Primary studies included in this systematic review

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Primary study

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Journal Lancet
Year 2011
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BACKGROUND: Newborn deaths account for 57% of deaths in children younger than 5 years in Pakistan. Although a large programme of trained lady health workers (LHWs) exists, the effectiveness of this training on newborn outcomes has not been studied. We aimed to evaluate the effectiveness of a community-based intervention package, principally delivered through LHWs working with traditional birth attendants and community health committees, for reduction of perinatal and neonatal mortality in a rural district of Pakistan. METHODS: We undertook a cluster randomised trial between February, 2006, and March, 2008, in Hala and Matiari subdistricts, Pakistan. Catchment areas of primary care facilities and all affiliated LHWs were used to define clusters, which were allocated to intervention and control groups by restricted, stratified randomisation. The intervention package delivered by LHWs through group sessions consisted of promotion of antenatal care and maternal health education, use of clean delivery kits, facility births, immediate newborn care, identification of danger signs, and promotion of careseeking; control clusters received routine care. Independent data collectors undertook quarterly household surveillance to capture data for births, deaths, and household practices related to maternal and newborn care. Data collectors were masked to cluster allocation; those analysing data were not. The primary outcome was perinatal and all-cause neonatal mortality. Analysis was by intention to treat. This trial is registered, ISRCTN16247511. FINDINGS: 16 clusters were assigned to intervention (23,353 households, 12,391 total births) and control groups (23,768 households, 11,443 total births). LHWs in the intervention clusters were able to undertake 4428 (63%) of 7084 planned group sessions, but were only able to visit 2943 neonates (24%) of a total 12,028 livebirths in their catchment villages. Stillbirths were reduced in intervention clusters (39·1 stillbirths per 1000 total births) compared with control (48·7 per 1000; risk ratio [RR] 0·79, 95% CI 0·68-0·92; p=0·006). The neonatal mortality rate was 43·0 deaths per 1000 livebirths in intervention clusters compared with 49·1 per 1000 in control groups (RR 0·85, 0·76-0·96; p=0·02). INTERPRETATION: Our results support the scale-up of preventive and promotive maternal and newborn interventions through community health workers and emphasise the need for attention to issues of programme management and coverage for such initiatives to achieve maximum potential. FUNDING: WHO; Saving Newborn Lives Program of Save the Children USA, funded by the Bill & Melinda Gates Foundation.

Primary study

Unclassified

Journal BMJ (Clinical research ed.)
Year 2011
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OBJECTIVE: To determine whether training traditional birth attendants to manage several common perinatal conditions could reduce neonatal mortality in the setting of a resource poor country with limited access to healthcare. DESIGN: Prospective, cluster randomised and controlled effectiveness study. SETTING: Lufwanyama, an agrarian, poorly developed district located in the Copperbelt province, Zambia. All births carried out by study birth attendants occurred at mothers' homes, in rural village settings. PARTICIPANTS: 127 traditional birth attendants and mothers and their newborns (3559 infants delivered regardless of vital status) from Lufwanyama district. INTERVENTIONS: Using an unblinded design, birth attendants were cluster randomised to intervention or control groups. The intervention had two components: training in a modified version of the neonatal resuscitation protocol, and single dose amoxicillin coupled with facilitated referral of infants to a health centre. Control birth attendants continued their existing standard of care (basic obstetric skills and use of clean delivery kits). MAIN OUTCOME MEASURES: The primary outcome was the proportion of liveborn infants who died by day 28 after birth, with rate ratios statistically adjusted for clustering. Secondary outcomes were mortality at different time points; and comparison of causes of death based on verbal autopsy data. RESULTS: Among 3497 deliveries with reliable information, mortality at day 28 after birth was 45% lower among liveborn infants delivered by intervention birth attendants than control birth attendants (rate ratio 0.55, 95% confidence interval 0.33 to 0.90). The greatest reductions in mortality were in the first 24 hours after birth: 7.8 deaths per 1000 live births for infants delivered by intervention birth attendants compared with 19.9 per 1000 for infants delivered by control birth attendants (0.40, 0.19 to 0.83). Deaths due to birth asphyxia were reduced by 63% among infants delivered by intervention birth attendants (0.37, 0.17 to 0.81) and by 81% within the first two days after birth (0.19, 0.07 to 0.52). Stillbirths and deaths from serious infection occurred at similar rates in both groups. CONCLUSIONS: Training traditional birth attendants to manage common perinatal conditions significantly reduced neonatal mortality in a rural African setting. This approach has high potential to be applied to similar settings with dispersed rural populations. Trial registration Clinicaltrials.gov NCT00518856.

