Estimating maternity ward birth attendant time use in India: a microcosting study.

OBJECTIVES: Despite global concern over the quality of maternal care, little is known about the time requirements to complete the essential birth practices. Using three microcosting data collection methods within the BetterBirth trial, we aimed to assess time use and the specific time requirements to incorporate the WHO Safe Childbirth Checklist into clinical practice. SETTING: We collected detailed survey data on birth attendant time use within the BetterBirth trial in Uttar Pradesh, India. The BetterBirth trial tested whether the peer-coaching-based implementation of the WHO Checklist was effective in improving the quality of facility-based childbirth care. PARTICIPANTS: We collected measurements of time to completion for 18 essential birth practices from July 2016 through October 2016 across 10 facilities in five districts (1559 total timed observations). An anonymous survey asked about the impact of the WHO Checklist on birth attendants at every intervention facility (15 facilities, 83 respondents) in the Lucknow hub. Additionally, data collectors visited facilities to conduct a census of patients and birth attendants across 20 facilities in seven districts between June 2016 and November 2016 (six hundred and ten 2-hour facility observations). PRIMARY AND SECONDARY OUTCOME MEASURES: The primary outcome measure of this study is the per cent of staff time required to complete the essential birth practices included in the WHO Checklist. RESULTS: When birth attendants were timed, we found practices were completed rapidly (18 s to 2 min). As the patient load increased, time dedicated to clinical care increased but remained low relative to administrative and downtime. On average, WHO Checklist clinical care accounted for less than 7% of birth attendant time use per hour. CONCLUSIONS: We did not find that a coaching-based implementation of the WHO Checklist was a burden on birth attendant's time use. However, questions remain regarding the performance quality of practices and how to accurately capture and interpret idle and break time. TRIAL REGISTRATION NUMBER: NCT02148952.

Mixed-methods, descriptive and observational cohort study examining feeding and growth patterns among low birthweight infants in India, Malawi and Tanzania: the LIFE study protocol.

INTRODUCTION: Ending preventable deaths of newborns and children under 5 will not be possible without evidence-based strategies addressing the health and care of low birthweight (LBW, <2.5 kg) infants. The majority of LBW infants are born in low- and middle-income countries (LMICs) and account for more than 60%-80% of newborn deaths. Feeding promotion tailored to meet the nutritional needs of LBW infants in LMICs may serve a crucial role in curbing newborn mortality rates and promoting growth. The Low Birthweight Infant Feeding Exploration (LIFE) study aims to establish foundational knowledge regarding optimal feeding options for LBW infants in low-resource settings throughout infancy. METHODS AND ANALYSIS: LIFE is a formative, multisite, observational cohort study involving 12 study facilities in India, Malawi and Tanzania, and using a convergent parallel, mixed-methods design. We assess feeding patterns, growth indicators, morbidity, mortality, child development and health system inputs that facilitate or hinder care and survival of LBW infants. ETHICS AND DISSEMINATION: This study was approved by 11 ethics committees in India, Malawi, Tanzania and the USA. The results will be disseminated through peer-reviewed publications and presentations targeting the global and local research, clinical, programme implementation and policy communities. TRIAL REGISTRATION NUMBERS: NCT04002908 and CTRI/2019/02/017475.

The effect of milk type and fortification on the growth of low-birthweight infants: An umbrella review of systematic reviews and meta-analyses.

Approximately 15% of infants worldwide are born with low birthweight (<2500 g). These children are at risk for growth failure. The aim of this umbrella review is to assess the relationship between infant milk type, fortification and growth in low-birthweight infants, with particular focus on low- and lower middle-income countries. We conducted a systematic review in PubMed, CINAHL, Embase and Web of Science comparing infant milk options and growth, grading the strength of evidence based on standard umbrella review criteria. Twenty-six systematic reviews qualified for inclusion. They predominantly focused on infants with very low birthweight (<1500 g) in high-income countries. We found the strongest evidence for (1) the addition of energy and protein fortification to human milk (donor or mother's milk) leading to increased weight gain (mean difference [MD] 1.81 g/kg/day; 95% confidence interval [CI] 1.23, 2.40), linear growth (MD 0.18 cm/week; 95% CI 0.10, 0.26) and head growth (MD 0.08 cm/week; 95% CI 0.04, 0.12) and (2) formula compared with donor human milk leading to increased weight gain (MD 2.51 g/kg/day; 95% CI 1.93, 3.08), linear growth (MD 1.21 mm/week; 95% CI 0.77, 1.65) and head growth (MD 0.85 mm/week; 95% CI 0.47, 1.23). We also found evidence of improved growth when protein is added to both human milk and formula. Fat supplementation did not seem to affect growth. More research is needed for infants with birthweight 1500-2500 g in low- and lower middle-income countries.

Does adherence to evidence-based practices during childbirth prevent perinatal mortality? A post-hoc analysis of 3,274 births in Uttar Pradesh, India.

