Bone sarcoma surgery in times of COVID-19 pandemic lockdown-early experience from a tertiary centre in India.

BACKGROUND AND OBJECTIVES: Coronavirus disease 2019 (COVID-19) lockdown has presented a unique challenge for sarcoma care. The purpose of this study is to evaluate the early results and feasibility of surgeries for bone sarcomas during the COVID-19 lockdown. METHODS: Our prospectively collected orthopaedic oncological database was reviewed to include two groups of patients- those who underwent surgery in the immediate 4 weeks before lockdown (non-lockdown group) and those operated in the first 4 weeks of lockdown (lockdown group). All patients were followed-up clinically and telephonically to collect the outcome data. RESULTS: Out of the 91 patients who qualified for inclusion, fifty were classified into the non-lockdown group while 41 patients formed the lockdown group. Both the groups were comparable with respect to baseline demographic parameters. However, during the lockdown period 37 patients (90%) had undergone a major surgical intervention as against 24 patients (48%) in the non-lockdown group (P < .001). There was no significant difference in type of anaesthesia, median estimated blood loss and procedure duration. None of the patients/health care workers had evidence of severe acute respiratory syndrome-coronavirus 2 infection at 15 days follow-up. CONCLUSION: Our study results suggest that appendicular bone tumours can be safely operated with adequate precautions during the lockdown period.

A Huge Mesenteric Lymphangioma Presenting as a Small Bowel Volvulus in a Paediatric Patient: A Case Report.

Lymphangioma is a benign tumor characterized by proliferation of thin-walled lymphatic spaces. Lymphangioma of the small-bowel mesentery is rare, with an incidence of 1 : 250,000, representing less than 1% of all lymphangiomas. The predilection of the tumor is in the head and neck (70%), axillary (20%), and internal organs (10%). They are usually asymptomatic but can cause acute abdominal symptoms due to complications such as volvulus, bleeding, or lymphangioma rupture that require emergent surgery. Here, we report a case of mesenteric lymphangioma (ML) of a small bowel in a paediatric patient who presented with pain abdomen on and off which increased in severity and later had features of subacute intestinal obstruction. He underwent explorative laparotomy, and the mass was excised completely along with the part of small intestine. Pathological analysis of the surgical specimen confirmed the diagnosis of ML of the small intestine. The postoperative recovery was uneventful, and the patient was discharged after ten days of hospital stay. Though benign in nature, ML may cause acute abdominal symptoms that require emergent surgery. Therefore, it has to be kept in differential diagnosis of the acute abdominal condition.

State-of-the-Art Smart and Intelligent Nanobiosensors for SARS-CoV-2 Diagnosis.

The novel coronavirus appeared to be a milder infection initially, but the unexpected outbreak of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), commonly called COVID-19, was transmitted all over the world in late 2019 and caused a pandemic. Human health has been disastrously affected by SARS-CoV-2, which is still evolving and causing more serious concerns, leading to the innumerable loss of lives. Thus, this review provides an outline of SARS-CoV-2, of the traditional tools to diagnose SARS-CoV-2, and of the role of emerging nanomaterials with unique properties for fabricating biosensor devices to diagnose SARS-CoV-2. Smart and intelligent nanomaterial-enabled biosensors (nanobiosensors) have already proven their utility for the diagnosis of several viral infections, as various detection strategies based on nanobiosensor devices are already present, and several other methods are also being investigated by researchers for the determination of SARS-CoV-2 disease; however, considerably more is undetermined and yet to be explored. Hence, this review highlights the utility of various nanobiosensor devices for SARS-CoV-2 determination. Further, it also emphasizes the future outlook of nanobiosensing technologies for SARS-CoV-2 diagnosis.

Mucinous Carcinoma of the Skin: A Case Report.

Primary mucinous carcinoma of the skin is a rare malignant neoplasm showing predilection to the periorbital region. These tumours are indolent and low-grade, with a tendency for local, sometimes multiple, recurrences. Distinguishing between these primary neoplasms and the more frequent metastatic mucinous deposits on the skin from primaries in the breast and gastrointestinal tract constitutes a diagnostic dilemma. In this case report, we have put forth the findings of a 70-year-old male who presented with a slow-growing periorbital swelling and was subsequently diagnosed with mucinous adenocarcinoma. An extensive workup in search of another primary tumour failed to show a primary malignancy elsewhere and the diagnosis of primary mucinous adenocarcinoma of the skin was rendered. Keywords: case reports; mucinous carcinoma; Nepal; sialomucins.

