This paper aims to describe the study protocol of a community based randomised controlled trial evaluating the impact of the use of iron-folic acid supplements early in pregnancy on the risk of neonatal mortality. This study is critical because it will determine if antenatal IFA supplements commenced in the first trimester of pregnancy, rather than later, will significantly reduce neonatal deaths in the first month of life, and if this approach is cost-effective. TRIAL REGISTRATION: This trial has been registered with the Australian New Zealand Clinical Trials Registry (ANZCTR) on 31 May 2012. The registration ID is ACTRN12612000588897 .

Women's participation in household decision-making: Qualitative findings from the Shonjibon Trial in rural Bangladesh.

A key element of women's empowerment is the ability to participate in household decision-making. This study presents the qualitative results from the Shonjibon Cash and Counselling Trial baseline process evaluation with the aim of exploring the status of women's decision-making at the trial's outset and to facilitate the exploration of any changes in women's empowerment over the course of the trial. Between January and March 2021, we conducted forty-one in-depth interviews with pregnant women in rural Bangladesh. The research team translated, transcribed, coded, and discussed the interviews. We used thematic analysis to examine women's experience and perceptions on household decision-making. The key findings that emerged; women jointly participated in financial decision-making with their husbands; men made the final decision regarding seeking healthcare, and women solely made choices regarding infant and young child feeding. Our findings revealed that women felt that they needed to discuss their plans to go outside the house with their husbands, many perceived a lack of importance in the community towards women's participation in decision-making. This study documents current contextual information on the status of women's involvement in household decision-making and intrahousehold power dynamics at the start of the Shonjibon Cash and Counselling Trial.

Effect of an integrated maternal and neonatal health intervention on maternal healthcare utilisation addressing inequity in Rural Bangladesh.

BACKGROUND: Although Bangladesh has made significant improvements in maternal, neonatal, and child health, the disparity between rich and poor remains a matter of concern. OBJECTIVE: The study aimed to increase coverage of skilled maternal healthcare services while minimising the inequity gap among mothers in different socioeconomic groups. METHODS: We implemented an integrated maternal and neonatal health (MNH) intervention between 2009 and 2012, in Shahjadpur sub-district of Sirajganj district, Bangladesh. The study was quasi-experimental in design for the evaluation. Socioeconomic status was derived from household assets using principal component analysis. Inequity in maternal healthcare utilisation was calculated using rich-poor ratio and concentration index to determine the changes in inequity between the baseline and the endline time period. RESULT: The baseline and endline surveys included 3,158 (mean age 23.5 years) and 3,540 (mean age 24.3 years) recently delivered mothers respectively. Reduction in the rich-poor ratio was observed in the utilisation of skilled 4+ antenatal care (ANC) (2.4:1 to 1.1:1) and related concentration index decreased from 0.220 to 0.013 (p < 0.001). The rich-poor ratio for skilled childbirth reduced from 1.7:1 to 1.0:1 and the related concentration index declined from 0.161 to -0.021 (p < 0.001). A similar reduction was also observed in the utilisation of skilled postnatal care (PNC); where the rich-poor gap decreased from 2.5:1 to 1.0:1 and the related concentration index declined from 0.197 to -0.004 (p < 0.001). CONCLUSION: The MNH intervention was successful in reducing inequity in receiving skilled 4+ ANC, delivery, and PNC in rural Bangladesh.

Levels and determinants of quality antenatal care in Bangladesh: Evidence from the Bangladesh Demographic and Health Survey.

BACKGROUND: Assessing the quality of antenatal care (ANC) is imperative for improving care provisions during pregnancy to ensure the health of mother and baby. In Bangladesh, there is a dearth of research on ANC quality using nationally representative data to understand its levels and determinants. Thus, the current study aimed to assess ANC quality and identify the sociodemographic factors associated with the usage of quality ANC services in Bangladesh. METHODS: Secondary data analysis was conducted using the last two Bangladesh Demographic and Health Surveys (BDHSs) from 2014 and 2017-18. A total of 8,277 ever-married women were included in the analysis (3,631 from 2014 and 4,646 from 2017-18). The quality ANC index was constructed using a principal component analysis on the following ANC components: weight and blood pressure measurements, blood and urine test results, counselling about pregnancy complications and completion of a minimum of four ANC visits, one of which was performed by a medically trained provider. Multinomial logistic regression was used to determine the strength of the association. RESULTS: The percentage of mothers who received all components of quality ANC increased from about 13% in 2014 to 18% in 2017-18 (p < 0.001). Women from the poorest group, those in rural areas, with no education, a high birth order and no media exposure were less likely to receive high-quality ANC than those from the richest group, those from urban areas, with a higher level of education, a low birth order and media exposure, respectively. CONCLUSION: Although the quality of ANC improved from 2014 to 2017-18, it remains poor in Bangladesh. Therefore, there is a need to develop targeted interventions for different socio-demographic groups to improve the overall quality of ANC. Future interventions should address both the demand and supply-side perspectives.

Maternal mortality in Bangladesh: Who, when, why, and where? A national survey-based analysis.

