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.

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.

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.

Massive spontaneous intraperitoneal hemorrhage in a young female with chronic immune thrombocytopenic purpura masquerading as ruptured ovarian cyst: successful nonsurgical management of this rare catastrophic event.

Chronic immune thrombocytopenic purpura has mild bleeding manifestations and severe bleeding requiring hospitalization is rare. We are reporting a case of a 19-year-old girl with chronic immune thrombocytopenic purpura who presented with spontaneous massive hemoperitoneum without any identifiable source of hemorrhage. We chose nonsurgical treatment over laparotomy, and the patient was managed successfully with parenteral steroids and platelet transfusion. In young women presenting with massive hemoperitoneum, undiagnosed immune thrombocytopenia should be considered as an etiology. In absence of any identifiable source of hemoperitoneum, these patients may not require laparotomy and treatment with intravenous corticosteroid and platelet transfusions may be preferrable and lifesaving.

Association of inflammatory cytokines, lipid peroxidation end products and nitric oxide with the clinical severity and fetal outcome in preeclampsia in Indian women.

Preeclampsia is a multisystem disorder associated with maternal hypertension, placental abnormalities and adverse fetal outcomes. The various pathways involved in its etiology include endothelial dysfunction, inflammatory milieu, lipid peroxidation and immunological imbalance. The present study was conducted to evaluate the causative and predictive role of nitric oxide, lipid peroxidation end products (MDA) and inflammatory cytokines (IL-6, TNF-α) in clinical presentation, severity and fetal outcome in preeclampsia. The study population was divided into 3 groups- Non- pregnant females comprising the control population; G1 and G2 groups included normal pregnant and pregnant females with preeclampsia with 50 patients in each group. Nitric Oxide and MDA levels were found to be highest in the preeclamptic patients as compared to other two groups. ROC curve analysis shows the superiority of the inflammatory markers as determinants of severity of preeclampsia which suggests the emerging role of pro inflammatory markers in the various pathological changes in preeclampsia. TNF-α emerged as the best marker in multivariate analysis and thus, has the potential for being used as a marker for PIH. Our study illustrates the multifactorial etiology of preeclampsia involving oxidative stress, proinflammatory milieu and endothelial dysfunction.

Incidence of and risk factors for small vulnerable newborns in north India: a secondary analysis of a prospective pregnancy cohort.

BACKGROUND: Globally, recent estimates have shown there have been 3·6 million stillbirths and neonatal deaths in 2022, with nearly 60% occurring in low-income and middle-income countries. The Small Vulnerable Newborn Consortium has proposed a framework combining preterm birth (<37 weeks of gestation), small for gestational age (SGA) by INTERGROWTH-21st standard, and low birthweight (<2500 g) under the category small vulnerable newborns (SVN). Reliable data on SVN from sub-Saharan Africa, central Asia, and south Asia are sparse. We aimed to estimate the incidence of SVN and its types, and quantify risk factors, both overall and trimester-specific, from a pregnancy cohort in north India. METHODS: In the GARBH-Ini (Interdisciplinary Group for Advanced Research on Birth Outcomes-DBT India Initiative) pregnancy cohort, 8000 participants were enrolled with less than 20 weeks' gestation between May 11, 2015, and Aug 8, 2020, at a secondary-care hospital in north India. The cohort was followed up across the antenatal period for a detailed study on preterm birth. We conducted a secondary analysis of cohort data for the outcome of SVN, classified into its types: preterm-SGA, preterm-nonSGA, and term-SGA. We estimated the relative risk and population attributable fraction of candidate risk factors for SVN (modified Poisson regression) and its types (multinomial regression). FINDINGS: 7183 (89·9%) of 7990 participants completed the study. Among 6206 newborns included for analysis, the incidence of SVN was 48·4% (35·1% term-SGA newborns [n=2179], 9·7% preterm-nonSGA newborns [n=605], and 3·6% preterm-SGA newborns [n=222]). Compared with term-nonSGA newborns, proportions of stillbirths and neonatal deaths within 72 h of birth among SVN were three times and 2·5 times higher, respectively. Preterm-SGA newborns had the highest incidence of stillbirth (15 [6·8%] of 222) and neonatal deaths (six [4·2%] of 142). Low body-mass index (BMI <18·5 kg/m2) of participants at the start of pregnancy was associated with higher risk for preterm-SGA (adjusted relative risk [RR] 1·61 [95% CI 1·17-2·22]), preterm-nonSGA (1·35 [1·09-1·68]), and term-SGA (1·44 [1·27- 1·64]), with population attributable fraction ranging from 8·7% to 13·8%. Pre-eclampsia (adjusted RR 1·48 [95% CI 1·30-1·71]), short cervical length (1·15 [1·04-1·26]), and bacterial vaginosis (1·13 [0·88-1·45]) were other important antenatal risk factors. INTERPRETATION: In a comprehensive analysis of SVN and its types from north India, we identified risk factors to guide prioritisation of interventions. Complemented with risk-stratification tools, this focused approach will enhance antenatal care, and accelerate achievement of Sustainable Development Goals-namely, to end preventable deaths of newborns and children younger than 5 years by 2030 (target 3·2). FUNDING: Department of Biotechnology, Government of India and Grand Challenges India-Biotechnology Industry Research Assistance Council, Government of India. TRANSLATION: For the Hindi translation of the abstract see Supplementary Materials section.

