Primary Care 2030: Creating an Enabling Ecosystem for Disruptive Primary Care Models to Achieve Universal Health Coverage in Low- and Middle-Income Countries.

Background: Forty years after Alma Ata, there is renewed commitment to strengthen primary health care as a foundation for achieving universal health coverage, but there is limited consensus on how to build strong primary health care systems to achieve these goals. Methods: We convened a diverse group of global stakeholders for a high-level dialogue on how to create an enabling ecosystem for disruptive primary care innovation. We focused our discussion on four themes: workforce innovation and strengthening; impactful use of data and technology; private sector engagement; and innovative financing mechanisms. Findings: Here, we present a summary of our convening's proceedings, with specific recommendations for strengthening primary health care systems within each of these four domains. Conclusions: In the wake of the Astana Declaration, there is global consensus that high-quality primary health care must be the foundation for universal health coverage. Significant disruptive innovation will be required to realize this goal. We offer our recommendations to the global community to catalyze further discourse and inform policy-making and program development on the path to Health for All by 2030.

Innovative bridging of the rural-urban divide: comparison of scope, safety, and impact of collaborative rural surgery camps and an urban surgical program.

BACKGROUND: In medically under-resourced regions worldwide, non-permanent surgery programs or camps have been conducted to expand access to surgical services. Surgery camp programs have been reported in rural India, primarily in the ophthalmic and obstetric fields; however, the provision of general surgical services in these settings is largely unknown. METHODS: A 12-month retrospective review of non-ambulatory procedures performed at a rural hospital surgery camp program and at an urban hospital in Maharashtra, India, was completed to characterize relative differences in procedural activity, frequency and severity of perioperative complications, and to evaluate efficacy of care. RESULTS: A total of 449 cases performed in rural hospital surgery camps were compared with 344 cases performed in an urban hospital during the course of the study period. The majority of rural surgical cases were elective and of intermediate complexity. Approximately 4% of rural cases were complex-major compared to 17% of urban cases. Intraoperative complications occurred in 0.2% rural cases compared to 5.5% of urban cases; p = 0.01. Postoperative complications were predominantly low grade in both groups. The postoperative complication rate was higher among rural surgical patients (43.4%; 23.5%; p < 0.01), though the Surgical Risk Score was significantly lower in this group (p < 0. 01). Rural surgery camp activity over 12 months achieved diagnostic and/or therapeutic goals in 92.2% of procedures and rendered 1.74-2.69 disability-adjusted life-years (DALYs) averted per patient. CONCLUSIONS: Rural general surgery camps can safely and effectively provide a wide range of surgical services under appropriate collaborative and clinical conditions. Surgery camps may be a safe, temporizing solution to unmet needs until substantial gains in rural healthcare are realized.

Impact of anemia on surgical outcomes: innovative interventions in resource-poor settings.

BACKGROUND: The aim of this work was to study the impact of anemia on surgical outcomes and the impact of instituting appropriate workup and treatment of anemia on surgical outcomes. METHODS: We conducted a case-control retrospective chart review of all hernia repair, hydrocele repair, and hysterectomy cases at the SEARCH Hospital in Gadchiroli, India, from January 2008 to April 2010, and included 340 male and 112 female surgical patients. We also performed a prospective assessment of the impact of the institution of appropriate workup and treatment of anemia on the surgical outcomes for all hernia repair, hydrocele repair, and hysterectomy cases at SEARCH from May 2010 to May 2011 and included 138 male and 76 female surgical patients. RESULTS: The retrospective arm of the study included 340 males and 112 females with a median age of 39 and 41 years, respectively. The mean hemoglobin values were 12.50 (range = 8.8-15.4) for men and 10.39 (range = 5.2-14.8) for women. Patients with anemia had (1) increased incidence of spinal headache after inguinal hernia repair (p = 0.0266) and (2) increased incidence of fever after total hysterectomy (p = 0.0070). There was no statistically significant correlation between anemia and other outcomes (all p > 0.05). The prospective arm of the study included 138 males and 76 females with a median age of 35 and 40, respectively. The mean hemoglobin values were 11.8 (range = 6.4-14.8) for men and 10.6 (range = 6.9-12.8) for women. There was no statistically significant correlation between anemia and any surgical outcomes (p > 0.05). The incidence of complications in both the retrospective and the prospective arm was compared according to increasing severity of anemia across genders. Overall, there was no statistically significant increase in complication rates with increasing severity of anemia (p > 0.05). CONCLUSIONS: In the retrospective arm of this study, anemia was associated with increased incidence of spinal headache and fever. In the prospective arm of this study, there was no statistically significant correlation between anemia and any surgical outcome. The incidence of complications did not increase with the severity of anemia in either arm of the study. Further investigation is needed into the optimal management and treatment of anemia prior to surgery in resource-poor settings.

