Dataset Information

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

ABSTRACT:

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.

SUBMITTER: Marx Delaney M

PROVIDER: S-EPMC6639352 | biostudies-literature |

REPOSITORIES: biostudies-literature

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Project description:Shifting childbirth into facilities has not improved health outcomes for mothers and newborns as significantly as hoped. Improving the quality and safety of care provided during facility-based childbirth requires helping providers to adhere to essential birth practices-evidence-based behaviors that reduce harm to and save lives of mothers and newborns. To achieve this goal, we developed the BetterBirth Program, which we tested in a matched-pair, cluster-randomized controlled trial in Uttar Pradesh, India. The goal of this intervention was to improve adoption and sustained use of the World Health Organization Safe Childbirth Checklist (SCC), an organized collection of 28 essential birth practices that are known to improve the quality of facility-based childbirth care. Here, we describe the BetterBirth Program in detail, including its 4 main features: implementation tools, an implementation strategy of coaching, an implementation pathway (Engage-Launch-Support), and a sustainability plan. This coaching-based implementation of the SCC motivates and empowers care providers to identify, understand, and resolve the barriers they face in using the SCC with the resources already available. We describe important lessons learned from our experience with the BetterBirth Program as it was tested in the BetterBirth Trial. For example, the emphasis on relationship building and respect led to trust between coaches and birth attendants and helped influence change. In addition, the cloud-based data collection and feedback system proved a valuable asset in the coaching process. More research on coaching-based interventions is required to refine our understanding of what works best to improve quality and safety of care in various settings.Note: At the time of publication of this article, the results of evaluation of the impact of the BetterBirth Program were pending publication in another journal. After the impact findings have been published, we will update this article with a reference to the impact findings.

Project description:ObjectiveEvaluate the impact of a World Health Organization Safe Childbirth Checklist coaching-based intervention (BetterBirth Program) on availability and procurement of essential childbirth-related supplies.DesignMatched pair, cluster-randomized controlled trial.SettingUttar Pradesh, India.Participants120 government-sector health facilities (60 interventions, 60 controls). Supply-availability surveys were conducted quarterly in all sites. Coaches collected supply procurement sources from intervention sites.InterventionsCoaching targeting implementation of Checklist with data feedback and action planning.Main outcome measuresMean supply availability by study arm; change in procurement sources for intervention sites.ResultsAt baseline, 6 and 12 months, the intervention sites had a mean of 20.9 (95% confidence interval (CI): 20.2-21.5); 22.4 (95% CI: 21.8-22.9) and 22.1 (95% CI:21.4-22.8) items, respectively. Control sites had 20.8 (95% CI: 20.3-21.3); 20.9 (95% CI: 20.3-21.5) and 21.7 (95% CI: 20.8-22.6) items at the same time-points. There was a small but statistically significant higher availability in intervention sites at 6 months (difference-in-difference (DID) = 1.43, P < 0.001), which was not seen by 12 months (DID = 0.37, P = 0.53). Greater difference between intervention and control sites starting in the bottom quartile of supply availability was seen at 6 months (DID = 4.0, P = 0.0002), with no significant difference by 12 months (DID = 1.5, P = 0.154). No change was seen in procurement sources with ~5% procured by patients with some rates as high as 29% (oxytocin).ConclusionsImplementation of the BetterBirth Program, incorporating supply availability, resulted in modest improvements with catch-up by control facilities by 12 months. Supply-chain coaching may be most beneficial in sites starting with lower supply availability. Efforts are needed to reduce reliance on patient-funding for some critical medications.Trial registrationClinicalTrials.gov #NCT02148952; Universal Trial Number: U1111-1131-5647.

Project description: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.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.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%).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.

Project description:BACKGROUND:Coaching can improve the quality of care in primary-level birth facilities and promote birth attendant adherence to essential birth practices (EBPs) that reduce maternal and perinatal mortality. The intensity of coaching needed to promote and sustain behavior change is unknown. We investigated the relationship between coaching intensity, EBP adherence, and maternal and perinatal health outcomes using data from the BetterBirth Trial, which assessed the impact of a complex, coaching-based implementation of the World Health Organization's Safe Childbirth Checklist in Uttar Pradesh, India. METHODS:For each birth, we defined multiple coaching intensity metrics, including coaching frequency (coaching visits per month), cumulative coaching (total coaching visits accrued during the intervention), and scheduling adherence (coaching delivered as scheduled). We considered coaching delivered at both facility and birth attendant levels. We assessed the association between coaching intensity and birth attendant adherence to 18 EBPs and with maternal and perinatal health outcomes using regression models. RESULTS:Coaching frequency was associated with modestly increased EBP adherence. Delivering 6 coaching visits per month to facilities was associated with adherence to 1.3 additional EBPs (95% confidence interval [CI]=0.6, 1.9). High-frequency coaching delivered with high coverage among birth attendants was associated with greater improvements: providing 70% of birth attendants at a facility with at least 1 visit per month was associated with adherence to 2.0 additional EBPs (95% CI=1.0, 2.9). Neither cumulative coaching nor scheduling adherence was associated with EBP adherence. Coaching was generally not associated with health outcomes, possibly due to the small magnitude of association between coaching and EBP adherence. CONCLUSIONS:Frequent coaching may promote behavior change, especially if delivered with high coverage among birth attendants. However, the effects of coaching were modest and did not persist over time, suggesting that future coaching-based interventions should explore providing frequent coaching for longer periods.

