Publications by authors named "Pratima Mittal"

40 Publications

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

J Obstet Gynaecol India 2021 Jun 21;71(3):226-234. Epub 2021 Jan 21.

Department of Obstetrics and Gynaecology, Vardhman Mahavir Medical College and Safdarjung Hospital, New Delhi, India.

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 (f-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 f-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,  < 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. f-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 f-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 f-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).
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http://dx.doi.org/10.1007/s13224-020-01420-7DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8310817PMC
June 2021

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

Int Urogynecol J 2021 07 5;32(7):1875-1882. Epub 2021 Jun 5.

Department of Obstetrics and Gynaecology, Vardhman Mahavir Medical College and Safdarjung Hospital, New Delhi, India.

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.
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http://dx.doi.org/10.1007/s00192-021-04846-3DOI Listing
July 2021

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

N Engl J Med 2021 05;384(21):2028-2038

The affiliations of the members of the writing committee are as follows: the Department of Maternal, Newborn, Child, and Adolescent Health, and Ageing, World Health Organization, Geneva (S.P.N.R., S.Y., N.M., H.V.J., H.T., R.B.); Vardhman Mahavir Medical College and Safdarjung Hospital (S.A., P.M., N.C., J.S., P.A., K.N., I.S., K.C.A., H.C.) and the All India Institute of Medical Sciences (M.J.S.), New Delhi, and Translational Health Science and Technology Institute, Faridabad (N.W.) - all in India; Muhimbili University of Health and Allied Sciences (H.N., E.A., A.M.) and Muhimbili National Hospital (M.N., R.M.) - both in Dar es Salaam, Tanzania; the University of Malawi, College of Medicine, Blantyre, Malawi (K.K., L.G., A.T.M., V.S., Q.D.); Obafemi Awolowo University, Ile-Ife, Nigeria (C.H.A., O.K., B.P.K., E.A.A.); Kwame Nkrumah University of Science and Technology (S.N., R.L.-R., D.A., G.P.-R.) and Komfo Anokye Teaching Hospital (A.B.-Y., N.W.-B., I.N.), Kumasi, and the School of Public Health, University of Ghana, Accra (A.A.M.) - all in Ghana; Karolinska University Hospital (A.L.) and Karolinska Institute (N.B., A.L., B.W.), Stockholm; the Institute for Safety Governance and Criminology, University of Cape Town, Cape Town, South Africa (B.M.); and Stavanger University Hospital, Stavanger, Norway (S.R.).

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.).
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http://dx.doi.org/10.1056/NEJMoa2026486DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8108485PMC
May 2021

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.

Indian J Radiol Imaging 2020 Jul-Sep;30(3):304-318. Epub 2020 Oct 15.

Department of Pathology, Vardhman Mahavir Medical College and Safdarjung Hospital, New Delhi, India.

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.
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http://dx.doi.org/10.4103/ijri.IJRI_279_20DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7694716PMC
October 2020

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

Indian J Crit Care Med 2020 Aug;24(8):677-682

Department of Pulmonary, Critical Care and Sleep Medicine, Vardhaman Mahavir Medical College and Safdarjung Hospital, New Delhi, India.

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 PaO/FiO and a higher APACHE II score. Patients with a high severity of illness score and a lower PaO/FiO 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.
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http://dx.doi.org/10.5005/jp-journals-10071-23519DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7519589PMC
August 2020

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

Indian J Crit Care Med 2020 Jun;24(6):398-403

Department of Obstetrics and Gynecology, Vardhaman Mahavir Medical College and Safdarjung Hospital, New Delhi, India.

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.
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http://dx.doi.org/10.5005/jp-journals-10071-23453DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7435103PMC
June 2020

Burden of preconception morbidity in women of reproductive age from an urban setting in North India.

PLoS One 2020 18;15(6):e0234768. Epub 2020 Jun 18.

Centre for Health Research and Development, Society for Applied Studies, New Delhi, India.

Background: There is a growing interest in the life course approach for the prevention, early detection and subsequent management of morbidity in women of reproductive age to ensure optimal health and nutrition when they enter pregnancy. Reliable estimates of such morbidities are lacking. We report the prevalence of health or nutrition-related morbidities, specifically, anemia, undernutrition, overweight and obesity, sexually transmitted infections (STIs) or reproductive tract infections (RTIs), diabetes or prediabetes, hypothyroidism, hypertension, and depressive symptoms, during the preconception period among women aged 18 to 30 years.

Methods: A cross-sectional study was conducted among 2000 nonpregnant married women aged 18 to 30 years with no or one child who wished to have more children in two low- to middle-income urban neighborhoods in Delhi, India, in the context of a randomized controlled trial. STIs and RTIs were measured by symptoms and signs, blood pressure by a digital device, height by stadiometer and weight by a digital weighing scale. A blood specimen was taken to screen for anemia, diabetes, thyroid disorders and syphilis. Maternal depressive symptoms were assessed using the Patient Health Questionnaire-9 (PHQ-9). Multivariable logistic regression analysis was performed to identify sociodemographic factors associated with individual morbidity.

Results: Overall, 58.7% of women were anemic; 16.5%, undernourished; 26%, overweight or obese; 13.2%, hypothyroid; and 10.5% with both symptoms and signs of STIs/RTIs. There was an increased risk of RTI/STI symptoms and signs in undernourished women and an increased risk of diabetes or prediabetes in overweight or obese women. An increased risk of undernutrition was also observed in women from lower categories of wealth quintiles. A decreased risk of moderate to severe anemia was seen in overweight women and those who completed at least secondary education.

Conclusions: Our findings show a high burden of undernutrition, anemia, RTIs, hypothyroidism and prediabetes among women in the study. This information will aid policymakers in planning special programs for women of reproductive age.
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http://journals.plos.org/plosone/article?id=10.1371/journal.pone.0234768PLOS
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7302496PMC
August 2020

Niche role of MRI in the evaluation of female infertility.

Indian J Radiol Imaging 2020 Jan-Mar;30(1):32-45. Epub 2020 Mar 30.

