Eff ectiveness of 4% chlorhexidine umbilical cord care on neonatal mortality in Southern Province, Zambia (ZamCAT): a cluster-randomised controlled trial

Background Chlorhexidine umbilical cord washes reduce neonatal mortality in south Asian populations with high neonatal mortality rates and predominantly home-based deliveries. No data exist for sub-Saharan African populations with lower neonatal mortality rates or mostly facility-based deliveries. We compared the eff ect of chlorhexidine with dry cord care on neonatal mortality rates in Zambia. Methods We undertook a cluster-randomised controlled trial in Southern Province, Zambia, with 90 health facilitybased clusters. We enrolled women who were in their second or third trimester of pregnancy, aged at least 15 years, and who would remain in the catchment area for follow-up of 28 days post-partum. Newborn babies received clean dry cord care (control) or topical application of 10 mL of a 4% chlorhexidine solution once per day until 3 days after cord drop (intervention), according to cluster assignment. We used stratifi ed, restricted randomisation to divide clusters into urban or two rural groups (located <40 km or ≥40 km to referral facility), and randomly assigned clusters (1:1) to use intervention (n=45) or control treatment (n=45). Sites, participants, and fi eld monitors were aware of their study assignment. The primary outcomes were all-cause neonatal mortality within 28 days post-partum and all-cause neonatal mortality within 28 days post-partum among babies who survived the fi rst 24 h of life. Analysis was by intention to treat. Neonatal mortality rate was compared with generalised estimating equations. This study is registered at ClinicalTrials.gov (NCT01241318). Findings From Feb 15, 2011, to Jan 30, 2013, we screened 42 356 pregnant women and enrolled 39 679 women (mean 436·2 per cluster [SD 65·3]), who had 37 856 livebirths and 723 stillbirths; 63·8% of deliveries were facility-based. Of livebirths, 18 450 (99·7%) newborn babies in the chlorhexidine group and 19 308 (99·8%) newborn babies in the dry cord care group were followed up to day 28 or death. 16 660 (90·0%) infants in the chlorhexidine group had chlorhexidine applied within 24 h of birth. We found no signifi cant diff erence in neonatal mortality rate between the chlorhexidine group (15·2 deaths per 1000 livebirths) and the dry cord care group (13·6 deaths per 1000 livebirths; risk ratio [RR] 1·12, 95% CI 0·88–1·44). Eliminating day 0 deaths yielded similar fi ndings (RR 1·12, 95% CI 0·86–1·47). Interpretation Despite substantial reductions previously reported in south Asia, chlorhexidine cord applications did not signifi cantly reduce neonatal mortality rates in Zambia. Chlorhexidine cord applications do not seem to provide clear benefi ts for newborn babies in settings with predominantly facility-based deliveries and lower (<30 deaths per 1000 livebirths) neonatal mortality rates

Neonatal mortality within 24 hours of birth in six low- and lower-middle-income countries.

OBJECTIVE: To estimate neonatal mortality, particularly within 24 hours of birth, in six low- and lower-middle-income countries. METHODS: We analysed epidemiological data on a total of 149 570 live births collected between 2007 and 2013 in six prospective randomized trials and a cohort study from predominantly rural areas of Bangladesh, Ghana, India, Pakistan, the United Republic of Tanzania and Zambia. The neonatal mortality rate and mortality within 24 hours of birth were estimated for all countries and mortality within 6 hours was estimated for four countries with available data. The findings were compared with published model-based estimates of neonatal mortality. FINDINGS: Overall, the neonatal mortality rate observed at study sites in the six countries was 30.5 per 1000 live births (range: 13.6 in Zambia to 47.4 in Pakistan). Mortality within 24 hours was 14.1 per 1000 live births overall (range: 5.1 in Zambia to 20.1 in India) and 46.3% of all neonatal deaths occurred within 24 hours (range: 36.2% in Pakistan to 65.5% in the United Republic of Tanzania). Mortality in the first 6 hours was 8.3 per 1000 live births, i.e. 31.9% of neonatal mortality. CONCLUSION: Neonatal mortality within 24 hours of birth in predominantly rural areas of six low- and lower-middle-income countries was higher than model-based estimates for these countries. A little under half of all neonatal deaths occurred within 24 hours of birth and around one third occurred within 6 hours. Implementation of high-quality, effective obstetric and early newborn care should be a priority in these settings

Burden of severe maternal morbidity and association with adverse birth outcomes in sub-Saharan Africa and south Asia: protocol for a prospective cohort study

