Physical fitness in Indian women with epilepsy on anti-seizure medications and its association with reproductive status, quality of life and stigma: A cross-sectional study.

PURPOSE: To determine the status of physical fitness, reproductive abnormalities, QOL and epilepsy associated stigma in women with epilepsy (WWE) and their association with ASM therapy and seizure frequency. METHODS: This cross-sectional study included WWE of reproductive age (18-50 years) on antiseizure medications (ASMs) for at least three months before enrolment. Physical fitness was assessed using International Physical Activity Questionnaires (IPAQ) and Body composition analysis. Subjects were interviewed for menstrual abnormalities [menstrual disturbance or Polycystic Ovary Syndrome (PCOS)/hirsutism]. Validated questionnaires were used for assessment of, QOL (QOLIE-10) and Stigma in epilepsy (Epilepsy Stigma Scale). Sub-group analysis was done to compare the above parameters on the basis of a) type of therapy (mono or polytherapy), b) type of ASMs treatment (conventional, newer, or conventional + newer ASMs), and c) seizure type and (d) seizure frequency. Correlation and regression analysis were done to find out the association among different variables with physical fitness. RESULTS: The overall prevalence of poor physical fitness, reproductive abnormalities, worsened QOL and stigma in the enrolled WWE (n = 203) were 21.18 %, 20.19 %, 52.7 %, and 21.67 %, respectively. Sub-group analysis revealed that WWE on monotherapy (n = 99) had higher median IPAQ score (p = 0.002), comparatively less reproductive abnormalities (24.03 %, p = 0.008), and higher stigma (24.03 %, p = 0.04) than polytherapy group. WWE on conventional ASMs had significantly higher IPAQ scores compared to newer and conventional + newer ASMs groups (p = 0.02). The prevalence of poor physical fitness and stigma was significantly higher in WWE with higher number of seizures (p = 0.007, <0.001, respectively). No significant difference in QOL was observed on the basis of ASM type and therapy; however, WWE with generalized onset seizures had worsened QOL compared to those with focal onset seizures (p = 0.04). A significant negative correlation was found among seizure frequency and IPAQ score in WWE (p = 0.04). CONCLUSION: WWE on polytherapy were physically less active, higher occurrence of reproductive abnormalities, and stigma compared to the monotherapy group. WWE with higher seizure frequency had poor physical fitness, and higher stigma compared to those with lesser number of seizures. These findings may aid value in optimization of ASM treatment in WWE of reproductive age.

Prevalence of FSH-R Asn680Ser and Ala307Thr receptor polymorphism and their correlation with ART outcomes among infertile Indian-Asian women-a prospective cohort study.

The present prospective cohort study evaluated the prevalence of FSH-R receptor Asn680Ser and Ala307Thr among infertile Indian women and the correlation of these polymorphisms with ART outcomes. Total 804 infertile and 209 fertile controls were enrolled for FSH-R analysis. Correlation of different genotypes with ovarian reserve markers, IVF parameters, and cumulative live birth rates (CLBR) was done among women undergoing IVF. In fertile controls, at 680 position GG (Ser/Ser) was the most common genotype; but among infertile women, all the genotypes were equally distributed. There was no significant difference in ovarian response parameters, oocyte yield, and CLBR among the three genotype groups. Empty follicle syndrome (EFS) was highest in women with AA or AG type at both positions. On categorisation of unexpected poor responders according to POSEIDON stratification; GG genotype at both positions had the lowest risk ratio of low-oocyte yield in ART cycles, but these differences were not statistically significant. This is the largest study from Indian ethnicity showing GG (Ser/Ser) genotype is most common among fertile women. The effect of FSH-R genotypes is very marginal on IVF parameters and is not reflected in CLBR. More prospective data may be required on the correlation of these genotypes with genuine EFS, thus stratifying the next cycles with self or donor oocytes. Routine genetic testing of FSH-R polymorphism should not be done except in a research setting. As both 680 and 307 positions are in linkage disequilibrium, only 680 position analysis may be done in a research setting.