Department of Obstetrics and Gynecology, Maulana Azad Medical College, New Delhi, India.

Infertility is a major social and clinical problem affecting 13-15% of couples worldwide. The pelvic causes of female infertility are categorized as ovarian disorders, tubal, peritubal disorders, and uterine disorders. Appropriate selection of an imaging modality is essential to accurately diagnose the aetiology of infertlity, since the imaging diagnosis directs the appropriate treatment to be instituted. Imaging evaluation begins with hystero- salpingography (HSG), to evaluate fallopian tube patency. Uterine filling defects and contour abnormalities may be discovered at HSG but usually require further characterization with pelvic ultrasound (US), sono-hysterography (syn: hystero-sonography/saline infusion sonography) or pelvic magnetic resonance imaging (MRI), when US remains inconclusive. The major limitation of hysterographic US, is its inability to visualize extraluminal pathologies, which are better evaluated by pelvic US and MRI. Although pelvic US is a valuable modality in diagnosing entities comprising the garden variety, however, extensive pelvic inflammatory disease, complex tubo-ovarian pathologies, deep-seated endometriosis deposits with its related complications, Mulllerian duct anomalies, uterine synechiae and adenomyosis, often remain unresolved by both transabdominal and transvaginal US. Thus, MRI comes to the rescue and has a niche role in resolving complex adnexal masses, endometriosis, and Mullerian duct anomalies with greater ease. This is a review, based on the authors' experience at tertiary care teaching hospitals and aims to provide an imaging approach towards the abnormalities which are not definitively diagnosed by ultrasound alone.
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http://dx.doi.org/10.4103/ijri.IJRI_377_19DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7240899PMC
March 2020

Trend Prediction for Cesarean Deliveries Based on Robson Classification System at a Tertiary Referral Unit of North India.

J Obstet Gynaecol India 2020 Apr 11;70(2):111-118. Epub 2019 Oct 11.

Department of Obstetrics and Gynecology, Vardhman Mahavir Medical College and Safdarjung Hospital, New Delhi, 110029 India.

Background: World Health Organization proposed use of Robson Classification as a global standard for assessing, maintaining and comparing Cesarean section (CS) rates. This paper aimed to examine CS trend at a tertiary center according to Robson Ten-Group Classification System (TGCS) over three-year period (2015-2017) and to predict future Cesarean trends.

Methods: This prospective observational study was conducted at a tertiary teaching institute and included 81,784 females who delivered at this hospital over three-year duration (2015-2017). The data compilation was done according to Robson TGCS. The main outcome measures were overall annual CS rates, Robson group-wise CS rates, future overall and Robson group-wise CS trend. These parameters were calculated, trend analysis was done and trend over future 3 years was predicted.

Results: There were 81,784 deliveries (62,336 vaginal and 19,448 Cesarean deliveries) over the study period. The year-wise CS rate was 22.4%, 23.5% and 25.5%, respectively. The largest contribution was by group 5 followed by group 2 and group 1. Based on 3-year data, it was predicted that CS rate will increase by 0.905% annually over coming 3 years. In groups 3, 4, 6, 7 and 8, predicted trend value showed an annual increase by 0.65%, 0.05%, 0.05%, 0.05% and 0.10%, respectively; in groups 1, 2, 5, 9 and 10, it showed an annual decrease of 0.45%, 0.05%, 1.50%, 0.50% and 0.05%, respectively.

Conclusion: Increasing CS rate trend was seen over last 3 years with a predicted rise of 0.905% per year. Robson groups 5, 2 and 1 were at present major contributors; however, the trend analysis predicted a decreasing trend. Trend analysis predicted annual increment in groups 3, 4, 6, 7 and 8 over next 3 years, thereby suggesting need to focus on these groups as well.
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http://dx.doi.org/10.1007/s13224-019-01275-7DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7109230PMC
April 2020

Perinatal-Neonatal Management of COVID-19 Infection - Guidelines of the Federation of Obstetric and Gynaecological Societies of India (FOGSI), National Neonatology Forum of India (NNF), and Indian Academy of Pediatrics (IAP).

Indian Pediatr 2020 Jun 1;57(6):536-548. Epub 2020 Apr 1.

Department of Obstetrics and Gynecology, Ashwini Maternity and Surgical Centre, Mumbai; India.

Justification: During the current rapidly evolving pandemic of COVID-19 infection, pregnant women with suspected or confirmed COVID-19 and their newborn infants form a special vulnerable group that needs immediate attention. Unlike other elective medical and surgical problems for which care can be deferred during the pandemic, pregnancies and childbirths continue. Perinatal period poses unique challenges and care of the mother-baby dyads requires special resources for prevention of transmission, diagnosis of infection and providing clinical care during labor, resuscitation and postnatal period.

Process: The GRADE approach recommended by the World Health Organization was used to develop the guideline. A Guideline Development Group (GDG) comprising of obstetricians, neonatologists and pediatricians was constituted. The GDG drafted a list of questions which are likely to be faced by clinicians involved in obstetric and neonatal care. An e-survey was carried out amongst a wider group of clinicians to invite more questions and prioritize. Literature search was carried out in PubMed and websites of relevant international and national professional organizations. Existing guidelines, systematic reviews, clinical trials, narrative reviews and other descriptive reports were reviewed. For the practice questions, the evidence was extracted into evidence profiles. The context, resources required, values and preferences were considered for developing the recommendations.

Objectives: To provide recommendations for prevention of transmission, diagnosis of infection and providing clinical care during labor, resuscitation and postnatal period.

Recommendations: A set of twenty recommendations are provided under the following broad headings: 1) pregnant women with travel history, clinical suspicion or confirmed COVID-19 infection; 2) neonatal care; 3) prevention and infection control; 4) diagnosis; 5) general questions.
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http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7340735PMC
June 2020

Impact of an integrated nutrition, health, water sanitation and hygiene, psychosocial care and support intervention package delivered during the pre- and peri-conception period and/or during pregnancy and early childhood on linear growth of infants in the first two years of life, birth outcomes and nutritional status of mothers: study protocol of a factorial, individually randomized controlled trial in India.

