Cohort Study In India Research Articles

Does induction or augmentation of labor increase the risk of postpartum hemorrhage in pregnant women with anemia? A multicenter prospective cohort study in India.

To investigate whether induction/augmentation of labor in pregnant women with anemia increases the risk of postpartum hemorrhage (PPH) and whether this risk varied by indications for labor induction/augmentation and by anemia severity in pregnancy. In a prospective cohort study of 9420 pregnant women from 13 hospitals across India, we measured hemoglobin concentrations at recruitment (≥28 weeks of gestation) and blood loss after childbirth during follow-up and collected clinical information about PPH. Clinical obstetric and childbirth information at both visits were extracted from medical records. Anemia severity in the third trimester was categorized using hemoglobin concentrations (no/mild anemia: hemoglobin ≥10 g/dL; moderate: hemoglobin 7 to 9.9 g/dL; severe: hemoglobin <7 g/dL), while PPH was defined based on blood loss volume (vaginal births: ≥500 mL or cesarean sections: ≥1000 mL) and clinical diagnosis. Indications for labor induction/augmentation were classified as clinically indicated and elective as per guidelines. We performed multivariable modified Poisson regression analyses to investigate the associations of anemia severity and indications for labor induction/augmentation, including their interaction, with PPH, adjusted for potential confounders. PPH was associated with anemia but not with indications for labor induction/augmentation. However, there was a significant interaction between the two factors in relation to PPH (P = 0.003). Among pregnant women with severe anemia, a higher risk of PPH was associated with elective (adjusted risk ratio, 3.44 [95% confidence interval, 1.29-9.18]) but not with clinically indicated (adjusted risk ratio, 1.22 [95% confidence interval, 0.42-3.55]) labor induction/augmentation. No associations were observed among pregnant women with no/mild and moderate anemia. The risk of PPH is higher in women who have moderate-severe anemia in late pregnancy. Induction/augmentation of labor is generally safe for women with anemia, but it can increase the risk of PPH in women with severe anemia if performed electively.

Evaluation of Short-term Functional Mobility Outcomes in Patients with Traumatic Lower Limb Amputations: A Prospective Cohort Study in India

Evaluation of Short-term Functional Mobility Outcomes in Patients with Traumatic Lower Limb Amputations: A Prospective Cohort Study in India

One-year continuation of postpartum intrauterine contraceptive device: Findings from a prospective cohort study in India

One-year continuation of postpartum intrauterine contraceptive device: Findings from a prospective cohort study in India

Prevalence of DSM-5 mild and major neurocognitive disorder in India: Results from the LASI-DAD.

India, with its rapidly aging population, faces an alarming burden of dementia. We implemented DSM-5 criteria in large-scale, nationally representative survey data in India to characterize the prevalence of mild and major Neurocognitive disorder. The Harmonized Diagnostic Assessment of Dementia for the Longitudinal Aging Study in India (LASI-DAD) (N = 4,096) is a nationally representative cohort study in India using multistage area probability sampling methods. Using neuropsychological testing and informant reports, we defined DSM-5 mild and major neurocognitive disorder, reported its prevalence, and evaluated criterion and construct validity of the algorithm using clinician-adjudicated Clinical Dementia Ratings (CDR)®. The prevalence of mild and major neurocognitive disorder, weighted to the population, is 17.6% and 7.2%. Demographic gradients with respect to age and education conform to hypothesized patterns. Among N = 2,390 participants with a clinician-adjudicated CDR, CDR ratings and DSM-5 classification agreed for N = 2,139 (89.5%) participants. The prevalence of dementia in India is higher than previously recognized. These findings, coupled with a growing number of older adults in the coming decades in India, have important implications for society, public health, and families. We are aware of no previous Indian population-representative estimates of mild cognitive impairment, a group which will be increasingly important in coming years to identify for potential therapeutic treatment.

Comparing patient-reported outcomes of the Oxford Ankle and Foot Questionnaire in children with clubfoot from two different geographic and cultural environments: a cohort study in India and Canada.

