Therapeutic Drug Monitoring of Levetiracetam in Different Trimesters of Pregnant Women with Epilepsy in a Tertiary Care Center: A Prospective Study.

BACKGROUND: Levetiracetam is the most commonly used antiepileptic drug in pregnant women due to its low teratogenic risk profile, favorable pharmacokinetic characteristics, and safety profile. Serum levels of levetiracetam vary in epilepsy during pregnancy. Therefore, the aim of the study was to evaluate the serum levels of levetiracetam during different trimesters of pregnancy by using therapeutic drug monitoring (TDM). MATERIALS AND METHODS: This was a single-center, prospective study. Pregnant women with epilepsy on levetiracetam were enrolled after getting written informed consent from them. Serum trough levels of levetiracetam were estimated at all trimesters by high-performance liquid chromatography (HPLC). RESULTS: The study included 16 participants with mean ± standard deviation (SD) age of 27.75 ± 4 years. There were nine (56.2%) participants with generalized seizure disorder and seven (43.8%) participants of focal seizure disorder. Among 16 patients, 10 (62.5%) participants were on levetiracetam alone and six (37.5%) participants were on levetiracetam combined with other antiepileptic drugs. In a total of 48 trough samples, 45 sample concentrations were below the therapeutic range of 12-46 mg/l and three sample concentrations were within the therapeutic range. There was a statistically significant difference in the concentration-dose ratio (CDR) of levetiracetam between the third and first trimesters (P-value 0.018). CONCLUSION: There was a statistically significant difference in serum levetiracetam concentration between the third and first trimesters. A well-conducted, intensive pharmacokinetic sampling study in PWWE with a control group is needed in future to evaluate the whole pharmacokinetic profile of levetiracetam and to correlate the clinical outcome.

B12 Deficiency is the Commonest Cause of Anaemia During Pregnancy in Northern India: Study from a Tertiary Care Institute.

Iron deficiency anemia is considered the leading cause of anemia during pregnancy; however, there is a lack of comprehensive studies on the etiological factors of anemia in pregnant women. The objective of this study was to systematically investigate the causes of anemia in pregnancy. Five hundred women with hemoglobin levels < 11 g/dl between 6 and 40 weeks of pregnancy underwent a complete hemogram, iron studies, serum folate, serum B12, serum copper, and serum zinc level assessments using standard methods. The median age of the patients was 26 years (range 24-29 years). The majority of patients were in the third trimester (449/500, 89.8%). Among the patients, 325 (65%) had vitamin B12 deficiency, with 159 (31.8%) having isolated B12 deficiency and 142 (28.4%) having combined B12 and iron deficiency. Isolated iron deficiency anemia was present in 74 patients (14.8%). Additionally, 28 patients (5.6%) had beta-thalassemia minor, and anemia of chronic disease was found in 17.2% (86) of the patients. Vitamin B12 deficiency was the most common cause of anemia, followed by combined B12 and iron deficiency. Further studies in diverse populations are warranted as they have broader implications for nutrient supplementation during pregnancy. Supplementary Information: The online version contains supplementary material available at 10.1007/s12288-023-01682-x.

Association of Altered Ratio of Maternal Folic Acid and Vitamin B12 during Pregnancy with Newborn Birth Weight, Head Circumference, and Chest Circumference.

OBJECTIVE: This study evaluated the effect of an altered ratio of maternal RBC folate (MRF) to serum vitamin B12 (MB12) on pregnancy and newborn outcomes. METHODS: Blood samples were collected from pregnant women and the umbilical cord at the time of delivery. Estimations of RBC folate and serum vitamin B12 from maternal and cord blood samples and total homocysteine (HCY) were performed. Maternal and newborn anthropometric parameters like placental weight (PW), head circumference (HC), chest circumference (CC), and body weight (BW) were measured in offsprings after birth. We stratified the pregnant women into six groups (a) vitamin B12 normal and folic acid normal (BNFN)-control group, (b) vitamin B12 normal and folic acid elevated (BNFE), (c) vitamin B12 normal and folic acid deficient (BNFD), (d) vitamin B12 deficient and folic acid normal (BDFN), (e) vitamin B12 deficient and folic acid elevated (BDFE) and (f) vitamin B12 deficient and folic acid deficient (BDFD) based on their levels of RBC folate (MRF) and vitamin B12 (MB12). The expression of the one-carbon metabolism genes (methionine synthase (MS), glycine N-methyltransferase (GNMT), and cystathionine ß-synthase (CBS) was also studied in placental tissue by using real-time PCR. RESULTS: Cord blood RBC folate was significantly reduced in groups BDFE and BDFD as compared to the control group (BNFN). The cord blood vitamin B12 levels were also reduced in the BDFE group as compared to the BDFD. All the newborn parameters viz. PW, HC, CC, and BW, were reduced in the altered MRF/MB12 ratio (low & high vs. normal ratio). Total HCY was significantly elevated in the groups with (BDFE & BDFN) an imbalance of maternal RBC folate and serum vitamin B12 as compared to the control group. Downregulation of one-carbon metabolism genes like MS (p < 0.001), GNMT (p < 0.05), and CBS (p < 0.01) in placental tissue was observed in the high MRF/MB12 ratio group as compared to the normal ratio group. A strong positive correlation was also observed between MRF, MB12, and newborn parameters. CONCLUSIONS: The altered ratio of folate to vitamin B12 in the maternal blood is associated with adverse growth and development of the newborn.

