BACKGROUND: There is a lack of literature on how to adapt new evidence-based interventions for maternal and newborn care into local health systems and policy for rapid scale-up, particularly for community-based interventions in low-income settings. The Uganda Newborn Study (UNEST) was a cluster randomised control trial to test a community-based care package which was rapidly taken up at national level. Understanding this process may help inform other studies looking to design and evaluate with scale-up in mind.
OBJECTIVE: This study aimed to describe the process of using evidence to design a community-based maternal and newborn care package in rural eastern Uganda, and to determine the dissemination and advocacy approaches used to facilitate rapid policy change and national uptake.
DESIGN: We reviewed UNEST project literature including meeting reports and minutes, supervision reports, and annual and midterm reports. National stakeholders, project and district staff were interviewed regarding their role in the study and perceptions of what contributed to uptake of the package under evaluation. Data related to UNEST formative research, study design, implementation and policy influence were extracted and analysed.
RESULTS: An advisory committee of key players in development of maternal and newborn policies and programmes in Uganda was constituted from many agencies and disciplines. Baseline qualitative and quantitative data collection was done at district, community and facility level to examine applicability of aspects of a proposed newborn care package to the local setting. Data were summarised and presented to stakeholders to adapt the intervention that was ultimately tested. Quarterly monitoring of key activities and events around the interventions were used to further inform implementation. The UNEST training package, home visit schedule and behaviour change counselling materials were incorporated into the national Village Health Team and Integrated Community Case Management packages while the study was ongoing.
CONCLUSIONS: Designing interventions for national scale-up requires strategies and planning from the outset. Use of evidence alongside engagement of key stakeholders and targeted advocacy about the burden and potential solutions is important when adapting interventions to local health systems and communities. This approach has the potential to rapidly translate research into policy, but care must be taken not to exceed available evidence while seizing the policy opportunity.
BACKGROUND: In 2001, the WHO Antenatal Care Trial (WHOACT) concluded that an antenatal care package of evidence-based screening, therapeutic interventions and education across four antenatal visits for low-risk women was not inferior to standard antenatal care and may reduce cost. However, an updated Cochrane review in 2010 identified an increased risk of perinatal mortality of borderline statistical significance in three cluster-randomized trials (including the WHOACT) in developing countries. We conducted a secondary analysis of the WHOACT data to determine the relationship between the reduced visits, goal-oriented antenatal care package and perinatal mortality. METHODS: Exploratory analyses were conducted to assess the effect of baseline risk and timing of perinatal death. Women were stratified by baseline risk to assess differences between intervention and control groups. We used linear modeling and Poisson regression to determine the relative risk of fetal death, neonatal death and perinatal mortality by gestational age. RESULTS: 12,568 women attended the 27 intervention clinics and 11,958 women attended the 26 control clinics. 6,160 women were high risk and 18,365 women were low risk. There were 161 fetal deaths (1.4%) in the intervention group compared to 119 fetal deaths in the control group (1.1%) with an increased overall adjusted relative risk of fetal death (Adjusted RR 1.27; 95% CI 1.03, 1.58). This was attributable to an increased relative risk of fetal death between 32 and 36 weeks of gestation (Adjusted RR 2.24; 95% CI 1.42, 3.53) which was statistically significant for high and low risk groups. CONCLUSION: It is plausible the increased risk of fetal death between 32 and 36 weeks gestation could be due to reduced number of visits, however heterogeneity in study populations or differences in quality of care and timing of visits could also be playing a role. Monitoring maternal, fetal and neonatal outcomes when implementing antenatal care protocols is essential. Implementing reduced visit antenatal care packages demands careful monitoring of maternal and perinatal outcomes, especially fetal death.
OBJECTIVE: To assess the effectiveness of the Maternal and Child Health (MCH) handbook in Mongolia to increase antenatal clinic attendance, and to enhance health-seeking behaviors and other health outcomes.