The purpose of this study is to compare the results of the Oxford Ankle and Foot Questionnaire (OxAFQ) in children with clubfoot in Canada and India to assess its ability to predict outcomes and capture patient experiences in different cultural contexts. This is a retrospective study of children with clubfoot in India and Canada who completed the OxAFQ. Statistical analyses were implemented on registry-collected data to test for independent predictors of poor outcomes and compare scores between countries, among children and their parents, and in Canada where relapse data was collected and the effect of a relapse on scores. A total of 361 children were included. The mean Indian OxAFQ scores were higher (p < 0.001) in all domains. Pirani score, tenotomy, laterality, and age at presentation were found to be predictive of outcomes between the sites (p < 0.05). OxAFQ scores decreased after relapse for children in Canada (p < 0.05). Canadian children were found to generally have lower OxAFQ scores in all domains compared to their parents (n = 95; Z = -3.178, -3.493, -3.353, and -3.635 for physical, school and play, emotion, and footwear, respectively; p < 0.001). Indian parents and children showed no significant differences in their scores. A difference was observed in scores between both sites, suggesting there may be differences in how these populations assess personal health outcomes. These findings support the need for cultural validity of patient-reported outcome measures.

Maternal depressiveness and infant growth outcomes: Findings from the MAASTHI cohort study in India

ObjectiveThe study aims to examine the association between depressiveness in mothers on infant obesity and stunting at one year of age. MethodsWe enrolled 4829 pregnant women, followed them up at public health facilities in Bengaluru for one year after birth. We collected information on women's sociodemographic characteristics, obstetric history, depressive symptoms during pregnancy and delivery within 48 h. We took infant anthropometric measurements at birth and one year. We used chi-square tests, and calculated an unadjusted odds ratio using univariate logistic regression. We used multivariate logistic regression to examine the association between maternal depressiveness, childhood adiposity, and stunting. ResultsWe found that the prevalence of depressiveness was 31.8% in mothers who delivered in public health facilities in Bengaluru. Infants born to mothers with depressiveness at birth had 3.9 times higher odds of having larger waist circumference than infants born to mothers with no depressiveness (AOR: 3.96, 95% Confidence Interval: 1.24,12.58) and 1.9 times higher odds of having a larger sum of skinfold thickness (AOR: 1.99, 95% CI: 1.18,3.38). Additionally, we found that infants born to mothers with depressiveness at birth had 1.7 times higher odds of stunting than infants born to mothers with no depressiveness (AOR: 1.72; 95%CI: 1.22,2.43) after adjusting for confounders. ConclusionOur study highlights a high prevalence of depressiveness among mothers seeking antenatal care at a public hospital is associated with an increased risk of infant adiposity and stunting at one year. Further research is needed to understand the underlying mechanisms and identify effective interventions.

Feasibility of the International Wealth Index and the Gapminder tool as instruments to assess household income and estimate catastrophic expenditure: A prospective patient-level cohort study in India.

Patient income assessment is required to assess healthcare catastrophic expenditure (Sustainable Development Goal) but self-reported income has several biases. This study aimed to assess the feasibility of the International Wealth Index (IWI) and the Gapminder tool as indirect instruments to assess household income. Prospective cohort study of colorectal cancer patients in five tertiary care hospitals in India (Dec 2020-August 2021). Patient self-reported household income was compared to income estimated from the IWI (twelve questions about household goods) and the Gapminder tool (five pictures of household assets). Agreement between instruments was explored with Bland-Altman methods. Cancer care expenditure from the same cohort was used to illustrate the impact of these tools in catastrophic expenditure rates. From the 226 patients included, 99.5% completed the IWI and the Gapminder tool. Overall, self-reported incomes were lower than the estimated from the IWI and Gapminder tools (median incomes: 17350₹ for self-reported, 37491₹ for IWI and 51520₹ for Gapminder). The IWI showed better agreement with the self-reported income than the Gapminder tool. For both instruments, the agreement was better for low income earning households. Illustrative catastrophic expenditure rates range from 71% to 56% to 43% when using self-reported, IWI and Gapminder incomes respectively. It is feasible to use the IWI and the Gapminder tools to estimate household income although they might overestimate income, with an impact on catastrophic expenditure rates. Further refinement of these tools could enable global monitoring and modelling of catastrophic expenditure from real-world data, at low burden for patients.

