Components of clean delivery kits and newborn mortality in the Zambia Chlorhexidine Application Trial (ZamCAT): An observational study.

BACKGROUND: Neonatal infection, a leading cause of neonatal death in low- and middle-income countries, is often caused by pathogens acquired during childbirth. Clean delivery kits (CDKs) have shown efficacy in reducing infection-related perinatal and neonatal mortality. However, there remain gaps in our current knowledge, including the effect of individual components, the timeline of protection, and the benefit of CDKs in home and facility deliveries. METHODS AND FINDINGS: A post hoc secondary analysis was performed using nonrandomized data from the Zambia Chlorhexidine Application Trial (ZamCAT), a community-based, cluster-randomized controlled trial of chlorhexidine umbilical cord care in Southern Province of Zambia from February 2011 to January 2013. CDKs, containing soap, gloves, cord clamps, plastic sheet, razor blade, matches, and candle, were provided to all pregnant women. Field monitors made a home-based visit to each participant 4 days postpartum, during which CDK use and newborn outcomes were ascertained. Logistic regression was used to study the association between different CDK components and neonatal mortality rate (NMR). Of 38,579 deliveries recorded during the study, 36,996 newborns were analyzed after excluding stillbirths and those with missing information. Gloves, cord clamps, and plastic sheets were the most frequently used CDK item combination in both home and facility deliveries. Each of the 7 CDK components was associated with lower NMR in users versus nonusers. Adjusted logistic regression showed that use of gloves (odds ratio [OR] 0.33, 95% CI 0.24-0.46), cord clamp (OR 0.51, 95% CI 0.38-0.68), plastic sheet (OR 0.46, 95% CI 0.34-0.63), and razor blade (OR 0.69, 95% CI 0.53-0.89) were associated with lower risk of newborn mortality. Use of gloves and cord clamp were associated with reduced risk of immediate newborn death (<24 hours). Reduction in risk of early newborn death (1-6 days) was associated with use of gloves, cord clamps, plastic sheets, and razor blades. In examining perinatal mortality (stillbirth plus neonatal death in the first 7 days of life), similar patterns were observed. There was no significant reduction in risk of late newborn mortality (7-28 days) with CDK use. Study limitations included potential recall bias of CDK use and inability to establish causality, as this was a secondary observational study. CONCLUSIONS: CDK use was associated with reductions in early newborn mortality at both home and facility deliveries, especially when certain kit components were used. While causality could not be established in this nonrandomized secondary analysis, given these beneficial associations, scaling up the use of CDKs in rural areas of sub-Saharan Africa may improve neonatal outcomes. TRIAL REGISTRATION: Name of trial: Zambia Chlorhexidine Application Trial (ZamCAT) Name of registry: Clinicaltrials.gov Trial number: NCT01241318.

Tracking progress towards safe motherhood: meeting the benchmark yet missing the goal? An appeal for better use of health-system output indicators with evidence from Zambia and Sri Lanka.

OBJECTIVES: Indicators of health-system outputs, such as Emergency Obstetric Care (EmOC) density, have been proposed for monitoring progress towards reducing maternal mortality, but are currently underused. We seek to promote them by demonstrating their use at subnational level, evaluating whether they differentiate between a high-maternal-mortality country (Zambia) and a low-maternal-mortality country (Sri Lanka) and assessing whether benchmarks are set at the right level. METHODS: We compared national and subnational density of health facilities, EmOC facilities and health professionals against current benchmarks for Zambia and Sri Lanka. For Zambia, we also examined geographical accessibility by linking health facility data to population data. RESULTS: Both countries performed similarly in terms of EmOC facility density, implying this indicator, as currently used, fails to discriminate between high- and low-maternal-mortality settings. In Zambia, the WHO benchmarks for doctors/midwives were met overall, but distribution between provinces was highly unequal. Sri Lanka overshot the suggested benchmarks by three times for midwives and over 30 times for doctors. Geographical access in Zambia--which is much less densely populated than Sri Lanka--was poor, less than half the population lived within 15 km of an EmOC facility. CONCLUSIONS: Current health-system output indicators and benchmarks on EmOC need revision to enhance discriminatory power and should be adapted for different population densities. Subnational disaggregation and assessing geographical access can identify gaps in EmOC provision and should be routinely considered. Increased use of an improved set of output indicators is crucial for guiding international efforts towards reducing maternal mortality.

Modern contraceptive and dual method use among HIV-infected women in Lusaka, Zambia.

