The Association of Abnormal Doppler and Abnormal Amniotic Fluid Volume in the Third Trimester of Pregnancy with Preterm Birth in Pregnant Women in Agra, India.

Aim This article determines the association and diagnostic effectiveness of abnormal Doppler and abnormal amniotic fluid volume (AFV) in the third trimester of pregnancy with preterm births. Methods The third trimester screening protocol of the Samrakshan program of the Indian Radiological and Imaging Association utilizes trimester-specific fetal Doppler studies and ultrasound assessments, estimation of the risk for preterm preeclampsia (PE), assessment of the fetal environment, growth, and structure, and staging of fetal growth restriction. A multivariate logistic regression model was used to explore associations of abnormal Doppler and AFV with preterm birth. The diagnostic effectiveness of Doppler and amniotic fluid measurements for preterm births was assessed. Results One hundred and sixty-one (25.6%) of the 630 women had a preterm birth before 37 gestational weeks. Eighty (21.1%) of the 379 women with normal AFV and normal fetal Doppler studies in the third trimester had a preterm birth. The proportion of preterm birth declined from 35.14% in 2019 to 19.53% in 2022 (chi-square test p = 0.009). Preterm birth was associated with preterm PE (adjusted odds ratio: 3.66, 95% confidence interval: 1.42, 9.44) in a multivariate logistic regression model. Both abnormal fetal Doppler and AFV did not have a good discriminatory ability for preterm births. Conclusion Integration of fetal Doppler studies helped reduce the preterm birth rate by providing an objective measure of fetal well-being, contrary to a common belief that the use of color Doppler in the third trimester may result in iatrogenic increased preterm birth. Preterm births are associated with preterm PE and early identification of high-risk women and early initiation of low-dose aspirin may have an added benefit on preterm birth rates.

Samrakshan Yodha Dashboard of Diagnostic and Performance Metrics for Fetal Radiologists.

We used the data collection experience of the initial 3 years of Samrakshan to develop a live dashboard for individual practitioners to examine diagnostic and performance metrics in real-time and to assess trends. The dashboard was created in MS Excel (Microsoft 365 MSO version 2209) and the output provides useful information on actionable items like compliance with low-dose aspirin and estimates of preterm and term pre-eclampsia and fetal growth restriction, congenital anomalies, the proportion of preterm births, and perinatal mortality estimates. The output will help individual practitioners to generate practice-related actionable evidence and can further optimize service delivery for local populations. The dashboard can be used on any platform with MS Excel and does not require the installation of any additional software or license. The dashboard is provided as a free, open-access resource by the Samrakshan Program of Indian Radiological and Imaging Association.

A Comparison of Changes in the Mean Arterial Blood Pressure and Mean Uterine Artery Pulsatility Index from 11-14 to 19-24 + 6 Gestation Weeks in Low-Risk and High-Risk Asian Indian Pregnant Women.

Aim The aim of this study was to determine the changes in the mean arterial blood pressure (MAP) and mean uterine artery (UtA) pulsatility index (PI) from 11-14 to 19-24 + 6 gestation weeks in Asian Indian pregnant women. Methods Clinical and demographic details, MAP, and mean UtA PI measures were ascertained for pregnant women at 11 to 14 gestation weeks and 19-24 + 6 gestation weeks. Women were categorized as a high-or-low risk for preterm preeclampsia using the Fetal Medicine Foundation algorithm and 1 in 150 cutoff. High-risk pregnant women were recommended low-dose aspirin 150 mg daily at bedtime. Changes in MAP and mean UtA PI were compared for gestational age intervals and high-and-low risk women using nonparametric tests. Results The study analyzed the results of 1,163 pregnant women. Both MAP (mean difference: 5.14, p < 0.001) and mean UtA PI (mean difference: 0.14, p < 0.001) remained significantly higher at the second-trimester assessment in high-risk pregnant women compared to low-risk pregnant women. Seventy-seven (35.16%) of the 219 pregnant women with abnormal mean UtA PI in the first trimester had an abnormal mean UtA PI in the second-trimester assessment. One hundred (10.59%) of the 944 pregnant women with normal mean UtA PI in the first trimester had an abnormal mean UtA PI in the 19-24 + 6 weeks assessment. Seventy-seven pregnant women (6.62% of 1,163 women, 95% confidence interval: 5.33, 8.20) had an abnormal mean UtA PI at both gestation age intervals. High-risk pregnant women taking low-dose aspirin daily showed a larger reduction in mean UtA PI compared to high-risk pregnant women that did not report the use of low-dose aspirin (0.89 vs. 0.62, p <0.001) Conclusion MAP and mean UtA PI decreased significantly from the first to the second trimester of pregnancy. Sequential assessment of the MAP and mean UtA PI in the first and second trimesters of pregnancy will be useful for fetal radiologists in India to identify a subgroup of women with abnormal mean UtA PI at both trimesters that may need more intense surveillance and follow-up till childbirth.