METHODS: A cluster randomized trial was conducted using the translated MCH handbook in Bulgan, Mongolia to assess its effectiveness in promoting antenatal care attendance. Pregnant women were recruited from 18 randomly allocated districts using shuffled, sealed envelopes. The handbook was implemented immediately for women at their first antenatal visit in the intervention group, and nine months later in the control group. The primary outcome was the number of antenatal care visits of all women residing in the selected districts. Cluster effects were adjusted for using generalized estimation equation. Masking was not possible among care providers, pregnant women and assessors.
FINDINGS: Nine districts were allocated to the intervention group and the remainder to the control group. The intervention group (253 women) attended antenatal clinics on average 6•9 times, while the control group (248 women) attended 6•2 times. Socioeconomic status affected the frequency of clinic attendance: women of higher socioeconomic status visited antenatal clinics more often. Pregnancy complications were more likely to be detected among women using the handbook.
CONCLUSION: The MCH handbook promotes continuous care and showed an increase in antenatal visits among the intervention group. The intervention will help to identify maternal morbidities during pregnancy and promote health-seeking behaviors.
TRIAL REGISTRATION: UMIN Clinical Trial Registry UMIN000001748.
BACKGROUND: Interventions are needed to reduce poor perinatal health. We trained community health workers (CHWs) as home visitors to address maternal/infant risks.
METHODS: In a cluster randomised controlled trial in Cape Town townships, neighbourhoods were randomised within matched pairs to 1) the control, healthcare at clinics (n = 12 neighbourhoods; n = 594 women), or 2) a home visiting intervention by CBW trained in cognitive-behavioural strategies to address health risks (by the Philani Maternal, Child Health and Nutrition Programme), in addition to clinic care (n = 12 neighbourhoods; n = 644 women). Participants were assessed during pregnancy (2% refusal) and 92% were reassessed at two weeks post-birth, 88% at six months and 84% at 18 months later. We analysed 32 measures of maternal/infant well-being over the 18 month follow-up period using longitudinal random effects regressions. A binomial test for correlated outcomes evaluated overall effectiveness over time. The 18 month post-birth assessment outcomes also were examined alone and as a function of the number of home visits received.
RESULTS: Benefits were found on 7 of 32 measures of outcomes, resulting in significant overall benefits for the intervention compared to the control when using the binomial test (p = 0.008); nevertheless, no effects were observed when only the 18 month outcomes were analyzed. Benefits on individual outcomes were related to the number of home visits received. Among women living with HIV, intervention mothers were more likely to implement the PMTCT regimens, use condoms during all sexual episodes (OR = 1.25; p = 0.014), have infants with healthy weight-for-age measurements (OR = 1.42; p = 0.045), height-for-age measurements (OR = 1.13, p<0.001), breastfeed exclusively for six months (OR = 3.59; p<0.001), and breastfeed longer (OR = 3.08; p<0.001). Number of visits was positively associated with infant birth weight ≥2500 grams (OR = 1.07; p = 0.012), healthy head-circumference-for-age measurements at 6 months (OR = 1.09, p = 0.017), and improved cognitive development at 18 months (OR = 1.02, p = 0.048).
CONCLUSIONS: Home visits to neighbourhood mothers by CHWs may be a feasible strategy for enhancing maternal/child outcomes. However, visits likely must extend over several years for persistent benefits.
TRIAL REGISTRATION: ClinicalTrials.gov NCT00996528.
BACKGROUND: Perinatal common mental disorders (PCMDs) are a major cause of disability among women and disproportionately affect lower income countries. Interventions to address PCMDs are urgently needed in these settings, and group-based and peer-led approaches are potential strategies to increase access to mental health interventions. Participatory women's health groups led by local women previously reduced postpartum psychological distress in eastern India. We assessed the effect of a similar intervention on postpartum psychological distress in rural Bangladesh.
