A prospective study on the effectiveness of a combination regime (Mifepristone and Misoprostol) in comparison with Misoprostol for missed abortion.

Introduction: Misoprostol is widely used in the medical management of missed abortions. However, pretreatment with Mifepristone has shown to be effective but still not recommended to be used in missed abortions. Aims and Objectives: To compare the outcome of medically managed missed abortion or blighted ovum using combination regime (Mifepristone and Misoprostol) vs Misoprostol alone. Materials and Methods: It was a prospective single-centre study performed in the Department of Obstetrics and Gynaecology, HIMSR and HAHC hospital, New Delhi, over, for one year. All the patients with diagnosed missed abortions were randomized into two groups (Group A and Group B). Group A was given Mifepristone 200 mg orally followed by Misoprostol 800 microgram per vaginal. Group B was given Misoprostol 800 microgram per vaginal. All the patients were observed for 24 hours for the expulsion of products of conception following the given regime. Ethical approval was taken from the Institutional Ethical Committee. Results: Both groups were comparable in demographic characteristics. On applying Fisher's exact test, it has been observed that the odds of nonexpulsion of the product of conception, time taken in expulsion, and surgical evacuation because of excessive bleeding were significantly higher in Group B (Misoprostol) compared with Group A (Mifepristone followed by Misoprostol). The cost-effective analysis showed that the cost is higher among Misoprostol Group B compared with combination drugs of Group A (Mifepristone + Misoprostol), but this result is not significant. Conclusion: Mifepristone can be considered before Misoprostol in missed abortions. This regime might decrease the need for surgical evacuation.

Huge Abdominopelvic Mass Arising from Cervical Fibroid around an Infected Cervical Diverticulum: A Very Rare Case and a Review of Literature.

Primary uterine diverticula are a very rare congenital anomaly of the uterus with only 21 reported cases. Even rarer is the occurrence of primary cervical diverticula with only six cases reported so far. This is a unique case of a huge abdominopelvic mass arising from cervical fibroid around an infected cervical diverticulum. A 44 year-old, P4L4 came to the OPD with a eighteen weeks size abdomino-pelvic mass. She had a failed surgery 6 months back, attempted to remove the mass. Magnetic resonance imaging revealed a cervical diverticulum which possibly had a pus collection. Relaparotomy was done. It revealed a huge cervical fibroid with dense adhesions all around the mass. A pan hysterectomy was done. In the postoperative period, she developed high-grade fever owing to the development of a pelvic collection, which had to be drained by dilating the vault sutures. Histopathology report confirmed a cervical fibroid with an infected diverticulum within. Primary uterine or cervical diverticula are a very rare anamoly which possibly arise because of a weakness in the area where the two mullerian ducts fuse. Women with this rare condition may suffer from infertility, fever and pain abdomen, acute abdomen owing to torsion or hemoperitoneum, pregnancy complications, and menorrhagia. Diverticulectomy and cervical/uterine reconstruction can be done on nulliparous women while hysterectomy can be offered to perimenopausal women. To conclude, unless known by the gynecologists, radiologists, and the pathologists, this diagnosis can be easily missed out, leading to multiple preventable complications.

Developing Standard Treatment Workflows-way to universal healthcare in India.

Primary healthcare caters to nearly 70% of the population in India and provides treatment for approximately 80-90% of common conditions. To achieve universal health coverage (UHC), the Indian healthcare system is gearing up by initiating several schemes such as National Health Protection Scheme, Ayushman Bharat, Nutrition Supplementation Schemes, and Inderdhanush Schemes. The healthcare delivery system is facing challenges such as irrational use of medicines, over- and under-diagnosis, high out-of-pocket expenditure, lack of targeted attention to preventive and promotive health services, and poor referral mechanisms. Healthcare providers are unable to keep pace with the volume of growing new scientific evidence and rising healthcare costs as the literature is not published at the same pace. In addition, there is a lack of common standard treatment guidelines, workflows, and reference manuals from the Government of India. Indian Council of Medical Research in collaboration with the National Health Authority, Govt. of India, and the WHO India country office has developed Standard Treatment Workflows (STWs) with the objective to be utilized at various levels of healthcare starting from primary to tertiary level care. A systematic approach was adopted to formulate the STWs. An advisory committee was constituted for planning and oversight of the process. Specialty experts' group for each specialty comprised of clinicians working at government and private medical colleges and hospitals. The expert groups prioritized the topics through extensive literature searches and meeting with different stakeholders. Then, the contents of each STW were finalized in the form of single-pager infographics. These STWs were further reviewed by an editorial committee before publication. Presently, 125 STWs pertaining to 23 specialties have been developed. It needs to be ensured that STWs are implemented effectively at all levels and ensure quality healthcare at an affordable cost as part of UHC.

