Child Neurodevelopment After Multidomain Interventions From Preconception Through Early Childhood: The WINGS Randomized Clinical Trial.

Importance: Multidomain interventions in pregnancy and early childhood have improved child neurodevelopment, but little is known about the effects of additional preconception interventions. Objective: To evaluate the effect of a multifaceted approach including health; nutrition; water, sanitation, and hygiene (WASH); and psychosocial support interventions delivered during the preconception period and/or during pregnancy and early childhood on child neurodevelopment. Design, Setting, and Participants: In this randomized trial involving low- and middle-income neighborhoods in Delhi, India, 13 500 participants were assigned to preconception interventions or routine care for the primary outcome of preterm births and childhood growth. Participants who became pregnant were randomized to pregnancy and early childhood interventions or routine care. Neurodevelopmental assessments, the trial's secondary outcome reported herein, were conducted in a subsample of children at age 24 months, including 509 with preconception, pregnancy, and early childhood interventions; 473 with preconception interventions alone; 380 with pregnancy and early childhood interventions alone; and 350 with routine care. This study was conducted from November 1, 2000, through February 25, 2022. Interventions: Health, nutrition, psychosocial care and support, and WASH interventions delivered during preconception, pregnancy, and early childhood periods. Main Outcomes and Measures: Cognitive, motor, language, and socioemotional performance at age 24 months, assessed using the Bayley Scales of Infant and Toddler Development 3 tool. Results: The mean age of participants at enrollment was 23.8 years (SD, 3.0 years). Compared with the controls at age 24 months, children in the preconception intervention groups had higher cognitive scores (mean difference [MD], 1.16; 98.3% CI, 0.18-2.13) but had similar language, motor, and socioemotional scores as controls. Those receiving pregnancy and early childhood interventions had higher cognitive (MD, 1.48; 98.3% CI, 0.49-2.46), language (MD, 2.29; 98.3% CI, 1.07-3.50), motor (MD, 1.53; 98.3% CI, 0.65-2.42), and socioemotional scores (MD, 4.15; 98.3% CI, 2.18-6.13) than did controls. The pregnancy and early childhood group also had lower incidence rate ratios (RRs) of moderate to severe delay in cognitive (incidence RR, 0.62; 98.3% CI, 0.40-0.96), language (incidence RR, 0.73; 98.3% CI, 0.57-0.93), and socioemotional (incidence RR, 0.49; 98.3% CI, 0.24-0.97) development than did those in the control group. Children in the preconception, pregnancy, and early childhood intervention group had higher cognitive (MD, 2.60; 98.3% CI, 1.08-4.12), language (MD, 3.46; 98.3% CI, 1.65-5.27), motor (MD, 2.31; 98.3% CI, 0.93-3.69), and socioemotional (MD, 5.55; 98.3% CI, 2.66-8.43) scores than did those in the control group. Conclusions and Relevance: Multidomain interventions during preconception, pregnancy and early childhood led to modest improvements in child neurodevelopment at 24 months. Such interventions for enhancing children's development warrant further evaluation. Trial Registration: Clinical Trials Registry-India CTRI/2017/06/008908.

Carle's obstetric early warning score as a screening tool for critical care admission.

BACKGROUND OBJECTIVES: Early warning systems (EWS) involve serial observations (track) with criteria (trigger) to timely identify patients at risk of complications. Carle designed a statistically based clinically modified obstetric early warning score (Carle's OEWS). This study evaluated Carle's OEWS and its individual components for predicting admission to the obstetric critical care unit (OCCU). Maternal near-miss and maternal mortality were the secondary outcomes. METHODS: A prospective observational study was conducted among 1250 pregnant women with a period of gestation ≥28 week admitted in the labour wards of a tertiary centre over 18 months. The physiological parameters of OEWS were recorded and aggregate score was calculated at admission and at regular intervals thereafter, till discharge or OCCU admission. RESULTS: The area under receiver operating characteristic (ROC) curve of OEWS was 0.975 for predicting OCCU admission, 0.971 for near-miss, and 0.996 for predicting maternal mortality and was significant for all outcomes. All individual parameters, except diastolic blood pressure, had a significant relative risk for predicting OCCU requirement. INTERPRETATION CONCLUSIONS: Carle's OEWS is a useful screening tool for predicting obstetric OCCU admission and can be routinely used in labour wards to ensure timely intervention.

Burden, risk factors and outcomes associated with adequately treated hypothyroidism in a population-based cohort of pregnant women from North India.