Project description:Effective, scalable strategies to improve maternal, fetal, and newborn health and reduce preventable morbidity and mortality are urgently needed in low- and middle-income countries. Building on the successes of previous checklist-based programs, the World Health Organization (WHO) and partners led the development of the Safe Childbirth Checklist (SCC), a 28-item list of evidence-based practices linked with improved maternal and newborn outcomes. Pilot-testing of the Checklist in Southern India demonstrated dramatic improvements in adherence by health workers to essential childbirth-related practices (EBPs). The BetterBirth Trial seeks to measure the effectiveness of SCC impact on EBPs, deaths, and complications at a larger scale.This matched-pair, cluster-randomized controlled, adaptive trial will be conducted in 120 facilities across 24 districts in Uttar Pradesh, India. Study sites, identified according to predefined eligibility criteria, were matched by measured covariates before randomization. The intervention, the SCC embedded in a quality improvement program, consists of leadership engagement, a 2-day educational launch of the SCC, and support through placement of a trained peer "coach" to provide supportive supervision and real-time data feedback over an 8-month period with decreasing intensity. A facility-based childbirth quality coordinator is trained and supported to drive sustained behavior change after the BetterBirth team leaves the facility. Study participants are birth attendants and women and their newborns who present to the study facilities for childbirth at 60 intervention and 60 control sites. The primary outcome is a composite measure including maternal death, maternal severe morbidity, stillbirth, and newborn death, occurring within 7 days after birth. The sample size (n?=?171,964) was calculated to detect a 15% reduction in the primary outcome. Adherence by health workers to EBPs will be measured in a subset of births (n?=?6000). The trial will be conducted in close collaboration with key partners including the Governments of India and Uttar Pradesh, the World Health Organization, an expert Scientific Advisory Committee, an experienced local implementing organization (Population Services International, PSI), and frontline facility leaders and workers.If effective, the WHO Safe Childbirth Checklist program could be a powerful health facility-strengthening intervention to improve quality of care and reduce preventable harm to women and newborns, with millions of potential beneficiaries.BetterBirth Study Protocol dated: 13 February 2014; ClinicalTrials.gov: NCT02148952 ; Universal Trial Number: U1111-1131-5647.

Project description: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. 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. 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. 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. Bill & Melinda Gates Foundation. ClinicalTrials.gov: NCT02148952; Universal Trial Number: U1111-1131-5647.

Project description:OBJECTIVES:The major objective of this study was to investigate the prevalence of labour room violence (LRV) (one of the forms of obstetric violence) faced by the women during the time of delivery in Uttar Pradesh (UP) (the largest populous state of India which is also considered to be a microcosm of India). Furthermore, this study also analyses the association between prevalence of obstetric violence and socioeconomic characteristics of the respondents. DESIGN:The study was longitudinal in design with the first visit to women made at the time of first trimester. The second visit was made at the time of second trimester and the last visit was made after the delivery. However, we have continuously tracked women over phone to keep record of developments and adverse consequences. SETTINGS:Urban and rural areas of UP, India. PARTICIPANTS:Sample of 504 pregnant women was systematically selected from the Integrated Child Development Scheme Register of pregnant women. OUTCOME:We aimed to assess the levels and determinants of LRV using data collected from 504 pregnant women in a longitudinal survey conducted in UP, India. The dataset comprised three waves of survey from the inception of pregnancy to childbirth and postnatal care. Logistic regression model has been used to assess the association between prevalence of LRV faced by the women at the time of delivery and their background characteristics. RESULT:About 15.12% of women are facing LRV in UP, India. Results from logistic regression model (OR) show that LRV is higher among Muslim women (OR 1.8, 95% CI 0.7 to 4.3) relative to Hindu women (OR 1). The prevalence of LRV is higher among lower castes relative to general category, and is higher among those women who have no mass media exposure (OR 4.7, 95% CI 1.7 to 12.8) compared with those who have (OR 1). CONCLUSION:In comparison with global evidence, the level of LRV in India is high. Women from socially disadvantaged communities are facing higher LRV than their counterparts.