Leadership Driven Persistent Reduction in Cesarean Trends: An Interventional Study for Quality Improvement.

Background: This is a quality improvement study in North India undertaken to observe the efficacy and safety of a proposed set of interventions along Quality Improvement guidelines to reduce cesarean rates. Materials and Methods: It was a retrospective cross-sectional study conducted in New Delhi. Measures were iteratively introduced from 2017 and improved using multiple PDSA (Plan, Do, Study, Act) cycles to note the overall reduction in cesarean rates. Chi square tests were done with subanalysis based on the Robsons classification. Results: There was a significant reduction of annual cesarean rates from 36.35 to 22.87% over four years (p < 0.01) and in neonatal nursery admissions (p < 0.01). Covid outbreak saw a comparatively increased cesarean rate in 2020, for which it was excluded from the detailed study. The relative risk of cesarean delivery in the postintervention period was 0.62. Maximum reductions were seen in Robsons II, VI &VII. Conclusion: Devising multipronged interventions and their implementation through PDSA cycles are essential. Such measures in moderate resources are replicable elsewhere as well.

A Prospective Study to Determine if Management of Cases of Gestational Diabetes Mellitus (GDM) can be Modified.

Background: To study maternal-fetal outcomes in patients of GDM diagnosed by International Association of Diabetes and Pregnancy Study Groups (IADPSG) criteria but subsequently using a twenty-four-hour seven-value sugar profile to evaluate patients before instituting management. Methods: This prospective observational study was conducted at a tertiary hospital in New Delhi, India, over a period of one year. During this period, women diagnosed as GDM between 24 and 28 weeks of gestation using IADPSG criteria underwent seven-value sugar profile in twenty-four hours before initiating any therapy. Those with normal profile were kept on observation only, whereas others were managed by Medical Nutrition Therapy (MNT) with or without pharmacotherapy as required to maintain euglycemia. Maternal and fetal outcomes were documented and analysed to detect differences between the groups. Results: Out of 2279 pregnant women, 201 (8.8%) were diagnosed as GDM. The twenty-four-hour seven-value sugar profile was normal in 78 (38.8%) patients, who were managed only by close observation. Treatment was given to other patients; 93 (46.2%) patients were managed with MNT only, whereas pharmacotherapy by way of metformin was added to 22 (10.9%) patients and 8 (3.9%) patients required insulin. Differences in maternal-fetal outcomes between the treated and untreated groups were not found to be statistically significant. Conclusions: The policy of evaluating patients with twenty-four-hour seven-value sugar profile after an abnormal Oral Glucose Tolerance Test eliminated over one-third women from receiving treatment and interventions for GDM without compromising maternal-fetal outcomes.

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

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

Comparison of efficacy & safety of iron polymaltose complex & ferrous ascorbate with ferrous sulphate in pregnant women with iron-deficiency anaemia.