Hypothyroidism is the commonest endocrine disorder of pregnancy, with known adverse feto-maternal outcomes. There is limited data on population-based prevalence, risk factors and outcomes associated with treatment of hypothyroidism in early pregnancy. We conducted analysis on data from an urban and peri-urban low to mid socioeconomic population-based cohort of pregnant women in North Delhi, India to ascertain the burden, risk factors and impact of treatment, on adverse pregnancy outcomes- low birth weight, prematurity, small for gestational age and stillbirth. This is an observational study embedded within the intervention group of the Women and Infants Integrated Interventions for Growth Study, an individually randomized factorial design trial. Thyroid stimulating hormone was tested in 2317 women in early (9-13 weeks) pregnancy, and thyroxin replacement started hypothyroid (TSH ≥2.5mIU/mL). Univariable and multivariable generalized linear model with binomial family and log link were performed to ascertain risk factors associated with hypothyroidism and association between hypothyroidism and adverse pregnancy outcomes. Of 2317 women, 29.2% (95% CI: 27.4 to 31.1) had hypothyroidism and were started on thyroxin replacement with close monitoring. Overweight or obesity was associated with increased risk (adjusted RR 1.29, 95% CI 1.10 to 1.51), while higher hemoglobin concentration was associated with decreased risk (adjusted RR 0.93, 95% CI 0.88 to 0.98 for each g/dL) for hypothyroidism. Hypothyroid women received appropriate treatment with no increase in adverse pregnancy outcomes. Almost a third of women from low to mid socio-economic population had hypothyroidism in early pregnancy, more so if anemic and overweight or obese. With early screening and adequate replacement, adverse pregnancy outcomes may be avoided. These findings highlight the need in early pregnancy for universal TSH screening and adequate treatment of hypothyroidism; as well as for attempts to reduce pre and peri-conception overweight, obesity and anemia. Clinical trial registration: Clinical trial registration of Women and Infants Integrated Interventions for Growth Study Clinical Trial Registry-India, #CTRI/2017/06/008908; Registered on: 23/06/2017, (http://ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=19339&EncHid=&userName=society%20for%20applied%20studies).

Ultrasonographic Assessment of Body Fat Index for Prediction of Gestational Diabetes Mellitus and Neonatal Complications.

OBJECTIVES: To assess maternal pre-peritoneal fat and subcutaneous fat at 16-20 weeks gestation by ultrasound. Thus, calculate body fat index (BFI) and determine its cut-off value for prediction of gestational diabetes mellitus (GDM) and neonatal subcutaneous adiposity. METHODS: A cohort study was conducted in 200 pregnant women with singleton fetus during anomaly scan using BFI where they were screened for GDM at 24-28 weeks gestation by oral glucose tolerance test. Labour and neonatal outcomes were recorded. The receiver operating characteristic curve was used to determine the cut-offs for BFI, pre-peritoneal fat thickness, and subcutaneous fat thickness in order to predict GDM. RESULTS: The area under receiver operating characteristic curve for BFI was 0.967 (95% CI 0.932-0.987) with a sensitivity of 97.3%, specificity of 89.57%, negative predictive value of 99.3%, and diagnostic accuracy of 91% at a BFI cut-off of 0.88. The study analysis demonstrated BFI to be statistically superior to BMI > 22.9 kg/m2 for prediction of GDM. BFI > 0.88 was a risk factor for developing neonatal subcutaneous adiposity. CONCLUSIONS: BFI is a practical and convenient non-invasive screening tool to predict GDM and neonatal subcutaneous adiposity.

Multiple sexually transmitted co-infections are associated with adverse reproductive outcomes in asymptomatic adolescent pregnant women; A Prospective cohort study.

Background: A prospective cohort was conducted to assess the prevalence of seven RTIs/STIs in adolescent asymptomatic pregnant women to find a significant correlation between infection and pregnancy. Methods: The study was restricted to 18-19 years of asymptomatic adolescent pregnant women attending Ante-Natal Care and the health status of the pregnant women were followed up to parturition. The health status of the infant was followed till 6 months post-delivery. The prevalence of the concerning pathogens and the significance of their association with adverse outcomes of pregnancy were determined. Results: Among 279 subjects, the most significant co-infections were observed for M. hominis with U. parvum (9.31%; p-value-0.0071/OR-2.6421) and U. urealyticum (7.88%; p-value-0.0119/OR-2.6455). Statistically significant associations were found between C. trachomatis [(p-value-0.0439); OR-2.9902] and M. genitalium [(p-value-0.0284); OR-3.442] with PTB, N. gonorrhoeae with LBW <2.5 kg [(p-value-0.0052);OR-4.9017], U. urealyticum with VLBW <2 kg [(p-value-0.0262);OR-3.0207], M. genitalium [(p-value-0.0184); OR-11.7976] and T. vaginalis with PROM [(p-value 0.0063); OR-19.4275] while M. genitalium [(p-value 0.0190); OR-12.9230] and U. urealyticum [(p-value 0.0063); OR-14.5149] with PPROM with 95% CI respectively. Conclusions: Asymptomatic adolescents are at high risk of adverse pregnancy outcomes if infected with the concerned pathogens.

Impact of a package of health, nutrition, psychosocial support, and WaSH interventions delivered during preconception, pregnancy, and early childhood periods on birth outcomes and on linear growth at 24 months of age: factorial, individually randomised controlled trial.