Diagnostic Effectiveness of Third-Trimester Fetal Doppler Studies in Pregnancy to Predict Late-and-Term Stillbirth and Neonatal Mortality in the Samrakshan Program in India.

Aim To determine the diagnostic effectiveness of third-trimester fetal Doppler studies in pregnancy for stillbirths and neonatal mortality in the Samrakshan program of the Indian Radiological and Imaging Association (IRIA). Methods The mean uterine artery (UtA) pulsatility index (PI) > 95th percentile, umbilical artery PI > 95th percentile, middle cerebral artery (MCA) PI < 5th percentile, and/or cerebroplacental ratio (CPR) < 5th percentile in the third trimester fetal Doppler study was considered as abnormal. The results of the fetal Doppler study closest to childbirth were considered for analysis. Late stillbirth (SB) was defined as a fetal loss between 28 and 36 gestation weeks and the term SB was defined as a fetal loss at ≥ 37 gestation weeks. Neonatal death was defined as the demise of a live-born baby within the first 28 days of life. Parameters of diagnostic effectiveness such as sensitivity, specificity, positive and negative predictive values and likelihood ratios, diagnostic odds ratio, and the area under receiver operator characteristic (AUROC) curve were assessed. Results Screening of 1,326 pregnant women in the third trimester of pregnancy between September 2019 and February 2022, identified 308 (23.23%) abnormal Doppler studies, 11 (0.83%) SB, and 11 (0.84%) neonatal deaths. An abnormal Doppler study was significantly associated with late stillbirths (OR 37.2, 95% CI: 2.05, 674) but not with term SB (OR: 3.38, 95% CI: 0.76, 15) or neonatal deaths (OR 1.39, 95% CI: 0.40, 4.87). Mean UtA PI, umbilical artery PI, MCA PI, and CPR were significantly associated with late SB and not term SB. The AUROC of Doppler measures was excellent for late SB but did not show discriminatory ability for term SB or neonatal deaths. Conclusion Integration of fetal Doppler with routine third-trimester antenatal scans can help identify pregnant women at high risk for late SB. The effectiveness of fetal Doppler to identify pregnant women at high risk for term SB and neonatal deaths needs further study on a larger sample size.

Effectiveness of the First Trimester Samrakshan Protocol for the Identification of Pregnant Women at High Risk for Preterm Pre-eclampsia.

Aim To determine the effectiveness of the first trimester Samrakshan protocol for the identification of pregnant women at high risk for preterm pre-eclampsia (PE). Methods Samrakshan uses a protocol that integrates routine first-trimester ultrasound assessment at 11 to 14 gestation weeks with the measurement of mean arterial blood pressure and mean uterine artery pulsatility index assessment to determine a customized risk for preterm PE and fetal growth restriction. Based on the risk assessment, pregnant women are classified as high or low risk. Results The protocol had a high specificity (90.4%, 95% CI: 89.4%, 91.2%) and negative predictive value (98.1%, 95% CI: 97.6%, 99%) for preterm PE. The odds ratio and positive likelihood ratio for preterm PE were 16.7 (95% CI: 12.3, 22.6) and 6.64 (95% CI: 5.77, 7.63), respectively. Conclusions The positive likelihood ratio and odds ratios indicate that pregnant women identified as high risk for preterm PE using the first-trimester protocol of Samrakshan are significantly more likely to develop preterm PE than low-risk women.