BACKGROUND: Evidence-based practices that reduce childbirth-related morbidity and mortality are core processes to quality of care. In the BetterBirth trial, a matched-pair, cluster-randomised controlled trial of a coaching-based implementation of the WHO Safe Childbirth Checklist (SCC) in Uttar Pradesh, India, we observed a significant increase in adherence to practices, but no reduction in perinatal mortality. METHODS: Within the BetterBirth trial, we observed birth attendants in a subset of study sites providing care to labouring women to assess the adherence to individual and groups of practices. We observed care from admission to the facility until 1 hour post partum. We followed observed women/newborns for 7-day perinatal health outcomes. Using this observational data, we conducted a post-hoc, exploratory analysis to understand the relationship of birth attendants' practice adherence to perinatal mortality. FINDINGS: Across 30 primary health facilities, we observed 3274 deliveries and obtained 7-day health outcomes. Adherence to individual practices, containing supply preparation and direct provider care, varied widely (0·51 to 99·78%). We recorded 166 perinatal deaths (50·71 per 1000 births), including 56 (17·1 per 1000) stillbirths. Each additional practice performed was significantly associated with reduced odds of perinatal (OR: 0·82, 95% CI: 0·72, 0·93) and early neonatal mortality (OR: 0·78, 95% CI: 0·71, 0·85). Each additional practice as part of direct provider care was associated strongly with reduced odds of perinatal (OR: 0·73, 95% CI: 0·62, 0·86) and early neonatal mortality (OR: 0·67, 95% CI: 0·56, 0·80). No individual practice or single supply preparation was associated with perinatal mortality. INTERPRETATION: Adherence to practices on the WHO SCC is associated with reduced mortality, indicating that adherence is a valid indicator of higher quality of care. However, the causal relationships between practices and outcomes are complex. FUNDING: Bill & Melinda Gates Foundation. TRIAL REGISTRATION DETAILS: ClinicalTrials.gov: NCT02148952; Universal Trial Number: U1111-1131-5647.

Who's your coach? The relationship between coach characteristics and birth attendants' adherence to the WHO Safe Childbirth Checklist.

Background: Research demonstrates that coaching is an effective method for promoting behavior change, yet little is known about which attributes of a coach make them more or less effective. This post hoc, sub-analysis of the BetterBirth trial used observational data to explore whether specific coaches' and team leaders' characteristics were associated with improved adherence to essential birth practices listed on the World Health Organization Safe Childbirth Checklist. Methods: A descriptive analysis was conducted on the coach characteristics from the 50 BetterBirth coaches and team leaders. Data on adherence to essential birth practices by birth attendants who received coaching were collected by independent observers. Bivariate linear regression models were constructed, accounting for clustering by site, to examine the association between coach characteristics and attendants' adherence to practices.  Results: All of the coaches were female and the majority were nurses. Team leaders were comprised of both males and females; half had clinical backgrounds. There was no association between coaches' or team leaders' characteristics, namely gender, type of degree, or years of clinical training, and attendants' adherence to essential birth practices. However, a significant inverse relationship was detected between the coach or team leader's age and years of experience and the birth attendants' adherence to the checklist.  Conclusion: Younger, less experienced coaches were more successful in promoting essential birth practices adherence in this population. More data is needed to fully understand the relationship between coaches and birth attendants.

Just-in-time postnatal education programees to improve newborn care practices: needs and opportunities in low-resource settings.

Worldwide, many newborns die in the first month of life, with most deaths happening in low/middle-income countries (LMICs). Families' use of evidence-based newborn care practices in the home and timely care-seeking for illness can save newborn lives. Postnatal education is an important investment to improve families' use of evidence-based newborn care practices, yet there are gaps in the literature on postnatal education programees that have been evaluated to date. Recent findings from a 13 000+ person survey in 3 states in India show opportunities for improvement in postnatal education for mothers and families and their use of newborn care practices in the home. Our survey data and the literature suggest the need to incorporate the following strategies into future postnatal education programming: implement structured predischarge education with postdischarge reinforcement, using a multipronged teaching approach to reach whole families with education on multiple newborn care practices. Researchers need to conduct robust evaluation on postnatal education models incorporating these programee elements in the LMIC context, as well as explore whether this type of education model can work for other health areas that are critical for families to survive and thrive.

Unpacking the null: a post-hoc analysis of a cluster-randomised controlled trial of the WHO Safe Childbirth Checklist in Uttar Pradesh, India (BetterBirth).

BACKGROUND: A coaching-based implementation of the WHO Safe Childbirth Checklist in Uttar Pradesh, India, improved adherence to evidence-based practices, but did not reduce perinatal mortality, maternal morbidity, or maternal mortality. We examined facility-level correlates of the outcomes, which varied widely across the 120 study facilities. METHODS: We did a post-hoc analysis of the coaching-based implementation of the WHO Safe Childbirth Checklist in Uttar Pradesh. We used multivariable modelling to identify correlations between 30 facility-level characteristics and each health outcome (perinatal mortality, maternal morbidity, or maternal mortality). To identify contexts in which the intervention might have had an effect, we then ran the models on data restricted to the period of intensive coaching and among patients not referred out of the facilities. FINDINGS: In the multivariable context, perinatal mortality was associated with only 3 of the 30 variables: female literacy at the district level, geographical location, and previous neonatal mortality. Maternal morbidity was only associated with geographical location. No facility-level predictors were associated with maternal mortality. Among facilities in the lowest tertile of birth volume (<95 births per month), our models estimated perinatal mortality was 17 (95% CI 11·7-24·8) per 1000 births in the intervention group versus 38 (31·6-44·8) per 1000 in the control group (p<0·0001). INTERPRETATION: Mortality was not directly associated with measured facility-level indicators but was associated with general risk factors. The absence of correlation between expected predictors and patient outcomes and the association between improved outcomes and the intervention in smaller facilities suggest a need for additional measures of quality of care that take into account complexity. FUNDING: Bill & Melinda Gates Foundation.