OBJECTIVE: To determine the effect of integrated and concurrent delivery of health, nutrition, water, sanitation and hygiene (WaSH), and psychosocial care interventions during the preconception period alone, during pregnancy and early childhood, and throughout preconception, pregnancy, and early childhood on birth outcomes and linear growth at 24 months of age compared with routine care. DESIGN: Individually randomised factorial trial. SETTING: Low and middle income neighbourhoods of Delhi, India. PARTICIPANTS: 13 500 women were randomised to receive preconception interventions (n=6722) or routine care (n=6778). 2652 and 2269 pregnant women were randomised again to receive pregnancy and early childhood interventions or routine care. The analysis of birth outcomes included 1290 live births for the preconception, pregnancy, and early childhood interventions (group A), 1276 for the preconception intervention (group B), 1093 for the pregnancy and early childhood interventions (group C), and 1093 for the control (group D). Children aged 24 months by 30 June 2021 were included in the 24 month outcome analysis (453 in group A, 439 in B, 293 in C, and 271 in D). INTERVENTIONS: Health, nutrition, psychosocial care and support, and WaSH interventions were delivered during preconception, pregnancy, and early childhood periods. MAIN OUTCOME MEASURES: The primary outcomes were low birth weight, small for gestational age, preterm, and mean birth weight. At 24 months, the outcomes were mean length-for-age z scores and proportion stunted. Three prespecified comparisons were made: preconception intervention groups (A+B) versus no preconception intervention groups (C+D); pregnancy and early childhood intervention groups (A+C) versus routine care during pregnancy and early childhood (B+D) and preconception, pregnancy, and early childhood interventions groups (A) versus control group (D). RESULTS: The proportion with low birth weight was lower in the preconception intervention groups (506/2235) than in the no preconception intervention groups (502/1889; incidence rate ratio 0.85, 98.3% confidence interval 0.75 to 0.97; absolute risk reduction -3.80%, 98.3% confidence interval -6.99% to -0.60%). The proportion with low birth weight was lower in the pregnancy intervention groups (502/2096) than in the no pregnancy intervention groups (506/2028) but the upper limit of the confidence interval crossed null effect (0.87, 0.76 to 1.01; -1.71%, -4.96% to 1.54%). There was a larger effect on proportion with low birth weight in the group that received interventions in the preconception and pregnancy periods (267/1141) compared with the control group (267/934; 0.76, 0.62 to 0.91; -5.59%, -10.32% to -0.85%). The proportion stunted at 24 months of age was substantially lower in the pregnancy and early childhood intervention groups (79/746) compared with the groups that did not receive these interventions (136/710; 0.51, 0.38 to 0.70; -8.32%, -12.31% to -4.32%), and in the group that received preconception, pregnancy, and early childhood interventions (47/453) compared with the control group (51/271; 0.49, 0.32 to 0.75; -7.98%, -14.24% to -1.71%). No effect on stunting at 24 months was observed in the preconception intervention groups (132/892) compared with the no preconception intervention groups (83/564). CONCLUSIONS: An intervention package delivered during preconception, pregnancy, and early childhood substantially reduced low birth weight and stunting at 24 months. Pregnancy and early childhood interventions alone had lower but important effects on birth outcomes and 24 month outcomes. Preconception interventions alone had an important effect on birth outcomes but not on 24 month outcomes. TRIAL REGISTRATION: Clinical Trial Registry-India CTRI/2017/06/008908.

Adiponectin to Leptin Ratio and its Association with Insulin Resistance in Women with Polycystic Ovarian Syndrome.

Background: Adiponectin and leptin play a major role in metabolic homeostasis. Adiponectin to Leptin ratio can be used as an indicator of insulin resistance and a marker of polycystic ovarian syndrome (PCOS). The study was planned to compare serum adiponectin, leptin, and adiponectin to leptin ratio in age and BMI matched women with and without PCOS and to find out the association of adiponectin to leptin ratio with Insulin resistance in these women. Methods: It was a cross-sectional study done in the Gynecology outpatient clinic in a tertiary care center. A total of 120 women, 60 with PCOS and 60 age and BMI matched women without PCOS, who presented in the clinic after the index cases were enrolled and tested for serum adiponectin, leptin, and insulin sensitivity. The main outcome measures were serum levels of adiponectin, leptin, adiponectin to leptin ratio, oral glucose tolerance test, serum insulin and HOMA-IR. Results: PCOS women had lower serum Adiponectin, higher serum Leptin level and lower Adiponectin to Leptin ratio compared to non PCOS women, 2.15 ± 3.07 ng/ml vs 10.7 ± 27.91 ng/ml, P < 0.0001; 24.25 ± 16.5 ng/ml vs 13.89 ± 11.19 ng/ml, P = 0.0003 and 0.15 ± 0.24 vs 3.03 ± 15.04, P < 0.0001, respectively. Plasma glucose 2 hours after 75 gm glucose and serum Insulin was significantly increased in PCOS women (108.78 ± 10.22 mg/dl vs 100.18 ± 4.89 mg/dl, P = 0.001 and 5.7 ± 9.53 mU/ml vs 3.02 ± 5.34 mU/ml, P = 0.02, respectively). The mean values of fasting plasma glucose and HOMA-IR were comparable in both groups, P = 0.145, P = 0.719, respectively. There was no significant association of A/L Ratio with BMI, plasma glucose 2 hours after 75 gm glucose, serum Insulin and HOMA-IR, in these women, r = -0.074, P = 0.5754; r = -0.203, P = 0.12; r = -0.018, P = 0.8915; and r = -0.041, P = 0.757, respectively. Conclusion: Adiponectin to leptin ratio is significantly reduced in women with PCOS but has no association with insulin resistance.

Improved management can be achieved by introducing additional parameters in the syndromic diagnosis of nonviral sexually transmitted infections at low-resource settings.