Utility of Visceral Adiposity Index and Lipid Accumulation Products to Define Metabolically-Unhealthy Polycystic Ovary Syndrome in Asian Indian Women - A Cross Sectional Study.

Background: Polycystic ovary syndrome (PCOS) women are at risk of developing diabetes, cardiovascular disease and metabolic syndrome (MetS) due to insulin resistance (IR) and hyperandrogenism (HA). Both visceral adiposity index (VAI) and lipid accumulation product (LAP) are simple outpatient department-based metric tools that have been introduced to screen PCOS women who are metabolically unhealthy and are at risk of development of MetS. Aims: The aim of the study was to evaluate VAI and LAP in women with PCOS and to correlate them with metabolic and endocrine markers. The study also assessed these parameters amongst different PCOS phenotypes and determined their usefulness to define metabolically healthy PCOS (MH-PCOS) and metabolically unhealthy PCOS (MU-PCOS). Settings and Design: The design of the study was a cross-sectional study. Materials and Methods: Two hundred PCOS women were included in the study, and all the clinical, anthropometric, hormonal, biochemical and metabolic markers were assessed. The cohort was divided into MH-PCOS and MU-PCOS by the modified National Cholesterol Education Programme criteria. VAI and LAP were calculated and correlated with clinical, endocrine and metabolic parameters. Statistical Analysis Used: Univariate and multivariate logistic regression analysis was used to study the independent role of VAI and LAP to predict MetS. Adjusted and unadjusted odds ratios were calculated. Receiver-operating characteristic (ROC) analysis was done to define cut-offs in Asian Indian women. Results: VAI and LAP had good ability to correctly discriminate MU-PCOS from MH-PCOS (area under the curve [AUC] [95% confidence interval (CI)]: 0.89 [0.82-0.95]) and (AUC [95% CI [0.81-0.92] =0.86) using ROC, respectively. The sensitivity of VAI and LAP corresponding to the optimal cut-off of ≥2.76 and ≥48.06 (Youden) was 84.09% and 79.55%, respectively. Similarly, the specificity of VAI and LAP was 85.26% and 79.49%, respectively. VAI has a positive predictive value of 61.7% (95% CI [23.7%-40.3%]) and a negative predictive value of 95% (95% CI [88%-99.1%]). LAP has a positive predictive value of 53% (95% CI [40.3%-65.4%]) and a negative predictive value of 93.3% (95% CI [87.6%-96.9%]). PCOS women having VAI ≥ 2.76 had 19.3 times ([95% CI: 6.50-57.70]) more chance of developing MetS. PCOS women having LAP (≥48.06) have 3.7 times ([95% CI: 1.35-10.60]) more odds. There was no difference between ROC curves of VAI and LAP (P = 0.32). Conclusion: VAI cut-off ≥ 2.76 and LAP with a cut-off of ≥ 48.06 may be used as markers for predicting MetS amongst PCOS women.

Comparison of the effects of two different trigger strategies - dual (hCG + Leuprolide) versus hCG trigger - in antagonist non-donor IVF: a randomized controlled trial.

OBJECTIVE: Conventionally, hCG is used as a 'faux' LH surge to bring final oocyte maturation due to structural similarity with LH. Although GnRH agonists induce a more physiological gonadotropin surge for follicular maturation, they have been associated with luteal phase deficiency. Our aim was to assess whether adding a gonadotropin-releasing hormone agonist (GnRHa) to hCG trigger improves oocyte maturation and the number of high-grade embryos in GnRH antagonist IVF cycles. METHODS: This was a single center, open-labelled, randomized controlled trial including 100 patients between 21-38 years (tubal factor, male factor, unexplained infertility, with normal ovarian reserve) undergoing IVF using the GnRH antagonist protocol. Patients were randomized to receive either the dual trigger (Leuprolide acetate 1mg + rhCG 250µg, n=50) or a single hCG trigger (rhCG 250µg, n=50). Analysis was done by ITT. Independent-t and chi-square tests were used in the comparisons of normally distributed quantitative variables and qualitative variables. RESULTS: With similar baseline characteristics, the number of MII oocytes (7.82 vs. 5.92, p=0.003) and day-3 grade-1 embryos (4.24 vs. 1.8, p<0.001) and consequently, number of embryos cryopreserved (2.68 vs. 0.94, p<0.001) were significantly higher in the dual trigger group. However, the fertilization (91.82% vs. 88.51%, p=0.184) and clinical pregnancy rates between the two groups (21% vs. 19.6%, p=0.770) were comparable. Serum LH levels 12 hours post trigger were high in the dual trigger group (46.23mIU/ml vs. 0.93mIU/ml, p<0.0001). CONCLUSIONS: This study found that the addition of GnRHa to hCG trigger leads to improved embryological outcomes and the possibility of cryopreserving surplus embryos, thereby increasing cumulative live births.