Impact of the Community-Integrated Model of Samrakshan on Perinatal Mortality and Morbidity in Guna District of Central India.

Aim The aim of this study was to assess the impact of the community-integrated Samrakshan model on perinatal mortality and morbidity in the Guna district of Central India Methods The trimester-specific Samrakshan protocols were used to screen pregnant women in the first, second, and third trimesters of pregnancy and to stratify risk for preterm preeclampsia (PE) and fetal growth restriction (FGR) in the screened population. Low-dose aspirin was recommended for women identified at high risk in the first trimester screening. Fifty training programs were conducted over the duration of the program for district health workers including Anganwadi workers, Accredited Social Health Activist (ASHA) personnel, and women and child health staff. Data on the development of PE, stages of FGR, preterm births (PTBs), birthweight, neonatal mortality, and perinatal mortality were collected and compared with the baseline year to assess trends. Results The program covered 168 Anganwadi centers and screened 1,021 women in the first trimester, 870 women in the second trimester, and 811 women in the third trimester of pregnancy from 2019 to 2022 and obtained details on childbirth outcomes from 1,219 women. PE did not occur in 71.58% of pregnant women identified at high risk for PE and occurred in only 2.37% of pregnant women identified at low risk for PE. The incidence of PE reduced from 9.36 to 1.61%, stage 1 FGR from 18.71 to 11.83%, PTB from 19.49 to 11.25%, and birthweight less than 2,500 g from 33.66 to 21.46% from 2019 to 2022. The neonatal mortality rate reduced from 26 to 7.47/1,000 live births from 2019 to 2022 and the perinatal mortality rate reduced from 33.90 to 18.87/1,000 childbirths from 2019 to 2022 in the Samrakshan program area at Guna. Conclusion The community-integrated model of Samrakshan in the Guna district has led to a significant reduction in perinatal morbidity and mortality in the program area.

Prioritizing Fetal Structural Abnormalities Over Risk for Pre-Eclampsia and Fetal Growth Restriction in the 20-24 Gestation Week Assessment in India: Missing the Woods for the Trees?

Aim To compare the magnitude of fetuses with congenital anomalies, pregnant women identified at high risk for preterm pre-eclampsia (PE) or with preterm PE, and with early fetal growth restriction (FGR) or high risk for FGR at the second trimester assessment at 20 to 24 weeks of gestation. Methods A standardized trimester-specific protocol that included clinical and demographic details, fetal biometry, estimated fetal weight (EFW), fetal abdominal circumference (FAC), mean arterial blood pressure and fetal Doppler studies was used to identify high risk for preterm PE and FGR. The Targeted Imaging for Fetal Anomalies (TIFFA) scan was used to identify congenital anomalies. In addition, 95% confidence intervals of the point estimates were derived, and the p -value was estimated to assess the statistical significance of the difference in proportions. Results Analysis of the data of 4,572 pregnant women screened between 20 and 24 gestation weeks showed a significantly lower prevalence ( p < 0.001) of congenital abnormalities (3.81%) compared to women diagnosed with early PE (2.71%) or with a high risk for PE (4.00%) and women (6.80%) with early FGR or at higher risk for fetal growth restriction with both EFW and FAC < 10th percentile. Conclusion The data on prevalence from Samrakshan show that the second-trimester assessment of pregnant women in India must expand its scope from the TIFFA scan to also focus on screening to identify women at high risk for preterm PE and FGR.

Preterm Birth Rates after Initiating the Third-Trimester Screening Protocol of Samrakshan in India: Initial Results.