BACKGROUND: The syndromic approach is a simple and affordable strategy for the management of sexually transmitted infections in countries with low-resource settings. However, because of the lack of specificity and accuracy, the risk of overuse and misuse of antibiotics is very high. Here, we proposed a more specific and accurate algorithm compared with the current algorithm used for syndromic case management of 3 common sexually transmitted pathogens and compared its precision with laboratory-based tests. OBJECTIVE: This study aimed to report a comparative account of the accuracy of existing syndromic case management guidelines followed in mainstream hospitals, for taking care of patients with nonviral sexually transmitted infections, concerning an approach involving an alternative algorithm formulated in our laboratory followed by polymerase chain reaction testing. STUDY DESIGN: This was an observational study that compared the data between 2 categories based on diagnostics accuracy and treatment. In category I, symptoms of infection were scored on the basis of the existing National AIDS Control Organization and National AIDS Control Programme guidelines, and patients were treated before testing by polymerase chain reaction. In category II, patients were recruited on the basis of the National AIDS Control Organization and National AIDS Control Programme guidelines with additional alternative syndromic case management parameters. All samples were tested by polymerase chain reaction for Chlamydia trachomatis, Neisseria gonorrhoeae, and Trichomonas vaginalis and clinically correlated before giving the treatment. RESULTS: In category I, among 646 women with symptomatic infection, only 46 (7.82%) tested positive by polymerase chain reaction assay for at least 1 of the pathogens, and 600 (92.87%) tested negative for infection by any of the 3 pathogens. The total estimated percentages of the overuse and misuse of antibiotics were 92.87% and 8.69%, respectively. Correct and complete treatment based on laboratory outcome compared with National AIDS Control Programme guidelines was 42 of 46 (91.30%). The estimated overuse of azithromycin and cefixime (Gray Kit) was 29.69%, the estimated overuse of a combination of doxycycline, cefixime, and metronidazole (Yellow Kit) was 29.87%, and the estimated overuse of a combination of doxycycline, cefixime, metronidazole, and azithromycin (Gray with Yellow Kit) was 11.45%. In category II, wherein patients were treated using an alternative syndromic approach and polymerase chain reaction diagnostics, 243 of 319 patients (76.15%) were infected with either of the pathogens (Chlamydia trachomatis, Neisseria gonorrhoeae, and Trichomonas vaginalis), whereas 76 of 319 patients (23.82%) were negative for any of the 3 pathogens. Among 243 patients with infection, 99 of 243 (40.74%) were infected with a single pathogen, whereas 144 of 243 (59.20%) were coinfected. Of 144 coinfected patients, the percentage of Chlamydia trachomatis + Neisseria gonorrhoeae infection was the highest (51.38%), followed by coinfection with all 3 pathogens (30%). Coinfection with Chlamydia trachomatis + Trichomonas vaginalis was 9.72%, and coinfection with Neisseria gonorrhoeae + Trichomonas vaginalis was 9.03%. The estimated overuse of antibiotics was found to be 23.82% only. CONCLUSION: The proposed alternative strategies of syndromic case management can reduce the percentage of misuse and overuse of antibiotics from 92.87% to 23.82%. Moreover, syndromic case management alone was insufficient for disease management.

Role of Placenta Accreta Index for Diagnosis of Placenta Accreta Spectrum in High-Risk Patients.

Background: Antenatal diagnosis of placenta accreta spectrum (PAS) can ensure multidisciplinary management at center of excellence which can reduce maternal and fetal complications. This can be established by a scoring system which provides a standardized criterion for the diagnosis and management. The objective of our study was to assess the placenta accreta index (PAI) and its individual parameters for diagnosis of PAS in high-risk patients. Methods: A prospective study was conducted on 71 pregnant women with placenta previa and previous cesarean section. After informed consent, history was taken and ultrasonography was used to calculate the PAI for each patient. Definitive diagnosis was made clinically during cesarean section or by histopathology for those requiring hysterectomy. The data were evaluated using the latest version of Statistical Package for the Social Sciences software. Results: All ultrasound parameters of placenta accreta index were statistically significant for predicting PAS (p value < 0.001). ROC curve with AUC of 0.87 95% CI of 0.77-0.94 showed that a score of 4.75 was the best cutoff value to diagnose PAS. Out of the 30 patients found to have placental invasion, 22 had a PAI score of more than 4.75. The score was found to have a sensitivity of 73.3%, specificity 95.1%, positive predictive value 91.7%, negative predictive value 83% and diagnostic accuracy 85.9%. Conclusions: Women with placenta previa and history of previous CS should undergo screening by PAI, and a cutoff value of ≥ 4.75 should be viewed with high index of suspicion for the presence of PAS.

Physical morbidity and psychological and social comorbidities at five stages during pregnancy and after childbirth: a multicountry cross-sectional survey.

