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IntroductionThe 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.MethodsWe 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.ResultsThe 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.DiscussionA comprehensive approach to managing undernutrition with high-quality energy-dense food supplementation substantially improved weight gain in women during preconception and pregnancy.Clinical trial registrationhttp://ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=19339%26EncHid=%26userName=societyforappliedstudies, identifier: Clinical Trial Registry India #CTRI/2017/06/008908.

Abstract Objective: Despite the literature on dydrogesterone, studies on dydrogesterone utilization patterns are largely lacking in Indian patients. Methods: This was a multi-center, retrospective, observational, cross-sectional, and descriptive study across 817 centers in India. Data of patients who received dydrogesterone in past and provided consent for future use of their medical record for research purpose was were retrieved and analyzed. Results: Data of 7287 subjects (aged 29.55±4.84 years) was analyzed. Threatened abortion was the most common indication for which the subjects received dydrogesterone (46.9%) followed by recurrent pregnancy loss. Polycystic ovary syndrome (PCOS), thyroid disorders and anemia were the most common comorbid conditions and prior pregnancy loss, advanced maternal age and obesity were the most common risk factors seen in subjects who received dydrogesterone. Total 27.5% of subjects received a loading dose of dydrogesterone, and majority (64%) received 40 mg as loading dose. 10 mg dose was used as maintenance or regular dose in 81.4% of the subjects. Twice daily (BID) was the most common dosing frequency (66.6%). The most common concomitant medications being taken by the subjects on dydrogesterone included folic acid (45.1%), iron supplements (30.3%) and calcium and vitamin D3 supplements (25.5%). Another progesterone preparation (oral, injection, vaginal, tubal) other than dydrogesterone was used concurrently in 7.8% of subjects. Conclusion: The study helped to identify the patient population that is benefitted by dydrogesterone and the preferred indications, risk factors, comorbid conditions and concomitant medication used in this patient population at real-life scenario.

Abstract 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 ).

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 μU/ml vs 3.02 ± 5.34 μU/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.

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).

BackgroundA 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.MethodsThe 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.ResultsAmong 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

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.

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.

Abstract 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

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.

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.

Abstract Despite the high prevalence of inadequate gestational weight gain (GWG) and adverse pregnancy outcomes, very few studies have addressed the association between GWG and pregnancy outcomes in South Asia. Our objectives were to estimate the prevalence of GWG during the second and third trimesters within, below and above the Institute of Medicine (IOM) guidelines, and to estimate the effect of the rate and adequacy of GWG on gestational age at the time of delivery, weight, length, length‐for‐age z‐score (LAZ), weight‐for‐length z‐score (WLZ) and adverse pregnancy outcomes, namely prematurity, small‐for‐gestational age (SGA), low birth weight (LBW), stunting and wasting at birth. We analysed data from the intervention group of the Women and Infants Integrated Interventions for Growth Study (WINGS), which is an ongoing individually randomized factorial design study. Of the 1332 women analysed, 40.2% [95% confidence interval (CI) 37.5 to 42.8] had GWG below the IOM guidelines. For every 100‐g/week increase in GWG, birth weight increased by 61 g, birth length by 0.16 cm, LAZ score by 0.08 SD, WLZ score by 0.14 SD, and gestational age at birth by 0.48 days. Women with GWG below the IOM guidelines had a higher relative risk of adverse pregnancy outcomes (44% for LBW, 27% for SGA, 32% for stunting and 42% for wasting at birth) than women who had GWG within the IOM guidelines, except for prematurity. The association between GWG and LAZ scores at birth was modified by early pregnancy body mass index (BMI). GWG is a strong predictor of newborn anthropometric outcomes and duration of gestation but not prematurity.

BackgroundThe incidence of preterm birth (PTB) in India is around 13%. Specific bacterial communities or individual taxon living in the vaginal milieu of pregnant women is a potential risk factor for PTB and may play an important role in its pathophysiology. Besides, bacterial taxa associated with PTB vary across populations.ObjectiveConduct a comparative analysis of vaginal microbiome composition and microbial genomic repertoires of women who enrolled in the Interdisciplinary Group for Advanced Research on Birth Outcomes – A DBT India Initiative (GARBH-Ini) pregnancy cohort to identify bacterial taxa associated with term birth (TB) and PTB in Indian women.MethodsVaginal swabs were collected during all three trimesters from 38 pregnant Indian women who delivered spontaneous term (n=20) and preterm (n=18) neonates. Paired-end sequencing of V3-V4 region of 16S rRNA gene was performed using the metagenomic DNA isolated from vaginal swabs (n=115). Whole genome sequencing of bacterial species associated with birth outcomes was carried out by shotgun method. Lactobacillus species were grown anaerobically in the De Man, Rogosa and Sharpe (MRS) agar culture medium for isolation of genomic DNA and whole genome sequencing.ResultsVaginal microbiome of both term and preterm samples reveals similar alpha diversity indices. However, significantly higher abundance of Lactobacillus iners (p-value All_Trimesters

BackgroundThere 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.MethodsA 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.ResultsOverall, 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.ConclusionsOur 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.

Summary: 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.

Abstract 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.

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. Candida albicans 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 C. albicans 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.