Determinants of polycystic ovary syndrome: A matched case-control study.

BACKGROUND: Polycystic ovarian syndrome (PCOS) is a multifaceted endocrine disorder of women of reproductive age with a multifactorial aetiology. Despite much research, there is still inconclusive data on the impact of dietary, lifestyle and socio-economic factors on PCOS aetiology. Thus, the present study explored the association of PCOS with diet, eating behaviour, other lifestyle and socio-economic factors. METHODS: A matched-pair case-control study was conducted on 150 women with PCOS and 150 healthy controls. Information on diet, eating behaviour and physical activity, and also anthropometric and socio-economic data were collected through standard questionnaires. The adjusted odds ratios (AmOR) were calculated and reported using conditional multivariable logistic regression. RESULTS: The results showed low education level (AmOR = 8.44; 95% confidence interval [CI] = 1.63-43.68), high sugar consumption (AmOR = 11.61; 95% CI = 2.05-65.72) along with higher body mass index (BMI) and inactivity to be significantly associated with PCOS. Also, a significant protective effect was found for cognitive dietary restraint (AmOR = 0.79; 95% CI = 0.66-0.93), crude fibre (AmOR = 0.61; 95% CI = 0.45-0.82) and protein intake. CONCLUSIONS: Low education status may contribute to higher receptiveness to choosing unhealthy diets and lifestyles, resulting in adiposity and an increased risk of PCOS.

Cervical Cancer Screening Coverage at Tertiary Care Institutes Across India.

OBJECTIVES: The 70% screening coverage target proposed in the global cervical cancer elimination strategy is not achieved even at tertiary centres in India. A situational analysis was done to assess the currently existing facilities and barriers in tertiary care institutes. METHODS: This cross sectional multicentric study was conducted from August to September 2021 in six tertiary care institutes across India. Women aged 30-49 years attending outpatient services (OPD) were invited for cervical screening. Women and health care professionals (HCPs) were administered structured questionnaires to assess knowledge, attitude and practices regarding cervical cancer screening services. RESULTS: Out of 6709 eligible women who attended OPD, 1666 (24.8%; range:19-57%) received screening. Availability of screening kits was limited to 10-25 Pap/HPV tests per day. Visual inspection with acetic acid (VIA) and HPV testing were offered only at certain centres. Colposcopy and treatment facilities were optimal at all centres. Knowledge, attitude and practices were analysed for 1800 women: 45.7% had heard of cervical cancer, 78.0% did not know that it is preventable, 75.8% never heard about screening. Common symptoms correctly identified included postmenopausal bleeding (4.8%), postcoital bleeding (5.7%), intermenstrual bleeding (5.8%) and vaginal discharge (12.4%). Risk factors were identified by minority: poor menstrual hygiene (6.6%), oral contraceptive pill use (6.4%), multiparity (4.4%), and HPV infection (3.0%). Out of 21, mean total knowledge score (MTKS) was 2.07± 2.67. Out of 317 HCPs, 96.5% knew that cervical cancer is caused by HPV infection, is preceded by premalignant stage, and that it is preventable by screening and treatment (80.1%). Knowledge about screening modalities was present in 87.4% for cytology, 75.1% for VIA, 68.8% for HPV test. MTKS of HCPs was 20.88±6.61 out of 32. CONCLUSION: Even at tertiary centres, limited availability of HPV tests, reluctance to implement VIA and lack of awareness among women remain the major barriers.

Naturalistic Evaluation of ERAS Bundle Implementation Feasibility in Elective Cesarean Deliveries of Tertiary Care Hospital in a Low-Middle-Income Country.