Aim To determine the trends in preterm birth (PTB) rates in Samrakshan after initiating a third-trimester screening protocol. Methods The Samrakshan program of IRIA focused on clinical stage-based management of fetal growth restriction (FGR) in the third trimester integrating fetal Doppler studies with routine trimester-specific antenatal scans. Mean uterine artery pulsatility index (PI), umbilical artery PI, middle cerebral artery PI, and cerebroplacental ratio were assessed for all third-trimester pregnant women in the program. Results From 2019 to 2022, 249 (18.33%, 95% CI: 16.34, 20.54) women had PTB with 221 (16.67%, 95% CI: 14.73, 18.75) PTBs between 34 and 37 gestation weeks and 22 (1.66%, 95% CI: 1.10, 2.50) PTBs at gestation < 34 weeks. The overall preterm birth rates showed a significant (chi-square p < 0.001) declining trend each year from 23.18% ( n = 121) in 2019-2020 to 16.81% ( n = 99) in 2020-2021 and 10.75% ( n = 23) in 2021-2022. Conclusion The declining trend of PTB rates in the Samrakshan program shows that the reduction of PTB is an added benefit of the integration of fetal Doppler studies in the third trimester of pregnancy.

Reducing Perinatal Mortality in India: Two-Years Results of the IRIA Fetal Radiology Samrakshan Program.

Aim The aim of the study is to determine improvements in perinatal mortality at the end of the first 2 years from the initiation of the Samrakshan program of the Indian Radiological and Imaging Association. Methods Samrakshan is a screening program of pregnant women that uses trimester-specific risk assessment protocols including maternal demographics, mean arterial pressure, and fetal Doppler studies to classify women as high risk or low risk for preterm preeclampsia (PE) and fetal growth restriction (FGR). Low dose aspirin 150 mg daily once at bedtime was started for pregnant women identified as high risk in the 11-13 6/7 weeks screening. The third-trimester screening focused on the staging of FGR and protocol-based management for childbirth and risk assessment for PE. Outcomes of childbirth including gestational age at delivery, development of PE, and perinatal mortality outcomes were collected. Results Radiologists from 38 districts of 16 states of India participated in the Samrakshan program that screened 2,816 first trimester, 3,267 second trimester, and 3,272 third trimester pregnant women, respectively. At 2 years, preterm PE was identified in 2.76%, preterm births in 19.28%, abnormal Doppler study in 25.76% of third trimester pregnancies, and 75.32% of stage 1 FGR delivered at term. The neonatal mortality rate was 9.86/1,000 live births, perinatal mortality rate was 18.97/1,000 childbirths, and maternal mortality was 58/100,000 live births compared with 29.5, 36, and 113, respectively in 2016. Conclusion Fetal Doppler integrated antenatal ultrasound studies in Samrakshan led to a significant reduction in preterm PE rates, preterm birth rates, and a significant improvement in mean birth weights. Perinatal, neonatal, and maternal mortality rates are significantly better than the targets for 2030 set by the Sustainable Development Goals-3.

Discordant dating of pregnancy by LMP and ultrasound and its implications in perinatal statistics.

CONTEXT: High perinatal mortality in India may be caused by inaccurate dating of pregnancy resulting from suboptimal uptake of antenatal care and ultrasound services during pregnancy. AIM: To determine the discrepancy in the last menstrual period (LMP) assigned expected date of delivery (EDD) and ultrasound assigned EDD in pregnant women in a rural district of central India. METHODS: Data from an ongoing cross-sectional screening program providing fetal radiology imaging in Guna district of Madhya Pradesh from 2012-2019 was analyzed for recall of LMP and discordance between LMP and ultrasound assigned EDD. The discrepancy was present when EDD assigned by ultrasound differed by 3 or more days at gestational ages less than 8+6 weeks, 5-7 days at gestational ages 8+6 weeks till 14 weeks, and 7-10 days at gestational ages 14-20 weeks. RESULTS: The program screened 14,701 pregnant women of which 4,683 (31.86%, 95% CI: 31.11, 32.61) could not recall LMP. EDD assigned by LMP and ultrasound matched in 7,035 (70.22%, 95% CI: 69.32, 71.12) of the remaining 10,018 pregnant women. EDD was overestimated by LMP for 26.06% (95% CI: 25.21, 26.93) women; these foetuses were at risk of being misclassified as a term fetus. In 2018, the project had no maternal deaths, infant mortality rate of 24.7, low birth weight rate of 9.69%, and 100% antenatal coverage. CONCLUSION: Accurate dating of pregnancy and systematic follow-up integrating radiology imaging and obstetrics care for appropriate risk-based management of pregnant women can significantly improve perinatal statistics of India.