Benign Skin Neoplasms among the Histopathological Specimens of Skin Neoplasm in a Teaching Hospital: A Descriptive Cross-sectional Study.

INTRODUCTION: Skin tumors are relatively uncommon malignancies worldwide, but its incidence has been progressively increased over the last few decades. Skin tumor belongs to a diverse group of neoplasms arising from the epidermis, adnexal structures and dermis rendering the classification difficult. The study aims to find out the prevalence of benign skin neoplasm among the histopathological specimens of skin neoplasm of a teaching hospital. METHODS: A descriptive cross-sectional study among the hospital records of histopathological samples of skin neoplasm in the Department of Pathology of a tertiary care center from January 2017 to December 2020. Ethical approval was taken from the Institutional Review Committee (Ref: MEMG/IRC/427/GA). Convenient sampling was done. Data were entered in Microsoft Excel and analyzed using Statistical Package for the Social Sciences version 21 software. Point estimate at 95% Confidence Interval was calculated with frequency and descriptive statistics. RESULTS: Out of total skin neoplasm samples, 121 (57.34%) (50.67-64.01 at 95% Confidence Interval) benign skin neoplasms were present. Among them, the majority were keratinocytic tumor 81 (66.9%) followed by skin appendageal 23 (19.0%) and melanocytic tumors 17 (14.0%). Acrochordan 18 (14.9%) and pilomatricoma 12 (9.9%) were the predominant keratinocytic and appendageal neoplasms respectively. Most of the cases occurred in head and neck region 64 (52.9%). CONCLUSIONS: The study concluded that the prevalence of benign skin neoplasm was slightly lower compared to the other studies. Most of the benign skin neoplasms were keratinocytic tumors followed by appendageal and melanocytic tumors. Acrochordan was the commonest benign keratinocytic tumor.

Providencia rettgeri infection complicating cranial surgery: illustrative cases.

BACKGROUND: Providencia rettgeri is a rare cause of nosocomial infection in humans. These organisms are capable of biofilm production and are intrinsically resistant to commonly used antibiotics, leading to high rates of morbidity and mortality. P. rettgeri may very rarely cause postneurosurgical infection. OBSERVATIONS: In this report, the authors describe two patients in whom P. rettgeri infection complicated the postoperative course. Both the patients underwent craniotomy at approximately the same time under similar environments. The organism isolated was resistant to most of the commonly used antibiotics, and therapy tailored to the results of susceptibility testing led to resolution of infection in both cases. LESSONS: P. rettgeri is a rare cause of postneurosurgical nosocomial infection. Timely identification and early tailoring of antibiotic therapy based on susceptibility testing is the key to treatment. Every effort should be made to identify the source of infection and rectify it so that mortality, morbidity, and financial burden are reduced. Contact isolation and use of sterile gloves after each patient contact are effective in preventing its spread, as in most cases of nosocomial infection.

Histopathology of Sinonasal and Nasopharyngeal Neoplastic Lesions in a Tertiary Care Center of Western Nepal: A Descriptive Cross-sectional Study.

INTRODUCTION: Sinonasal and nasopharyngeal regions harbor diverse clinical conditions including many non-neoplastic and neoplastic lesions presenting with nasal obstruction, facial pain and swelling, rhinorrhea, epistaxis, and other oral, ear, and orbital symptoms. Histopathology of excised lesions is the mainstay for the definitive diagnosis and management of neoplastic lesions. The aim of this study is to find out the prevalence of neoplastic lesions among sinonasal and nasopharyngeal masses. METHODS: This was a descriptive cross-sectional study conducted among sinonasal and nasopharyngeal masses in the Department of Pathology of a tertiary care center of western Nepal with primary data of 20 years from January 2001 to May 2020. Ethical approval was taken from the Institutional Review Committee. Convenience sampling method was used. Data management and statistical analysis were done using Statistical Package for Social Sciences. Point estimate at 95% Confidence Interval was calculated along with frequency and percentage. RESULTS: Out of 395 sinonasal and nasopharyngeal lesions, 134 (33.92%) (29.26-38.58 at 95% Confidence Interval) were neoplastic lesions. The malignant lesions were found to be 60 (44.77%). Inverted papilloma was the most common benign lesion comprising 28 (20.89%) of cases, and squamous cell carcinoma and nasopharyngeal carcinoma were the most common malignant lesions comprising 12 (8.95%) cases each. CONCLUSIONS: This study observed a variety of neoplastic lesions. The most common benign lesion was nasal polyp and squamous cell carcinoma and nasopharyngeal carcinoma were the most common malignant lesions.