OBJECTIVE: Maternal morbidity affects millions of women, the burden of which is highest in low resource settings. We sought to explore when this ill-health occurs and is most significant. SETTINGS: A descriptive observational cross-sectional study at primary and secondary-level healthcare facilities in India, Pakistan, Kenya and Malawi. PARTICIPANTS: Women attending for routine antenatal care, childbirth or postnatal care at the study healthcare facilities. PRIMARY AND SECONDARY OUTCOMES: Physical morbidity (infectious, medical, obstetrical), psychological and social comorbidity were assessed at five stages: first half of pregnancy (≤20 weeks), second half of pregnancy (>20 weeks), at birth (within 24 hours of childbirth), early postnatal (day 1-7) and late postnatal (week 2-12). RESULTS: 11 454 women were assessed: India (2099), Malawi (2923), Kenya (3145) and Pakistan (3287) with similar numbers assessed at each of the five assessment stages in each country. Infectious morbidity and anaemia are highest in the early postnatal stage (26.1% and 53.6%, respectively). For HIV, malaria and syphilis combined, prevalence was highest in the first half of pregnancy (10.0%). Hypertension, pre-eclampsia and urinary incontinence are most common in the second half of pregnancy (4.6%, 2.1% and 6.6%). Psychological (depression, thoughts of self-harm) and social morbidity (domestic violence, substance misuse) are significant at each stage but most commonly reported in the second half of pregnancy (26.4%, 17.6%, 40.3% and 5.9% respectively). Of all women assessed, maternal morbidity was highest in the second half of pregnancy (81.7%), then the early postnatal stage (80.5%). Across the four countries, maternal morbidity was highest in the second half of pregnancy in Kenya (73.8%) and Malawi (73.8%), and in the early postnatal stage in Pakistan (92.2%) and India (87.5%). CONCLUSIONS: Women have significant maternal morbidity across all stages of the continuum of pregnancy and childbirth, and especially in the second half of pregnancy and after childbirth.

Mother-Newborn Care Unit (MNCU) Experience in India: A Paradigm Shift in Care of Small and Sick Newborns.

While a Cochrane review (2016) showed that kangaroo mother care (KMC) initiated after clinical stabilization reduces mortality by 40%, evidence of the effect of initiating KMC immediately after birth without waiting for babies to become stable was unavailable until recently. This research gap was addressed by a multicountry, randomized, controlled trial co-ordinated by WHO. This trial was conducted in five hospitals in Ghana, India, Malawi, Nigeria, and Tanzania. Implementation of this trial led to development of the "mother-newborn care unit (MNCU)." Mother-newborn care unit or mother-newborn intensive care unit (M-NICU) is a facility where sick and small newborns are cared with their mothers 24 × 7 with all facilities of level II newborn care and provision for postnatal care to mothers. The mother is not a mere visitor, but she has her bed inside the special newborn care unit (SNCU)/newborn intensive care unit (NICU) and as a resident of MNCU, becomes an active caregiver and is involved in continuum of neonatal care. The study results show that intervention babies in MNCU had 25% less mortality at 28 d of life, 35% less incidence of hypothermia, and 18% less suspected sepsis as compared to control babies cared in conventional NICU. World Health Organization is in the process of reviewing the current recommendations on care of preterm or LBW newborns considering new evidence that has become available. However, it would require national policy change to permit mother and surrogate in SNCU/NICU 24 × 7, making the concept of zero-separation a reality.

Burden, risk factors and outcomes associated with gestational diabetes in a population-based cohort of pregnant women from North India.

BACKGROUND: The burden of gestational diabetes mellitus (GDM) appears to be increasing in India and may be related to the double burden of malnutrition. The population-based incidence and risk factors of GDM, particularly in lower socio-economic populations, are not known. We conducted analyses on data from a population-based cohort of pregnant women in South Delhi, India, to determine the incidence of GDM, its risk factors and association with adverse pregnancy outcomes (stillbirth, preterm birth, large for gestational age babies) and need for caesarean section. METHODS: We analyzed data from the intervention group of the Women and Infants Integrated Interventions for Growth Study (WINGS), an individually randomized factorial design trial. An oral glucose tolerance test (OGTT) was performed at the time of confirmation of pregnancy, and for those who had a normal test (≤140 mg), it was repeated at 24-28 and at 34-36 weeks. Logistic regression was performed to ascertain risk factors associated with GDM. Risk ratios (RR) were calculated to find association between GDM and adverse pregnancy outcomes and need for caesarean section. RESULTS: 19.2% (95% CI: 17.6 to 20.9) pregnant women who had at least one OGTT were diagnosed to have GDM. Women who had prediabetes at the time of confirmation of pregnancy had a significantly higher risk of developing GDM (RR 2.08, 95%CI 1.45 to 2.97). Other risk factors independently associated with GDM were woman's age (adjusted OR (AOR) 1.10, 95% CI 1.06 to 1.15) and BMI (AOR 1.04, 95% CI 1.01 to 1.07). Higher maternal height was found to be protective factor for GDM (AOR 0.98, 95% CI 0.96 to 1.00). Women with GDM, received appropriate treatment did not have an increase in adverse outcomes and no increased need for caesarean section CONCLUSIONS: A substantial proportion of pregnant women from a low to mid socio-economic population in Delhi had GDM, with older age, higher BMI and pre-diabetes as important risk factors. These findings highlight the need for interventions for prevention and provision of appropriate management of GDM in antenatal programmes. CLINICAL TRIAL REGISTRATION: Clinical Trial Registry - India, #CTRI/2017/06/008908 ( http://ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=19339&EncHid=&userName=society%20for%20applied%20studies ).

Determinants of maternal mortality in a critical care unit: A prospective analysis.