Samrakshan: An Indian Radiological and Imaging Association program to reduce perinatal mortality in India.

CONTEXT: India has a high perinatal mortality rate. The Indian Radiological and Imaging Association (IRIA) is supplementing efforts to address perinatal mortality in India through the Samrakshan program. AIMS: To describe various elements of the Samrakshan program that aims to reduce perinatal mortality in India. METHODS: Samrakshan focuses on two priority areas, preeclampsia (PE) and fetal growth restriction (FGR). Samrakshan aims at technical skill upgradation, specifically focused on improved interpretative ability, prognostic and therapeutic efficacy using Doppler studies, a free online learning platform and offline continuous medical educations (CMEs), building an evidence base from the program to develop policy and guidelines, and improving synergy with the RAKSHA program of IRIA and other fetal care stakeholders. RESULTS: Two courses on Doppler studies focused on first trimester and third trimester, supplemented by case discussions and journal articles, have started on the online platform with 230 registrants. The first statewide CME was held at Indore. Samrakshan screening identified 10 (17.24%, 95% CI: 8.59, 29.43) women at high risk for preterm PE and 29 (50.00%, 95% CI 36.58, 63.42) women at high risk for FGR in the first trimester. Ten fetuses (7.63%, 95% CI: 3.72, 13.59) including 9 with stage 1 FGR were identified in the third-trimester screening. CONCLUSIONS: Samrakshan is a flagship program of IRIA that aims to reduce perinatal mortality in India through a synergistic, holistic approach that complements and supplements existing efforts in India.

An efficacy study on alleviating micronutrient deficiencies through a multiple micronutrient fortified salt in children in South India.

BACKGROUND: Multiple micronutrient deficiencies are prevalent in India. OBJECTIVE: The study aims to establish the efficacy of multi-micronutrient fortified salt in addressing multiple micronutrient deficiencies among children compared to nutrition education and no intervention in Tamilnadu. METHODS: The study employed a community based randomized controlled trial designed to study the impact of multiple micronutrient salt (micronutrient group) in comparison with nutrition education (education group) and no intervention (control group) on haemoglobin, serum ferritin, soluble transferrin receptor, body iron stores, serum retinol and urinary iodine outcomes over a period of 8 months. The fortified salt contained iron, iodine, vitamin A, vitamin B12 and folic acid. All the children were dewormed at baseline and at the end of the study just before the biochemical measurements. RESULTS: There was a significant improvement in most biochemical parameters studied in the micronutrient group when compared with the control group whereas this was not seen between the education and control. Over 8 months, in the micronutrient group, hemoglobin increased by 0.52 g/dL, retinol by 8.56 µg/dL, ferritin by 10.8 µg/L, body iron stores by 1.27 mg and the decrease in the prevalence of retinol deficiency was from 51.6% to 28.1%, anaemia from 46.0% to 32.6%, iron deficiency from 66.9% to 51.3% and iron deficiency anaemia from 35.2% to 31.0%, while the prevalence of all these deficiencies increased or the changes were not significant in the other two groups. CONCLUSIONS: Multiple micronutrient fortified salt was able to improve iron and vitamin A status, whereas this was not seen in the nutrition education group.

Organ dysfunction and organ failure as predictors of outcomes of severe maternal morbidity in an obstetric intensive care unit.

BACKGROUND: Most of the maternal deaths are preceded by severe maternal morbidity (SMM). Organ dysfunction and organ failure may occur as part of the pathophysiologic spectrum in SMM. AIM: To determine the predictive and discriminative abilities of the Sequential Organ Failure Assessment (SOFA) scores to determine outcomes in pregnant women with SMM, who were admitted to a maternal ICU. MATERIALS AND METHODS: A retrospective study design was used to ascertain the diagnostic effectiveness of Sequential Organ Failure Assessment (SOFA) scores. Maximum individual SOFA scores and total maximum SOFA score were compared between women with and without SMM, and in women with SMM who survived or did not survive. Primary outcome measure of interest was maternal mortality. RESULTS: A majority (n=73, 85.88%) of the 85 women in the study had obstetrics related causes. The total maximum SOFA score was significantly higher in women with SMM as compared to that in women without SMM (p<0.001). The total maximum SOFA score showed ability to discriminate pregnant women with SMM who would not survive (AUROC 0.77, 95% CI: 0.46, 1.00). The positive likelihood ratios and accuracy for total SOFA scores of ≥10 and ≥12 were 19.20 and 38.40, and 94.20% and 95.65% respectively. The post-test probabilities for maternal deaths in women with SMM for SOFA scores ≥10 and ≥12 were 60.01% and 75.01% respectively. CONCLUSION: The total maximum SOFA score showed good predictive and discriminative abilities for maternal mortality in pregnant women with SMM, who were admitted to ICU.