Trials 2020 Jan 31;21(1):127. Epub 2020 Jan 31.

Centre for Health Research and Development, Society for Applied Studies, 45, Kalu Sarai, New Delhi, India.

Background: The period from conception to two years of life denotes a critical window of opportunity for promoting optimal growth and development of children. Poor nutrition and health in women of reproductive age and during pregnancy can negatively impact birth outcomes and subsequent infant survival, health and growth. Studies to improve birth outcomes and to achieve optimal growth and development in young children have usually tested the effect of standalone interventions in pregnancy and/or the postnatal period. It is not clearly known whether evidence-based interventions in the different domains such as health, nutrition, water sanitation and hygiene (WASH) and psychosocial care, when delivered together have a synergistic effect. Further, the effect of delivery of an intervention package in the pre and peri-conception period is not fully understood. This study was conceived with an aim to understand the impact of an integrated intervention package, delivered across the pre and peri-conception period, through pregnancy and till 24 months of child age on birth outcomes, growth and development in children.

Methods: An individually randomized controlled trial with factorial design is being conducted in urban and peri-urban low- to mid-socioeconomic neighbourhoods in South Delhi, India. 13,500 married women aged 18 to 30 years will be enrolled and randomized to receive either the pre and peri-conception intervention package or routine care (first randomization). Interventions will be delivered until women are confirmed to be pregnant or complete 18 months of follow up. Once pregnancy is confirmed, women are randomized again (second randomization) to receive either the intervention package for pregnancy and postnatal period or to routine care. Newborns will be followed up till 24 months of age. The interventions are delivered through different study teams. Outcome data are collected by an independent outcome ascertainment team.

Discussion: This study will demonstrate the improvement that can be achieved when key factors known to limit child growth and development are addressed together, throughout the continuum from pre and peri-conception until early childhood. The findings will increase our scientific understanding and provide guidance to nutrition programs in low- and middle-income settings.

Trial Registration: Clinical Trial Registry - India #CTRI/2017/06/008908; Registered 23 June 2017, http://ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=19339&EncHid=&userName=society%20for%20applied%20studies.
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http://dx.doi.org/10.1186/s13063-020-4059-zDOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6995212PMC
January 2020

Safety and effectiveness of intravenous iron sucrose versus standard oral iron therapy in pregnant women with moderate-to-severe anaemia in India: a multicentre, open-label, phase 3, randomised, controlled trial.

Lancet Glob Health 2019 12;7(12):e1706-e1716

Ministry of Health and Family Welfare, Government of India, New Delhi, India.

Background: Intravenous iron sucrose is a promising therapy for increasing haemoglobin concentration; however, its effect on clinical outcomes in pregnancy is not yet established. We aimed to assess the safety and clinical effectiveness of intravenous iron sucrose (intervention) versus standard oral iron (control) therapy in the treatment of women with moderate-to-severe iron deficiency anaemia in pregnancy.

Methods: We did a multicentre, open-label, phase 3, randomised, controlled trial at four government medical colleges in India. Pregnant women, aged 18 years or older, at 20-28 weeks of gestation with a haemoglobin concentration of 5-8 g/dL, or at 29-32 weeks of gestation with a haemoglobin concentration of 5-9 g/dL, were randomly assigned (1:1) to receive intravenous iron sucrose (dose was calculated using a formula based on bodyweight and haemoglobin deficit) or standard oral iron therapy (100 mg elemental iron twice daily). Logistic regression was used to compare the primary maternal composite outcome consisting of potentially life-threatening conditions during peripartum and postpartum periods (postpartum haemorrhage, the need for blood transfusion during and after delivery, puerperal sepsis, shock, prolonged hospital stay [>3 days following vaginal delivery and >7 days after lower segment caesarean section], and intensive care unit admission or referral to higher centres) adjusted for site and severity of anaemia. The primary outcome was analysed in a modified intention-to-treat population, which excluded participants who refused to participate after randomisation, those who were lost to follow-up, and those whose outcome data were missing. Safety was assessed in both modified intention-to-treat and as-treated populations. The data safety monitoring board recommended stopping the trial after the first interim analysis because of futility (conditional power 1·14% under the null effects, 3·0% under the continued effects, and 44·83% under hypothesised effects). This trial is registered with the Clinical Trial Registry of India, CTRI/2012/05/002626.

Findings: Between Jan 31, 2014, and July 31, 2017, 2018 women were enrolled, and 999 were randomly assigned to the intravenous iron sucrose group and 1019 to the standard therapy group. The primary maternal composite outcome was reported in 89 (9%) of 958 patients in the intravenous iron sucrose group and in 95 (10%) of 976 patients in the standard therapy group (adjusted odds ratio 0·95, 95% CI 0·70-1·29). 16 (2%) of 958 women in the intravenous iron sucrose group and 13 (1%) of 976 women in the standard therapy group had serious maternal adverse events. Serious fetal and neonatal adverse events were reported by 39 (4%) of 961 women in the intravenous iron sucrose group and 45 (5%) of 982 women in the standard therapy group. At 6 weeks post-randomisation, minor side-effects were reported by 117 (16%) of 737 women in the intravenous iron sucrose group versus 155 (21%) of 721 women in the standard therapy group. None of the serious adverse events was found to be related to the trial procedures or the interventions as per the causality assessment made by the trial investigators, ethics committees, and regulatory body.

Interpretation: The study was stopped due to futility. There is insufficient evidence to show the effectiveness of intravenous iron sucrose in reducing clinical outcomes compared with standard oral iron therapy in pregnant women with moderate-to-severe anaemia.

Funding: WHO, India.
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http://dx.doi.org/10.1016/S2214-109X(19)30427-9DOI Listing
December 2019

Evaluation of reliability of self-collected vaginal swabs over physician-collected samples for diagnosis of bacterial vaginosis, candidiasis and trichomoniasis, in a resource-limited setting: a cross-sectional study in India.

BMJ Open 2019 08 27;9(8):e025013. Epub 2019 Aug 27.