The present study assessed whether applying enhanced recovery after surgery (ERAS) guidelines for cesarean delivery is feasible in the tertiary care setting with an add-on objective to identify barriers to successful implementation. The cross-sectional study included women undergoing elective CS and willing to participate. The study attempted to understand barriers to ERAS implementation through timely interviewing study participants. Sixty-two patients participated in the study. Antenatal and fetal complications were observed in 39(63%) and 32(51%) participants. The study observed that at least 80% of the proposed components could be applied to 71% of the study population. All 15 components could be applied to 7(11.2%) patients, and at least 50% could be applied to 58(94%) patients. The least applied component was minimizing starvation by taking clear liquids until 2 hrs before surgery in 26(42%) patients due to waiting hours outside the operation-theater (OT). When fitness-for-discharge was assessed against the percent components of ERAS implemented, the area under the curve (AUC) value was 0.75, with a specificity value of 95.65% and a positive predictive value of 94.12%. In the postoperative ERAS bundle, fitness-for-discharge on day-two was statistically associated with early and frequent breastfeeding (p = 0.000) and prevention of intra-op hypotension (p = 0.03). In conclusion, the primary barriers to implementing ERAS were resource limitations in the form of single functional OT and limited doctors.

Immunogenicity and safety of a new quadrivalent HPV vaccine in girls and boys aged 9-14 years versus an established quadrivalent HPV vaccine in women aged 15-26 years in India: a randomised, active-controlled, multicentre, phase 2/3 trial.

BACKGROUND: To meet global cervical cancer elimination efforts, a wider range of affordable and accessible vaccines against human papillomavirus (HPV) are needed. We aimed to evaluate the immunogenicity and safety of a quadrivalent HPV vaccine (targeting HPV types 6, 11, 16, and 18), developed and manufactured by the Serum Institute of India (SIIPL). Here we report outcomes in the 9-14 years cohort. METHODS: This randomised, active-controlled, phase 2/3 trial was conducted at 12 tertiary care hospitals across India. Healthy participants aged 9-14 years or 15-26 years with no history of HPV vaccination were eligible for enrolment. Female participants were randomly assigned (1:1) with an interactive web response system, by use of a central computer-generated schedule and block randomisation (block sizes of 2, 4, 6, and 8), to receive the SIIPL quadrivalent HPV vaccine (Cervavac; SIIPL, Pune, India) or the comparator quadrivalent HPV vaccine (Gardasil; Merck Sharp & Dohme, Harleem, the Netherlands). Participants, investigators, laboratory technicians, and sponsors were masked to treatment allocation of female participants. Male participants were given the SIIPL quadrivalent HPV vaccine in an open-label manner. Study vaccines were administered intramuscularly with a two-dose schedule (at day 0 and 6 months) in the cohort aged 9-14 years, and with a three-dose schedule (at day 0, month 2, and month 6) in the cohort aged 15-26-years. Immunogenicity was assessed 30 days after the last dose by use of multiplexed ELISA. The primary outcome was the non-inferiority of immune response in terms of the geometric mean titre (GMT) of antibodies against HPV types 6, 11, 16, and 18 generated by the SIIPL quadrivalent HPV vaccine in girls and boys (aged 9-14 years) compared with the GMT generated by the comparator quadrivalent HPV vaccine in women aged 15-26 years at month 7 in the modified per-protocol population (ie, all participants who received all doses of study vaccines per assigned treatment group and had both day 0 and 1-month immunogenicity measurements after the last dose following protocol-defined window periods with no major protocol deviations). Non-inferiority was established if the lower bound of the 98·75% CI of the GMT ratio was 0·67 or higher. The co-primary outcome of occurrence of solicited adverse events (within 7 days of each dose) and unsolicited adverse events (up to 30 days after the last dose) was assessed in all participants who were enrolled and received at least one dose of study vaccine. The trial is registered with the Clinical Trials Registry - India (CTRI/2018/06/014601), and long-term follow-up is ongoing. FINDINGS: Between Sept 20, 2018, and Feb 9, 2021, 2341 individuals were screened, of whom 2307 eligible individuals were enrolled and vaccinated: 1107 (738 girls and 369 boys) in the cohort aged 9-14 years and 1200 (819 women and 381 men) in the cohort aged 15-26 years. No race or ethnicity data were collected. 350 girls and 349 boys in the SIIPL quadrivalent HPV vaccine group and 338 women in the comparator vaccine group were included in the modified per-protocol population for the primary endpoint analysis. The median follow-up for the analyses was 221 days (IQR 215-231) for girls and 222 days (217-230) for boys in the SIIPL quadrivalent HPV vaccine group, 223 days (216-232) for girls in the comparator vaccine group, and 222 days (216-230) for women in the comparator vaccine group. GMT ratios were non-inferior in girls and boys receiving the SIIPL quadrivalent HPV vaccine compared with women receiving the comparator vaccine: GMT ratios for girls were 1·97 (98·75% CI 1·67-2·32) for HPV type 6, 1·63 (1·38-1·91) for HPV type 11, 1·90 (1·60-2·25) for HPV type 16, and 2·16 (1·79-2·61) for HPV type 18. For boys the GMT ratios were 1·86 (1·57-2·21) for HPV type 6, 1·46 (1·23-1·73) for HPV type 11, 1·62 (1·36-1·94) for HPV type 16, and 1·80 (1·48-2·18) for HPV type 18. The safety population comprised all 1107 participants (369 girls and 369 boys in the SIIPL quadrivalent HPV vaccine group, and 369 girls in the comparator group). Solicited adverse events occurred in 176 (48%) of 369 girls and 124 (34%) of 369 boys in the SIIPL vaccine group and 179 (49%) of 369 girls in the comparator vaccine group. No grade 3-4 solicited adverse events occurred within 7 days of each dose. Unsolicited adverse events occurred in 143 (39%) girls and 147 (40%) boys in the SIIPL vaccine group, and 143 (39%) girls in the comparator vaccine group. The most common grade 3 unsolicited adverse event was dengue fever, in one (<1%) girl in the SIIPL vaccine group and three (1%) girls in the comparator group. There were no grade 4 or 5 adverse events. Serious adverse events occurred in three (1%) girls and three (1%) boys in the SIIPL vaccine group, and five (1%) girls in the comparator vaccine group. No vaccine-related serious adverse events were reported. There were no treatment-related deaths. INTERPRETATION: We observed a non-inferior immune response with the SIIPL quadrivalent HPV vaccine in girls and boys aged 9-14 years and an acceptable safety profile compared with the comparator vaccine. These findings support extrapolation of efficacy from the comparator vaccine to the SIIPL quadrivalent HPV vaccine in the younger population. The availability of the SIIPL quadrivalent HPV vaccine could help meet the global demand for HPV vaccines, and boost coverage for both girls and boys globally. FUNDING: Biotechnology Industry Research Assistance Council, Department of Biotechnology (DBT), Government of India, and Serum Institute of India.