Concurrent use of Foley catheter and misoprostol for induction of labor: a randomized clinical trial of efficacy and safety.

AIM: The aim of this study was to compare the efficacy of combined intracervical Foley catheter and low-dose vaginal misoprostol with low-dose vaginal misoprostol alone for induction of labor. MATERIAL AND METHODS: This prospective non-blinded randomized controlled trial was conducted over a 2-year period in 126 pregnant women planned for induction of labor at a tertiary care centre. Women at ≥ 28 gestational weeks with a singleton fetus in cephalic presentation, intact membranes and a Bishop score of ≤ 4 were randomized for labor induction with either a combination of Foley catheter and misoprostol or only misoprostol. The primary outcome variable was the induction-to-delivery interval between the two groups. The secondary outcome variables included rate of vaginal deliveries, uterine hyperstimulation, cesarean section rate, Apgar scores at 1 and 5 min, neonatal intensive care unit admissions and chorioamnionitis. RESULTS: The mean induction-to-delivery interval and rate of vaginal deliveries were not significantly different between the groups (26.52 h in the combination group and 27.64 h in the misoprostol group, P = 0.65; 65.07% and 65.07%, respectively, P = 0.9). Uterine hyperstimulation and meconium-stained liquor were significantly more prevalent in the misoprostol group (P = 0.001). Neonatal outcomes did not differ significantly between the groups. CONCLUSION: The addition of Foley catheter to misoprostol did not cause any statistically significant benefit in reducing the induction-to-delivery time. However, it reduced the incidence of uterine hyperstimulation and meconium-stained liquor.

Associations for birthweight of twin pairs in south India.

AIM: The aim of this study was to determine the distribution and associations of birthweight in twin pairs among a population of pregnant women in south India. MATERIAL AND METHODS: This was a retrospective case record analysis of 705 twin pair pregnancies during the period 2008-2012. Associations of birthweight with maternal age, parity, pregnancy-induced hypertension (PIH), gestational diabetes, obesity, chorionicity and sex of the twin pairs was explored using bivariate and multivariate analysis. RESULTS: The median birthweight (4250 g, interquartile range 3530-4810) of dichorionic twins was significantly higher (P < 0.0001) than monochorionic twins (3880 g, interquartile range 3000-4380). Birthweight was associated with chorionicity (t = 4.04, P < 0.001), obesity (t = 2.44, P = 0.03), nulliparity (t = -2.87, P = 0.004), and PIH (t = -2.11, P = 0.04) in a multivariate linear regression model. Birthweights did not differ significantly between female-male and female-female pairs (t = 0.11, P = 0.81), female-male and male-male pairs (t = -0.62, P = 0.54) or female-female and male-male pairs (t = -0.78, P = 0.43) in a multivariate linear regression model. The highest birthweight of the twin pair did not differ significantly (t = 1.27, P = 0.21) by sex of the twin. CONCLUSIONS: Birthweight of twins was significantly associated with chorionicity, obesity, PIH and nulliparity in this population. A potential masculinization effect was not found as the total birthweights did not differ significantly by sex of the twin pairs.

Cross-sectional study of gestational weight gain and perinatal outcomes in pregnant women at a tertiary care center in southern India.