INTRODUCTION: An admission of a pregnant woman to an intensive care unit (ICU) is considered as an objective marker of maternal near miss. Only a few studies from the Indian subcontinent have reported on the ability of ICU scoring systems in predicting the mortality in obstetric patients. METHODS: A prospective analysis of all critically ill obstetric patients admitted to the critical care department was done. RESULTS: In the period between April 2013 and September 2017, there were 101 obstetric admissions to the critical care ICU. Of these, 82 patients (81.2%) were discharged from the hospital, 18 patients (17.8%) died, and one left against medical advice. The common diagnoses seen in these patients were cardiac failure (n = 39; 38.6%); pregnancy-induced hypertension (n = 26; 25.7%); acute respiratory distress syndrome (n = 20; 19.8%); intra-abdominal sepsis (n = 19; 18.8%); tropical diseases (n = 19; 18.8%); and tuberculosis (n = 13; 12.9%).When we compared the survivors with the nonsurvivors, a higher severity of illness score and a low PaO2/FiO2 were found to increase the odds of death. The area of distribution under the receiver operator characteristic curve was 0.726 (95% confidence interval [CI] = 0.575-0.877), 0.890 (95% CI = 0.773-1.006), 0.867 (95% CI = 0.755-0.979), and 0.850 (95% CI = 0.720-0.980) for the PaO2/FiO2, Simplified Acute Physiology Score (SAPS) II, Sequential Organ Failure Assessment and Acute Physiology and Chronic Health Evaluation (APACHE) II score, respectively, for predicting mortality. The standardized mortality ratio was better with SAPSII than with APACHE II. CONCLUSIONS: Cardiac dysfunction is a leading cause of ICU admission. Obstetric patients frequently require ventilatory support, intensive hemodynamic monitoring, and blood transfusion. The APACHE II score is a good index for assessing ICU outcomes.

Gestational weight gain trajectories in GARBH-Ini pregnancy cohort in North India and a comparative analysis with global references.

BACKGROUND: To describe the pattern of gestational weight gain (GWG), derive reference centiles for GWG specific to North Indian population, and to compare the weight gain across different periods of gestation with the INTERGROWTH-21st reference. METHODS: A prospective pregnancy (GARBH-Ini) cohort was initiated and followed between May 2015 and June 2019 in a district hospital, Gurguram, North India. GWG centile curves were modelled by Generalized Additive Models for Location, Scale and Shape method (n = 2844) and compared with INTERGROWTH-21st reference. The independent association of GWG with biological and social predictors was assessed using multivariable regression analysis. RESULTS: Percentiles (3rd, 10th, 50th, 90th and 97th) for each completed week from 18-40 weeks of gestation were derived from smoothed centile curves. The median GWG across pregnancy during specific antenatal visits was 1.29 at 18, 4.44 at 26, 5.8 at 30 and 9.06 kg at 40 weeks of gestation. Nearly 26% of participants had GWG < 10th centile at 18-20 weeks as per INTERGROWTH-21st reference and this increased to 45% at delivery. Significant predictors of GWG included maternal age, height, first trimester body mass index, parity, type of family, and use of clean fuel for cooking. CONCLUSION: These GWG percentiles will serve as a useful reference, particularly during the WHO recommended antenatal visit schedule for optimum pregnancy outcomes, for clinicians and researchers. Multiple independent biological and social predictors of GWG suggest that single interventions are unlikely to bridge the gap between general Indian population and international references.

Does the Addition of Serum PAPP-A and ß-hCG Improve the Predictive Value of Uterine Artery Pulsatility Index for Preeclampsia at 11-14 Weeks of Gestation? A Prospective Observational Study.

PURPOSE OF STUDY: To study the role of uterine artery Doppler pulsatility index (UtA-PI), serum pregnancy-associated plasma protein-A (PAPP-A) and free beta human chorionic gonadotropin (fß-hCG) levels, individually and in combination with each other, at 11-14 weeks of gestation for prediction of preeclampsia (PE). METHODS: In a prospective observational study, a total of 100 low-risk gravid females were recruited at 11-14-weeks of gestation. UtA-PI, PAPP-A and fß-hCG levels were estimated. These women were followed up until delivery for the development of PE and gestational hypertension (GH). RESULTS: The best individual marker for screening PE and GH was UtA-PI with ROC AUC (± standard error) = 0.934 ± 0.028, p < 0.0001. UtA-PI at a cutoff value of ≥ 2.8 (95th percentile) had 77.8% sensitivity, 98.9% specificity, 97.8% NPV and 87.5% PPV in detecting PE. PAPP-A (MoM) at a cutoff value of ≤ 0.27 (5th percentile) demonstrated 44.4% sensitivity, 95.6% specificity, 94.5% NPV and 50% PPV. fß-hCG (MoM) at a cutoff value of ≤ 0.5 (5th percentile) had a specificity of 94.5%. Among the combined markers, UtA-PI along with PAPP-A estimation served best with a sensitivity and specificity of 44% and 100%, respectively. Addition of fß-hCG to either UtA-PI or PAPP-A levels was not found sensitive for detecting PE but yielded 100% specificity and 96% NPV. CONCLUSION: UtA-PI as a stand-alone test was found most useful for the prediction of PE. Addition of either or both of PAPP-A and fß-hCG to UtA-PI did not improve the sensitivity of combined test with only a slight improvement in specificity and NPV. Their routine addition to UtA-PI studies is not recommended for prediction of PE at 11-14 weeks of gestation in low- and lower-middle-income countries (LMIC).