Apex Regional STI Training, Research & Reference Laboratory, VMMC and Safdarjung Hospital, New Delhi, India

Objectives: Self-collected vaginal swabs can facilitate diagnosis of vaginal discharge (VD) in resource-limited settings, provided reliability of the method is established. The aim of this study was to evaluate the concordance between self-collected and physician-collected vaginal swabs for aetiological diagnosis of VD and to determine the prevalence of bacterial vaginosis (BV), vulvovaginal candidiasis (VVC) and trichomonas vaginitis (TV).

Methods: A total of 550 females (median age: 32 years; range: 18-45 years) attending two sexually transmitted infection/reproductive tract infection (STI/RTI) clinics with VD from January 2015 to May 2016 were included in the study after obtaining written informed consent. Swabs were self-collected by patients after instructions and subsequently by a physician under speculum examination. Samples were processed for standard bedside tests, Gram staining, wet mount and culture (gold standard) according to the national guidelines. Concordance between the two methods was determined by the Cohen's kappa value.

Results: BV, VVC and TV were diagnosed in 79 (14.4%), 144 (26.2%) and 3 (0.5%) patients, respectively. VVC coexisted with BV in 58 (10.5%) patients. There was no coinfection of TV with BV or VVC. was isolated in 84 (58.3%) VVC cases. Sensitivity, specificity, positive predictive value (PPV) and negative predictive value (NPV) of self-collected swabs for diagnosing BV was 91.1%, 100%, 100% and 98.5%, respectively, while for the VVC and TV, sensitivity, specificity, PPV and NPV all were 100% as compared with physician-collected swabs. Highly concordant results were obtained between two methods by the Kappa values of 0.95 (BV), 0.99 (VVC) and 1.0 (TV).

Conclusion: The comparative performance of self-collected and physician-collected vaginal swabs establishes self-collection of samples for BV, VVC and TV as a viable alternative tool in the management of STIs/RTIs, especially in peripheral and resource-constrained settings. This would be effective in implementing the diagnostic approaches for STIs/RTIs in community-based surveillance studies at national or regional level and therefore strengthening the National STI/RTI Control Programme.
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http://dx.doi.org/10.1136/bmjopen-2018-025013DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6719764PMC
August 2019

Assessment of labor progression by intrapartum ultrasonography among term nulliparous women.

Int J Gynaecol Obstet 2019 Oct 29;147(1):78-82. Epub 2019 Jul 29.

Shishu Mangal Maternity and Fertility Clinic, New Delhi, India.

Objective: To assess cervical dilation, fetal head station, and fetal head position by intrapartum ultrasonography and to compare the approach with digital vaginal examination (DVE).

Methods: An observational study conducted from October 2015 to January 2017 among term nulliparous women in active labor at a tertiary hospital in Delhi, India. Cervical dilation, head station, and head position were assessed by DVE, followed by ultrasonography within 10 minutes. The women's preference was also evaluated.

Results: Overall, 458 observations were obtained for 215 women. Cervical dilation measured by DVE was strongly correlated with ultrasonography findings (intraclass correlation coefficient, 0.945; 95% confidence interval, 0.932-0.956; κ=0.837; P<0.001). Data for fetal head station and head position showed a fair correlation (κ=0.353 and κ=0.554, respectively; both P<0.001). The majority of women (186/215, 87%) reported a preference for ultrasonography over DVE for assessment of labor progression in a future pregnancy.

Conclusion: Intrapartum ultrasonography was preferred as an objective assessment tool for labor progression among term nulliparous women and therefore should be practiced in all labor rooms. Further studies on interobserver variation are recommended to establish the reproducibility of intrapartum assessment by ultrasonography.
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http://dx.doi.org/10.1002/ijgo.12906DOI Listing
October 2019

Psychosocial Implications of Stillborn Babies on Mother and Family: A Review from Tertiary Care Infirmary in India.

J Obstet Gynaecol India 2019 Jun 6;69(3):232-238. Epub 2018 Sep 6.

Department of Obstetrics and Gynecoclogy, VMMC and Safdarjung Hospital, New Delhi, 110029 India.

Background: When a mother loses a baby after the period of viability, there is no way to fathom her grief, neither any words, nor an explanation. It is an unexpected event. Stillbirth presents a situation where the early activation of the grief process primarily in mother is exacerbated by the circumstances surrounding the loss. It thus becomes imperative for the healthcare providers to evaluate the significance of parent's perception on the loss and the factors contributing to it before the initiation of therapy.

Objective: To evaluate the psychosocial impact of stillbirth among mothers and its contributing factors.

Materials And Methods: A WHO-funded prospective study was conducted in VMMC and Safdarjung Hospital from September 2015 to August 2016 on all women who gave birth to a stillborn baby, using a questionnaire based on EPDS, after taking their written informed consent. Data were entered on the predesigned proforma and analyzed after applying Chi-square test, keeping a null hypothesis value of 15% for all the variables.

Results: Out of the 709 women who delivered stillborn babies, 645 respondents, who willingly consented to participate, were included in the study. There was a significant relationship between psychosocial impact after perinatal loss and support from caregiver and family.

Conclusion: Mothers with stillborn fetuses should be screened for psychosocial impact and offered support when needed. Appropriate counseling by healthcare providers and continued psychosocial and emotional support by family members must be provided.
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http://dx.doi.org/10.1007/s13224-018-1173-xDOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6531591PMC
June 2019

Evaluating exercise challenge to validate cardiac autonomic dysfunction in lean PCOS phenotype.

J Basic Clin Physiol Pharmacol 2019 May 16;30(4). Epub 2019 May 16.

Department of Physiology, All India Institute of Medical Sciences Jodphur, Jodhpur, Rajasthan, India.