Non-neoplastic Lesions of Gallbladder Among Cholecystectomy Specimens of a Tertiary Care Center: A Descriptive Cross-sectional Study.

INTRODUCTION: Gallbladder diseases are prevalent worldwide and present with a diverse histopathological spectrum. Mucosal irritation and chronic inflammation is considered as an important etiological factor for the mechanical or functional dysfunction of emptying of the gallbladder. This study aims to find the prevalence of non-neoplastic lesions of gallbladder among cholecystectomy specimens of a tertiary care center. METHODS: A descriptive cross-sectional study was conducted in the Department of Pathology, of a tertiary care center from January 2005 to December 2020. Ethical approval was taken from the Institutional Review Committee. All the patients who had undergone cholecystectomy procedures which showed non-neoplastic lesions were enrolled in the study. Convenient sampling was done. Statistical Package for Social Sciences version 21 and Microsoft Excel were used for data analysis. Point estimate at 95% Confidence Interval was calculated along with frequency and proportion for binary data. RESULTS: Out of 4914 cholecystectomy specimens, 4852 (98.73%) (95% Confidence Interval= 98.42- 99.04) were non-neoplastic lesions. There were 1252 (25.8%) males and 3600 (74.2%) females with a male to female ratio of 1:2.87. Age ranged from 2 to 89 years with a mean age of 45±14.48 years. Gallbladder lesions were observed maximum in age group 41-50 years with 1200 (24.7%) cases. Among the non-neoplastic lesions, cholecystitis without any specific finding was the most common finding with 3028 (62.4%) cases followed by cholelithiasis with 1478 (30.5%) cases. CONCLUSIONS: The prevalence of non-neoplastic lesions of gallbladder is similar to other studies done in similar setings. Female predominance was noted in non-neoplastic lesions.

Adenosarcoma of Uterus- Rare Biphasic Malignant Tumor: A Case Report.

Uterine adenosarcoma is a rare variant of mixed Mullerian tumors comprised of neoplastic glands with the benign appearance and sarcomatous stroma. The epithelium most often consists of endometrium- like cells, while the sarcomatous component usually shows low-grade homologous uterine sarcoma. These tumors present as a pelvic mass or an enlarged uterus with abnormal vaginal bleeding. Here, we present a case of 61 years old postmenopausal female patient with chief complaints of excessive vaginal bleeding and urine retention.

Relationship between height and osteosarcoma at the time of diagnosis in the Indian population: A retrospective study.

BACKGROUND: It has been indicated in several instances that tall stature is also an important risk factor in the development of osteosarcoma. This relationship between height and osteosarcoma is substantiated even more by the increasing evidences being put forth in the recent literature on dependence of certain tumors on the growth factors and their receptors, acting through autocrine or paracrine mechanisms. There has been no study on the Indian population that attempts to define such a relationship. PURPOSE: The primary objective of this study was to define relationship between height of patients and osteosarcoma at the time of diagnosis in the Indian population. MATERIALS/METHODS: Retrospective data was collected from the old hospital records. Height of patients at the time of diagnosis was compared with expected height of patients of the same age with reference to the standardized growth charts provided by the Indian Academy of Paediatrics. RESULTS: Out of 98 patients, there were 65 male and 33 female patients with M: F ratio being 1.97:1. The mean age at diagnosis was 17 (SD = 8) years with range of 5-55 years (median = 17 years). Height of the patients at the time of diagnosis was 155.18 (SD = 15.47) cm with range of 115 cm-184 cm (median = 159 cm). Overall, patients with Osteosarcoma were found to be shorter than the expected height deduced from the national growth charts. When patients were divided into two groups of those who were of growing age and those who had completed growth, results were similar. CONCLUSION: The observation that majority of patients with osteosarcoma in our study were stunted, is an important finding. It could be deduced from this observation that these patients are unable to mount the usual biological response to the overstimulated growth as part of tumorigenesis in osteosarcoma. This could point to a different scenario in the Indian population and more studies need to be carried out with larger number of patients to further elaborate on this observation.

Histopathologic Profile of Salivary Gland Tumors among Specimens from a Tertiary Care Hospital: A Descriptive Cross-sectional Study.