The Post-Vaccination Quantitative Total Immunoglobulin Levels against SARS-CoV-2 in Healthcare Workers: A Multi-Centric Cohort Study in India.

Healthcare workers (HCWs) in India received the AZD1222 and BBV152 vaccines from January 2021 onwards. The objective of this study was to compare the immune response (seropositivity rate and geometric mean titer (GMT), and 95% confidence interval (CI)] against severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) in HCWs who received these vaccines, after the first and second doses. Therefore, the total immunoglobulin (Ig) levels specific to SARS-CoV-2 were measured using quantitative enzyme-linked immunosorbent assay (ELISA). The study population of 133 HCWs consisted of two groups in which the immune response was measured for the AZD1222 and BBV152 vaccines. Data collection was performed from 6 February to 20 August 2021. Four weeks after the first and second dose, the odds ratio of seroconversion for AZD1222 and BBV152 vaccine was 10.3 times (95% CI: 4.5–23.7) and 15.9 times (95% CI: 6.3–39.9), respectively. The GMT was 6392.93 and 6398.82 U/mL for AZD1222 and 1480.47 and 990.38 U/mL for BBV152 after the first and second doses, respectively. Both vaccines elicited an immune response, but the seroconversion rate and GMT after each dose were significantly higher for AZD1222 than those for the BBV152 vaccine in this study.

Effect of in utero exposure to SARS-CoV-2 infection on pregnancy outcomes and growth and development of infants: protocol for a multicentre ambispective cohort study in India

IntroductionPoor pregnancy and neonatal outcomes in infants born to COVID-19 positive mothers have been reported, but there is insufficient evidence regarding subsequent growth and development of these children. Our study...

Measuring Tuberculosis Medication Adherence: A Comparison of Multiple Approaches in Relation to Urine Isoniazid Metabolite Testing Within a Cohort Study in India.

BackgroundNonadherence to tuberculosis medications is associated with poor outcomes. However, measuring adherence in practice is challenging. In this study, we evaluated the accuracy of multiple tuberculosis adherence measures.MethodsWe enrolled adult Indians with drug-susceptible tuberculosis who were monitored using 99DOTS, a cellphone-based technology. During an unannounced home visit with each participant, we assessed adherence using a pill estimate, 4-day dose recall, a last missed dose question, and urine isoniazid metabolite testing. We estimated the area under the receiver operating characteristic curve (AUC) for each alternate measure in comparison to urine testing. 99DOTS data were analyzed using patient-reported doses alone and patient- and provider-reported doses, the latter reflecting how 99DOTS is implemented in practice. We assessed each measure’s operating characteristics, with particular interest in specificity—that is, the percentage of participants detected as being nonadherent by each alternate measure, among those who were nonadherent by urine testing.ResultsCompared with urine testing, alternate measures had the following characteristics: 99DOTS patient-reported doses alone (area under the curve [AUC], 0.65; specificity, 70%; 95% CI, 58%–81%), 99DOTS patient- and provider-reported doses (AUC, 0.61; specificity, 33%; 95% CI, 22%–45%), pill estimate (AUC, 0.55; specificity, 21%; 95% CI, 12%–32%), 4-day recall (AUC, 0.60; specificity, 23%; 95% CI, 14%–34%), and last missed dose question (AUC, 0.65; specificity, 52%; 95% CI, 40%–63%).ConclusionsAlternate measures missed detecting at least 30% of people who were nonadherent by urine testing. The last missed dose question performed similarly to 99DOTS using patient-reported doses alone. Tuberculosis programs should evaluate the feasibility of integrating more accurate, objective measures, such as urine testing, into routine care.