Background Polycystic ovary syndrome (PCOS) is frequently associated with infertility, obesity, hypertension, and diabetes mellitus. Cardiac autonomic dysfunction is well documented in long-term patients of PCOS, with impairment being proportionate to disease duration. However, there is paucity of literature on cardiac autonomic tone in the "lean" phenotype of PCOS. We used exercise challenge to probe for autonomic dysfunction, as assessed by heart rate variability (HRV), an index of cardiac autonomic tone. Methods Our study population consisted of 27 newly diagnosed PCOS patients and 25 healthy females matched by age and body mass index. Short-term HRV was assessed using time and frequency domain indices. Moderate, isotonic exercise was used as an interventional tool. Indices of both groups were compared in three bins - at baseline, immediate, and late postexercise stages. Results The groups had comparable HRV indices at baseline. However, low-frequency (LF) power was significantly reduced in PCOS patients during immediate and late postexercise phases when compared with controls (p = 0.03 and 0.03, respectively). Time domain indices also exhibited a fall postexercise, although not statistically significant. Conclusions Although "lean" phenotype PCOS patients had comparable HRV parameters as controls at baseline, the administration of exercise challenge led to reduced sympathetic drive, evident by reduced LF power in patient group. This may be due to latent autonomic dysfunction in "lean" PCOS, which is unmasked on exposure to exercise challenge. We propose that the evaluation of HRV response to exercise may serve as a sensitive screening tool to detect early cardiovascular dysfunction in newly diagnosed lean PCOS patients.
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http://dx.doi.org/10.1515/jbcpp-2018-0198DOI Listing
May 2019

Review of Maternal Mortality at a Tertiary Care Hospital: What Have we Achieved?

J Obstet Gynaecol India 2019 Apr 21;69(2):149-154. Epub 2018 May 21.

1Department of Obstetrics and Gynecology, VMMC & Safdarjung Hospital, New Delhi, India.

Background: Mothers are the nurturing pillar of the family. When a woman dies or becomes ill, either during or after giving birth, the consequences have the potential to affect not only the woman herself, but her family, society and the nation as well.

Objectives: The study was designed to evaluate the maternal mortality ratio in a tertiary care hospital, assess the demographic profile, causes of maternal mortality, type of delay, and to suggest remedial measures for improvement.

Methods: A retrospective study was done from Jan 2013 to Dec 2016 at a tertiary care hospital in New Delhi. The medical records of all maternal deaths over a period of 4 years were reviewed and analyzed.

Results: The Maternal mortality ratio in the study period was 361.71/100,000 live births. The number of maternal death was 364. Unbooked cases accounted for the majority, i.e., 322, booked being 29 and registered 13. Two hundred and eleven cases were referred from other centers. Maximum deaths occurred between 21 and 30 years (73.07%). Anemia was widely prevalent. Most maternal deaths were due to direct causes like hypertensive disorders (28.02%), pregnancy-related infections (20.87%), and hemorrhage (12.36%). Among indirect causes, anemia, hepatitis, heart disease and respiratory illness accounted for 15.93, 11.53, 3.29 and 5.49%, respectively. Type I delay was most common (64.28%).

Conclusion: Strengthening of the peripheral centers, hiring competent staffs and adequate blood bank facilities together with reference linkages must be done. Auditing the causes for maternal mortality is extremely helpful to identify the preventable causes and delays.
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http://dx.doi.org/10.1007/s13224-018-1129-1DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6430275PMC
April 2019

Comparison of placenta accreta spectrum disorders diagnosed in intrapartum and antepartum period- A three year experience in a tertiary referral unit of India.

Eur J Obstet Gynecol Reprod Biol 2019 May 6;236:41-45. Epub 2019 Mar 6.

Vardhman Mahavir Medical College & Safdarjung Hospital, New Delhi, India.

Objective: To determine the frequency of placenta accreta spectrum (PAS) disorders and to study the demographic profile, risk factors and maternal and fetal outcomes in women with antepartum diagnosis of PAS as compared to women with diagnosis made in the intrapartum period.

Study Design: Retrospective analysis over a 3-year period of all patients who delivered with PAS. The cases were divided into 2 groups. Group 1 consisted of the patients who were diagnosed during the intra partum period and Group 2 was those diagnosed as PAS by ultrasound in the antepartum period. Maternal and fetal outcomes were compared between the 2 groups. The cases that underwent conservative management were also analyzed for need of secondary hysterectomy/placental resolution RESULTS: There were 81,480 deliveries conducted during the study period of which 74 were identified as PAS. Hence PAS was seen in 1:1101 deliveries (0.09%). The estimated blood loss and number of units of blood products required were significantly higher in Group 1 (2.36 ± 0.77 l vs 1.8 ± 0.91 L, p = 0.002; and 10.17 ± 5.12 vs 6.77 ± 4.22, p = 0.005) compared to Group 2. The ICU stay was also more common in Group 1 (p = 0.01). The perinatal mortality was significantly higher in Group 1(45.71% vs 23.08%, p = 0.040). 79.7% women underwent primary cesarean hysterectomy while others were managed conservatively. In conservatively managed group, placental resolution took place in 60% and 40% required secondary hysterectomy.

Conclusion: Antenatal diagnosis of placenta accreta spectrum disorders decreases the maternal morbidity and perinatal mortality.
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http://dx.doi.org/10.1016/j.ejogrb.2019.03.001DOI Listing
May 2019

Mother-Neonatal Intensive Care Unit (M-NICU): A Novel Concept in Newborn Care.

Indian Pediatr 2018 Dec;55(12):1035-1036

Department of Pediatrics, VMMC and Safdarjung Hospital, New Delhi, India.

Health facilities in India are faced with the challenge of providing quality newborn care in the face of major skilled human resource shortage. A possible solution is the concept of Mother-Neonatal ICU (M-NICU), where the mother has her bed inside the neonatal intensive care unit (NICU) by the side of baby's warmer. Our observations in M-NICU of a public sector hospital in New Delhi, India, indicate that mothers can be easily trained to follow asepsis routines and monitor the neonates, and are better prepared for their post-discharge care. Incorporating space for both mothers and their newborns in level-II NICUs may provide quality and developmentally supportive newborn care in coming years.
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December 2018

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

J Clin Lab Anal 2019 May 21;33(4):e22834. Epub 2019 Jan 21.

