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.).

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.

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.

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 ).

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.

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.

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.

Association of pro- and anti-inflammatory cytokines in preeclampsia.

INTRODUCTION: The pro- and anti-inflammatory cytokines play crucial role in the development and functions of placenta. Any changes in these cytokines may be associated with many pregnancy-related disorders like preeclampsia. Therefore, the present study is aimed to study the expression of pro-inflammatory (TNF-α, IL-6) and anti-inflammatory (IL-4, IL-10) cytokines in placenta and serum of preeclamptic pregnant women. MATERIAL AND METHODS: For this study, a total of 194 cases of preeclamptic and control cases were enrolled in two Groups as per the gestational age that is, Group I (28-36 weeks) and II (37 weeks onwards). The number of samples was 55 in Group I and 139 in Group II. The immunohistochemistry (IHC) and enzyme-linked immunosorbent assay (ELISA) were conducted on placenta and serum of both preeclamptic and normal samples, respectively. IHC results were revalidated by reverse transcriptase PCR (RT-PCR). RESULTS: Both Groups (I, II) of preeclampsia showed amended levels of pro- and anti-inflammatory cytokines in placental tissues and serum samples. The levels of TNF-α and IL-6 were significantly increased in preeclamptic cases (P = 0.0001, P = 0.0001) while the IL-4 and IL-10 were downregulated (P = 0.0001, P = 0.0001) in comparison to control. In addition, a negative correlation was also observed between the two in preeclampsia (P = 0.0001). CONCLUSION: The balanced ratio of pro- and anti-inflammatory cytokines is essential to regulate the maternal inflammation system throughout pregnancy. Therefore, the gradual cytokine profiling of the pregnant women may be useful for the management of preeclampsia.

Management of undernutrition during preconception and pregnancy in an urban setting in North India.

Introduction: The prevalence of underweight in women of reproductive age (WRA) in South Asia remains unacceptably high. Underweight women suffer from lowered immunity, infertility, and a risk of developing non-communicable diseases. In pregnancy, undernutrition results in poor neonatal and maternal outcomes. We present the findings and the management strategy of undernutrition in the preconception and pregnancy phase intervention group in the WING study in low- to lower-middle-income neighborhoods of North India. Methods: We analyzed data from the Women and Infants Integrated Interventions for Growth Study (WINGS) intervention group. In this individually randomized factorial design trial, 13,500 women were enrolled from low to middle-income neighborhoods of Delhi: 6,722 women in the preconception group and 2,640 from the pregnancy group. Food supplements in the form of locally prepared snacks were given to provide necessary calories and protein requirements as per the Body mass index (BMI) during the preconception period and each trimester of pregnancy. The snacks (sweet or savory) and milk or egg as a source of high-quality protein were delivered at home, and intakes were observed. Individual tracking and close monthly monitoring were done for compliance, besides screening and treatment of infections. Results: The enrolled women's mean (SD) age was 24.2 (3.1) years. Approximately 35% of women had a height of < 150 cm, and 50% had schooling >12 years. 17% of women in preconception and 14 % in pregnancy intervention groups were Underweight. Approximately two-thirds of underweight women improved 9-12 months after management in the preconception group, and the same proportion improved 4 weeks after management during pregnancy. The proportion of women with inadequate weight gain (IWG) during pregnancy was higher in women who were underweight during preconception. Discussion: A comprehensive approach to managing undernutrition with high-quality energy-dense food supplementation substantially improved weight gain in women during preconception and pregnancy. Clinical trial registration: http://ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=19339%26EncHid=%26userName=societyforappliedstudies, identifier: Clinical Trial Registry India #CTRI/2017/06/008908.