Simple clinical criteria to identify sepsis or pneumonia in neonates in the community needing treatment or referral.

BACKGROUND: Sepsis, meningitis and pneumonia annually kill 1.1 million neonates in developing countries; most deaths occur at home. OBJECTIVES: To develop simple clinical criteria, enabling health workers in communities to identify neonates with potentially fatal sepsis; and to identify the danger signs alerting mothers to seek care. METHODS: In a field trial in 39 villages in Gadchiroli, India, trained health workers visited all neonates at home 8 times during the first 28 days of life, recording signs and outcome without interventions during 1995-1996 and with home-based management of sick neonates during 1996-1999. An independent neonatologist assigned the cause of death. We use the term "sepsis" to include sepsis, meningitis and pneumonia. We evaluated 31 signs as predictors of 43 sepsis deaths among 3567 neonates. We also evaluated mothers' observations as the danger signs to seek care. RESULTS: Simultaneous presence of any 2 of 7 signs (reduced or stopped sucking; weak or no cry; limbs becoming limp; vomiting or abdominal distension; baby cold to touch; severe chest indrawing; umbilical infection) predicted sepsis death with sensitivity 100%, specificity 92%, positive predictive value 27.2% and negative predictive value 100% in the nonintervention period. The criteria identified 10.6% of the neonates in the community as suspected sepsis, at a mean of 5.4 days before death. The criteria remained valid in the postintervention period. Any 1 of the 5 maternally observed danger signs (reduced sucking, drowsy or unconscious, baby cold to touch, fast breathing and chest indrawing) gave 100% sensitivity and identified 23.9% neonates for seeking care. CONCLUSION: These criteria identify neonates in the community who are at risk for dying of infection with excellent sensitivity, specificity and negative predictive value but a moderate positive predictive value. They can be used by health workers to select sick neonates for treatment or referral. One potentially fatal case would be treated per 4 presumptive cases treated.

Home-based neonatal care: summary and applications of the field trial in rural Gadchiroli, India (1993 to 2003).

High levels of neonatal mortality and lack of access to neonatal health care are widespread problems in developing countries. A field trial of home-based neonatal care (HBNC) was conducted in rural Gadchiroli, India to develop and test the feasibility of a low-cost approach of delivering primary neonatal care by using the human potential available in villages, and to evaluate its effect on neonatal mortality. In the first half of this article we summarize various aspects of the field trial, presented in the previous 11 articles in this issue of the journal supplement. The background, objectives, study design and interventions in the field trial and the results over 10 years (1993 to 2003) are presented. Based on these results, the hypotheses are tested and conclusions presented. In the second half, we discuss the next questions: can it be replicated? Can this intervention become a part of primary health-care services? What is the cost and the cost-effectiveness of HBNC? The limitations of the approach, the settings where HBNC might be relevant and the management pre-requisites for its scaling up are also discussed. The need to develop an integrated approach is emphasized. A case for newborn care in the community is made for achieving equity in health care.