Esophageal cancer in relation to alcohol drinking and tobacco use among men in Kerala, India – Karunagappally cohort

BackgroundIn the Karunagappally cohort, esophageal cancer is the third most common cancer with an age-adjusted incidence rate of 6.2 per 100,000 person-years among men. The present study analyzed the risk of esophageal cancer in relation to alcohol drinking and tobacco use. MethodsThe study included 65,528 men aged 30–84 years in the Karunagappally cohort, India. ResultsPoisson regression analysis showed that alcohol drinking significantly increased (P = 0.027) the risk of esophageal cancer and the relative risk (RR) for current drinkers was 1.6, (95 % confidence interval (CI) = 1.1–2.3). The risk increased significantly in heavy alcohol drinkers (250 g of ethanol or above per day) (RR = 2.1, 95 % CI = 1.2–3.5) (P for trend = 0.014) and among current arrack consumers (RR = 1.8, 95 % CI = 0.99–3.29) (P for trend = 0.025). Current bidi and cigarette smokers showed an increase in the trend of cancer risk. A significantly higher risk was seen in those who had started smoking bidi before the age of 18 years, RR = 1.9 (95 % CI = 1.1–3.3) (P for trend = 0.044). Furthermore, increased RR for heavy bidi and cigarette smokers were 1.6 (95 % CI = 1.1–2.5) and 2.4 (95 % CI = 1.3–4.5), respectively. ConclusionTo the best of our knowledge, this is the first cohort study in India to report an increased esophageal cancer risk with respect to alcohol drinking.

Relationship between Anaemia, Coagulation Parameters During Pregnancy and Blood Loss in Childbirth: A Prospective Cohort Study in India

Background: Moderate (Haemoglobin (Hb) 7-9.9g/dl) and severe anaemia (Hb <7g/dl) during pregnancy increase the risk of postpartum haemorrhage (PPH). Objectives were to investigate the association between coagulation parameters and severity of anaemia during pregnancy and relate these to blood loss at childbirth. Methods: A prospective cohort study of 1342 pregnant women in the third trimester from 10 hospitals across India. Hb and coagulation parameters: fibrinogen, D-dimer, D-dimer/fibrinogen ratio, platelets, and INR were measured at baseline. Participants were followed-up to measure blood loss within two-hours after childbirth, and ‘high blood loss’ was measured for a threshold ≥500ml. Associations between coagulation parameters, anaemia and blood loss were examined. Findings: In women with severe anaemia during the third trimester, the D-dimer was 27% higher, mean fibrinogen 117mg/dl lower, D-dimer/fibrinogen ratio 69% higher, and INR 12% higher compared to women with no/mild anaemia. Mean platelets in severe anaemia was 37.8X109/L lower compared with women with moderate anaemia. Similar relationships with smaller effect sizes were identified for women with moderate anaemia compared with women with no/mild anaemia. Lower Hb at baseline significantly increased the odds of high blood loss at childbirth, and a stronger effect was moderated by an increase in D-dimer. Interpretation: Altered blood coagulation profile in pregnant women with severe anaemia may be a risk factor for PPH and requires further evaluation. Funding Statement: The study is funded by a Medical Research Council (GCRF) Career Development Award to Manisha Nair (Grant Ref: MR/P022030/1) and Nuffield Department of Population Health – Pumppriming award. Declaration of Interests: The authors declare that they have no competing interests. Ethics Approval Statement: The study was approved by the institutional review boards (IRB) of each coordinating Indian institution, namely: Srimanta Sankaradeva University of Health Sciences, Guwahati, Assam; Nazareth hospital, Shillong, Meghalaya; Emmanuel Hospital Association, New Delhi; Mahatma Gandhi Institute of Medical Sciences, Sevagram, Maharashtra; and the Institute of Medical Sciences, Banaras Hindu University, Varanasi, Uttar Pradesh. It also received approval from the Government of India’s Health Ministry’s Screening Committee, the Indian Council of Medical Research, New Delhi and by the Oxford Tropical Research Ethics Committee (OxTREC), University of Oxford, UK. Written informed participant consent was taken from all participants.