Department of Anatomy, Vardhman Mahavir Medical College & Safdarjung Hospital, New Delhi, India.

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.
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http://dx.doi.org/10.1002/jcla.22834DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6528584PMC
May 2019

Differences in multiple immune parameters between Indian and U.S. infants.

PLoS One 2018 16;13(11):e0207297. Epub 2018 Nov 16.

Institute for Immunity, Transplantation, and Infection, Stanford University School of Medicine, Stanford, United States of America.

To compare immune phenotypes across two geographic and ethnic communities, we examined umbilical cord blood by flow cytometry and Luminex in parallel cohorts of 53 newborns from New Delhi, India, and 46 newborns from Stanford, California. We found that frequencies of a B cell subset suggested to be B-1-like, and serum IgM concentration were both significantly higher in the Stanford cohort, independent of differences in maternal age. While serum IgA levels were also significantly higher in the Stanford cohort, IgG1, IgG2, and IgG4 were significantly higher in the New Delhi samples. We found that neutrophils, plasmacytoid dendritic cells, CD8+ T cells, and total T cells were higher in the U.S. cohort, while dendritic cells, patrolling monocytes (CD14dimCD16+), natural killer cells, CD4+ T cells, and naïve B cells were higher in the India cohort. Within the India cohort, we also identified cell types whose frequency was positively or negatively predictive of occurrence of infection(s) in the first six months of life. Monocytes, total T cells, and memory CD4+ T cells were most prominent in having an inverse relationship with infection. We suggest that these data provide impetus for follow-up studies linking phenotypic differences to environmental versus genetic factors, and to infection outcomes.
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http://journals.plos.org/plosone/article?id=10.1371/journal.pone.0207297PLOS
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6239317PMC
April 2019

Role of Ultrasonographic Placental Thickness in Prediction of Fetal Outcome: A Prospective Indian Study.

J Obstet Gynaecol India 2018 Oct 1;68(5):349-354. Epub 2017 Sep 1.

2Department of Radiology and Vice Principal, Vardhman Mahavir Medical College, Safdarjung Hospital, New Delhi, 110029 India.

Background Information: Placenta is the connecting organ between the mother and the fetus. It supplies oxygen and all the necessary elements for the growth and development of the fetus. In normal pregnancy, the growth of the placenta remains concordant with the growth of the fetus. The sonographic assessment of placenta can give information about the nutritional status of the fetus. It is known that normal placental thickness approximately equals gestational age. It is historically documented that placental weight is one-fifth of the fetal weight and abnormally thin or thick placenta is associated with increased incidence of perinatal morbidity and mortality. However, there are very few studies correlating placental thickness with Neonatal outcome.

Objectives: To correlate ultrasonographic placental thickness at 32 and 36 weeks pregnancy with neonatal outcome. To propose placental thickness as a simple test for prediction of neonatal outcome.

Methods: Placental thickness at 32 and 36 weeks was measured by ultrasound, in 130 pregnant mothers with confirmed dates and uncomplicated singleton pregnancy. Placental thickness was categorized as normal (10th-95th percentile), thin (<10th percentile) and thick (>95th percentile) at each stage and was correlated with birth weight and neonatal outcome.

Results: Neonatal outcome was good in women with normal placental thickness (10th-95th percentile) at 32 and 36 weeks and was compromised in women with thin (<10th percentile) and thick (>95th percentile) placentae.

Conclusion: Placental thickness at 32 and 36 weeks corresponds well with gestational age and is a good prognostic factor in assessing neonatal outcome. Therefore, placental thickness should be measured in addition to biometric parameters in antenatal women undergoing ultrasound.
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http://dx.doi.org/10.1007/s13224-017-1038-8DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6133799PMC
October 2018

Feto-maternal Outcomes in Pregnancies Complicated by Thermal Burns.

J Obstet Gynaecol India 2018 Aug 15;68(4):270-275. Epub 2017 Jun 15.

2Department of Burns and Plastic Surgery, VMMC and Safdarjung Hospital, New Delhi, India.

Background: Burns in pregnancy can be a potentially life-threatening condition for both mother and baby. Human physiology is altered during pregnancy and burns add further stress leading to diminished maternal reserves. Very few studies have been reported for management of such patients.

Materials And Methods: This was a prospective based study carried out in Department of Burns and Plastic Surgery in collaboration with Department of Obstetrics and Gynaecology and Department of Pediatrics for a period of 20 months from December 2011 to July 2013. Pregnant women with thermal injuries more than 15% TBSA were included in the study. Patients with coexisting obstetrics complications and burns other than thermal were excluded.

Results: Out of 3397 female patients of burns admitted, 1382 patients were in reproductive groups, 1116 were married and 67 were pregnant; these were enrolled. Maternal and fetal outcome is inversely linked with the TBSA of the mother ( < 0.001). In TBSA group 15-30%, there was no maternal and fetal mortality, but in TBSA >30-50% maternal mortality was 44%, and in 50-70% maternal mortality was 83% and no mother survived in >70%. In TBSA 30-50%, fetal mortality was 72%. Only one baby survived in 50-70% TBSA group and one in >70% TBSA group after intensive care in NICU for prematurity. Fetal survival was also dependent on gestational age, and there are better outcomes in late trimesters.

Conclusion: Maternal and fetal outcome are directly related to TBSA of mother, and best care can be offered to such patients with a multidisciplinary team-based approach.
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http://dx.doi.org/10.1007/s13224-017-1021-4DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6046666PMC
August 2018

Multi-centric validation of an in-house-developed beacon-based PCR diagnostic assay kit for Chlamydia and Neisseria and portable fluorescence detector.

J Med Microbiol 2018 Sep 27;67(9):1287-1293. Epub 2018 Jul 27.

1​Dr B. R. Ambedkar Center for Biomedical research (ACBR), University of Delhi, Delhi 110007, India.

Objective: The development of an accurate, sensitive, specific, rapid, reproducible, stable-at-room-temperature and cost-effective diagnostic kit, and a low-cost portable fluorescence detector to fulfil the requirements of diagnostic facilities in developing countries.