Methods and the baseline situation in the field trial of home-based neonatal care in Gadchiroli, India.

In this paper, we describe the planning of the field trial and the methods used for collecting baseline health and ethnographic data in a rural field study site. We describe the study hypotheses, specific objectives, study design, sample size estimates, selection of study area, community consent, the organization of study teams, review mechanism, financial support and baseline data collection. Baseline population characteristics and vital statistics are presented. The qualitative information on traditional beliefs and practices prevalent in the study area revealed that parents felt powerless about newborn health and sickness. There was an enormous unmet need to reach the home-delivered neonates and their care-givers with the correct knowledge and health-care practices.

The incidence of morbidities in a cohort of neonates in rural Gadchiroli, India: seasonal and temporal variation and a hypothesis about prevention.

BACKGROUND: The incidence of morbidities among home-cared neonates in rural areas has not been studied. OBJECTIVES: To estimate the incidence of various neonatal morbidities and the associated risk of death in home-cared neonates in rural setting. To estimate the variation in the incidence of neonatal morbidities by season and by day of life. To identify the scope for prevention of morbidities and suggest a hypothesis. STUDY DESIGN: A prospective observational study nested in the first year of the field trial in rural Gadchiroli, India. Trained village health workers in 39 villages observed neonates at the time of birth and in subsequent eight home visits up to 28 days. We diagnosed 20 neonatal morbidities by using clinical definitions. The data were analyzed for the incidence, case fatality, and relative risk of death and for the seasonal and day-wise variation in the incidence of morbidities. RESULTS: We observed total 763 neonates in 1 year. The incidence of morbidities was a mean of 2.2 morbidities per neonate. The case fatality in 13 morbidities was >10%. Only 2.6% neonates were seen or treated by a physician, and 0.4% were hospitalized. Hypothermia, fever, upper respiratory symptoms, umbilical and skin infections, and conjunctivitis showed statistically significant seasonal variation. Although the morbidities were concentrated in the first week of life, new cases continued to appear throughout the neonatal period. Various morbidities showed different distribution of incidence during 1 to 28 days. CONCLUSIONS: A large burden of disease occurs in rural home-cared neonates, and many morbidities are associated with high case fatality. Some morbidities show strong seasonal and day-wise variation in incidence, indicating poor care at home. We hypothesize that changes in practices and better home-based care will prevent the seasonal and temporal increase in morbidities. Some morbidities may not be preventable and will need early detection and treatment. Therefore, frequent home visits by a health worker are necessary to identify sick neonates.

Background of the field trial of home-based neonatal care in Gadchiroli, India.

The field trial of home-based neonatal care was conducted in Gadchiroli, India during 1993 to 1998. Owing to its new approach and the success in reducing newborn mortality in a rural area, it has attracted considerable attention. In this article, we describe the background of the trial -- the situation in 1990, why the problems of neonatal mortality and neonatal infection were selected for research, the area -- Gadchiroli district -- where the study was conducted, and the background work and philosophy of the organization, SEARCH, which conducted the study. This history and background will help readers understand the origins and the context of the field trial and the subsequent research papers in this supplement. We also hope that sharing this will be of use to other researchers and program managers working with communities in developing countries.

Why do neonates die in rural Gadchiroli, India? (Part II): estimating population attributable risks and contribution of multiple morbidities for identifying a strategy to prevent deaths.