METHOD: We conducted a secondary analysis of data from a cluster-randomised controlled trial with 18 clusters and an estimated population of 532,996. Nine clusters received an intervention comprising monthly meetings during which women's groups worked through a participatory learning and action cycle to develop strategies for improving women's and children's health. There was one group for every 309 individuals in the population, 810 groups in total. Mothers in nine control clusters had access to usual perinatal care. Postpartum psychological distress was measured with the 20-item Self Reporting Questionnaire (SRQ-20) between six and 52 weeks after delivery, during the months of January to April, in 2010 and 2011.
RESULTS: We analysed outcomes for 6275 mothers. Although the cluster mean SRQ-20 score was lower in the intervention arm (mean 5.2, standard deviation 1.8) compared to control (5.3, 1.2), the difference was not significant (β 1.44, 95% CI 0.28, 3.08).
CONCLUSIONS: Despite promising results in India, participatory women's groups focused on women's and children's health had no significant effect on postpartum psychological distress in rural Bangladesh.
BACKGROUND: Applying mobile phones in healthcare is increasingly prioritized to strengthen healthcare systems. Antenatal care has the potential to reduce maternal morbidity and improve newborns' survival but this benefit may not be realized in sub-Saharan Africa where the attendance and quality of care is declining. We evaluated the association between a mobile phone intervention and antenatal care in a resource-limited setting. We aimed to assess antenatal care in a comprehensive way taking into consideration utilisation of antenatal care as well as content and timing of interventions during pregnancy.
METHODS: This study was an open label pragmatic cluster-randomised controlled trial with primary healthcare facilities in Zanzibar as the unit of randomisation. 2550 pregnant women (1311 interventions and 1239 controls) who attended antenatal care at selected primary healthcare facilities were included at their first antenatal care visit and followed until 42 days after delivery. 24 primary health care facilities in six districts were randomized to either mobile phone intervention or standard care. The intervention consisted of a mobile phone text-message and voucher component. Primary outcome measure was four or more antenatal care visits during pregnancy. Secondary outcome measures were tetanus vaccination, preventive treatment for malaria, gestational age at last antenatal care visit, and antepartum referral.
RESULTS: The mobile phone intervention was associated with an increase in antenatal care attendance. In the intervention group 44% of the women received four or more antenatal care visits versus 31% in the control group (OR, 2.39; 95% CI, 1.03-5.55). There was a trend towards improved timing and quality of antenatal care services across all secondary outcome measures although not statistically significant.
CONCLUSIONS: The wired mothers' mobile phone intervention significantly increased the proportion of women receiving the recommended four antenatal care visits during pregnancy and there was a trend towards improved quality of care with more women receiving preventive health services, more women attending antenatal care late in pregnancy and more women with antepartum complications identified and referred. Mobile phone applications may contribute towards improved maternal and newborn health and should be considered by policy makers in resource-limited settings.
BACKGROUND: Mobile phones are increasingly used in health systems in developing countries and innovative technical solutions have great potential to overcome barriers of access to reproductive and child health care. However, despite widespread support for the use of mobile health technologies, evidence for its role in health care is sparse.
OBJECTIVE: We aimed to evaluate the association between a mobile phone intervention and perinatal mortality in a resource-limited setting.
METHODS: This study was a pragmatic, cluster-randomized, controlled trial with primary health care facilities in Zanzibar as the unit of randomization. At their first antenatal care visit, 2550 pregnant women (1311 interventions and 1239 controls) who attended antenatal care at selected primary health care facilities were included in this study and followed until 42 days after delivery. Twenty-four primary health care facilities in six districts were randomized to either mobile phone intervention or standard care. The intervention consisted of a mobile phone text message and voucher component. Secondary outcome measures included stillbirth, perinatal mortality, and death of a child within 42 days after birth as a proxy of neonatal mortality.
RESULTS: Within the first 42 days of life, 2482 children were born alive, 54 were stillborn, and 36 died. The overall perinatal mortality rate in the study was 27 per 1000 total births. The rate was lower in the intervention clusters, 19 per 1000 births, than in the control clusters, 36 per 1000 births. The intervention was associated with a significant reduction in perinatal mortality with an odds ratio (OR) of 0.50 (95% CI 0.27-0.93). Other secondary outcomes showed an insignificant reduction in stillbirth (OR 0.65, 95% CI 0.34-1.24) and an insignificant reduction in death within the first 42 days of life (OR 0.79, 95% CI 0.36-1.74).