HIV-infected women in sub-Saharan Africa are at substantial risk of unintended pregnancy and sexually transmitted infections (STIs). Linkages between HIV and reproductive health services are advocated. We describe implementation of a reproductive health counseling intervention in 16 HIV clinics in Lusaka, Zambia. Between November 2009 and November 2010, 18,407 women on antiretroviral treatment (ART) were counseled. The median age was 34.6 years (interquartile range (IQR): 29.9-39.7), and 60.1% of women were married. The median CD4(+) cell count was 394 cells/uL (IQR: 256-558). Of the women counseled, 10,904 (59.2%) reported current modern contraceptive use. Among contraceptive users, only 17.7% reported dual method use. After counseling, 737 of 7,503 women not previously using modern contraception desired family planning referrals, and 61.6% of these women successfully accessed services within 90 days. Unmet contraceptive need remains high among HIV-infected women. Additional efforts are needed to promote reproductive health, particularly dual method use.

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.

The state of routine and emergency obstetric and neonatal care in Southern Province, Zambia.

OBJECTIVE: To evaluate the capacity of health facilities in Southern Province, Zambia, to perform routine obstetric care and emergency obstetric and neonatal care (EmONC). METHODS: Surveys were completed at 90 health centers and 10 hospitals between September 1, 2011, and February 28, 2012. An expanded set of signal functions for routine care and EmONC was used to assess the facilities' capacity to provide obstetric and neonatal care. RESULTS: Interviews were completed with 172 health workers. Comprehensive EmONC was available in only six of 10 hospitals; the remaining four hospitals did not perform all basic EmONC signal functions. None of the 90 health centers performed the basic set of EmONC signal functions. Performance of routine obstetric care functions, health worker EmONC training, and facility infrastructure and staffing varied. CONCLUSION: Assessment of the indicators for routine care revealed that several low-cost interventions are currently underused in Southern Province. There is substantial room for improvement in emergency and routine obstetric and neonatal care at the surveyed facilities. Efforts should focus on improving infrastructure and supplies, EmONC training, and adherence to the UN guidelines for routine and emergency obstetric care.

Building on safety, feasibility, and acceptability: the impact and cost of community health worker provision of injectable contraception.

BACKGROUND: A critical shortage of doctors, nurses, and midwives in many sub-Saharan African countries inhibits efforts to expand access to family planning services, especially in rural areas. One way to fill this gap is for community health workers (CHWs) to provide injectable contraceptives, an intervention for which there is growing evidence and international support. In 2009, with approval from the Government of Zambia (GoZ), FHI 360 collaborated with ChildFund Zambia to design and implement such an intervention as part of its existing CHW family planning program. METHODS: The safety of CHW provision of injectable DMPA (depot medroxyprogesterone acetate) was measured by client reports and by a 21-item structured observation checklist. Feasibility and acceptability were measured by interviews with CHWs and a subset of DMPA clients. The impact of adding DMPA to pill and condom provision was assessed by family planning uptake among the clients of trained CHWs from February 2010 to February 2011. Costs were documented using spreadsheets over the period November 2009 to February 2011. RESULTS: Scores were high on all measures of safety, feasibility, and acceptability. Couple-years of protection (CYP, protection from pregnancy for 1 year) was provided to 51 condom clients, 391 pill clients, and 2,206 DMPA clients. Of the 1,739 clients new to family planning, 85% chose injectable DMPA, while 13% chose pills and 2% chose condoms. Continuation rates were also high, at 63% after 1 year as compared with 47% for pill users. Incremental costs per couple-year were US$21.24 if 50% of users continue with CHW-provided DMPA. CONCLUSION: The study affirms that the provision of injectable contraceptives by CHWs is safe, acceptable, and feasible in the Zambian context, with very high rates of uptake in hard-to-reach areas. High continuation rates among clients mean that costs of the intervention can be low when added to an existing community-based distribution program-a finding that is relevant to program replication (now underway in Zambia).

Dedicated providers of long-acting reversible contraception: new approach in Zambia.

BACKGROUND: Long-acting reversible contraception (LARC) is underused in many countries in sub-Saharan Africa. Many previous attempts to increase uptake of this important class of contraception have not been successful. STUDY DESIGN: This program in Zambia employed 18 dedicated providers of LARC, placed them in high volume public sector facilities and collected routine, anonymous information over a 14-month period. We tallied uptake of LARC, analyzed user characteristics to see what populations were reached by the program and compared this to nationally representative data. We also estimated costs per couple-year of protection of the program. RESULTS: In a 14-month period, 33,609 clients chose either a subdermal implant (66%) or an intrauterine device (34%). The program reached a younger and lower parity population compared to nationally representative surveys of Zambian women using contraception. The estimated program costs, including the value of donated commodities, averaged $13.0 per couple-year of protection. CONCLUSION: By having the necessary time, skills and materials - as well as a mandate to both generate informed demand and provide quality services - dedicated providers of LARC can expand contraceptive choice. This new approach shows what can be achieved in a short period and in a region of the world where uptake of LARC is limited.