OBJECTIVES: The understanding about why neonates die in rural areas in developing countries is limited. In the first year (1995 to 1996) of the field trial of home-based neonatal care in rural Gadchiroli, India, we prospectively observed a cohort of neonates in 39 villages. In Part I of this article, we presented the primary causes of death. The data were further analyzed: To estimate the population attributable risk (PAR) of death for the main causes of neonatal mortality. To evaluate the effect of a multiplicity of morbidities and to identify which morbidity combinations cause neonatal deaths. To develop a hypothesis about how best to reduce neonatal mortality. STUDY DESIGN: We analyzed the observational data by logistic regression to estimate the PAR of death for six major morbidities. The effect of the number of morbidities per neonate on case fatality (CF) was estimated. Then we identified the main combinations of morbidities as the component causes leading to death. We estimated the excess deaths attributable to sepsis. RESULTS: This cohort included 763 neonates among whom 40 neonatal deaths occurred. Six major morbidities were associated with the following proportion of deaths: preterm, 62.5%; sepsis, 60%; intrauterine growth restriction (IUGR), 27.5%; asphyxia, 25%; hypothermia, 22.5%, and feeding problems, 15%. The estimated PARs were: preterm, 0.74; IUGR, 0.55; sepsis, 0.55; asphyxia, 0.35; hypothermia, 0.08, and feeding problems, 0.04. The CF associated with the number of morbidities per neonate was: with no morbidity, 0.3%; one morbidity, 2.1%; two morbidities, 15.3%; three or more morbidities, 41.4% (p<0.001). In all, 82.5% of all deaths occurred in neonates with two or more morbidities. The proportion of total deaths associated with only preterm was 7.5%, and with only IUGR was 2.5%; however, with the main morbidity combinations it was preterm+sepsis, 35%; IUGR+sepsis, 22.5%; preterm+asphyxia, 20%; preterm+hypothermia, 15%; and preterm+feeding problem, 12.5%. The % CF with low birth weight (LBW) <2500 g alone was 5.2% and with infection alone was 1.9%, but with LBW+infection it was 31.9%. The estimated excess deaths caused by sepsis over and above LBW was 44% of the total deaths. CONCLUSIONS: Preterm and IUGR are ubiquitous components, but usually not sufficient to cause death. Most deaths occur due to a combination of preterm or IUGR with other comorbidities. If preterm birth or IUGR cannot be prevented, the strategy should be to ensure neonatal survival by addressing comorbidities, that is, infections, asphyxia, hypothermia, and feeding problems in that order of priority. We hypothesize that the prevention and/or management of neonatal infections will reduce neonatal mortality by 40 to 50%.

Reduced incidence of neonatal morbidities: effect of home-based neonatal care in rural Gadchiroli, India.

OBJECTIVE: We found a high burden of morbidities in a cohort of neonates observed in rural Gadchiroli, India. We hypothesised that interventions would reduce the incidence of neonatal morbidities, including the seasonal increase observed in many of them. This article reports the effect of home-based neonatal care on neonatal morbidities in the intervention arm of the field trial by comparing the early vs late periods, and the possible explanation for this effect. METHODS: During 3 years (1995 to 1998), trained village-health-workers (VHWs) in 39 villages prospectively collected data by making home visits during pregnancy, home-delivery and during neonatal period. We estimated the incidence and burden of neonatal morbidities over the 3 years from these data. In the first year, the VHWs made home visits only to observe. From the second year, they assisted mothers in neonatal care and managed the sick neonates at home. Health education of mothers and family members, individually and in group, was added in the third year. We measured the coverage of interventions over the 3 years and evaluated maternal knowledge and practices on 21 indicators in the third year. The effect on 17 morbidities was estimated by comparing the incidence in the first year with the third year. RESULTS: The VHWs observed 763 neonates in the first year, 685 in the second and 913 in the third year. The change in the percent incidence of morbidities was (i) infections, from 61.6 to 27.5 (-55%; p<0.001), (ii) care-related morbidities (asphyxia, hypothermia, feeding problems) from 48.2 to 26.3 (-45%; p<0.001); (iii) low birth weight from 41.9 to 35.2 (-16%; p<0.05); (iv) preterm birth and congenital anomalies remained unchanged. The mean number of morbidities/100 neonates in the 3 years was 228, 170 and 115 (a reduction of 49.6%; p<0.001). These reductions accompanied an increasing percent score of interventions during 3 years: 37.9, 58.4 and 81.3, thus showing a dose-response relationship. In the third year, the proportion of correct maternal knowledge was 78.7% and behaviours was 69.7%. The significant seasonal increase earlier observed in the incidence of five morbidities reduced in the third year. CONCLUSION: The home-based care and health education reduced the incidence and burden of neonatal morbidities by nearly half. The effect was broad, but was especially pronounced on infections, care-related morbidities and on the seasonal increase in morbidities.