Maternally transmitted anti-measles antibodies, and susceptibility to disease among infants in Chandigarh, India: A prospective birth cohort study.

Prior to the age of measles vaccination, infants are believed to be protected against measles by passively transferred maternal antibodies. However, the quantity and quality of such protection have not been well established in the Indian setting. We undertook this study to characterize the transfer and decline in maternal anti-measles antibodies among infants, and determine their susceptibility to measles. In this population-based, birth-cohort study, we enrolled pregnant women and their newborn infants, from a catchment area of 30 Anganwadis in Chandigarh, India. We collected maternal blood at delivery, and infant blood samples at birth, and 3, 6, and 9 months of age. Anti-measles IgG antibodies were measured using quantitative ELISA. We assessed antibody decline using log-linear models. In total, 428 mother-infant dyads were enrolled, and data from 413 dyads were analyzed. At birth, 91.5% (95% CI: 88.8, 94.2) of infants had protective antibody levels, which declined to 26.3% (95% CI: 21.0%, 31.9) at 3 months, 3.4% (95% CI: 0.9, 5.9) at 6 months, and 2.1% (95% CI: 0.1, 4.1) at 9 months. Younger mothers transferred lower levels of antibodies to their infants. We concluded that the majority of infants are susceptible to measles as early as three months of age, much earlier than their eligibility to receive measles vaccination.

Mind-body practice as a primer to maintain psychological health among pregnant women-YOGESTA-a randomized controlled trial.