Antenatal and postnatal assessment of pelvic floor muscles in continent and incontinent primigravida women.

INTRODUCTION AND HYPOTHESIS: Reduced pelvic floor muscle (PFM) strength and thickness are considered critical factors in pregnancy-related stress urinary incontinence. Various methods have been evaluated for the measurement of these two factors, but validity needs to be well established. The objective was to assess the strength and thickness of pelvic floor muscles of continent and incontinent primigravida women using the digital method and transperineal ultrasound, and to study the correlation between the two methods. METHODS: Assessment of pelvic floor muscle strength and thickness using digital assessment and transperineal ultrasound antepartum and postpartum in 100 primigravida women. RESULTS: A total of 100 primigravida women with 46 in the study group (incontinent) and 54 in the control group (continent) were assessed. PFM strength was lower in incontinent women, with a score of 3 or less in 82.61% (38 out of 46) compared with a score of 4 or more in 98.15% of continent women (53 out of 54; p < 0.0001) antenatally, as well as postnatally, with 81.25% of the incontinent women (26 out of 32), with a score of 3 or less compared with 100% of continent women (24 out of 24), with a score of 4 or more (p < 0.0001). The PFM thickness in the incontinent group compared with the continent group at relaxation was 5.94 ± 0.51 mm and 6.64 ± 0.26 mm (p < 0.0001) antenatally and 5.98 ± 0.55 mm and 6.69 ± 0.23 mm (p < 0.0001) postnatally; at contraction it was 7.29 ± 0.56 mm and 8.70 ± 0.24 mm (p < 0.0001) antenatally and 7.39 ± 0.56 mm and 8.77 ± 0.20 mm (p < 0.0001) postnatally. The Pearson correlation coefficient for the two methods during the antenatal and postpartum periods was 0.864 and 0.743 respectively, suggestive of a positive correlation between the two methods. CONCLUSIONS: Pelvic floor muscle strength, as well as thickness, is significantly lower among the incontinent group than among the continent group, both during antenatal and during the postnatal period.

Immediate "Kangaroo Mother Care" and Survival of Infants with Low Birth Weight.

BACKGROUND: "Kangaroo mother care," a type of newborn care involving skin-to-skin contact with the mother or other caregiver, reduces mortality in infants with low birth weight (<2.0 kg) when initiated after stabilization, but the majority of deaths occur before stabilization. The safety and efficacy of kangaroo mother care initiated soon after birth among infants with low birth weight are uncertain. METHODS: We conducted a randomized, controlled trial in five hospitals in Ghana, India, Malawi, Nigeria, and Tanzania involving infants with a birth weight between 1.0 and 1.799 kg who were assigned to receive immediate kangaroo mother care (intervention) or conventional care in an incubator or a radiant warmer until their condition stabilized and kangaroo mother care thereafter (control). The primary outcomes were death in the neonatal period (the first 28 days of life) and in the first 72 hours of life. RESULTS: A total of 3211 infants and their mothers were randomly assigned to the intervention group (1609 infants with their mothers) or the control group (1602 infants with their mothers). The median daily duration of skin-to-skin contact in the neonatal intensive care unit was 16.9 hours (interquartile range, 13.0 to 19.7) in the intervention group and 1.5 hours (interquartile range, 0.3 to 3.3) in the control group. Neonatal death occurred in the first 28 days in 191 infants in the intervention group (12.0%) and in 249 infants in the control group (15.7%) (relative risk of death, 0.75; 95% confidence interval [CI], 0.64 to 0.89; P = 0.001); neonatal death in the first 72 hours of life occurred in 74 infants in the intervention group (4.6%) and in 92 infants in the control group (5.8%) (relative risk of death, 0.77; 95% CI, 0.58 to 1.04; P = 0.09). The trial was stopped early on the recommendation of the data and safety monitoring board owing to the finding of reduced mortality among infants receiving immediate kangaroo mother care. CONCLUSIONS: Among infants with a birth weight between 1.0 and 1.799 kg, those who received immediate kangaroo mother care had lower mortality at 28 days than those who received conventional care with kangaroo mother care initiated after stabilization; the between-group difference favoring immediate kangaroo mother care at 72 hours was not significant. (Funded by the Bill and Melinda Gates Foundation; Australian New Zealand Clinical Trials Registry number, ACTRN12618001880235; Clinical Trials Registry-India number, CTRI/2018/08/015369.).

Prospective revalidation of IOTA "two-step", "alternative two-step" and "three-step" strategies for characterization of adnexal masses - An Indian study focussing the radiology context.