Is home-based diagnosis and treatment of neonatal sepsis feasible and effective? Seven years of intervention in the Gadchiroli field trial (1996 to 2003).

OBJECTIVES: To further evaluate our earlier findings on the feasibility and effectiveness of home-based management of neonatal sepsis by analysing 7 years data (1996 to 2003) from the field trial in Gadchiroli, India. STUDY DESIGN: Neonates in 39 villages were monitored by trained village health workers (VHWs) from 1995 onwards. In 1996, we trained VHWs to diagnose sepsis by using a clinical algorithm and provide domiciliary treatment using intramuscular gentamicin and oral co-trimoxazole. Health records for all neonates were kept by the VHWs, checked by field supervisors, and computerized. Live births and neonatal deaths were recorded by an independent vital statistics collection system. We evaluated the feasibility and effectiveness of this approach. RESULTS: During September 1996 to March 2003, VHWs monitored 93% of all neonates in 39 villages (N=5268). As compared to 552 cases of sepsis diagnosed by computer algorithm, VHWs correctly diagnosed 492 cases (89%). Parents agreed to home-based treatment for the majority of infants (448, 91%), refused treatment in 31 (6.4%) cases, and hospitalized 13 infants (2.6%). VHWs treated 470 neonates with antibiotics, that is, 8.9% of all neonates in community. Of 552 cases diagnosed by computer, VHWs correctly treated 448 (81.2%) and gave unnecessary treatment to 22/470 (4.7%) of treated neonates. The case fatality (CF) was 6.9% in treated cases vs 22% in untreated or 16.6% in the pre-intervention period (p<0.001). Home-based treatment resulted in 67.2% reduction in %CF among preterm and a 72% reduction among LBW neonates. CONCLUSIONS: Home-based management of neonates with suspected sepsis is acceptable to most parents, safe, and effective in reducing sepsis case fatality by nearly 60%. With proper selection, training, and supervision of health workers, this method may be applicable in areas in developing countries where access to hospital care is limited.

Low birth weight and preterm neonates: can they be managed at home by mother and a trained village health worker?

OBJECTIVE: Observations on a cohort of neonates in the preintervention year of the field trial of home-based neonatal care (HBNC) in rural Gadchiroli, India, showed that preterm birth and low birth weight (LBW), <2500 g, constituted the most important risk factors. Owing to a limited access to hospital care, most neonates were managed at home in the subsequent intervention years. The objective of this paper is to evaluate the feasibility and effectiveness of managing LBW and preterm neonates in home setting. DESIGN: We retrospectively analyzed data from the intervention arm (39 villages) in the HBNC trial. Feasibility was assessed by coverage and by quality (19 indicators) of care. Effectiveness was evaluated by change in case fatality (CF) and in the incidence of comorbidities in LBW or preterm neonates by comparing the preintervention year (1995 to 1996) with the intervention years (1996 to 2003). RESULTS: During 1996 to 2003, total 5919 live births occurred in the intervention villages, out of whom 5510 (93%) received HBNC. These included 2015 LBW neonates and 533 preterm neonates, out of whom 97% received only home-based care. The coverage and quality of interventions assessed on 19 indicators was 80.5%. The CF in LBW neonates declined by 58% (from 11.3 to 4.7%, p<0.001), and in preterm neonates, by 69.5% (from 33.3 to 10.2%, p<0.0001). Incidence of the major comorbidities, viz., sepsis, asphyxia, hypothermia and feeding problems, declined significantly. Preterm-LBW neonates without sepsis (270) received only supportive care -- CF in them decreased from 28.2 to 11.5% (p<0.01), and those with sepsis (53) received supportive care and antibiotics -- CF in them decreased from 61 to 13.2% (p<0.005). Supportive care contributed 75% and treatment with antibiotics 25% in the total averted deaths in preterm-LBW neonates. The intrauterine growth restriction (IUGR)-LBW neonates without sepsis (1409) received only supportive care -- the CF was unchanged, and 181 with sepsis received supportive care and antibiotics -- the CF decreased from 18.4 to 8.8% (p<0.05). Treatment with antibiotics explained entire reduction in mortality in IUGR neonates. In total, 55 deaths in LBW neonates were averted by supportive care and 35 by the treatment with antibiotics. CONCLUSIONS: Home-based management of LBW and the preterm neonates is feasible and effective. It remarkably improved survival by preventing comorbidities, by supportive care, and by treating infections.