Primary study

Unclassified

Authors Midhet F , Becker S
Journal Reproductive health
Year 2010
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BACKGROUND: Pakistan has high maternal mortality, particularly in the rural areas. The delay in decision making to seek medical care during obstetric emergencies remains a significant factor in maternal mortality. METHODS: We present results from an experimental study in rural Pakistan. Village clusters were randomly assigned to intervention and control arms (16 clusters each). In the intervention clusters, women were provided information on safe motherhood through pictorial booklets and audiocassettes; traditional birth attendants were trained in clean delivery and recognition of obstetric and newborn complications; and emergency transportation systems were set up. In eight of the 16 intervention clusters, husbands also received specially designed education materials on safe motherhood and family planning. Pre- and post-intervention surveys on selected maternal and neonatal health indicators were conducted in all 32 clusters. A district-wide survey was conducted two years after project completion to measure any residual impact of the interventions. RESULTS: Pregnant women in intervention clusters received prenatal care and prophylactic iron therapy more frequently than pregnant women in control clusters. Providing safe motherhood education to husbands resulted in further improvement of some indicators. There was a small but significant increase in percent of hospital deliveries but no impact on the use of skilled birth attendants. Perinatal mortality reduced significantly in clusters where only wives received information and education in safe motherhood. The survey to assess residual impact showed similar results. CONCLUSIONS: We conclude that providing safe motherhood education increased the probability of pregnant women having prenatal care and utilization of health services for obstetric complications.

Primary study

Unclassified

Journal Lancet
Year 2010
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BACKGROUND: Two recent trials have shown that women's groups can reduce neonatal mortality in poor communities. We assessed the effectiveness of a scaled-up development programme with women's groups to address maternal and neonatal care in three rural districts of Bangladesh. METHODS: 18 clusters (with a mean population of 27 953 [SD 5953]) in three districts were randomly assigned to either intervention or control (nine clusters each) by use of stratified randomisation. For each district, cluster names were written on pieces of paper, which were folded and placed in a bottle. The first three cluster names drawn from the bottle were allocated to the intervention group and the remaining three to control. All clusters received health services strengthening and basic training of traditional birth attendants. In intervention clusters, a facilitator convened 18 groups every month to support participatory action and learning for women, and to develop and implement strategies to address maternal and neonatal health problems. Women were eligible to participate if they were aged 15-49 years, residing in the project area, and had given birth during the study period (Feb 1, 2005, to Dec 31, 2007). Neither study investigators nor participants were masked to treatment assignment. In a population of 229 195 people (intervention clusters only), 162 women's groups provided coverage of one group per 1414 population. The primary outcome was neonatal mortality rate (NMR). Analysis was by intention to treat. This trial is registered as an International Standard Randomised Controlled Trial, number ISRCTN54792066. FINDINGS: We monitored outcomes for 36 113 births (intervention clusters, n=17 514; control clusters, n=18 599) in a population of 503 163 over 3 years. From 2005 to 2007, there were 570 neonatal deaths in the intervention clusters and 656 in the control clusters. Cluster-level mean NMR (adjusted for stratification and clustering) was 33.9 deaths per 1000 livebirths in the intervention clusters compared with 36.5 per 1000 in the control clusters (risk ratio 0.93, 95% CI 0.80-1.09). INTERPRETATION: For participatory women's groups to have a significant effect on neonatal mortality in rural Bangladesh, detailed attention to programme design and contextual factors, enhanced population coverage, and increased enrolment of newly pregnant women might be needed. FUNDING: Women and Children First, the UK Big Lottery Fund, Saving Newborn Lives, and the UK Department for International Development.

Primary study

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Background: Of the 3.7 million neonatal deaths and 3.3 million stillbirths each year, 98% occur in developing countries. An evaluation of community-based interventions designed to reduce the number of these deaths is needed. Methods: With the use of a train-the-trainer model, local instructors trained birth attendants from rural communities in six countries (Argentina, Democratic Republic of Congo, Guatemala, India, Pakistan, and Zambia) in the World Health Organization Essential Newborn Care course (which focuses on routine neonatal care, resuscitation, thermoregulation, breast-feeding, "kangaroo" [skin-to-skin] care, care of the small baby, and common illnesses) and (except in Argentina) in a modified version of the American Academy of Pediatrics Neonatal Resuscitation Program (which teaches basic resuscitation in depth). The Essential Newborn Care intervention was assessed among 57,643 infants with the use of a before-and-after design. The Neonatal Resuscitation Program intervention was assessed as a cluster-randomized, controlled trial involving 62,366 infants. The primary outcome was neonatal death in the first 7 days after birth. Results: The 7-day follow-up rate was 99.2%. After birth attendants were trained in the Essential Newborn Care course, there was no significant reduction from baseline in the rate of neonatal death from all causes in the 7 days after birth (relative risk with training, 0.99; 95% confidence interval [CI], 0.81 to 1.22) or in the rate of perinatal death; there was a significant reduction in the rate of stillbirth (relative risk with training, 0.69; 95% CI, 0.54 to 0.88; P = 0.003). In clusters of births in which attendants had been randomly assigned to receive training in the Neonatal Resuscitation Program, as compared with control clusters, there was no reduction in the rates of neonatal death in the 7 days after birth, stillbirth, or perinatal death. Conclusions: The rate of neonatal death in the 7 days after birth did not decrease after the introduction of Essential Newborn Care training of community-based birth attendants, although the rate of stillbirths was reduced. Subsequent training in the Neonatal Resuscitation Program did not significantly reduce the mortality rates. Copyright © 2010 Massachusetts Medical Society. All rights reserved.