INTRODUCTION: Salivary gland tumors are rare, comprising about 3% of all head and neck neoplasms. About 80% of the tumors are in parotids, 10% in submandibular glands and the remainders are distributed in sublingual and minor salivary glands. This study was conducted to evaluate the relative frequencies, types, site of distribution and the histopathological features of salivary gland tumors. METHODS: A descriptive cross-sectional study was conducted in the Department of Pathology, Manipal College of Medical Sciences, Pokhara from January 2011 to December 2019. Ethical approval was taken from the institutional review committee of Manipal College of Medical Sciences (Ref: 314). Convenient sampling was done among specimen. Data were entered in Microsoft Excel and analyzed using Statistical Package for the Social Sciences version 21. RESULTS: Among the 130 specimens, the patients' age ranged from 6 to 78 years with a mean age of 37.26 years for benign tumors and 48.45 years for malignant tumors. There was female predominance with a male to female ratio of 1:1.36. There were 98 cases of benign tumors, commonest being pleomorphic adenoma with 82 (83.67%) cases which was noticed more frequently in fourth decade of life. Among the 32 malignant tumors, mucoepidermoid carcinoma was the commonest tumor 20 (62.5%), followed by adenoid cystic carcinoma 7 (23.33%). CONCLUSIONS: Benign salivary gland tumors were more common than malignant tumors and the most common site of location was the parotid for both the benign and malignant tumors. Female outnumbered the male population in benign tumors whereas males were slightly more than females in malignant tumors. This study corroborated well with other previously published studies.

Histopathological Spectrum of Non-Neoplastic and Neoplastic Lesions of Thyroid: A Descriptive Cross-sectional Study.

INTRODUCTION: Thyroid gland lesions are the most common endocrine disorders encountered globally. Diseases of the thyroid gland present with either an alteration of hormone secretion or as an enlargement of the thyroid gland. The objective of the study is to find the frequency of different thyroid lesions. METHODS: A descriptive cross-sectional study was conducted at Manipal Teaching Hospital, Pokhara from Jan 2005 to Jan 2020. Ethical approval was taken from the Institutional Review Committee (Ref: 330). Patients who had undergone thyroidectomy procedures for both non-neoplastic and neoplastic thyroid lesions were enrolled. Convenient sampling was done. IBM Statistical Package for Social Sciences version 21 and Microsoft Excel were used. RESULTS: Out of 345 thyroidectomy specimens, 246 (71.3%) cases of non-neoplastic lesions, and 99 (28.69%) cases of neoplastic lesions were present. There were 54 males and 291 females with a male to female ratio of 1:5.4. The age ranged from 9 to 76 years with a mean age of 43.67 years. In non-neoplastic lesions, the predominant lesion was the colloid goiter with 205 (83.33%) cases followed by Grave's disease and lymphocytic thyroiditis with 14 (5.69%) cases each. In neoplastic lesions, papillary carcinoma was the commonest lesion with 56 (56.56%) cases followed by follicular carcinoma with 14 (14.14%) cases and follicular adenoma with 13 (13.13%) cases. There were also 9 (9.09%) cases of anaplastic carcinoma in neoplastic lesions. CONCLUSIONS: Colloid goiter and papillary carcinoma was the most commonly encountered non-neoplastic and neoplastic lesion with a female predominance. Rare tumors like anaplastic carcinoma, papillary carcinoma, and follicular carcinoma with anaplastic transformation were also encountered.

A Misdiagnosed Case of Hypertrophic Gastropathy.

Hypertrophic gastropathy is a rare idiopathic hyperproliferative disorder which may present as Menetrier's disease (MD) characterized by foveolar hyperplasia in the gastric fundus and body. It is often accompanied by a severe loss of plasma proteins (including albumin) from the altered gastric mucosa. The disease occurs in two forms, a childhood form due to cytomegalovirus infection and an adult form attributed to overexpression of transforming growth factor-alpha (TGF-α). The most common symptoms include epigastric pain with fullness and vomiting and generalized peripheral edema with hypoalbuminemia. We present a case of 75-year-old female presenting with epigastric pain and vomiting. Upper gastrointestinal endoscopy and computed tomography scan revealed an irregular mucosal fold at the body and antrum and thickening of the stomach wall, respectively. Though the endoscopic gastric mucosal biopsy was nonspecific, the patient underwent partial gastrectomy due to clinicoradiological suspicion of carcinoma. On histopathology, the case was reported as hypertrophic gastropathy, consistent with MD. Though there is a strong clinical and radiological suspicion of malignancy in the hypertrophied gastric mucosa, MD should be one of the important differential diagnoses.

Hydatidosis of infratemporal fossa with proptosis - an unusual presentation: a case report and review of the literature.