Management of birth asphyxia in home deliveries in rural Gadchiroli: the effect of two types of birth attendants and of resuscitating with mouth-to-mouth, tube-mask or bag-mask.

OBJECTIVES: To evaluate the effect of home-based neonatal care on birth asphyxia and to compare the effectiveness of two types of workers and three methods of resuscitation in home delivery. STUDY DESIGN: In a field trial of home-based neonatal care in rural Gadchiroli, India, birth asphyxia in home deliveries was managed differently during different phases. Trained traditional birth attendants (TBA) used mouth-to-mouth resuscitation in the baseline years (1993 to 1995). Additional village health workers (VHWs) only observed in 1995 to 1996. In the intervention years (1996 to 2003), they used tube-mask (1996 to 1999) and bag-mask (1999 to 2003). The incidence, case fatality (CF) and asphyxia-specific mortality rate (ASMR) during different phases were compared. RESULTS: During the intervention years, 5033 home deliveries occurred. VHWs were present during 84% home deliveries. The incidence of mild birth asphyxia decreased by 60%, from 14% in the observation year (1995 to 1996) to 6% in the intervention years (p<0.0001). The incidence of severe asphyxia did not change significantly, but the CF in neonates with severe asphyxia decreased by 47.5%, from 39 to 20% (p<0.07) and ASMR by 65%, from 11 to 4% (p<0.02). Mouth-to-mouth resuscitation reduced the ASMR by 12%, tube-mask further reduced the CF by 27% and the ASMR by 67%. The bag-mask showed an additional decrease in CF of 39% and in the fresh stillbirth rate of 33% in comparison to tube-mask (not significant). The cost of bag and mask was US dollars 13 per averted death. Oxytocic injection administered by unqualified doctors showed an odds ratio of three for the occurrence of severe asphyxia or fresh stillbirth. CONCLUSIONS: Home-based interventions delivered by a team of TBA and a semiskilled VHW reduced the asphyxia-related neonatal mortality by 65% compared to only TBA. The bag-mask appears to be superior to tube-mask or mouth-to-mouth resuscitation, with an estimated equipment cost of US dollars 13 per death averted.

Neonatal and infant mortality in the ten years (1993 to 2003) of the Gadchiroli field trial: effect of home-based neonatal care.