Objective: The objective of this study was to investigate the impact of Gestational Yoga-YOGESTA (Gestational Yoga), on the neuropsychology, quality of life, and personality of pregnant women. Design: Open label, randomized controlled trial, used allocation concealment to allocate the treatment. Setting: Department of Obstetrics and Gynecology and Neuroscience Research Lab, Department of Neurology, Post Graduate Institute of Medical Education and Research, Chandigarh, India. Participants: We recruited a total of 100 pregnant women visiting the Outpatient Department of Obstetrics and Gynecology. Participants were aged between 18 and 35 with uncomplicated pregnancies and they were randomly assigned to either the Yoga group (YG) or the usual care group (UCG). A total of 77 pregnant women completed both the pre- and post-survey, with 34 participants in the Yoga group and 43 in the Usual care group. Intervention: Pregnant women in their second and third trimesters were provided with a 16-week online Prenatal Yoga intervention. The intervention began after enrollment in the 2nd trimester, specifically between the 16th and 20th week, and was conducted 5 days a week until delivery, with an average intervention period of 47.18 ± 2.031 (mean ± SEM) days. Chief outcome measures: We measured Perceived stress, Depression, Anxiety, Stress, and quality of life by using standard questionnaires. Results: A total of 77 participants were included in the analysis, with 34 assigned to the Yoga group and 43 assigned to the control group. Most of the measured parameters demonstrated significant changes. The Yoga group exhibited a noteworthy decrease in perceived stress, depression, anxiety, and psychological stress, as well as an improvement in the psychological and environmental domains of QOL-BREF. Conversely, the control group demonstrated a significant increase in perceived stress, depression, anxiety, and psychological stress, along with a reduction in the physical, psychological, and social domains of QOL-BREF at the follow-up stage. Although the two groups were similar at baseline, the Yoga group showed substantial enhancements in perceived stress, depression, anxiety, physiological stress, and overall quality of life when compared to the control group at follow-up. Conclusion: The study's findings indicate that stress, anxiety, and depression are more likely to occur as gestational age progresses during pregnancy. Nevertheless, practicing Prenatal Yoga can effectively manage these changes and enhance the quality of life for expectant mothers.Clinical trial registration: Clinical Trials Registry-India, Identifier CTRI/2021/01/030827.

Prevalence, Regional Variations, and Predictors of Overweight, Obesity, and Hypertension Among Healthy Reproductive-Age Indian Women: Nationwide Cross-Sectional Polycystic Ovary Syndrome Task Force Study.

BACKGROUND: A clear understanding of the anthropometric and sociodemographic risk factors related to BMI and hypertension categories is essential for more effective disease prevention, particularly in India. There is a paucity of nationally representative data on the dynamics of these risk factors, which have not been assessed among healthy reproductive-age Indian women. OBJECTIVE: This cross-sectional polycystic ovary syndrome (PCOS) task force study aimed to assess the anthropometric and sociodemographic characteristics of healthy reproductive-age Indian women and explore the association of these characteristics with various noncommunicable diseases. METHODS: We conducted a nationwide cross-sectional survey from 2018 to 2022 as part of the Indian Council of Medical Research-PCOS National Task Force study, with the primary aim of estimating the national prevalence of PCOS and regional phenotypic variations among women with PCOS. A multistage random sampling technique was adopted, and 7107 healthy women (aged 18-40 years) from 6 representative geographical zones of India were included in the study. The anthropometric indices and sociodemographic characteristics of these women were analyzed. Statistical analysis was performed to assess the association between exposure and outcome variables. RESULTS: Of the 7107 study participants, 3585 (50.44%) were from rural areas and 3522 (49.56%) were from urban areas. The prevalence of obesity increased from 8.1% using World Health Organization criteria to 40% using the revised consensus guidelines for Asian Indian populations. Women from urban areas showed higher proportions of overweight (524/1908, 27.46%), obesity (775/1908, 40.62%), and prehypertension (1008/1908, 52.83%) categories. A rising trend of obesity was observed with an increase in age. Women aged 18 to 23 years were healthy (314/724, 43.4%) and overweight (140/724, 19.3%) compared with women aged 36 to 40 years with obesity (448/911, 49.2%) and overweight (216/911, 23.7%). The proportion of obesity was high among South Indian women, with 49.53% (531/1072) and 66.14% (709/1072), using both World Health Organization criteria and the revised Indian guidelines for BMI, respectively. BMI with waist circumference and waist-to-height ratio had a statistically significant linear relationship (r=0.417; P<.001 and r=0.422; P<.001, respectively). However, the magnitude, or strength, of the association was relatively weak (0.3<|r|<0.5). Statistical analysis showed that the strongest predictors of being overweight or obese were older age, level of education, wealth quintile, and area of residence. CONCLUSIONS: Anthropometric and sociodemographic characteristics are useful predictors of overweight- and obesity-related syndromes, including prehypertension, among healthy Indian women. Increased attention to the health of Indian women from public health experts and policy makers is warranted. The findings of this study can be leveraged to offer valuable insights, informing health decision-making and targeted interventions that mitigate risk factors of overweight, obesity, and hypertension. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): RR2-10.2196/23437.

Pregnancy and long-term outcomes of female patients with chronic myeloid leukemia on tyrosine kinase inhibitors who experienced unplanned pregnancies.