BACKGROUND: Hydatid disease is one of the common zoonotic diseases caused by the larval stage of Echinococcus granulosus. It is endemic in sheep-raising and cattle-raising areas worldwide and humans are an accidental intermediate host following the ingestion of the larvae. Head and neck involvement of echinococcosis is a rare entity and involvement of the infratemporal region is extremely rare even in endemic areas. Only a few cases of hydatid cysts located in the infratemporal fossa have been reported in the literature. Moreover, extension of the hydatid cyst into the intraorbital region and infiltrating into the surrounding orbital bone is even rarer. CASE PRESENTATION: We present a case of a 65-year-old Gurung Nepalese woman with painless proptosis of her left eyeball of 2 months' duration with recent progressive diminution of vision for 15 days. Radiological findings showed a cystic mass in the left infratemporal fossa extending into the left orbit and involving the surrounding orbital bone. Surgical removal was carried out. On histopathological evaluation, it was reported as hydatid cyst infiltrating into the bone. She was prescribed albendazole and discharged after surgery. However, she was lost to follow up and returned after 15 months with recurrence and proptosis of the same eye. Repeat excision of the lesion was carried out and postoperatively she was administered tablet albendazole. She was found to be disease free after 6 months of follow up. CONCLUSIONS: Clinical and radiological findings are important but may not be sufficient in the preoperative diagnosis of hydatid disease especially if rare sites are involved. Proptosis may be seen in several conditions and orbital or infratemporal hydatidosis, although rare, should be considered a differential diagnosis.

Warty Carcinoma Penis: An Uncommon Variant.

Penile carcinoma frequency varies widely in different parts of the world and comprises 1-10% of all the malignancies in males. Majority of the cases of penile carcinoma are squamous cell carcinoma of penis comprising 60% to 70% of all cases. Warty carcinoma of penis is an unusual neoplasm and a variant of penile squamous cell carcinoma comprising 5%-10% of all the variants. The other histological variants include basaloid, verrucous, papillary, sarcomatous, mixed, and adenosquamous carcinoma. The various histological entities with an exophytic papillary lesions including warty carcinoma are together referred to as the "verruciform" group of neoplasms. The warty carcinoma has to be differentiated from these lesions and is typically distinguished by histological features of hyperkeratosis, arborescent papillomatosis, acanthosis, and prominent koilocytosis with nuclear pleomorphism. We present a case of 65-year-old male with growth measuring 6 × 4 cm in the penis who underwent total penectomy and was diagnosed as warty carcinoma penis.

Squamous cell carcinoma arising in familial gingival fibromatosis-a rare case report.

Familial gingival fibromatosis is a rare hereditary condition due to chromosomal abnormality which can occur as an isolated disease or as part of a syndrome and has an incidence of 1:350 000. This condition leads to esthetic, functional, psychological and masticatory disturbance of the oral cavity. Here, we present a case of 21-year-old female with severe enlargement of gums in maxilla and mandible. Deciduous teeth were erupted at normal age but the permanent teeth in the oral cavity were not erupted. Her grandmother, father and younger sister were also affected with the same condition. Incisional biopsy from the chronic ulcerated gingiva showed squamous cell carcinoma. Patient was referred to other cancer institution, where metastases to lung, bone and lymph node was detected on CT scan. The diagnosis was made based on clinical examination, family history and histopathological examination.

Diffuse vascular malformation of large intestine clinically and radiologically misdiagnosed as ulcerative colitis.

Hemangiomas and vascular malformations of the gastrointestinal tract are rare clinical entities that usually present as overt or occult bleeding. They can be distributed throughout the gastrointestinal system, or present as a singular cavernous hemangioma. Overall, 80% of such malformations are of cavernous subtype and are misdiagnosed as hemorrhoids and ulcerative colitis. Mucosal edema, nodularity and vascular congestion can lead to the incorrect diagnosis of inflammatory bowel disease. We present a case of 26-year-old male who presented with pain abdomen, bleeding per rectum and was treated as a case of ulcerative colitis for past 12 years on the basis of clinical and radiological features. As the patient did not respond, subtotal colectomy was done which on histopathologically reported as cavernous vascular malformation-diffuse infiltrating (expansive type).

Basal Cell Carcinoma in Cases with or without Xeroderma Pigmentosum.