AIM: The aim of this study was to determine maternal and neonatal outcomes of less than recommended or excess gestational weight gain (GWG) based on the recommended Institute of Medicine (IOM) guidelines. MATERIAL AND METHODS: Using a cross-sectional study design, GWG was assessed for 1462 pregnant women presenting to a tertiary care perinatal institute in India. Body mass index at baseline, co-existing morbidities, fetal growth, details of delivery, and maternal and fetal outcomes were determined and documented. Appropriate GWG for each woman was determined based on the revised IOM guidelines. Outcome measures included the proportion of pregnant women compliant with IOM guidelines for GWG and associations of less than recommended or excess GWG with maternal and neonatal outcomes. RESULTS: A total of 547 (37.41%, 95% confidence interval [CI]: 34.96-39.92) pregnant women gained less than recommended and 313 (21.41%, 95%CI: 19.36-23.57) pregnant women gained more than the recommended weight. Preterm deliveries were associated with less than optimal weight gain (adjusted odds ratio 3.58, 95%CI: 1.75-7.32) after adjusting for gestational age at delivery. GWG was not associated with neonatal outcomes in this population. CONCLUSIONS: The lack of associations with perinatal outcomes indicates that the IOM guidelines may not be the appropriate standard for monitoring GWG in this population.

Diagnostic effectiveness of 75 g oral glucose tolerance test for gestational diabetes in India based on the International Association of the Diabetes and Pregnancy Study Groups guidelines.

BACKGROUND: To determine the diagnostic effectiveness of the fasting and one-hour plasma glucose levels for gestational diabetes (GDM) based on International Association of the Diabetes and Pregnancy Study Groups (IADPSG) criteria. METHODS: A Cross-sectional study that included 2348 pregnant women booked for antenatal care in 2011 at a tertiary care perinatal institute. Pregnant women underwent a 75 g oral glucose tolerance test (OGTT) between 24 and 28 weeks of gestation. Outcome measures include the incidence of GDM based on the IADPSG criteria and the diagnostic effectiveness of the recommended fasting and one-hour plasma glucose cut-off if used in isolation. RESULTS: The incidence of GDM was 21.81% (n = 520, 95% CI: 20.15, 23.57) with the IADPSG criteria. A fasting plasma glucose cut-off 92 mg/dL, in isolation, correctly classified 87.16% of GDM, with a specificity of 96.08%, clinically significant positive likelihood ratio (14.08) and a post-test probability of 79.71%. The one-hour 75 g test, in isolation, correctly classified 85.74% of GDM, had specificity of 99.68% and clinically significant positive likelihood ratio (111.12) and post-test probability of 96.87%. The application of the World Health Organization criteria would misclassify 11.91% (95% CI: 10.66, 13.26) of GDM as normal. CONCLUSIONS: Additional testing of plasma glucose levels can be avoided for 18.25% (n = 435, 95% CI: 16.73, 19.84) if the IADPSG diagnostic criteria for GDM are applied with exit on a positive fasting or one-hour test result.

A randomized controlled trial assessing the effectiveness of strategies delivering low vision rehabilitation: design and baseline characteristics of study participants.

PURPOSE: To design a randomized controlled trial (RCT) to compare the effectiveness of four different strategies to deliver low vision rehabilitation services. METHODS: The four arms of the RCT comprised-center based rehabilitation, home based rehabilitation, a mix of center based and home based rehabilitation, and center based rehabilitation with home based non interventional supplementary visits by rehabilitation workers. Outcomes were assessed 9 months after baseline and included measuring changes in adaptation to age-related vision loss, quality of life, impact of vision impairment and effectiveness of low vision rehabilitation training. The socio-demographic and vision characteristics of the sample in each of the 4 arms were compared to ensure that outcomes are not associated with differences between the groups. RESULTS: Four hundred and thirty six individuals were enrolled in the study; 393 individuals completed the study. One-fifth of participants were children aged 8 to 16 years. At baseline, socio-demographic and clinical characteristics were similar between individuals in the four arms of the trial. Socio-demographic and clinical characteristics did not differ significantly, except for age, between the 393 individuals who completed the trial and the 43 individuals who dropped out of the study. Twenty six (60.46%) of the forty three drop outs were from the center based arm of the trial. CONCLUSIONS: Information from this trial has the potential to shape policy and practice pertaining to low vision rehabilitation services.