Evaluation of cervical cancer screening during pregnancy in India: Human papillomavirus testing can change the paradigm.

Background The World Health Organization's call for elimination of cervical cancer envisages 70% screening coverage of women aged 35 and 45 years by an effective test. In India, this target seems unrealistic as awareness and access to cancer prevention services are poor. However, the institutional delivery rate is now >80%. We evaluated the acceptability and feasibility of human papillomavirus (HPV) testing and its role in screening during pregnancy. Methods This observational study recruited 275 pregnant women aged >25 years between 12 and 34 weeks of gestation for screening by cytology and HPV testing. Colposcopy was advised if either test was positive. Acceptability and feasibility were assessed by a questionnaire. Results Cytology and HPV reports were available for 269 subjects. The median age was 28 years and median parity was two. Only 98 (36.4%) had heard about carcinoma cervix. Awareness improved with education (p < 0.001). On cytology, only 4 (1.5%) were abnormal (atypical squamous cells of undetermined significance 3; low-grade squamous intraepithelial lesion 1). The prevalence of high-risk HPV infection was 8.2% (22/269). On colposcopy, all had the Swede score <5. No high-grade cervical intraepithelial neoplasia or carcinoma was detected. Pre-procedure, 183 (68.0%) subjects expressed apprehension, post-procedure 114 (42.4%) of them had realized that their apprehensions were unfounded. Women found screening to be more uncomfortable after 28 weeks of gestation (n=26/68; 38.2%; p<0.001). Physicians found the cervix more difficult to visualize after 20 weeks of gestation (p<0.001). Conclusions HPV screening at 16-20 weeks of pregnancy is acceptable, feasible, and can greatly improve screening coverage in resource-limited settings. Pregnancy is a good opportunity to improve awareness of the screening programmes.

Comparison of Cumulative Live Birth Rate (CLBR) According to Patient Oriented Strategies Encompassing Individualized Oocyte Number (POSEIDON) Stratification Among Low Prognosis Women Undergoing IVF-ICSI Cycles.

Background: The purpose of the current study was to evaluate patient-oriented strategies encompassing individualized oocyte number (POSEIDON) criteria, validate stratification of low prognosis women, and prognosticate their reproductive potential in terms of cumulative live birth rate (CLBR) in Indian women. Methods: Out of 4048 women who underwent IVF/ICSI, 3287 women met the criteria for final evaluation of CLBR. They criteria were divided into (a) group 1a as cases with <4 oocytes retrieved and 1b with 4-9 oocytes retrieved; (b) group 2a as cases with <4 oocytes retrieved and 2b with 4-9 oocytes retrieved; (c) group 3 (<35 years, AMH <1.2 ng/ml, AFC <5); and (d) group 4 (≥35 years, AMH <1.2 ng/ml, AFC <5). Non-POSEIDON group was sub-divided into normo-responders (10-20 oocytes) and hyper-responder (>20 oocytes). Results: Overall CLBR was two-fold lower in POSEIDON group as compared to non-POSEIDON group (p<0.001). For every one-year increase in the age, the odds of CLBR decreased by 4% (OR 0.96, CI 0.93-0.99) in POSEIDON group and by 5% (OR 0.95, CI 0.92-0.98) in non-POSEIDON group. For every unit increase in number of oocytes retrieved, the odds of CLBR increased by 1.22 times (OR1.22, CI 1.16-1.28) in POSEIDON group and by 1.08 times (OR 1.08, CI 1.05-1.11) in non-POSEIDON group. Among POSEIDON groups, the highest values in CLBR belonged to group 1b followed by 3, 2b, 4, 1a, and 2a. Conclusion: POSEIDON stratification of low-prognosis women undergoing IVF may be considered valid to prognosticate and counsel women undergoing IVF. Prospective studies will strengthen its validity among different ethnic populations.