Methods: We developed the 'Chlamy and Ness CT/NG kit' based on molecular beacons for the detection of Chlamydia trachomatis (CT) and Neisseriagonorrhoeae (NG). Multi-centric evaluation of the CT/NG kit was performed using the commercially available nucleic acid amplification test (NAAT)-based FTD Urethritis basic kit for comparison from December 2014 to November 2016. The stability of the kit reagents at 4 and 37 ˚C and the inter-day reproducibility of results were also analysed.

Results: The sensitivity and specificity of the kit were found to be 95.83 and 100.00 % for the detection of C. trachomatis and 93.24 and 99.75 % for N. gonorrhoeae, respectively, when tested against the commercial kit. The positive predictive value (PPV) was 100.00 and 98.57 %, whereas the negative predictive value (NPV) was 99.54 and 98.79 % for C. trachomatis and N. gonorrhoeae, respectively. Analysis of the kappa statistics enhanced the 'inter-rater' κ=0.976 for Chlamydia and κ=0.943 for Neisseria.

Conclusion: Our kit was found to be as sensitive and specific as commercially available kits. Its low cost and ease of use will make it suitable for the routine diagnosis of C. trachomatis and N. gonorrhoeae in the resource-limited settings of developing countries.
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http://dx.doi.org/10.1099/jmm.0.000803DOI Listing
September 2018

Burden of physical, psychological and social ill-health during and after pregnancy among women in India, Pakistan, Kenya and Malawi.

BMJ Glob Health 2018 3;3(3):e000625. Epub 2018 May 3.

Centre for Maternal and Newborn Health, Liverpool School of Tropical Medicine, Liverpool, UK.

Introduction: For every woman who dies during pregnancy and childbirth, many more suffer ill-health, the burden of which is highest in low-resource settings. We sought to assess the extent and types of maternal morbidity.

Methods: Descriptive observational cross-sectional study at primary-level and secondary-level healthcare facilities in India, Pakistan, Kenya and Malawi to assess physical, psychological and social morbidity during and after pregnancy. Sociodemographic factors, education, socioeconomic status (SES), quality of life, satisfaction with health, reported symptoms, clinical examination and laboratory investigations were assessed. Relationships between morbidity and maternal characteristics were investigated using multivariable logistic regression analysis.

Results: 11 454 women were assessed in India (2099), Malawi (2923), Kenya (3145), and Pakistan (3287). Almost 3 out of 4 women had ≥1 symptoms (73.5%), abnormalities on clinical examination (71.3%) or laboratory investigation (73.5%). In total, 36% of women had infectious morbidity of which 9.0% had an identified infectious disease (HIV, malaria, syphilis, chest infection or tuberculosis) and an additional 32.5% had signs of early infection. HIV-positive status was highest in Malawi (14.5%) as was malaria (10.4%). Overall, 47.9% of women were anaemic, 11.5% had other medical or obstetric conditions, 25.1% reported psychological morbidity and 36.6% reported social morbidity (domestic violence and/or substance misuse). Infectious morbidity was highest in Malawi (56.5%) and Kenya (40.4%), psychological and social morbidity was highest in Pakistan (47.3%, 60.2%). Maternal morbidity was not limited to a core at-risk group; only 1.2% had all four morbidities. The likelihood of medical or obstetric, psychological or social morbidity decreased with increased education; adjusted OR (95% CI) for each additional level of education ranged from 0.79 (0.75 to 0.83) for psychological morbidity to 0.91 (0.87 to 0.95) for infectious morbidity. Each additional level of SES was associated with increased psychological morbidity (OR 1.15 (95% CI 1.10 to 1.21)) and social morbidity (OR 1.05 (95% CI 1.01 to 1.10)), but there was no difference regarding medical or obstetric morbidity. However, for each morbidity association was heterogeneous between countries.

Conclusion: Women suffer significant ill-health which is still largely unrecognised. Current antenatal and postnatal care packages require adaptation if they are to meet the identified health needs of women.
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http://dx.doi.org/10.1136/bmjgh-2017-000625DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC5935159PMC
May 2018

Retained Intra-uterine Foetal Bones Resulting in Secondary Infertility: A Case Report.

Cureus 2018 May 3;10(5):e2575. Epub 2018 May 3.

Department of Obstetrics and Gynaecology, VMMC and Safdarjung Hospital, New Delhi, IND.

Termination of pregnancy (abortion) is a reasonably safe procedure when properly performed. However, even after being performed with due precautions, complications may occur. Retention of fetal products following a mid-trimester abortion is a rare complication of abortion which can then result in secondary infertility. We are here presenting the case of a young woman who underwent an abortion in the 15th week of gestation due to anencephaly in the fetus and who then failed to conceive for the next five years. Transvaginal ultrasonographic examination suggested the presence of bone-like structures in the uterine cavity which were removed hysteroscopically. The patient was able to conceive after the hysteroscopic removal of bony fragments. Retained bony fragments from a previous mid-trimester abortion should thus be kept in the list of differentials of secondary infertility.
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http://dx.doi.org/10.7759/cureus.2575DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6710494PMC
May 2018

Visibility of Strings After Postplacental Intracesarean Insertion of CuT380A and Cu375 Intrauterine Contraceptive Device: A Randomized Comparative Study.

J Obstet Gynaecol India 2017 10 30;67(5):324-329. Epub 2017 Jan 30.

NIMS, Delhi, India.

Objectives: To compare the incidence of visible strings after postplacental intracesarean insertion of Cu375 and CuT380A intrauterine contraceptive devices (IUD).

Methods: This was a prospective, randomized comparative study. A total of 100 women fulfilling the inclusion and exclusion criteria underwent postplacental intracesarean insertion of either Cu375 IUD or CuT380A IUD. Women were followed up at 1, 6 weeks and 3 months after IUD insertion and were questioned about IUD expulsion or removal at each visit. The cervix was inspected to visualize the IUD strings. Data were analyzed by Chi-square test.