Background: Despite a notable decline in recent decades, maternal mortality in Bangladesh remains high. A thorough understanding of causes of maternal deaths is essential for effective policy and programme planning. Here we report the current level and major causes of maternal deaths in Bangladesh, focusing on care-seeking practices, timing, and place of deaths. Methods: We analysed data from the 2016 Bangladesh Maternal Mortality and Health Care Survey (BMMS), conducted with nationally representative sample of 298 284 households. We adapted the World Health Organization's 2014 verbal autopsy (VA) questionnaire. Trained physicians reviewed the responses and assigned the cause of death based on the International Classification of Diseases (ICD-10). We included 175 maternal deaths in our analysis. Results: The maternal mortality ratio was 196 (uncertainty range = 159-234) per 100 000 live births. Thirty-eight per cent of maternal deaths occurred on the day of delivery and 6% on one day post-delivery. Nineteen per cent of the maternal deaths occurred at home, another 19% in-transit, almost half (49%) in a public facility, and 13% in a private hospital. Haemorrhage contributed to 31% and eclampsia to 23% of the maternal deaths. Twenty-one per cent of the maternal deaths occurred due to indirect causes. Ninety-two per cent sought care before dying, of which 7% sought care from home. Thirty-three per cent of women who died due to maternal causes sought care from three or more different places, indicating they were substantially shuttled between facilities. Eighty per cent of the deceased women who delivered in a public facility also died in a public facility. Conclusions: Two major causes accounted for around half of all maternal deaths, and almost half occurred during childbirth and by two days of birth. Interventions to address these two causes should be prioritised to improve the provision and experience of care during childbirth. Significant investments are required for facilitating emergency transportation and ensuring accountability in the overall referral practices.

Costs of services and funding gap of the Bangladesh National Tuberculosis Control Programme 2016-2022: An ingredient based approach.

BACKGROUND: Bangladesh National Tuberculosis (TB) Control Programme (NTP) has deployed improved diagnostic technologies which may drive up the programme costs. We aimed to estimate the supply-side costs associated with the delivery of the NTP and the funding gap between the cost of implementation and available funding for the Bangladesh NTP. METHODS: An ingredient-based costing approach was applied using WHO's OneHealth Tool software. We considered 2016, as the base year and projected cost estimates up to 2022 using information on NTP planned activities. Data were collected through consultative meetings with experts and officials/managers, review of documents and databases, and visits to five purposively selected TB healthcare facilities. The estimated costs were compared with the funds allocated to the NTP between 2018 and 2022 to estimate the funding gap. FINDINGS: The estimated total cost of NTP was US$ 49.22 million in 2016, which would increase to US$ 146.93 million in 2022. Human resources (41.1%) and medicines and investigations/ supplies (38.0%) were the major two cost components. Unit costs were highest for treating extensively drug-resistant TB at US$ 7,422.4 in 2016. Between 2018-2022, NTP would incur US$ 536.8 million, which is US$ 235.18 million higher than the current allocation for NTP. CONCLUSION: Our results indicated a funding gap associated with the NTP in each of the years between 2018-2022. Policy planners should advocate for additional funding to ensure smooth delivery of TB services in the upcoming years. The cost estimates of TB services can also be used for planning and budgeting for delivering TB services in similar country contexts.

Haemorrhage-related maternal mortality in Bangladesh: Levels, trends, time of death, and care-seeking practices based on nationally representative population-based surveys.

Background: Haemorrhage is a major cause of maternal deaths globally, most of which are preventable and predominantly happen in low and middle-income countries, including Bangladesh. We examine the current levels, trends, time of death, and care-seeking practices for haemorrhage-related maternal deaths in Bangladesh. Methods: We conducted a secondary analysis with data from the nationally representative 2001, 2010, and 2016 Bangladesh Maternal Mortality Surveys (BMMS). The cause of death information was collected through verbal autopsy (VA) interviews using a country-adapted version of the standard World Health Organization VA questionnaire. Trained physicians reviewed the VA questionnaire and assigned the cause of death using the International Classification of Diseases (ICD) codes. Results: Haemorrhage accounted for 31% (95% confidence interval (CI) = 24-38) of all maternal deaths in 2016 BMMS, which was 31% (95% CI = 25-41) in 2010 BMMS and 29% (95% CI = 23-36) in 2001 BMMS. The haemorrhage-specific mortality rate remained unchanged between 2010 BMMS (60 per 100 000 live births, uncertainty range (UR) = 37-82) and 2016 BMMS (53 per 100 000 live births, UR = 36-71). Around 70% of haemorrhage-related maternal deaths took place within 24 hours of delivery. Of those who died, 24% did not seek health care outside the home and 15% sought care from more than three places. Approximately two-thirds of the mothers who died due to haemorrhage gave birth at home. Conclusions: Postpartum haemorrhage remains the primary cause of maternal mortality in Bangladesh. To reduce these preventable deaths, the Government of Bangladesh and stakeholders should take steps to ensure community awareness about care-seeking during delivery.