PURPOSE: Despite the general recommendation to avoid Tyrosine Kinase Inhibitors (TKIs) for Chronic Myeloid Leukemia (CML) during pregnancy, unplanned pregnancies still occur, particularly among female patients residing in low- and middle-income countries (LMICs). We aimed to investigate the outcomes of pregnancy, foetal development, and disease progression among female CML patients in chronic phase (CML-CP) undergoing TKI therapy who encountered unplanned pregnancies in a tertiary care hospital in northern India. METHODS: We conducted a retrospective analysis of all pregnancies in female CML-CP between January 2002 and December 2022 at our hospital. Patients were included if they had a confirmed diagnosis of CML-CP, were receiving TKI therapy during conception, and had available medical records. We analysed the data on pregnancy outcomes, foetal development, and disease progression through a review of medical records. RESULTS: We identified 36 pregnancies in female CML-CP patients on TKI therapy during the study period, with 33 (91.7%) being unplanned. Sixteen pregnancies (48.5%) were conceived at less than major molecular remission (MMR) status. Twelve pregnancies (36.4%) were electively terminated, 4 (12.1%) had miscarriages, and, 17 (51.5%) pregnancies resulted in childbirth. Out of the 17 childbirths, 10 were full-term deliveries, and 7 were preterm deliveries. Twin pregnancies had a high incidence (18.2%). Among the 21 pregnancies that were not electively terminated, TKI was stopped at the first pregnancy detection in 14 pregnancies, while imatinib was continued throughout 7 pregnancies. Patients who discontinued TKI had a higher but statistically non-significant incidence of adverse pregnancy outcomes compared to those who continued imatinib throughout pregnancy (64.2% vs. 28.6%, p = 0.18). Additionally, the risk of long-term disease progression among patients who discontinued TKI during pregnancy and those who continued imatinib throughout pregnancy was 21.4% and 16.7% (p = 0.9), respectively. The risk of long-term disease progression was significantly increased in those persistently at less than MMR pre- and post-gestation (p = 0.0002). CONCLUSION: Our findings suggest that continuing imatinib therapy during pregnancy, may be a reasonable option for CML patients residing in low- and middle-income countries to reduce the risk of disease progression and adverse pregnancy outcomes. Patients persistently at less than MMR levels pre- and post-gestation should be closely monitored for the risk of long-term disease progression. Further studies with larger sample sizes are needed to confirm these results.

Normative range of various serum hormonal parameters among Indian women of reproductive age: ICMR-PCOS task force study outcome.

Background: The hormonal profile varies considerably with age, gender, ethnicity, diet or physiological state of an individual. Limited population-specific studies have studied the variations in hormonal parameters among apparently healthy women. We aimed to analyse the biological reference interval for various hormonal parameters in the reproductive-aged healthy Indian women. Methods: Out of 3877 participants that were clinically evaluated, 1441 subjects were subjected to laboratory investigations. All participants underwent a detailed clinical, biochemical and hormonal profiling. The hormone analysis was carried out at a single centre using a uniform methodology. Among the participants evaluated for biochemical and hormonal parameters, subjects that presented any abnormal profile or had incomplete investigations (n = 593) were excluded for further analysis. Findings: The mean age (±SD) of the subjects retained in the final analysis (n = 848) was 29.9 (±6.3) years. In the present study, the biological reference interval (2.5th-97.5th centile) observed were: serum T4: µg/dL (5.23-12.31), TSH: µg/mL (0.52-4.16) and serum prolactin: ng/mL (5.13-37.35), LH: mIU/mL (2.75-20.68), FSH: mIU/mL 2.59-15.12), serum total testosterone: ng/mL (0.06-0.68), fasting insulin: mIU/mL (1.92-39.72), morning cortisol: µg/dL (4.71-19.64), DHEAS:µg/dL (50.61-342.6) and SHBG: nmol/L (21.37-117.54). Unlike T4, TSH, LH, and E2, the biological reference interval for prolactin, FSH, testosterone, C-peptide insulin and DHEAS varied when the subjects were stratified by age (p < 0.05). The comparative analysis showed marginal differences in the normative ranges for the hormones analysed among different populations. Interpretation: Our first large composite data on hormonal measures will benefit future endeavours to define biological reference intervals in reproductive-aged Indian women. Funding: The study was financially supported by the grant-in-aid from ICMR vide file No:5/7/13337/2015-RBMH.

Assessment of quality of life in patients having Poly-Cystic Ovarian Syndrome: A cross-sectional facility-based study.