Primary study

Unclassified

Journal Bulletin of the World Health Organization
Year 2008
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OBJECTIVE: This pilot study investigated the feasibility of delivering a package of community-based interventions for improving perinatal care using lady health workers (LHWs) and traditional birth attendants (Dais) in rural Pakistan. METHODS: The intervention was implemented in four of eight village clusters (315 villages, total population 138,600), while four served as a comparison group. The LHWs in intervention clusters received additional training focused on essential maternal and newborn care, conducted community education group sessions, and were encouraged to link up with local Dais. The intervention was delivered within the regular government LHW programme and was supported by the creation of voluntary community health committees. FINDINGS: In intervention villages, there were significant reductions from baseline in stillbirth (from 65.9 to 43.1 per 1000 births, P < 0.001) and neonatal mortality rates (from 57.3 to 41.3 per 1000 live births, P < 0.001). The proportion of deliveries conducted by skilled attendants at public sector facilities also increased, from 18% at baseline to 30%, while the proportion of home births decreased from 79% to 65%. A household survey indicated a higher frequency of key behaviours (e.g. early and exclusive breastfeeding, delayed bathing and cord care) in intervention villages. CONCLUSION: The improved stillbirth and neonatal mortality rates observed indicate that community health workers (i.e. LHWs and Dais) can be effective in implementing a community and outreach package that leads to improved home care practices by families, increased care-seeking behaviour and greater utilization of skilled care providers. These preliminary observations require confirmation in an adequately powered trial.

Primary study

Unclassified

Authors Jokhio AH , Winter HR , Cheng KK
Journal The New England journal of medicine
Year 2005
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BACKGROUND: There are approximately 4 million neonatal deaths and half a million maternal deaths worldwide each year. There is limited evidence from clinical trials to guide the development of effective maternity services in developing countries. METHODS: We performed a cluster-randomized, controlled trial involving seven subdistricts (talukas) of a rural district in Pakistan. In three talukas randomly assigned to the intervention group, traditional birth attendants were trained and issued disposable delivery kits; Lady Health Workers linked traditional birth attendants with established services and documented processes and outcomes; and obstetrical teams provided outreach clinics for antenatal care. Women in the four control talukas received usual care. The primary outcome measures were perinatal and maternal mortality. RESULTS: Of the estimated number of eligible women in the seven talukas, 10,114 (84.3 percent) were recruited in the three intervention talukas, and 9443 (78.7 percent) in the four control talukas. In the intervention group, 9184 women (90.8 percent) received antenatal care by trained traditional birth attendants, 1634 women (16.2 percent) were seen antenatally at least once by the obstetrical teams, and 8172 safe-delivery kits were used. As compared with the control talukas, the intervention talukas had a cluster-adjusted odds ratio for perinatal death of 0.70 (95 percent confidence interval, 0.59 to 0.82) and for maternal mortality of 0.74 (95 percent confidence interval, 0.45 to 1.23). CONCLUSIONS: Training traditional birth attendants and integrating them into an improved health care system were achievable and effective in reducing perinatal mortality. This model could result in large improvements in perinatal and maternal health in developing countries.

Primary study

Unclassified

Journal Journal of midwifery & women's health
Year 2001
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This study was designed to assess the utility and impact on perinatal mortality of a model traditional birth attendant (TBA) training program in rural Mozambique by comparing birth attendance and outcomes in similar communities with and without trained TBAs. Birth attendants and pregnancy outcomes were compared in 1) communities with good access to trained TBAs, 2) randomly selected, comparable communities with no access to trained TBAs, and 3) communities with good access to functioning maternities. Information was collected by interviews with women in randomly selected households. A total of 4,169 women were interviewed who reported on 3,616 completed pregnancies, which resulted in a birth or fetal death. Among women with good access to trained TBAs, 33% reported giving birth attended by a trained TBA, 43% reported giving birth at a health facility, and 24% reported giving birth attended by an untrained person. Among women without access to trained TBAs, 58% reported giving birth at health facilities, and 42% reported attendance by untrained persons. Among women with access to functioning maternity centers, 77% reported giving birth at a health facility and 22% said their birth was attended by an untrained person. There was no significant difference in perinatal or infant mortality among the groups. This study demonstrated a preference for health facility deliveries among rural Mozambican women with good access to trained TBAs. It also failed to demonstrate a reduction in perinatal or infant mortality associated with TBA training. Women said they preferred to deliver in health facilities because conditions were considered better and interventions could be performed if needed. The preference for health facility birth over home birth with a TBA may have been related to difficulties with TBA neighbors and their families or fear of potential witchcraft. Efforts to promote TBA training should be balanced with support for birthing services based in health facilities.