Robert's Uterus versus Juvenile Cystic Adenomyoma - Diagnostic and Therapeutic Challenges - Case Report and Review of Literature.

This case report highlights the diagnostic dilemma and therapeutic challenges encountered while managing adolescent girls with progressive dysmenorrhoea and management of Robert's uterus. Two girls aged 20 years and 13 years presented with severe progressive dysmenorrhoea. In the first case, laparoscopy revealed juvenile cystic adenomyoma (JCA) of 3 cm × 3 cm on the left side anteroinferior to the round ligament. Laparoscopic resection of the lesion was done, and histopathology revealed features of adenomyosis. In the second case, there was a globular enlargement of the right half of the uterine body with round ligament and adnexa attached to the lesion (Robert's uterus). In view of severe symptoms, complete resection of the lesion and partial resection of hemi-uterus was done, followed by myometrial defect closure. Both cases were initially diagnosed as JCA, and the final diagnosis was made on laparoscopy. Both girls had complete symptomatic relief from the next menstrual cycle and have been under follow-up for 24 months and 18 months, respectively. Due to the rarity of conditions, Robert's uterus and JCA are usually misdiagnosed with each other or with other Mullerian anomalies such as a non-communicating unicornuate uterus. Radiologists and clinicians should be aware of these different pathologies causing similar symptoms. Understanding the pathology, early diagnosis, timely referral and correct surgical procedure are emphasised to improve reproductive outcomes.

In vitro fertilization as an independent risk factor for perinatal complications: Single-center 10 years cohort study.

OBJECTIVES: Assisted Reproductive Technology (ART) has made great strides in the past forty-years, but no medical treatment comes without side effects. Despite several studies reporting high incidences of perinatal complications, the association is inconclusive. Also, the effect of racially and ethnically distinguished Asian population undergoing ART on perinatal outcomes is not well studied. Therefore, this study attempts to compare various perinatal outcome parameters in ART, and spontaneously conceived singleton pregnancies from a single high-volume tertiary care center. METHODS: This is a retrospective cohort study from a single tertiary infertility center, carried out from January 2011 to September 2020. The study included 1,125 IVF conceived babies (AB group) and 7,193 spontaneous conceived babies (SB group). The groups were compared using the Pearson Chi-square test and adjusted odds ratio, calculated using the multivariate analysis. RESULTS: Most of the perinatal complications, such as preterm birth (PTB), early preterm birth, low birth weight (LBW), extremely low birth weight, small for gestational age, large for gestational age babies, neonatal intensive care unit (NICU) admission, need for surfactant, meconium aspiration syndrome, neonatal seizures, intraventricular hemorrhage, hypoxic-ischemic encephalopathy, and patent ductus arteriosus was significantly increased in the AB group when compared to the SB group (p<0.05). In-vitro fertilization (IVF) independently increases the risk of LBW (aOR 2.530; 95% CI 2.194-2.917), PTB (aOR 4.004; 95% CI 3.496-4.587), NICU admission (aOR 2.003; 95% CI 1.610-2.492) and neonatal seizures (aOR 9.805; 95% CI 5.755-16.706).Conclusions: All ART-conceived pregnant patients should receive antenatal counselling regarding perinatal complications and should deliver at a tertiary care center with appropriate NICU support.

Serum Anti-Mullerian Hormone (AMH) Levels Among Different PCOS Phenotypes and Its Correlation with Clinical, Endocrine, and Metabolic Markers of PCOS.