CONCLUSIONS: Mobile phone applications may contribute to improved health of the newborn and should be considered by policy makers in resource-limited settings.
TRIAL REGISTRATION: ClinicalTrials.gov NCT01821222; http://www.clinicaltrials.gov/ct2/show/NCT01821222 (Archived by WebCite at http://www.webcitation.org/6NqxnxYn0).
BACKGROUND: In Sub-Saharan Africa over one million newborns die annually. We developed a sustainable and scalable home-based counselling intervention for delivery by community volunteers in rural southern Tanzania to improve newborn care practices and survival. Here we report the effect on newborn care practices one year after full implementation.
METHODS: All 132 wards in the 6-district study area were randomised to intervention or comparison groups. Starting in 2010, in intervention areas trained volunteers made home visits during pregnancy and after childbirth to promote recommended newborn care practices including hygiene, breastfeeding and identification and extra care for low birth weight babies. In 2011, in a representative sample of 5,240 households, we asked women who had given birth in the previous year both about counselling visits and their childbirth and newborn care practices.
RESULTS: Four of 14 newborn care practices were more commonly reported in intervention than comparison areas: delaying the baby's first bath by at least six hours (81% versus 68%, OR 2.0 (95% CI 1.2-3.4)), exclusive breastfeeding in the three days after birth (83% versus 71%, OR 1.9 (95% CI 1.3-2.9)), putting nothing on the cord (87% versus 70%, OR 2.8 (95% CI 1.7-4.6)), and, for home births, tying the cord with a clean thread (69% versus 39%, OR 3.4 (95% CI 1.5-7.5)). For other behaviours there was little evidence of differences in reported practices between intervention and comparison areas including childbirth in a health facility or with a skilled attendant, thermal care practices, breastfeeding within an hour of birth and, for home births, the birth attendant having clean hands, cutting the cord with a clean blade and birth preparedness activities.
CONCLUSIONS: A home-based counselling strategy using volunteers and designed for scale-up can improve newborn care behaviours in rural communities of southern Tanzania. Further research is needed to evaluate if, and at what cost, these gains will lead to improved newborn survival.
TRIAL REGISTRATION: Trial Registration Number NCT01022788 (http://www.clinicaltrials.gov, 2009).
Paraprofessional home visitors trained to improve multiple outcomes (HIV, alcohol, infant health, and malnutrition) have been shown to benefit mothers and children over 18 months in a cluster randomised controlled trial (RCT). These longitudinal analyses examine the mechanisms which influence child outcomes at 18 months post-birth in Cape Town, South Africa. The results were evaluated using structural equation modelling, specifically examining the mediating effects of prior maternal behaviours and a home visiting intervention post-birth. Twelve matched pairs of neighbourhoods were randomised within pairs to: 1) the control condition, receiving comprehensive healthcare at community primary health care clinics (n=12 neighbourhoods; n=594 pregnant women), or 2) the Philani Intervention Program, which provided home visits by trained, paraprofessional community health workers, here called Mentor Mothers, in addition to clinic care (n=12 neighbourhoods; n=644 pregnant women). Recruitment of all pregnant neighbourhood women was high (98%) with 88% reassessed at six months and 84% at 18 months. Infants' growth and diarrhoea episodes were examined at 18 months in response to the intervention condition, breastfeeding, alcohol use, social support, and low birth weight, controlling for HIV status and previous history of risk. We found that randomisation to the intervention was associated with a significantly lower number of recent diarrhoea episodes and increased rates and duration of breastfeeding. Across both the intervention and control conditions, mothers who used alcohol during pregnancy and had low birth weight infants were significantly less likely to have infants with normal growth patterns, whereas social support was associated with better growth. HIV-infection was significantly associated with poor growth and less breastfeeding. Women with more risk factors had significantly smaller social support networks. The relationships among initial and sustained maternal risk behaviours and the buffering impact of home visits and social support are demonstrated in these analyses.