Comparing effectiveness of high-dose Atorvastatin and Rosuvastatin among patients undergone Percutaneous Coronary Interventions: A non-concurrent cohort study in India.

Atorvastatin-80mg/day and Rosuvastatin-40mg/day are the commonest high-dose statin (3-hydroxy-3-methylglutaryl coenzyme-A reductase inhibitors) regimes for post-PCI (Percutaneous Coronary Interventions) patients to lower (by ≥50%) blood low-density-lipoprotein cholesterol (LDL-C). Dearth of conclusive evidence from developing world, regarding overall safety, tolerability and comparative effectiveness (outcome/safety/tolerability/endothelial inflammation control) of Rosuvastatin over Atorvastatin in high-dose, given its higher cost, called for an overall and comparative assessment among post-PCI patients in a tertiary cardiac-care hospital of Kolkata, India. A record-based non-concurrent cohort study was conducted involving 942 post-PCI patients, aged 18-75 years, on high-dose statin for three months and followed up for ≥one year. Those on Atorvastatin-80mg (n = 321) and Rosuvastatin-40mg (n = 621) were compared regarding outcome (death/non-fatal myocardial infarction: MI/repeated hospitalization/target-vessel revascularisation/control of LDL and high-sensitivity C-reactive protein: hsCRP), safety (transaminitis/myopathy/myalgia/myositis/rhabdomyolysis), tolerability (gastroesophageal reflux disease: GERD/gastritis) and inflammation control adjusting for socio-demographics, tobacco-use, medications and comorbidities using SAS-9.4. Groups varied minimally regarding distribution of age/gender/tobacco-use/medication/comorbidity/baseline (pre-PCI) LDL and hs-CRP level. During one-year post-PCI follow up, none died. One acute MI and two target vessel revascularizations occurred per group. Repeated hospitalization for angina/stroke was 2.18% in Atorvastatin group vs. 2.90% in Rosuvastatin group. At three-months follow up, GERD/Gastritis (2.18% vs 4.83%), uncontrolled hs-CRP (22.74% vs 31.08%) and overall non-tolerability (4.67% vs. 8.21%) were lower for Atorvastatin group. Multiple logistic regression did show that compared to Atorvastatin-80mg, Rosuvastatin-40mg regime had poorer control of hs-CRP (A3OR = 1.45,p = 0.0202), higher (A3OR = 2.07) adverse effects, poorer safety profile (A3OR = 1.23), higher GERD/Gastritis (A3OR = 1.50) and poorer overall tolerability (A3OR = 1.50). Post-PCI high dose statins were effective, safe and well-tolerated. High dose Rosuvastatin as compared to high dose Atorvastatin were similar in their clinical efficacy. Patients treated with Atrovastatin had significantly lower number of patients with hs-CRP (high-sensitivity C-reactive protein)/C-reactive protein (CRP) level beyond comparable safe limit and relatively better tolerated as opposed to Rosuvastatin-40mg.Thus given the lower price, Atorvastatin 80mg/day appeared to be more cost-effective. A head-to-head cost-effectiveness as well as efficacy trial may be the need of the hour.

Predictors of long-term retention on opioid agonist treatment with buprenorphine: a 6-year, community-based retrospective cohort study in India