Introduction: Hypertensive Disorders of Pregnancy (HDP) affect 6-8% of all pregnancies, contributing immensely to maternal morbidity and mortality. Pre-eclampsia is a common, yet a major medical complication of pregnancy and is responsible for 10%-15% of maternal deaths. Lactate Dehydrogenase (LDH) is an intracellular enzyme, which when present in serum signifies tissue damage and haemolysis. Aim: To study the correlation of serum LDH levels with blood pressure range in patients with gestational hypertension and pre-eclampsia, and the feto-maternal outcome. Materials and Methods: Based on the eligibility criteria, 150 hypertensive pregnant women were enrolled as cases. Also, 150 normotensive women admitted after 28 weeks of gestation were taken as controls in the study. Serum LDH was measured in both the groups and its correlation with blood pressure was studied, after applying appropriate clinical tests. (Quantitative variables-unpaired t-test/Mann-Whitney test between two groups and ANOVA/Kruskal Wallis test between more than two groups; Qualitative variables: chi-square/Fisher exact test. Pearson/Spearsman correlation coefficient was used to assess correlation between various quantitative parameters) Association of other biochemical parameters with feto-maternal outcome was also studied. Results: The mean age of women in hypertensive group was 25.06±4.13 years, while that in normotensive group was 24.38±3.8 years. Most women belonged to lower and lower middle class (75.33%). The mean serum LDH levels in hypertensive group was 1011.81±539.31 IU/L, while it was 555.24±237.69 IU/L in normotensive groups (p-value=0.017). Serum LDH levels were significantly associated with the range of blood pressure (p-value

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.

Introduction: Cardiac disorders of varying severity complicate nearly 1% of pregnancies and are an important cause of maternal morbidity and mortality. It is important to define the risk stratification of women with heart disease for optimal prepregnancy counselling and obstetric management. Aim: To study the spectrum of heart disease in pregnancy, identification of various predictors of feto-maternal complications and comparison of the obstetric outcome in women with heart disease who received Comprehensive Medical Care (CMC) beginning at ≤28 weeks, with those who began Antenatal Care (ANC) supervision after 28 weeks. Materials and Methods: A prospective observational study was conducted in the Department of Obstetrics and Gynaecology in Safdarjung Hospital (SJH), New Delhi, India, from October 2014 to March 2016. Pregnant women with heart disease attending the OPD/or delivering in labour room were scrutinised through the eligibility criteria. Out of the 66 eligible women, beginning antenatal supervision at ≤28 weeks of gestation were designated as Group A (n=32) who received CMC. Remaining women (n=34), who supervised after 28 weeks in the hospital for further management were designated as Group B. Analysis was done after applying appropriate tests: t-test, Chi-square test and univariate analysis, as applicable. Results: Incidence of heart disease was 0.35% (71/21,000), out of which Rheumatic Heart Disease (RHD) was predominant. Left heart obstruction was the most common (29/66) predictor for adverse maternal cardiovascular and neonatal event, followed by baseline New York Heart Association (NYHA) Class>II (22/66). Cardiac complications were 2.4 times higher and cardiac mortality was ~3 times more in Group B as compared to Group A. Neonatal mortality occurred in 5.6% (2/36) women in Group B. Conclusion: All pregnant women with heart disease should receive comprehensive multidisciplinary prenatal care. Early ANC supervision and extra prenatal surveillance is recommended according to pregnancy associated risk status. Women with ≥1 predictor of cardiac and neonatal events should be referred to a tertiary care centre for CMC.

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.

Cerebral Venous Thrombosis (CVT), also known as cortical venous, cerebral sinus, cerebral venous sinus, or dural sinus thrombosis, is an infrequent grave condition affecting pregnant females, resulting from clot formation in one of the many outflow tracts of the brain. Although pregnancy-associated stroke or CVT is uncommon, the risk of stroke is greatly increased above the low baseline rate in young patients during late pregnancy and, even more so, during the puerperium. Haemorrhagic infarction can occur in the acute stage of CVT. The article reports a case of CVT in puerperium in woman without any risk factors for thrombosis, highlighting the difficulties encountered in differentiating this rare cause from common diagnoses such as eclampsia. Also, clinical considerations and relevant literature review on prognostic factors affecting outcome have been addressed. CVT is an uncommon serious neurologic disorder in young gravidas requiring prudent assessment of the potential differential diagnoses and prompt management.

Introduction: Short interconception period after caesarean section and its associated risk of increased morbidity, mortality and surgical interventions could be avoided by postplacental IUCD insertion during the procedure. Despite the safety reports on intracaesarean IUCD insertion, obstetricians are still hesitant to extend the benefit of this long acting reversible contraception to women undergoing operative delivery. Objective: To study the clinical outcome (safety, efficacy, expulsion and continuation rates) of postplacental Copper T 380A insertion in primiparous women undergoing caesarean section. Materials and Methods: This study was a prospective observational study, carried out in the Department of Obstetrics and Gynaecology, Safdarjung hospital, which is a tertiary care hospital of Northern India. Primiparous women who delivered by caesarean section over a period of six months (July 2012 to December 2012), willing for postplacental intracaesarean IUCD insertion, and willing to comply with the study protocol, were recruited for the study. All these subjects fulfilled the WHO Standard Medical Criteria for PPIUCD insertion; follow up visits were scheduled at 1, 3, 6 and 12 months. Results: A total of 300 primiparous women underwent postpartum intracaesarean insertion of Copper T 380A. The mean age of women included in the study was 23.12 ± 2.42 years. Most common postinsertion complication observed in the immediate postoperative period was febrile morbidity (2%). Majority of women (94.33%) had hospital stay of less than 4 days. The common adverse events observed during follow-up of 12 months were menstrual complaints, excessive vaginal discharge and persistent pelvic pain. At the end of one year, there were 16 expulsions, 21 removals, and 2 pregnancies with gross cumulative expulsion, removal, failure and continuation rates of 5.33%, 7%, 0.67% and 91%, respectively. Conclusion: Postplacental intracaesarean Copper T 380A insertion in primiparous women is a safe and effective method of reversible contraception, with low expulsion and high continuation rates.