IMPORTANCE: Community-based interventions can reduce neonatal mortality when health systems are weak. Population coverage of target groups may be an important determinant of their effect on behavior and mortality. A women's group trial at coverage of 1 group per 1414 population in rural Bangladesh showed no effect on neonatal mortality, despite a similar intervention having a significant effect on neonatal and maternal death in comparable settings.
OBJECTIVE: To assess the effect of a participatory women's group intervention with higher population coverage on neonatal mortality in Bangladesh.
DESIGN: A cluster randomized controlled trial in 9 intervention and 9 control clusters.
SETTING: Rural Bangladesh.
PARTICIPANTS: Women permanently residing in 18 unions in 3 districts and accounting for 19 301 births during the final 24 months of the intervention.
INTERVENTIONS: Women's groups at a coverage of 1 per 309 population that proceed through a participatory learning and action cycle in which they prioritize issues that affected maternal and neonatal health and design and implement strategies to address these issues.
MAIN OUTCOMES AND MEASURES: Neonatal mortality rate.
RESULTS: Analysis included 19 301 births during the final 24 months of the intervention. More than one-third of newly pregnant women joined the groups. The neonatal mortality rate was significantly lower in the intervention arm (21.3 neonatal deaths per 1000 live births vs 30.1 per 1000 in control areas), a reduction in neonatal mortality of 38% (risk ratio, 0.62 [95% CI, 0.43-0.89]) when adjusted for socioeconomic factors. The cost-effectiveness was US $220 to $393 per year of life lost averted. Cause-specific mortality rates suggest reduced deaths due to infections and those associated with prematurity/low birth weight. Improvements were seen in hygienic home delivery practices, newborn thermal care, and breastfeeding practices.
CONCLUSIONS AND RELEVANCE: Women's group community mobilization, delivered at adequate population coverage, is a highly cost-effective approach to improve newborn survival and health behavior indicators in rural Bangladesh.
TRIAL REGISTRATION: isrctn.org Identifier: ISRCTN01805825.
There is a lack of literature on how to adapt new evidence-based interventions for maternal and newborn care into local health systems and policy for rapid scale-up, particularly for community-based interventions in low-income settings. The Uganda Newborn Study (UNEST) was a cluster randomised control trial to test a community-based care package which was rapidly taken up at national level. Understanding this process may help inform other studies looking to design and evaluate with scale-up in mind.
OBJECTIVE:
This study aimed to describe the process of using evidence to design a community-based maternal and newborn care package in rural eastern Uganda, and to determine the dissemination and advocacy approaches used to facilitate rapid policy change and national uptake.
DESIGN:
We reviewed UNEST project literature including meeting reports and minutes, supervision reports, and annual and midterm reports. National stakeholders, project and district staff were interviewed regarding their role in the study and perceptions of what contributed to uptake of the package under evaluation. Data related to UNEST formative research, study design, implementation and policy influence were extracted and analysed.
RESULTS:
An advisory committee of key players in development of maternal and newborn policies and programmes in Uganda was constituted from many agencies and disciplines. Baseline qualitative and quantitative data collection was done at district, community and facility level to examine applicability of aspects of a proposed newborn care package to the local setting. Data were summarised and presented to stakeholders to adapt the intervention that was ultimately tested. Quarterly monitoring of key activities and events around the interventions were used to further inform implementation. The UNEST training package, home visit schedule and behaviour change counselling materials were incorporated into the national Village Health Team and Integrated Community Case Management packages while the study was ongoing.
CONCLUSIONS:
Designing interventions for national scale-up requires strategies and planning from the outset. Use of evidence alongside engagement of key stakeholders and targeted advocacy about the burden and potential solutions is important when adapting interventions to local health systems and communities. This approach has the potential to rapidly translate research into policy, but care must be taken not to exceed available evidence while seizing the policy opportunity.