Outcomes of a Coaching-Based WHO Safe Childbirth Checklist Program in India.

BACKGROUND: The prevalence of facility-based childbirth in low-resource settings has increased dramatically during the past two decades, yet gaps in the quality of care persist and mortality remains high. The World Health Organization (WHO) Safe Childbirth Checklist, a quality-improvement tool, promotes systematic adherence to practices that have been associated with improved childbirth outcomes. METHODS: We conducted a matched-pair, cluster-randomized, controlled trial in 60 pairs of facilities across 24 districts of Uttar Pradesh, India, testing the effect of the BetterBirth program, an 8-month coaching-based implementation of the Safe Childbirth Checklist, on a composite outcome of perinatal death, maternal death, or maternal severe complications within 7 days after delivery. Outcomes - assessed 8 to 42 days after delivery - were compared between the intervention group and the control group with adjustment for clustering and matching. We also compared birth attendants' adherence to 18 essential birth practices in 15 matched pairs of facilities at 2 and 12 months after the initiation of the intervention. RESULTS: Of 161,107 eligible women, we enrolled 157,689 (97.9%) and determined 7-day outcomes for 157,145 (99.7%) mother-newborn dyads. Among 4888 observed births, birth attendants' mean practice adherence was significantly higher in the intervention group than in the control group (72.8% vs. 41.7% at 2 months; 61.7% vs. 43.9% at 12 months; P<0.001 for both comparisons). However, there was no significant difference between the trial groups either in the composite primary outcome (15.1% in the intervention group and 15.3% in the control group; relative risk, 0.99; 95% confidence interval, 0.83 to 1.18; P=0.90) or in secondary maternal or perinatal adverse outcomes. CONCLUSIONS: Birth attendants' adherence to essential birth practices was higher in facilities that used the coaching-based WHO Safe Childbirth Checklist program than in those that did not, but maternal and perinatal mortality and maternal morbidity did not differ significantly between the two groups. (Funded by the Bill and Melinda Gates Foundation; Clinical Trials number, NCT02148952 .).

Improving Adherence to Essential Birth Practices Using the WHO Safe Childbirth Checklist With Peer Coaching: Experience From 60 Public Health Facilities in Uttar Pradesh, India.

BACKGROUND: Adherence to evidence-based essential birth practices is critical for improving health outcomes for mothers and newborns. The WHO Safe Childbirth Checklist (SCC) incorporates these practices, which occur during 4 critical pause points: on admission, before pushing (or cesarean delivery), soon after birth, and before discharge. A peer-coaching strategy to support consistent use of the SCC may be an effective approach to increase birth attendants' adherence to these practices. METHODS: We assessed data from 60 public health facilities in Uttar Pradesh, India, that received an 8-month staggered coaching intervention from December 2014 to September 2016 as part of the BetterBirth Trial, which is studying effectiveness of an SCC-centered intervention on maternal and neonatal harm. Nurse coaches recorded birth attendants' adherence to 39 essential birth practices. Practice adherence was calculated for each intervention month. After 2 months of coaching, a subsample of 15 facilities was selected for independent observation when the coach was not present. We compared adherence to the 18 practices recorded by both coaches and independent observers. RESULTS: Coaches observed birth attendants' behavior during 5,971 deliveries. By the final month of the intervention, 35 of 39 essential birth practices had achieved >90% adherence in the presence of a coach, compared with only 7 of 39 practices during the first month. Key behaviors with the greatest improvement included explanation of danger signs, temperature measurement, assessment of fetal heart sounds, initiation of skin-to-skin contact, and breastfeeding. Without a coach present, birth attendants' average adherence to practices and checklist use was 24 percentage points lower than when a coach was present (range: -1% to 62%). CONCLUSION: Implementation of the WHO Safe Childbirth Checklist with coaching improved uptake of and adherence to essential birth practices. Coordination and communication among facility staff, as well as behaviors with an immediate, tangible benefit, showed the greatest improvement. Difficult-to-perform behaviors and those with delayed or theoretical benefits were less likely to be sustained without a coach present. Coaching may be an important component in implementing the Safe Childbirth Checklist at scale.Note: At the time of publication of this article, the results of evaluation of the impact of the BetterBirth intervention were pending publication in another journal. After the impact findings have been published, we will update this article on the effect of the intervention on birth practices with a reference to the impact findings.