OBJECTIVES: The purpose of this study was to revalidate the diagnostic performance of IOTA "two step" (Simple Descriptors and Simple Rules), " alternative two step" (Simple Rules Risk Calculation tool / SRrisk score), and three step (two step with subjective assessment) strategies, for characterization of adnexal masses as benign or malignant, using histopathology as gold standard. MATERIALS AND METHODS: This prospective, study comprised of 100 patients with newly diagnosed adnexal masses, who underwent ultrasound evaluation first by a level I and then by a level III investigator (EFSUMB criteria). Initially, the level I investigator evaluated each adnexal mass, applying IOTA "two-step" strategy and simultaneously assigned a risk category, by applying the simple rules risk score (SRrisk score) or performing the "alternative two step" strategy. Subsequently the inconclusive masses were evaluated by the level III investigator using "real time subjective assessment", thereby performing the third step. Following histopathology diagnosis, the performance of each strategy was evaluated using diagnostic tests. RESULTS: The sensitivity, specificity, PPV, NPV, and diagnostic accuracy of "two-step" strategy were 87.5%, 79.2%, 89.4%, 76%, and 84.7%, respectively; those of "alternative two-step" strategy were 91.5%, 75.6%, 84.4%, 86.1% and 88%; and those of "three-step" strategy were 98.2%, 93.3%, 94.7%, 97.7% and 96%, respectively. CONCLUSION: All IOTA strategies showed good diagnostic performance for characterization of adnexal masses and the "three-step" strategy performed best. We believe this is the first ever prospective re-validation and comparative evaluation of all three IOTA strategies by Indian Radiologists. Since ultrasound is the primary modality for evaluation of adnexal masses, based on the good results of our study, a recommendation for henceforth standard application, of the three-step IOTA strategy in routine Radiology practice appears justified. Although, IOTA strategies been proposed and validated mainly by Gynaecologists and Oncology surgeons, based on the results of our study, this paradigm can now be made to shift back to the arena of Radiology and Radiologists, the imaging experts.

A Prospective Study of Clinical Characteristics and Interventions Required in Critically Ill Obstetric Patients.

INTRODUCTION: Obstetric patients are a special group of patients whose management is challenged by concerns for fetal viability, altered maternal physiology, and diseases specific to pregnancy. MATERIALS AND METHODS: A prospective analysis of all obstetric patients admitted to the critical care department was done to assess reasons for transfer to the critical care unit (CCU) and the interventions required for management of these patients. RESULTS: Between June 2013 and September 2017, obstetric admission comprised 95 women (5.9%) of the total critical care admissions. There were 77 patients (81.1%) who were discharged from the hospital and 18 patients (18.9%) died. In most of the cases, the primary reasons for shifting the patient to the CCU were severe preeclampsia with pulmonary edema (22.1%), eclampsia (8.4%), acute respiratory distress syndrome (ARDS) (14.7%), and hypovolemic shock in antepartum hemorrhage (APH) and postpartum hemorrhage (PPH) (10.5 and 13.7%, respectively). It was seen that 73 patients (76.8%) required ventilator support, 58 patients (57.4%) required vasopressor support, and intensive hemodynamic monitoring and blood/blood products were transfused in 55 patients (54.5%). The need for ventilator support was more in patients with a lower PaO2/FiO2 and a higher APACHE II score. Patients with a high severity of illness score and a lower PaO2/FiO2 had higher odds of requiring vasopressors. Low hemoglobin at the time of transfer to the CCU and a prolonged hospital stay were found to predict the need for blood transfusion. CONCLUSION: Obstetric patients are susceptible to critical illnesses but timely management improves the outcome of these young women. HOW TO CITE THIS ARTICLE: Suri J, Kumar R, Gupta A, Mittal P, Suri JC. A Prospective Study of Clinical Characteristics and Interventions Required in Critically Ill Obstetric Patients. Indian J Crit Care Med 2020;24(8):677-682.

Obstetric Early Warning Score for Prognostication of Critically Ill Obstetric Patient.

INTRODUCTION: Obstetric early warning score (OEWS) has been used conventionally for early identification of deteriorating obstetric patients in the labor room and ward settings. This study was conducted to determine if this simple clinical score could be used for prognosticating a critically ill patient in the ICU setting instead of sequential organ failure assessment score (SOFA) and acute physiology and chronic health evaluation (APACHE II) score. MATERIALS AND METHODS: A cohort study was conducted at Obstetrics Critical Care Unit, Vardhman Mahavir Medical College and Safdarjung Hospital, New Delhi. A total of 250 obstetric patients were recruited after informed consent. The OEWS, SOFA, and APACHE II scores were calculated within 24 hours of admission. The patients were followed to study the maternal outcome. RESULTS: The area under receiver operator characteristic (AUROC) curve of OEWS, SOFA, and APACHE II for prediction of maternal mortality was 0.894 (95% CI, 0.849-0.929), 0.924 (95% CI, 0.884-0.954), and 0.93 (95% CI, 0.891-0.958), respectively. The standardized mortality ratio (SMR) for OEWS, SOFA, and APACHE II was 66.3, 62.5, and 69.15%, respectively. CONCLUSION: Obstetric early warning score is as effective as the conventional SOFA and APACHE II to prognosticate the obstetric patient. Since OEWS is based only on clinical criteria, it can be done immediately on admission and can help in early allocation of appropriate manpower and resources for optimum outcome. CLINICAL SIGNIFICANCE: The clinical application of this study will help intensivists to prognosticate the critically ill obstetric patients immediately following admission to the critical care unit. HOW TO CITE THIS ARTICLE: Khergade M, Suri J, Bharti R, Pandey D, Bachani S, Mittal P. Obstetric Early Warning Score for Prognostication of Critically Ill Obstetric Patient. Indian J Crit Care Med 2020;24(6):398-403.