Results: At 6-week follow-up, 97.9% women in group A versus 41.7% women in group B had strings visible at the cervical os and at 3 months 100% women in group A versus only 47.9% women in group B ( < 0.001) had visible strings of IUD.

Conclusion: Both Cu375 and CuT380A IUD are safe postpartum method of contraception but Cu375 if used for intracesarean IUD insertion increases the incidence of visible IUD strings. Hence, it avoids radiological investigations and invasive procedures at follow-up visits required to locate the IUD when strings are not visible. CTRI/2015/09/006221.
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http://dx.doi.org/10.1007/s13224-017-0965-8DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC5561761PMC
October 2017

Severe Puerperal Sepsis-A Simmering Menace.

J Clin Diagn Res 2017 May 1;11(5):QC04-QC08. Epub 2017 May 1.

Professor and Consultant, Department of Obstetrics and Gynecology, Vmmc and Safdarjung Hospital, New Delhi, India.

Introduction: Even decades after the development of effective low-cost antibiotics, sepsis persists as the foremost cause of preventable maternal death worldwide. In developing countries like India, where the paramount impediment to intervention is poverty, maternal mortality due to sepsis is a continuing representation of maternal health inequality.

Aim: To determine the incidence, risk factors and mortality in women presenting with puerperal sepsis in a tertiary care health facility in India.

Materials And Methods: This retrospective study was carried out in VMMC and Safdarjung Hospital, New Delhi, India, from January 2016 to June 2016 in Department of Obstetrics and Gynaecology. Case records of all eligible patients of puerperal sepsis were reviewed and data were extracted regarding demographic profile, clinical profile on admission, course in hospital, management, complications and cause of mortality (in case of death). Inclusion criteria were any patient presenting either immediately after delivery or miscarriage or within 42 days of these events with fever and any of the following: pain abdomen, malodorous lochia, abdominal distention, uterine tenderness, pelvic abscess, peritonitis, mechanical or foreign body injury, any system/organ failure or shock. Exclusion criteria consisted of patients presenting with fever during pregnancy or more than 42 days after delivery or miscarriage, or patients presenting with fever due to medical conditions, wound infection, mastitis, UTI or thrombophlebitis. Data were entered in predesigned proformas and analysed. A p-value of less than 0.05 was considered significant.

Results: During the study period, a total of 33 cases met the inclusion criteria. Of these, 90% were referred cases. Anaemia, prolonged labour, delivery by an untrained person and unsafe abortion were the main identifiable risk factors. Surgical management was required in 75% cases, while 70% women succumbed to their illness, mostly due to multiorgan failure.

Conclusion: Maternal mortality due to maternal sepsis is very high; Lack of safe and hygienic practices for conducting delivery and abortion are important contributory factors.
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http://dx.doi.org/10.7860/JCDR/2017/23710.9815DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC5483754PMC
May 2017

A retrospective analysis of the symptoms and course of dengue infection during pregnancy.

Int J Gynaecol Obstet 2017 Oct 11;139(1):4-8. Epub 2017 Jul 11.

Department of Obstetrics and Gynaecology, Safdarjung Hospital, New Delhi, India.

Objective: To assess outcomes among pregnant women diagnosed with dengue infection.

Methods: In a retrospective study, the medical records of all pregnant women with dengue infection admitted to Safdarjung Hospital, New Delhi, India, from July to December 2015 were reviewed. Maternal and fetal outcomes were compared by pregnancy length and stage of disease at diagnosis.

Results: Overall, 62 pregnant women with dengue infection were identified. Of these, 56 (90%) tested negative for nonstructural protein 1 (NS1) antigen, indicating a later stage of disease. Maternal near miss and mortality were significantly more common among women with DHF or DSS than among those with dengue fever (P<0.001). Spontaneous abortion occurred for four of six women diagnosed in the first trimester, and one of two women diagnosed in the second trimester. Among 22 women diagnosed at 26-36  weeks, 9 (41%) delivered preterm. There was one case of stillbirth at 37 weeks and no cases of neonatal death.

Conclusion: Women diagnosed with dengue fever had far better outcomes than did those with DHF or DSS.
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http://dx.doi.org/10.1002/ijgo.12245DOI Listing
October 2017

Evaluating the utility of syndromic case management for three sexually transmitted infections in women visiting hospitals in Delhi, India.

Sci Rep 2017 05 3;7(1):1465. Epub 2017 May 3.

Medical Biotechnology Laboratory, Dr. B. R. Ambedkar Center for Biomedical Research, University of Delhi, Delhi, India.

Utility of syndromic case management (SCM) in women visiting obstetrics & gynecology department needs to be evaluated as it is subjective and imperfect. Consequently, antibiotic resistance has accelerated along with increased risk of infection to the partners. To understand the effectiveness and/or inadequacies of SCM, 11000 women were recruited and examined by clinicians for infection by Chlamydia trachomatis (CT), Neisseria gonorrhoeae (NG), Trichomonas vaginalis (TV), Bacterial vaginosis (BV) and others. Amongst these patients, 1797 (16.3%) reported vaginal discharge (VD). Other symptoms included: vaginitis (97%), cervicitis (75%), genital ulcers (60%), abnormal vaginal discharge (55%) and lower abdominal pain (48%). The patients were treated for single or co-infections using pre-packed National Aids Control Program III STI/RTI Kits. However, based on PCR diagnostics, 1453/1797 (81%) subjects were uninfected for NG/TV/CT. Amongst 344 (19%) infected patients, 257 (75%) carried infection with single pathogen (TV/NG/CT) while 87/344 (25%) were co-infected with multiple pathogens. Prevalence of TV, NG & CT was 4%, 7% and 8% respectively. Co-infection with CT + NG was highest, 51% (44/87), whereas, co-infection with CT + TV was 21% and NG + TV was 18% while co-infection with all three pathogens was 1.3%. We conclude that SCM is imprecise and successful intervention requires accurate and confirmatory diagnostic approach.
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Source
http://dx.doi.org/10.1038/s41598-017-01422-yDOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC5431118PMC
May 2017
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