INTRODUCTION: Basal cell carcinoma is the most common form of cancer in humans and comprises the vast majority of skin cancers. It predominantly affects fair-skinned individuals, and its incidence is rapidly increasing. The objective of the study is to identify the epidemiology, its topography and different histological subtypes of basal cell carcinoma in patients with or without Xeroderma Pigmentosum. METHODS: A cross-sectional descriptive study was conducted at Manipal Teaching Hospital, Pokhara from Jan 2009 to Dec 2016. Ethical approval was taken from MEMG/IRC/GA. The study included patients with a confirmed diagnosis of basal cell carcinoma irrespective of their age and sex. RESULTS: This study showed 77 individuals with 91 biopsies of BCC including 5 cases of Xeroderma Pigmentosum. The predominant histological subtype was nodular with 41 (53.94%) cases, followed by the 14 (18.42%) cases of pigmented and 10 (13.15%) cases baso-squamous subtype. The most frequent sites of involvement were the head and neck, with predominance in the nasal and orbital region. The mean age was 57.68 years but the basal cell carcinoma in cases of Xeroderma Pigmentosum was seen more in younger age groups. There were 43 (55.84 %) male patients and 34 (44.16 %) female patients with a male to female ratio of 1.26:1. CONCLUSIONS: Nodular and pigmented varieties were the most frequent subtypes with nose being the commonest site of involvement. Basal cell carcinomas in cases of Xeroderma Pigmentosum were noted in younger age group with multiple lesions.

Clinicohematological Study of Pancytopenia in a Tertiary Care Hospital of Western Region of Nepal.

INTRODUCTION: Pancytopenia is a relatively common hematological entity and is a manifestation of many illnesses which can be life threatening at times. The severity of pancytopenia and the underlying pathology determine the management and prognosis. This study was conducted to evaluate hematological and bone marrow findings in patients presenting with pancytopenia. METHODS: A prospective observational study was conducted in Department of Pathology, Manipal College of Medical Sciences, Pokhara from January 2011 to December 2016. Clinical and hematological parameters including bone marrow aspiration and biopsy were evaluated in all patients who presented with pancytopenia. RESULTS: Among 138 cases studied, patients' age ranged from 2 to 82 years with a mean age of 43.95 years, and there was male predominance. Most of the patients presented with generalized weakness, pallor, dypnoea and fever. Hypoplastic marrow was seen in 38 (27.5%) cases, followed by 26 (18.8%) cases of megaloblastic anemia and 19 (13.76%) cases of acute leukemia. Other findings included one case each of hemophagocyosis, leishmaniasis, plasmodium vivex malaria and metastatic carcinoma. CONCLUSIONS: This study highlights that pancytopenia is a common hematological problem and that the study of detailed primary hematological investigations along with bone marrow study in patients with pancytopenia will help to identify the cause for further planning and management.

Effect of a participatory intervention with women's groups on birth outcomes in Nepal: cluster-randomised controlled trial.

BACKGROUND: Neonatal deaths in developing countries make the largest contribution to global mortality in children younger than 5 years. 90% of deliveries in the poorest quintile of households happen at home. We postulated that a community-based participatory intervention could significantly reduce neonatal mortality rates. METHODS: We pair-matched 42 geopolitical clusters in Makwanpur district, Nepal, selected 12 pairs randomly, and randomly assigned one of each pair to intervention or control. In each intervention cluster (average population 7000), a female facilitator convened nine women's group meetings every month. The facilitator supported groups through an action-learning cycle in which they identified local perinatal problems and formulated strategies to address them. We monitored birth outcomes in a cohort of 28?931 women, of whom 8% joined the groups. The primary outcome was neonatal mortality rate. Other outcomes included stillbirths and maternal deaths, uptake of antenatal and delivery services, home care practices, infant morbidity, and health-care seeking. Analysis was by intention to treat. The study is registered as an International Standard Randomised Controlled Trial, number ISRCTN31137309. FINDINGS: From 2001 to 2003, the neonatal mortality rate was 26.2 per 1000 (76 deaths per 2899 livebirths) in intervention clusters compared with 36.9 per 1000 (119 deaths per 3226 livebirths) in controls (adjusted odds ratio 0.70 [95% CI 0.53-0.94]). Stillbirth rates were similar in both groups. The maternal mortality ratio was 69 per 100000 (two deaths per 2899 livebirths) in intervention clusters compared with 341 per 100000 (11 deaths per 3226 livebirths) in control clusters (0.22 [0.05-0.90]). Women in intervention clusters were more likely to have antenatal care, institutional delivery, trained birth attendance, and hygienic care than were controls. INTERPRETATION: Birth outcomes in a poor rural population improved greatly through a low cost, potentially sustainable and scalable, participatory intervention with women's groups.