ABSTRACT Introduction: Most studies on opioid agonist treatment (OAT) from South Asia have assessed retention over short term. The aim of this study was to assess retention rates on buprenorphine-based OAT in a community clinic at 6 years, and to assess factors associated with long-term retention. Methods: Retrospective cohort study. Consecutive case records of patients with opioid dependence syndrome (as per International Classification of Diseases, Version 10) started on buprenorphine from 2005 to 2007 were reviewed for 6 years after an individual’s initiation on buprenorphine. Multi-variate logistic regression and odd’s ratio was used to assess variables that could predict retention to buprenorphine. Results: The OAT retention rate of 150 participants by the sixth year was 36%. Mean dose of buprenorphine was 6.4 milligram per day (SD: 2.3). Opioid withdrawals (OR: 0.05, 95% CI: 0.01–0.52), concomitant opioid use (OR: 0.02, 95% CI: 0–0.14), and visits to counselor (OR: 0.1, 95%CI: 0.01–0.87) predicted poor retention to buprenorphine maintenance. Improved occupational functioning (OR: 14.08, 95%CI: 4.62–42.93) significantly predicted OAT retention. Adjusting for other variables, illicit opioid use (OR: 0.04, 95%CI: 0–0.37) negatively predicted, while improved occupational functioning (OR: 12.96, 95%CI: 3.43–48.91) positively predicted retention. Conclusion: Patients have fairly good long-term retention rates on OAT with buprenorphine in community-based setting. Maintaining abstinence and improved occupational functioning improve buprenorphine retention.

Comparison of emergency department trauma triage performance of clinicians and clinical prediction models: a cohort study in India

ObjectiveThe aim of this study was to evaluate and compare the abilities of clinicians and clinical prediction models to accurately triage emergency department (ED) trauma patients. We compared the decisions...

Maternal Nutrition and Inadequate Gestational Weight Gain in Relation to Birth Weight: Results from a Prospective Cohort Study in India.

Inadequate/excessive gestational weight gain (GWG) can cause adverse pregnancy outcomes and only few studies have described patterns of weight gain in Indian women. Also, studies pertaining to dietary intake throughout gestation are insufficient. This prospective cohort study was conducted to evaluate GWG and nutrient intake in all trimesters of pregnancy and investigate the relationship between themselves along with that of birth weight (BW). Our study was carried out in a population-based prospective birth cohort in Odisha, India. The 418 pregnant women were followed till delivery with measurements of maternal weight, weight gain throughout gestation, and BW. Macronutrients were assessed based on a 24-hour dietary recall method in each trimester. Women characterized by under-weight pre-pregnancy body mass index (BMI) were 16.20%, and a total of 6.45% did not comply with current weight gain recommendations. Particularly, overweight and obese women gained more weight than recommended. In a multivariate analysis GWG correlated significantly with BMI (p = 0.03), total calorie intake (p < 0.001) and fat intake (p < 0.001), while BW of newborns correlated significantly with adequacy of weight gain and fat intake (p < 0.001). Though measures are taken by health workers to record the weight but nutritional counseling is not being provided regularly. A high priority should be given to increase awareness among general population regarding the importance of diet in pregnancy and how to adhere to the balanced diet for optimal growth of child.

Maternal anaemia and maternal, fetal, and neonatal outcomes in a prospective cohort study in India and Pakistan.

To describe the association of maternal anaemia with maternal, fetal, and neonatal outcomes. Prospective cohort study. Rural India and Pakistan. Pregnant women residing in the study catchment area. We performed an analysis of a prospective pregnancy registry in which haemoglobin is commonly obtained as well as maternal, fetal, and neonatal outcomes for 42days post-delivery. Women 40years or older who delivered before 20weeks or had a haemoglobin level of <3.0g/dl were excluded. Our primary exposure was maternal anaemia, which was categorised in keeping with World Health Organization criteria based on a normal (≥11g/dl), mild (>10-10.9g/dl), moderate (7-9.9g/dl) or severe (<7g/dl). haemoglobin level. The primary maternal outcome was maternal death, the primary fetal outcome was stillbirth, and the primary neonatal outcome was neonatal mortality <28days. A total of 92247 deliveries and 93107 infants were included, of which 87.8% were born to mothers who were anaemic (mild 37.9%, moderate 49.1%, and severe 0.7%). Maternal mortality (number per 100000) was not associated with anaemia: normal 124, mild 106, moderate 135, and severe 325 (P=0.64). Fetal and neonatal mortality was associated with severe anaemia: stillbirth rate (n/1000)-normal 27.7, mild 25.8, moderate 30.1, and severe 90.9; P<0.0001; 28-day neonatal mortality (n/1000)-normal 24.7, mild 22.9, moderate 28.1, and severe 72.6 (P<0.0001). Severe maternal anaemia was also associated with low birthweight (<2500and <1500g), preterm birth, and postpartum haemorrhage. Severe maternal anaemia is associated with higher risks of poor maternal, fetal, and neonatal outcomes but otherdegrees of anaemia are not. Interventions directed at preventing severe anaemia in pregnant women should be considered. Severe maternal anaemia is associated with adverse fetal and neonatal outcomes in low/middle-income countries.