Project description: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 .).

Project description:BackgroundThe BetterBirth trial tested the effect of a peer coaching program around the WHO Safe Childbirth Checklist for birth attendants in primary-level facilities in Uttar Pradesh, India on a composite measure of perinatal and maternal mortality and maternal morbidity. This study aimed to examine the adherence to essential birth practices between two different cadres of birth attendants-nurses and auxiliary nurse midwives (ANMs)-during and after a peer coaching intervention for the WHO Safe Childbirth Checklist.MethodsThis is a secondary analysis of birth attendant characteristics, coaching visits, and behavior uptake during the BetterBirth trial through birth attendant surveys, coach observations, and independent observations. Descriptive statistics were calculated overall, and by staffing cadre (staff nurses and ANMs) for demographic characteristics. Logistic regression using the Pearson overdispersion correction (to account for clustering by site) was used to assess differences between staff nurses and ANMs in the intervention group during regular coaching (2-month time point) and 4 months after the coaching program ended (12-month time point).ResultsOf the 570 birth attendants who responded to the survey in intervention and control arms, 474 were staff nurses (83.2%) and 96 were ANMs (16.8%). In the intervention arm, more staff nurses (240/260, 92.3%) received coaching at all pause points compared to ANMs (40/53, 75.5%). At baseline, adherence to practices was similar between ANMs and staff nurses (~ 30%). Overall percent adherence to essential birth practices among ANMs and nurses was highest at 2 months after intervention initiation, when frequent coaching visits occurred (68.1% and 64.1%, respectively, p = 0.76). Practice adherence tapered to 49.2% among ANMs and 56.1% among staff nurses at 12 months, which was 4 months after coaching had ended (p = 0.68).ConclusionsOverall, ANMs and nurses responded similarly to the coaching intervention with the greatest increase in percent adherence to essential birth practices after 2 months of coaching and subsequent decrease in adherence 4 months after coaching ended. While coaching is an effective strategy to support some aspects of birth attendant competency, the structure, content, and frequency of coaching may need to be customized according to the birth attendant training and competency.Trial registrationClinicalTrials.gov: NCT2148952; Universal Trial Number: U1111-1131-5647.

Project description:BACKGROUND:The study aims to assess the discordance between self-reported and observed measures of mistreatment of women during childbirth in public health facilities in Uttar Pradesh, India, as well as correlates of these measures and their discordance. METHODS:Cross sectional data were collected through direct observation of deliveries and follow-up interviews with women (n = 875) delivering in 81 public health facilities in Uttar Pradesh. Participants were surveyed on demographics, mistreatment during childbirth, and maternal and newborn complications. Provider characteristics (training, age) were obtained through interviews with providers, and observation data were obtained from checklists completed by trained nurse investigators to document quality of care at delivery. Mistreatment was assessed via self-report and observed measures which included 17 and 6 items respectively. Cohen's kappas assessed concordance between the 6 items common in the self-report and observed measures. Regression models assessed associations between characteristics of women and providers for each outcome. RESULTS:Most participants (77.3%) self-reported mistreatment in at least 1 of the 17-item measure. For the 6 items included in both self-report and observations, 9.1% of women self-reported mistreatment, whereas observers reported 22.4% of women being mistreated. Cohen's kappas indicated mostly fair to moderate concordance. Regression analyses found that multiparous birth (AOR = 1.50, 95% CI = 1.06-2.13), post-partum maternal complications (AOR = 2.0, 95% CI = 1.34-3.06); new-born complications (AOR = 2.6, 95% CI = 1. 96-4.03) and not having an Skilled Birth Attendant (SBA) trained provider (AOR = 1.47, 95% CI = 1.05-2.04) were associated with increased risk for mistreatment as measured by self-report. In contrast, only provider characteristics like older provider (AOR = 1.03, 95% CI = 1.02-1.05) and provider not trained in SBA (AOR = 1.44, 95% CI = 1.02-2.02) were associated with mistreatment as measured through observations. Younger age at marriage (AOR = 0.86, 95% CI = 0.78-0.95) and provider characteristics (older provider AOR = 1.05, 95% CI = 1.01-1.09; provider not trained in SBA AOR = 0.96, 95% CI = 0.92-0.99) were associated with discordance (based on mistreatment reported by observer but not by women). CONCLUSION:Provider mistreatment during childbirth is prevalent in Uttar Pradesh and may be under-reported by women, particularly when they are younger or when providers are older or less trained. The findings warrant programmatic action as well as more research to better understand the context and drivers of both behavior and reporting. TRIAL REGISTRATION:CTRI/2015/09/006219. Registered 28 September 2015.