Background & objectives: Iron-deficiency anaemia (IDA) is a common nutritional deficiency among pregnant women in India. It has a significant impact on the health of the mother as well as that of the foetus. IDA generally responds well to treatment with oral iron supplementation. However, oral iron supplements are toxic to the gastrointestinal mucosa and intolerance is common, resulting in poor compliance and failure of treatment. The iron salts such as iron hydroxide polymaltose complex (IPC) and ferrous ascorbate (FeA) are claimed to have low gastrointestinal intolerance, therefore better patient compliance than the conventionally used ferrous sulphate (FS). These preparations also claim to increase haemoglobin level faster as well as improve the iron storage better than FS. This study was done to compare the efficacy and safety of FS with IPC and FeA. Methods: It was a randomized, parallel, open label, study among pregnant women of gestational age between 12 to 26 wk with moderate anaemia. Patients were randomly allocated to receive either FS, IPC or FeA. They were then followed up for 90 days to observe for improvement in the haemoglobin levels and other haematological parameters or any adverse drug reaction. Results: The haemoglobin levels were comparable in the three groups except at day 90 when FeA group had significantly higher haemoglobin level as compared to FS group (P<0.05). The overall adverse effect profiles were also comparable among the study groups except epigastric pain which was more commonly reported in the FS group. Interpretation & conclusions: The results of the study showed that FS, IPC and FeA have comparable efficacy and safety profile in the treatment of IDA of pregnancy.

Hyperinsulinemia and Hypoadiponectinemia are Associated with Increased Risk for Occurrence of Ovarian Cancer in Non-diabetic Women of North Indian Population.

Ovarian cancer has been emerged as a most common and lethal gynecological malignancy in India. High serum insulin and low adiponectin have been associated with increased risk of ovarian cancer. But their role in development of ovarian cancer is conflicting and little evidence is available. We aimed to evaluate blood levels of insulin and adiponectin in epithelial ovarian cancer (EOC) patients and their association with the risk to develop EOC. The study included following three groups; Group 1: fifty cases of cytohistopathologically confirmed cases of EOC, Group 2: fifty age matched cases of benign ovarian conditions and Group 3: fifty ages matched healthy controls with no evidence of any benign or malignant ovarian pathology as ruled out by clinical examination and relevant investigations. Cytohistopathologically confirmed and newly diagnosed cases of EOC and benign ovarian cancer were included in this study. The median value of fasting serum insulin was significantly high (15.0 µlU/ml, P = 0.02) and adiponectin were significantly low (5.1 µg/ml, P < 0.001) in ovarian cancer patients compared to benign ovarian tumors and healthy controls group. A significant increase risk of ovarian cancer was found in high tertile (≥ 18.7 µlU/ml) of serum insulin level (OR = 2.7; 95% CI = 1.00-6.67, P = 0.04) and lower tertile (≤ 5.45 µg/ml) of adiponectin level (OR = 3.2; 95% CI = 1.10-9.71, P = 0.03). High serum insulin level and low adiponectin levels were significantly associated with increased risk for development of ovarian cancer.

A validation study of early warning system in high-risk pregnant women.

High-risk obstetric patients have chances of deterioration which can be detected by any early warning score. This study was aimed to assess the suitability of the Obstetrics National Early Warning System (ONEWS) for the pregnant women. This prospective study was conducted on 500 high-risk pregnant women attending a tertiary care teaching hospital. The ONEWS charts were plotted for each of them. The primary outcome measure was composite adverse maternal outcome (CAMO) in the form of one or more among mortality, severe maternal morbidity and intensive care unit admissions. Of the 500 women who participated, 200 (40%) had a score ≥3 (triggered an intervention). The CAMO among the triggered group [59.5% (n=119)] was significantly higher compared to that in the non-triggered group [13.3% (n=40) (P=0.001)]. The area under the receiver operating characteristic curve was 0.800 (95% confidence interval 0.752-0.847). The sensitivity of the ONEWS in predicting CAMO was 74.8 per cent, specificity 76.2 per cent, positive predictive value 59.5 per cent and negative predictive value 86.7 per cent at a cut-off score of 3. ONEWS appears to be a useful tool for predicting adverse maternal outcomes in high-risk pregnant women.

Complete Uterine Septum with Cervical Duplication and Longitudinal Vaginal Septum: An Anomaly Supporting Alternative Embryological Development.

The diagnosis and management of Mullerian abnormalities have revolutionized with the advent of magnetic resonance imaging, three-dimensional ultrasound, and endoscopic techniques. All the earlier unclassified abnormalities can now be classified as per the new European Society of Human Reproduction and Embryology 2013 nomenclature. The presence of complete uterine septum with cervical duplication and longitudinal vaginal septum reinforces the alternative theory of Mullerian development. The presence of this complex anomaly is discussed in the light of embryonic development along with management issues.