One-year continuation of postpartum intrauterine contraceptive device: findings from a retrospective cohort study in India

ObjectiveTo evaluate outcomes of a national postpartum (within 48 h of delivery) copper intrauterine device placement (PPCuIUD) program in six “high-focus states” with high unmet family planning need in India. Study designWe identified high-volume district hospitals that provided PPCuIUD in six (Bihar, Jharkhand, Uttar Pradesh, Uttarakhand, Madhya Pradesh and Chhattisgarh) Indian states (two per state). Each selected hospital maintained a list of PPCuIUD acceptors with contact phone numbers. We randomly selected 100 women at each site for inclusion in a telephone survey of IUD outcomes at 1 year. Questions regarded IUD expulsion, discontinuation because of symptoms (e.g., pain, bleeding, discharge), discontinuation for other reasons and use of alternative contraception if discontinuation reported. ResultsWe could contact 844 of the 1200 randomly selected women, of whom 673 (79.7%) had postplacental insertion (within 10 min of delivery), while 171 (20.3%) had an early postpartum insertion (between 10 min to 48 h after delivery). Of those contacted, 530 women (62.8%) reported continuing with the method beyond 1 year, 63 (7.5%) reported having an expulsion, 163 (19.3%) reported having removals for associated side effects (bleeding, pain and discharge), and 88 (10.4%) reported having removals for other reasons. After removal or expulsion, almost half of the women (46.5%) did not switch to any other modern contraceptive method. ConclusionPPCuIUD continuation rate at 1 year was 62.8%. Most removals within 1 year were due to associated side effects. Almost half of the women discontinuing PPCuIUD did not switch to an alternative modern contraceptive method. ImplicationsThe 1-year continuation rate of PPCuIUD achieved through a large-scale national program in India is satisfactory. The program though needs to address the low uptake of other modern contraceptive methods after discontinuation.

262 Reducing Mortality in Near-Hanging Patients With a Novel Early Management Protocol: A Prospective Cohort Study in India

262 Reducing Mortality in Near-Hanging Patients With a Novel Early Management Protocol: A Prospective Cohort Study in India

Safety and tolerability of intrathecal liposomal amphotericin B (AmBisome) for cryptococcal meningitis: a retrospective study in HIV-infected patients.

While mortality of HIV-related cryptococcal meningitis (CM) in developed countries is relatively low, in developing countries over half of patients die within 10 weeks. Current recommended therapies are often not suitable for resource-poor settings, and new shorter regimens are urgently needed. Intrathecal administration of liposomal amphotericin B (lAmB) has shown promising results in animal models. However, the safety and tolerability of intrathecal lAmB in humans are not well known. In this retrospective observational study, we report the tolerability and safety of intrathecal lAmB in patients with CM from an HIV cohort study in India. In all, 18 patients were included in the analysis. Six were female and the median age was 40 years [interquartile range (IQR): 35-45]. The median CD4 count was 42 cells/µl (IQR: 19-127). Compared with a historical control group, the hazard ratio for mortality was 0.59 (95% confidence interval: 0.26-1.29). Two patients complained of transient lumbar pain in single occasion. One patient had a skin reaction to chlorhexidine, which was used as skin disinfectant. After initial improvement, one patient requested to stop lumbar punctures for the last 2 days of treatment. Intrathecal lAmB was safe and well tolerated in HIV-infected patients with CM.