BACKGROUND: Polycystic ovarian syndrome (PCOS) is a complex and heterogeneous disorder affecting various body organs. Menstrual irregularity, anovulation, and many cosmetic issues faced by PCOS patients endanger the essence of being a woman and may have a deleterious impact on their health-related quality of life (HRQOL). This study aimed to assess HRQOL in patients with PCOS and to identify the clinical and socio-demographic factors that might predict poor HRQOL. MATERIALS AND METHODS: This cross-sectional study was carried out in the tertiary care hospital in India. A total of 275 women visiting the same setting and diagnosed with PCOS were included. The participants' quality of life was studied using a disease-specific HRQOL questionnaire. Information regarding clinical and socio-demographics was collected using the interviewer schedule. For evaluating the predictors of HRQOL in PCOS subjects, analysis of variance and independent t-test was applied. For subgroup analysis, the post hoc (Gabriel) test was applied. RESULTS: The average total score of HRQOL of the study participants was 125.41 ± 29.1. The lowest weighted mean score was for menstrual problems. Among the socio-demographic variables, age and educational level influenced the HRQOL scores. Highly educated women reported the poorest HRQOL. The analysis of variance also indicated a significant variation in HRQOL scores among body mass index categories [F (4,270) = 5.09, P = <.001] and hirsutism status [F (2,272) = 14.222, P =<.001]. CONCLUSIONS: Menstrual irregularity, hirsutism, increased body mass index, educational status, and age are critical in altering HRQOL in PCOS cases. Clinicians should inquire about the HRQOL of patients with severe clinical manifestations and appropriate support must be provided during patient care.

Treatment seeking behavior among patients with polycystic ovarian syndrome (PCOS)-A cross-sectional study from Northern India.

BACKGROUND: Polycystic ovarian syndrome (PCOS) has now become a common problem among adolescent girls and young women in India. However, little is known about the treatment and satisfaction incurred from it. Our study aimed to assess the treatment-seeking behaviour among patients with PCOS. MATERIALS AND METHODS: The cross-sectional study was carried out in gynecology OPD of PGIMER, Chandigarh. Women with PCOS, 275, visiting the gynecology OPD were included. The treatment-seeking behavior for PCOS was elucidated among cases using a questionnaire. This included parameters like healthcare consulted, preferred system of medicine, referral pattern, treatment efficacy, and expenses incurred. Univariate descriptive analysis was used to present the results. RESULTS: The majority (68%) of the study participants were less than 25 years of age. The average weight was 66.78 (±13.0) Kg. Half of the participants were students. More than 70% belonged to the upper or upper-middle class. The study participants were diagnosed with PCOS at an average age of 21.4 (±4.7) years. The minimum age reported at diagnosis was 11 years, and the maximum age of diagnosis was 36 years. Most respondents preferred Allopathic treatment followed by homeopathy and Ayurveda. Few also opted for other treatment choices like diet therapy, yoga & meditation, weight loss supplements, and home remedies. Treatment efficacy ranged between 17.3%-34.2%. The majority of respondents reported the treatment to be moderately expensive. Most respondents (58.91%) were hardly influenced, while 16% were quite influenced by PCOS medicine or treatment advertisements. CONCLUSION: PCOS patients opt for different treatment options but generally find the treatment less effective and expensive.

Individualized lifestyle intervention in PCOS women (IPOS): a study protocol for a multicentric randomized controlled trial for evaluating the effectiveness of an individualized lifestyle intervention in PCOS women who wish to conceive.

BACKGROUND: Polycystic ovary syndrome (PCOS) is a common endocrine condition which affects women in the reproductive age group. South Asian women with PCOS have a higher risk of insulin resistance and metabolic disorder compared to women from other ethnic backgrounds. Lifestyle interventions such as dietary advice and physical exercise are recommended as a first-line management option for infertile women with PCOS. Most of the randomized controlled trials evaluating the role of lifestyle interventions in infertile PCOS women were characterized by methodological issues. The uptake of lifestyle modifications as a treatment strategy in the South Asian population is complicated by a difficult-to-change conventional high-carbohydrate diet and limited availability of space for physical activity in the region. METHODS: The study is designed as an open-label, multicentre, randomized controlled trial in South Asian women with PCOS. Women attending the fertility clinic will be screened for eligibility, and women aged between 19 and 37 years who have been diagnosed with PCOS and wishing to conceive will be invited to participate in the trial. We will include women with body mass index (BMI) between ≥ 23 and ≤ 35 kg/m2 and duration of infertility ≤ 3 years. We plan to randomize women with PCOS into two groups: group A will receive the intervention which will consist of individualized advice on diet and physical exercise along with a telephonic reminder system and follow-up visits, and group B (control) will receive one-time advice on diet and physical exercise. Both groups will receive up to three cycles of ovulation induction with letrozole after 3 months of randomization during the 6-month treatment period. The primary outcome of the trial will be the live birth following conception during the intervention period. The secondary outcomes include clinical pregnancy rate, ongoing pregnancy rate, miscarriage rate, ectopic pregnancy rate, stillbirth, time to pregnancy, mean weight loss, differences in anthropometric parameters, improvement in menstrual regularity and quality of life score. DISCUSSION: The IPOS trial results could help clarify and provide more robust evidence for advocating an individualized lifestyle intervention in PCOS women who wish to conceive. TRIAL REGISTRATION: Clinical Trial Registry of India CTRI/2023/04/051620. Registered on 13 April 2023.