Chlamydia trachomatis infection in HIV-infected women: need for screening by a sensitive and specific test.

Reproductive tract infection (RTIs)/sexually transmitted infections (STIs) are recognized as a major public health problem, particularly due to their relationship with HIV infection. Early detection and treatment of Chlamydia trachomatis infection (CTI) among HIV-infected and HIV-uninfected women may impact heterosexual HIV transmission. A total of 120 participants were enrolled: 30 HIV seropositive women with symptoms of RTIs, 30 HIV seropositive women without symptoms of RTIs, 30 HIV seronegative women with symptoms of RTIs, and 30 HIV seronegative women without symptoms of RTIs. One endocervical swab was collected from all participants and CTI was detected by real-time PCR (COBAS TaqMan CT Test, v2.0). CTI was detected in 4 (6.67%) HIV-infected women and in 1 (1.67%) HIV-uninfected woman (OR 4.214; 95% CI 0.457-38.865). Vaginal discharge was present in almost half of HIV-infected and HIV-uninfected women; lower abdominal pain was present in 11 (18.3%) of HIV-infected and in 9 (15%) of HIV-uninfected women. This study showed that CTI is more prevalent among HIV-infected females as compared to HIV-uninfected females. As the use of real-time PCR is not feasible in most hospitals, efforts should be made to develop a simple, sensitive, and specific test to identify women with CTI for prevention of sequelae and HIV transmission.

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.

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 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.

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.

Clinical evaluation of severe anemia in pregnancy with special reference to macrocytic anemia.

AIMS: Anemia in pregnancy has been almost synonymous with iron-deficiency anemia but there appears to be a changing trend with emerging evidence of macrocytic anemia. The aim of this study was to evaluate the clinical profile of patients having severe anemia in pregnancy. METHODS: This study included all antenatal patients presenting with severe anemia (hemoglobin<7gm%) over a period of 2years from January 2008 to December 2009 in the Department of Obstetrics and Gynaecology, Maulana Azad Medical College and Lok Nayak Hospital, New Delhi. RESULTS: Although iron-deficiency anemia remains the most important cause of anemia (48.1%) there is also a high prevalence of macrocytic anemia (40%) amongst these cases of severe anemia in pregnancy. The maternal and fetal morbidity and mortality is higher in macrocytic anemia as compared to iron-deficiency anemia. CONCLUSION: There is an emerging trend of macrocytic anemia among antenatal patients with severe anemia. Both maternal and fetal morbidity appears to be higher in these cases. This has important implications in terms of diagnosis and therapy to optimize both maternal and perinatal outcomes. Once clinicians and health administrators recognize the magnitude of this problem it may be considered relevant to start public health interventions by way of requirement of appropriate food fortification.

Screening for gestational diabetes mellitus: a prospective study in a tertiary care institution of North India.

AIM: The aim of this study was to determine the relevance of universal screening for gestational diabetes mellitus (GDM) in the patients attending the antenatal clinic of a tertiary institute of North India. MATERIAL AND METHODS: This was a prospective study conducted on 700 pregnant women attending the antenatal clinic of Lok Nayak Hospital, New Delhi at or before 24 weeks of gestation. All patients underwent screening with a 50-g 1-h glucose challenge test at 24-28 weeks of gestation. The women with an abnormal glucose challenge test subsequently underwent a diagnostic 3-h oral glucose tolerance test. All the patients were followed up till delivery. RESULTS: Out of 700, thirteen patients were lost to follow up and hence the final outcomes were measured on 687 patients. Out of 687, 613 patients (89.2%) had a normal glucose challenge test value, that is, <140 mg%, and 74 (10.8%) had a glucose challenge test value ≥140 mg%. On the subsequent oral glucose tolerance test, 64 (9.3%) had normal values and only 10 (1.5%) had an abnormal oral glucose tolerance test, that is, GDM. CONCLUSION: With such a low prevalence rate it appears to be unjustified to recommend universal screening for GDM. These findings may be considered as a basis for conducting larger, multicentric studies to establish the prevalence rate of GDM before deciding on a policy for screening.

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.