Clinical Validation of Mobile Cardiotocograph Device for Intrapartum and Antepartum Monitoring Compared to Standard Cardiotocograph: An Inter-Rater Agreement Study.

Objective: Electronic fetal monitoring (EFM) using cardiotocograph (CTG) is commonly used both to assess fetal wellbeing in late antepartum and for intervention during intrapartum period. We validated the performance of indigenously developed mobile cardiotocograph (CTG) device with wireless probes compared to standard CTG device. Materials and methods: We sequentially used mobile and standard CTG devices in 495 pregnant women in labour and 359 pregnant women with gestation > 32 weeks. The CTG interpreted by two independent obstetricians in a blinded manner were compared to estimate the agreement by kappa (k) statistic. Results: High level of agreements between mobile and standard CTG devices for both intrapartum (87.9%; kappa 0.61) and antepartum monitoring (91.2%; kappa 0.60) were observed. Most of the pregnant women (80% in intrapartum and 70% in antepartum groups) and all nurses and obstetricians preferred the mobile CTG device over standard CTG device. Conclusion: The mobile CTG device can reliably be used for both intrapartum and antepartum monitoring instead of the standard CTG devices. The smaller size, portability and ability to transmit the recordings for second opinion make it suitable for use by midwives for appropriate triaging and referral. Wider availability of CTG and interpretation support at the peripheral facilities would assist identifying at-risk pregnancies and foetuses for timely referral and appropriate action to reduce perinatal deaths, stillbirths and birth asphyxi.

Laparoscopic Management of Nonpuerperal Uterine Inversion.

Uterine inversions are a rare entity, and most occur in the postpartum period. Nonpuerperal inversion accounts for only 16% of cases and are mostly associated with a submucous myoma. A 38-year-old woman with a submucous myoma presented with severe lower abdominal pain, acute retention of urine, and hypotension. Because the clinical examination was inconclusive due to severe pain and the ultrasound was dubious, diagnosis was made with magnetic resonance imaging. Successful laparoscopic hysterectomy was contemplated after correcting uterine inversion. This case highlights the diagnostic dilemmas and the key points during laparoscopic management of uterine inversion.

Unilateral tubo-ovarian agenesis with contralateral adnexal torsion in a premenarchal girl.

Unilateral adnexal agenesis is a rare entity. Most of these cases are reported in reproductive age group. A case of a 10-year-old premenarchal girl is reported who presented with acute abdominal pain and vomiting. BothUltrasonography (USG) and MRI suggested right ovarian mass with torsion. Laparoscopic evaluation revealed an enlarged right ovary with torsion and contralateral agenesis of uterine tube and left ovary. Detortion of the ovary and an ovarian fixation to the ovarian pedicle was done. This is the first reported case of a premenarchal girl presenting with an acute abdomen due to adnexal torsion along with contralateral tubo-ovarian agenesis.

Role of laparoscopy in diagnosing genital tuberculosis in suspected women: A cross-sectional study from a tertiary care hospital in Northern India.

This study was included 60 women with suspected genital tuberculosis, attending outpatient department of a tertiary care hospital. The aim was to evaluate the role and accuracy of laparoscopy in the diagnosis of genital tuberculosis. The patients were investigated for tuberculosis with Erythrocyte Sedimentation Rate, Montoux, chest X-ray, serum ELISA, CA125, ultrasonography, endometrial biopsy and laparoscopic biopsy. Culture or histopathology was taken as a gold standard for confirming the cases of genital tuberculosis. 30 patients were confirmed as positive. Comparison was made between the various diagnostic modalities. Baseline investigations like complete blood count, differential leukocyte count, ESR, Montoux, and some special tests like CA125 and serum ELISA were helpful in supporting the diagnosis in only some patients. The sensitivity, specificity, positive and negative predictive value of endometrial biopsy in diagnosing GT was 6.6%, 100%, 100% and 51.7% respectively. Laparoscopic gross visualization alone, staining, culture and histology were able to detect 86.6%, 33.3%, 50% and 63.3% of cases respectively. Many patients would have been missed if laparoscopy was not performed. It helps in macroscopic visualization of pelvic cavity and obtaining biopsies for ZN staining, culture and histopathology. This increases the pickup rate of positive cases and helps in confirmation of the diagnosis.