Variation in normative values of major clinical biochemistry analytes in healthy reproductive-age women in India: A subset of data from a National Indian Council of Medical Research-Polycystic Ovary Syndrome task force study.

OBJECTIVES: Clinical biochemistry reference intervals (RIs) play a crucial role in interpreting patient test results and making informed clinical decisions. Using data from an ongoing Indian Council of Medical Research-National task force study on healthy women, normative ranges for commonly analyzed biochemical analytes were established. MATERIALS AND METHODS: A.total of 13,181 women of reproductive age (18-40 years) were recruited from different urban and rural regions of the country, of which 9898 women signed an informed consent were included. Among these, women having features of hyperandrogenism, menstrual cycle irregularities, and comorbidities were excluded. RIs of 22 analytes were computed in the remaining 938 women controls. To estimate the 95% range of the reference distribution, the limits of the 2.5th percentile and the 97.5th percentile were used in the study. RESULTS: Mean ± standard deviation of age and body mass index of participants was 30.12 ± 6.32 years and 22.8 ± 3.36 kg/m2 respectively. Centiles (2.5th-97.5th) of liver function parameters, lipid parameters, glycaemic parameters, and renal parameters are presented. No significant difference in analytes was observed in relation to the area of residence, and age groups except in albumin (P = 0.03). The distribution of most of the parameters was consistent with the various RI studies conducted in India as well as other countries. CONCLUSION: This is the first study generating biochemical RIs data among a large representative sample of healthy reproductive-age women recruited using a robust design across the country. The resource may serve as a reference range for common biochemical analytes for future in this age group.

Correction to: Postpartum Collapse Subsequent to Catatonia in a Female with COVID-19 Infection: A Rare Entity Visited.

[This corrects the article DOI: 10.1007/s13224-022-01737-5.].

An integrated qualitative and quantitative study on sexual and reproductive health problems faced by women with disabilities in Chandigarh, India.

OBJECTIVES: To estimate the prevalence of sexual and reproductive health (SRH) problems among women with disabilities (WWD) in Chandigarh, India, and to ascertain the difficulties experienced by WWD in accessing hospital services. METHODS: This cross-sectional study was conducted during 2014 to 2017 in Chandigarh, India. The study participants were women 15 years and older with at least 40% disability. A pretested questionnaire and in-depth interview were used to determine sociodemographic profile, medical history, sexual and reproductive morbidity, treatment-seeking behavior, and the type, extent, and course of the disability. Verbatim responses of the participants were noted. Data were manually coded and collated into possible themes. RESULTS: Postpolio residual paralysis (80; 30.7%) was the main reported disability, followed by severe sight impairment (52; 19.9%). A majority (170; 65%) of participants were unmarried. Of them, 66 (39%) were not willing to get married. The prevalence of SRH problems was high (151; 57.9%) among WWD, and only 82 (54%) took treatment. Dysmenorrhea (47; 31.1%), irregular periods (36; 23.8%), and vaginal discharge (17; 11.3%) were the main problems reported. The WWD in this study were likely to hide their SRH problems from others out of shame or fear. CONCLUSION: Among WWD, the prevalence of SRH problems is high and obtaining relief is difficult.

Acute kidney injury and it's outcome following maternal near miss event: A prospective observational study from a tertiary care hospital.

Purpose: Haemorrhage, preeclampsia and sepsis are the leading causes of renal dysfunction in women with a maternal nearmiss(MNM) complication. The study aimed to assess the prevalence, pattern and follow up of these women. Methods: This was a hospital based prospective observational study, conducted over one year. All women with a MNM leading to acute kidney injury (AKI) were analysed for fetomaternal outcomes and renal function at 1 year of followup. Results: The incidence of MNM was 43.04 per 1000 livebirths. 18.2% women developed AKI. 51.1% women developed AKI in the puerperal period. Most common cause of AKI was haemorrhage seen in 38.3% women. The majority of women had s.creatinine between 2.1 to 5 mg/dl and 44.68% required dialysis. 80.8% women recovered fully when the treatment was initiated within 24 h. One patient underwent renal transplant. Conclusion: Early diagnosis and treatment of AKI results in full recovery.