Primary study

Unclassified

Journal Lancet
Year 1999
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BACKGROUND: Neonatal care is not available to most neonates in developing countries because hospitals are inaccessible and costly. We developed a package of home-based neonatal care, including management of sepsis (septicaemia, meningitis, pneumonia), and tested it in the field, with the hypothesis that it would reduce the neonatal mortality rate by at least 25% in 3 years. METHODS: We chose 39 intervention and 47 control villages in the Gadchiroli district in India, collected baseline data for 2 years (1993-95), and then introduced neonatal care in the intervention villages (1995-98). Village health workers trained in neonatal care made home visits and managed birth asphyxia, premature birth or low birthweight, hypothermia, and breast-feeding problems. They diagnosed and treated neonatal sepsis. Assistance by trained traditional birth attendants, health education, and fortnightly supervisory visits were also provided. Other workers recorded all births and deaths in the intervention and the control area (1993-98) to estimate mortality rates. FINDINGS: Population characteristics in the intervention and control areas, and the baseline mortality rates (1993-95) were similar. Baseline (1993-95) neonatal mortality rate in the intervention and the control areas was 62 and 58 per 1000 live births, respectively. In the third year of intervention 93% of neonates received home-based care. Neonatal, infant, and perinatal mortality rates in the intervention area (net percentage reduction) compared with the control area, were 25.5 (62.2%), 38.8 (45.7%), and 47.8 (71.0%), respectively (p<0.001). Case fatality in neonatal sepsis declined from 16.6% (163 cases) before treatment, to 2.8% (71 cases) after treatment by village health workers (p<0.01). Home-based neonatal care cost US$5.3 per neonate, and in 1997-98 such care averted one death (fetal or neonatal) per 18 neonates cared for. INTERPRETATION: Home-based neonatal care, including management of sepsis, is acceptable, feasible, and reduced neonatal and infant mortality by nearly 50% among our malnourished, illiterate, rural study population. Our approach could reduce neonatal mortality substantially in developing countries.

Primary study

Unclassified

Journal Lancet
Year 1998
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BACKGROUND: A study in Matlab, Bangladesh, has provided evidence favouring a community-based maternity-care delivery system. 3 years of this programme coincided with a significant reduction in direct obstetric mortality compared with the 3 years before the programme. We have examined whether the effects of the programme are sustained over time. METHODS: Using data from the continuing demographic survelliance system and from special investigations into the rates and causes of maternal mortality during 1976-93, we compared the trends in direct obstetric maternal mortality ratios in the Maternal and Child Health and Family Planning (MCH-FP) area (which has received extensive services in health and family planning since 1977) with those in the comparison area (with no such intensive health inputs). We divided the areas and time periods into discrete groups that best represented the effects of the introduction of the maternity-care programme. FINDINGS: Direct obstetric mortality declined by 3% per year (rate ratio 0.97 per year [95% CI 0.95-0.99]); there was no difference between the MCH-FP and comparison areas (1.00 [0.96-1.05]). Direct obstetric mortality halved between 1976-86 and 1987-89 in the northern MCH-FP area, where the maternity-care programme was initiated in 1987 (0.50 [0.22-0.99]), but showed no change in the southern MCH-FP area, which had no such intervention at that time (1.07 [0.64-1.72]). After 1990, when the programme was expanded throughout the MCH-FP area, the southern part showed a downward (non-significant) trend in direct obstetric mortality (0.68 [0.35-1.32]). However, direct obstetric mortality also declined between 1987 and 1989 in the southern comparison area (0.48 [0.26-0.83]) in the absence of an intense maternity-care programme, and remained stable thereafter. In the northern comparison area, there was no such decline in direct obstetric mortality (0.78 [0.40-1.40]). INTERPRETATION: Although the introduction of the maternity-care programme coincided with declining trends in direct obstetric mortality in the areas covered by the programme, a decline also occurred in one of the areas not receiving any such interventions. Caution is required in the interpretation of short-term trends in one indicator in studies designed without random allocation of interventions into treatment and control groups.