Evaluation of 75 g glucose load in non-fasting state [Diabetes in Pregnancy Study group of India (DIPSI) criteria] as a diagnostic test for gestational diabetes mellitus.

BACKGROUND & OBJECTIVES: There is no consensus regarding optimal standard for diagnosis of gestational diabetes mellitus (GDM). In this study, use of 75 g glucose load in non-fasting state [Diabetes in Pregnancy Study Group of India (DIPSI) criteria] as a diagnostic test for GDM in pregnant women was compared with different oral glucose tolerance tests (OGTTs). METHODS: This prospective study included 936 pregnant women, who underwent plasma glucose evaluation two hours after the challenge of 75 g glucose load irrespective of the timing of last meal (DIPSI criteria for GDM). After three days, standard 75 g OGTT was done in all women irrespective of previous plasma glucose value. Accuracy of the first result was compared to OGTT using cut-offs as per the World Health Organization (WHO) and International Association of Diabetes and Pregnancy Study Groups (IADPSG) criteria for the diagnosis of GDM. RESULTS: Of the total 936 pregnant women, 73 (7.8%) patients had plasma glucose value ≥140 mg/dl when measured two hours after glucose load. When comparing with the WHO and IADPSG criteria, the sensitivity values were 65.1 and 74.1 per cent, respectively, and the corresponding specificity values were 96.3 and 96.9 per cent, respectively. On comparing with the WHO OGTT, only 41 of the 73 (56.2%) were true positives, whereas when IADPSG criteria were used, true positives were 46 (63%). False negative cases were also present when classified by the WHO and IADPSG criteria though in lesser numbers than false positives. The positive predictive values (PPVs) for the WHO and IADPSG criteria were 56.1 and 63 per cent, respectively, and their corresponding negative predictive values were 97.7 and 97.9 per cent, respectively. INTERPRETATION & CONCLUSIONS: Our findings showed that when 75 g glucose load in non-fasting state was used as a diagnostic test for GDM, almost one quarter of patients with GDM escaped diagnosis as sensitivity values were low. On the other hand, some GDM cases were falsely labelled as normal as this test did not account for cases of fasting hyperglycaemia. In addition, comparison with other OGTTs showed low PPVs. Hence, use of DIPSI criteria for diagnosing GDM must be reconsidered till further validation.

Comparison of Human Neonatal and Adult Blood Leukocyte Subset Composition Phenotypes.

The human peripheral leukocyte subset composition depends on genotype variation and pre-natal and post-natal environmental influence diversity. We quantified this composition in adults and neonates, and compared the median values and dispersal ranges of various subsets in them. We confirmed higher frequencies of monocytes and regulatory T cells (Tregs), similar frequencies of neutrophils, and lower frequencies of CD8 T cells, NKT cells, B1 B cells and gamma-delta T cells in neonatal umbilical cord blood. Unlike previous reports, we found higher frequencies of eosinophils and B cells, higher CD4:CD8 ratios, lower frequencies of T cells and iNKT cells, and similar frequencies of CD4 T cells and NK cells in neonates. We characterized monocyte subsets and dendritic cell (DC) subsets in far greater detail than previously reported, using recently described surface markers and gating strategies and observed that neonates had lower frequencies of patrolling monocytes and lower myeloid dendritic cell (mDC):plasmacytoid DC (pDC) ratios. Our data contribute to South Asian reference values for these parameters. We found that dispersal ranges differ between different leukocyte subsets, suggesting differential determination of variation. Further, some subsets were more dispersed in adults than in neonates suggesting influences of postnatal sources of variation, while some show the opposite pattern suggesting influences of developmental process variation. Together, these data and analyses provide interesting biological possibilities for future exploration.