Determinants of stillbirth in Zambia.

OBJECTIVE: The objective of this study was to estimate the rates and determinants of stillbirth in an urban African obstetric population. METHODS: In this retrospective cohort study, we reviewed vital outcomes of newborns whose mothers received antenatal care, delivery care, or both antenatal and delivery care in the Lusaka, Zambia, public sector between February 2006 and March 2009. We excluded newborns weighing less than 1,000 g, those whose mothers died before delivery, and those born outside Lusaka. RESULTS: There were 100,454 deliveries that met criteria for inclusion. The median maternal age at the initial visit was 24 years (interquartile range 21-29) and the median gestational age was 22 weeks (interquartile range 19-26). The median gestational age at birth was 38 weeks (interquartile range 36-40), and the median neonatal birth weight was 3,000 g (interquartile range 2,750-3,300). A total of 2,109 fetuses were stillborn (crude rate, 21 per 1,000 live births, 95% confidence interval 20.1 per 1,000 to 21.9 per 1,000). This included 1,049 (49.7%) stillbirths classified as "recent" (presumed to have occurred within 12 hours of delivery) and 1,060 (50.3%) classified as "macerated" (presumed to have occurred more than 12 hours before delivery). In adjusted analysis, increasing maternal age, baseline body mass index greater than 26, history of stillbirth, placental abruption, maternal untreated syphilis, cesarean delivery, operative vaginal delivery, assisted breech delivery, and extremes of neonatal birth weight were all significantly associated with stillbirth. CONCLUSION: Stillbirth is a major contributor to poor perinatal outcomes in Lusaka. Many deaths appear avoidable through investment in antenatal screening and better labor monitoring. Stillbirth should be adopted as a routine health indicator by the World Health Organization.

Implementation of the Zambia electronic perinatal record system for comprehensive prenatal and delivery care.

OBJECTIVE: To characterize prenatal and delivery care in an urban African setting. METHODS: The Zambia Electronic Perinatal Record System (ZEPRS) was implemented to record demographic characteristics, past medical and obstetric history, prenatal care, and delivery and newborn care for pregnant women across 25 facilities in the Lusaka public health sector. RESULTS: From June 1, 2007, to January 31, 2010, 115552 pregnant women had prenatal and delivery information recorded in ZEPRS. Median gestation age at first prenatal visit was 23weeks (interquartile range [IQR] 19-26). Syphilis screening was documented in 95663 (83%) pregnancies: 2449 (2.6%) women tested positive, of whom 1589 (64.9%) were treated appropriately. 111108 (96%) women agreed to HIV testing, of whom 22% were diagnosed with HIV. Overall, 112813 (98%) of recorded pregnancies resulted in a live birth, and 2739 (2%) in a stillbirth. The median gestational age was 38weeks (IQR 35-40) at delivery; the median birth weight of newborns was 3000g (IQR 2700-3300g). CONCLUSION: The results demonstrate the feasibility of using a comprehensive electronic medical record in an urban African setting, and highlight its important role in ongoing efforts to improve clinical care.

Integration of the practice of active management of the third stage of labor within training and service implementation programming in Zambia.

INTRODUCTION: Postpartum hemorrhage (PPH) is the leading cause of pregnancy-related mortality (cited at 591 per 100,000 Zambian women), and is responsible for up to 60% of maternal deaths in developing countries. Active management of the third stage of labor (AMTSL) has been endorsed as a means of reducing the risk of PPH. The Ministry of Health/Zambia has incorporated the use of AMTSL into its reproductive health guidelines. METHODS: Midwives employed in five public hospitals and eight health centers were interviewed (N = 62), and 82 observations were conducted during the second through fourth stages of labor. RESULTS: Data from facilities in which oxytocin was available (62 births in 11 settings) indicated that a uterotonic was used in 53 of the births (85.5%); however, AMTSL was conducted in strict accord with the currently recommended protocol (a time-specific use of the uterotonic, controlled cord traction, and fundal massage) in only 25 (40.4%) of births. DISCUSSION: Midwives have concerns about risks of maternal to newborn HIV blood transfusion; it is doubtful that they will adopt the currently recommended practice of delayed cord clamping and cutting. Infrastructure issues and supply shortages challenged the ability to correctly and safely implement the AMTSL protocol; nevertheless, facilities were generally ready to support it.