Objectives The AMANHI morbidity study aims to quantify and describe severe maternal morbidities and assess their associations with adverse maternal, fetal and newborn outcomes in predominantly rural areas of nine sites in eight South Asian and sub-Saharan African countries. Methods AMANHI takes advantage of on-going population-based cohort studies covering approximately 2 million women of reproductive age with 1- to 3-monthly pregnancy surveillance to enrol pregnant women. Morbidity information is collected at five follow-up home visits - three during the antenatal period at 24-28 weeks, 32-36 weeks and 37+ weeks of pregnancy and two during the postpartum period at 1-6 days and after 42-60 days after birth. Structured- questionnaires are used to collect self-reported maternal morbidities including hemorrhage, hypertensive disorders, infections, difficulty in labor and obstetric fistula, as well as care-seeking for these morbidities and outcomes for mothers and babies. Additionally, structured questionnaires are used to interview birth attendants who attended women's deliveries. All protocols were harmonised across the sites including training, implementation and operationalising definitions for maternal morbidities. Importance of the AMANHI morbidity study Availability of reliable data to synthesize evidence for policy direction, interventions and programmes, remains a crucial step for prioritization and ensuring equitable delivery of maternal health interventions especially in high burden areas. AMANHI is one of the first large harmonized population- based cohort studies being conducted in several rural centres in South Asia and sub-Saharan Africa, and is expected to make substantial contributions to global knowledge on maternal morbidity burden and its implications

Impact of beliefs on perception of newborn illness, caregiver behaviors, and care-seeking practices in Zambia's Southern province.

Despite reductions in the number of under-five deaths since the release of the Sustainable Development Goals, the proportion of neonatal deaths among all under-five deaths has remained high. Neonatal health is linked to newborn care practices which are tied to distinct cultural perceptions of health and illness. We assessed how community beliefs in Zambia's Southern Province influence newborn care behaviors, perception of illness, and care-seeking practices, using qualitative data collected between February and April 2010. A total of 339 women participated in 36 focus group discussions (FGDs), with 9 FGDs conducted in each of the four study districts. In addition, 42 in-depth interviews (IDIs) were conducted with various key informants, with 11 IDIs conducted in Choma, 11 IDIs in Monze, 10 IDIs in Livingstone, and 10 IDIs in Mazabuka. The FGDs and IDIs indicate that beliefs among the Tonga people regarding postnatal illness prevention and management influence perceptions of newborn illness and care-seeking practices. Care seeking behaviors including when, why, and where parents seek newborn care are intimately tied to perception of disease among the Tonga people. These beliefs may stem from both indigenous and Western perspectives in Zambia's Southern Province. Findings are consistent with other analyses from Southern Province that highlighted the benefit of integrating local practices with Western biomedical care. Health systems models, led by policy makers and program designers, could aim to find synergies between community practices and formal health systems to support positive behavior change and satisfy multiple stakeholders

Effectiveness of 4% chlorhexidine umbilical cord care on neonatal mortality in Southern Province, Zambia (ZamCAT): a cluster-randomised controlled trial

Background: Chlorhexidine umbilical cord washes reduce neonatal mortality in south Asian populations with high neonatal mortality rates and predominantly home-based deliveries. No data exist for sub-Saharan African populations with lower neonatal mortality rates or mostly facility-based deliveries. We compared the effect of chlorhexidine with dry cord care on neonatal mortality rates in Zambia. Methods: We undertook a cluster-randomised controlled trial in Southern Province, Zambia, with 90 health facility-based clusters. We enrolled women who were in their second or third trimester of pregnancy, aged at least 15 years, and who would remain in the catchment area for follow-up of 28 days post-partum. Newborn babies received clean dry cord care (control) or topical application of 10 mL of a 4% chlorhexidine solution once per day until 3 days after cord drop (intervention), according to cluster assignment. We used stratified, restricted randomisation to divide clusters into urban or two rural groups (located <40 km or ≥40 km to referral facility), and randomly assigned clusters (1:1) to use intervention (n=45) or control treatment (n=45). Sites, participants, and field monitors were aware of their study assignment. The primary outcomes were all-cause neonatal mortality within 28 days post-partum and all-cause neonatal mortality within 28 days post-partum among babies who survived the first 24 h of life. Analysis was by intention to treat. Neonatal mortality rate was compared with generalised estimating equations. This study is registered at ClinicalTrials.gov (NCT01241318). Findings: From Feb 15, 2011, to Jan 30, 2013, we screened 42 356 pregnant women and enrolled 39 679 women (mean 436·2 per cluster [SD 65·3]), who had 37 856 livebirths and 723 stillbirths; 63·8% of deliveries were facility-based. Of livebirths, 18 450 (99·7%) newborn babies in the chlorhexidine group and 19 308 (99·8%) newborn babies in the dry cord care group were followed up to day 28 or death. 16 660 (90·0%) infants in the chlorhexidine group had chlorhexidine applied within 24 h of birth. We found no significant difference in neonatal mortality rate between the chlorhexidine group (15·2 deaths per 1000 livebirths) and the dry cord care group (13·6 deaths per 1000 livebirths; risk ratio [RR] 1·12, 95% CI 0·88–1·44). Eliminating day 0 deaths yielded similar findings (RR 1·12, 95% CI 0·86–1·47). Interpretation: Despite substantial reductions previously reported in south Asia, chlorhexidine cord applications did not significantly reduce neonatal mortality rates in Zambia. Chlorhexidine cord applications do not seem to provide clear benefits for newborn babies in settings with predominantly facility-based deliveries and lower (<30 deaths per 1000 livebirths) neonatal mortality rates. Funding: Bill & Melinda Gates Foundation