OBJECTIVES: To evaluate the effect on neonatal and infant mortality during 10 years (1993 to 2003) in the field trial of home-based neonatal care (HBNC) in Gadchiroli. To estimate the contribution of the individual components in the intervention package on the observed effect. STUDY DESIGN: The field trial of HBNC in Gadchiroli, India, has completed the baseline phase (1993 to 1995), observational phase (1995 to 1996) and the 7 years of intervention (1996 to 2003). We measured the stillbirth rate (SBR), neonatal mortality rate (NMR), perinatal mortality rate (PMR), postneonatal mortality rate (PNMR) and the infant mortality rate (IMR) in the intervention area and the control area. The effect of HBNC on all these rates was estimated by comparing the change from baseline (1993 to 1995) to the last 2 years of intervention (2001 to 2003) in the intervention area vs in the control area. For other estimates, we made a before-after comparison of the rates in the intervention arm in the observation year (1995 to 1996) vs intervention years (1996 to 2003). We evaluated the effect on the cause-specific NMRs. By using the changes in the incidence and case fatality (CF) of the four main morbidities, we estimated the contribution of primary prevention and of the management of sick neonates. The proportion of deaths averted by different components of HBNC was estimated. RESULTS: The baseline population in 39 intervention villages was 39,312 and in 47 control villages it was 42,617, and the population characteristics and vital rates were similar. The total number of live births in 10 years (1993 to 2003) were 8811 and 9990, respectively. The NMR in the control area showed an increase from 58 in 1993 to 1995 to 64 in 2001 to 2003. The NMR in the intervention area declined from 62 to 25; the reduction in comparison to the control area was by 44 points (70%, 95% CI 59 to 81%). Early NMR decreased by 24 points (64%) and late NMR by 20 points (80%). The SBR decreased by 16 points (49%) and the PMR by 38 points (56%). The PNMR did not change, and the IMR decreased by 43 points (57%, 95% CI 46 to 68%). All reductions were highly significant (p<0.001) except for SBR it was <0.05. The cause-specific NMR (1995 to 1996 vs 2001 to 2003) for sepsis decreased by 90%, for asphyxia by 53% and for prematurity by 38%. The total reduction in neonatal mortality during intervention (1996 to 2003) was ascribed to sepsis management, 36%; supportive care of low birth weight (LBW) neonates, 34%; asphyxia management, 19%; primary prevention, 7% and management of other illnesses or unexplained, 4%. CONCLUSIONS: The HBNC package in the Gadchiroli field trial reduced the neonatal and perinatal mortality by large margins, and the gains were sustained at the end of the 7 years of intervention and were carried forward as improved survival through the first year of life. Most of the reduction in mortality was ascribed to sickness management, that is, management of sepsis, supportive care of LBW neonates and management of asphyxia, in that order, and a small portion to primary prevention.

Maternal morbidity during labour and the puerperium in rural homes and the need for medical attention: A prospective observational study in Gadchiroli, India.

OBJECTIVES: To estimate the incidence of maternal morbidity during labour and the puerperium in rural homes, the association with perinatal outcome and the proportion of women needing medical attention. DESIGN: Prospective observational study nested in a neonatal care trial. SETTING: Thirty-nine villages in the Gadchiroli district, Maharashtra, India. SAMPLE: Seven hundred and seventy-two women recruited over a one year period (1995-1996) and followed up from the seventh month in pregnancy to 28 days postpartum (up to 10 visits in total). METHODS: Observations at home by trained village health workers, validated by a physician. Diagnosis of morbidities by computer program. MAIN OUTCOMES: Direct obstetric complications during labour and the puerperium, breast problems, psychiatric problems and need for medical attention. RESULTS: The incidence of maternal morbidity was 52.6%, 17.7% during labour and 42.9% during puerperium. The most common intrapartum morbidities were prolonged labour (10.1%), prolonged rupture of membranes (5.7%), abnormal presentation (4.0%) and primary postpartum haemorrhage (3.2%). The postpartum morbidities included breast problems (18.4%), secondary postpartum haemorrhage (15.2%), puerperal genital infections (10.2%) and insomnia (7.4%). Abnormal presentation and some puerperal complications (infection, fits, psychosis and breast problems) were significantly associated with adverse perinatal outcomes, but prolonged labour was not. A third of the mothers were in need of medical attention: 15.3% required emergency obstetric care and 24.0% required non-emergency medical attention. CONCLUSIONS: Nearly 15% of women who deliver in rural homes potentially need emergency obstetric care. Frequent (43%) postpartum morbidity, and its association with adverse perinatal outcome, suggests the need for home-based postpartum care in developing countries for both mother and baby.