Anti-Mullerian hormone (AMH) is one of the direct indicators of follicular pool but no standard cutoff has been defined for diagnosis of polycystic ovary syndrome (PCOS). The present study evaluated the serum AMH levels among different PCOS phenotypes and correlated the AMH levels with clinical, hormonal, and metabolic parameters among Indian PCOS women. Mean serum AMH was 12.39 ± 5.3ng/mL in PCOS cohort and 3.83 ± 1.5 ng/mL in non-PCOS cohort (P < 0.01). Out of 608 PCOS women, 273 (44.9%) women belonged to phenotype A, 230 (37.8%) women were phenotype D. Phenotypes C and B were 12.17% and 5.10% respectively. Among those with the highest AMH group (AMH>20ng/ml; 8.05%), majority belonged to phenotype A. Menstrual cycle length, serum testosterone, fasting total cholesterol levels, and follicle number per ovary had positive correlation with serum anti-Mullerian levels (P < 0.05). AMH cutoff for the diagnosis of PCOS was calculated as ≥ 6.06 ng/mL on ROC analysis with sensitivity and specificity of 91.45% and 90.71% respectively. The study shows high serum AMH levels in PCOS are associated with worse clinical, endocrinological, and metabolic parameters. These levels may be used to counsel patients regarding treatment response, help in individualized management and prediction of reproductive and long-term metabolic outcomes.

An unusual association of type II Mayer-Rokitansky-Kuster-Hauser syndrome, turner mosaic syndrome and tubo-ovarian inguinal hernia- case report and review of literature.

BACKGROUND: Herniation of ovaries and Mullerian structures into inguinal canal is usually reported in infants and is rare among adults. We are presenting a rare case of Mullerian agenesis and Turner mosaic syndrome with tubo-ovarian inguinal hernia. CASE PRESENTATION: A 17-year-old girl presented with complaints of primary amenorrhea, phenotypical features of Turner syndrome with left inguinal hernia and severe hypertension. Baseline hormonal analysis was normal. Karyotype revealed Turner mosaic with 46XX (85%); 45XO (15%). MRI showed Mullerian agenesis with normally located right ovary in pelvis and left ovary prolapsed through deep inguinal ring into the canal of Nuck. Anti-hypertensives were started and patient optimized for surgery. Laparoscopic hernia repair and repositioning of left ovary into the pelvis was done. Patient had uneventful post-operative course and was discharged in stable condition on anti-hypertensive medication. Future reproductive issues and need of passive vaginal dilatation or vaginoplasty before marriage were explained to the patient and family. CONCLUSION: This is the first ever reported case with unusual association of atypical MRKH, Turner mosaic syndrome and tubo-ovarian hernia into the inguinal canal. The case emphasizes the need and importance of complete work up of these atypical cases as patients may have more than one cause of primary amenorrhea and complete evaluation is must before any medical or surgical intervention.

Serum progesterone on the day of human chorionic gonadotropin (hCG) trigger as a predictor of in-vitro fertilization (IVF) outcome - a retrospective analysis of seven years.

OBJECTIVE: To investigate the relationship between progesterone (P4) levels on the day of hCG trigger and IVF outcomes. METHODS: This is a retrospective analysis of IVF cycles from January-2013 to December-2019 from a single center. Women (21-39 years) submitted to IVF treatment for various infertility factors were included, while donor oocyte cycles and cancelled cycles were excluded from the study. The primary outcome measure was live birth rate. RESULTS: A total of 2149 cycles were analyzed. Of these, 223 (10.38%) were in the low P4 group (<0.5 ng/ml), 1163 (54.12%) in the normal P4 group (0.5-1.5 ng/ml), and 763 (35.50%) in the high P4 group (>1.5ng/ml). The groups were comparable with respect to age, factor of infertility and baseline AMH. The antagonist protocol was significantly more prescribed to the high P4 group (p<0.001). Live birth rates were 14.4%, 21.6%, and 21% (p<0.001), respectively, in three groups. Univariate analysis found that total cetrotide dose, total number of retrieved and fertilized oocytes, total number of embryos formed, transferred, and vitrified, and P4 on the day of hCG (p<0.001) were statistically significant after adjusting for age and BMI. In multivariate logistic regression after adjusting for age and BMI, only high P4 (aOR:0.60; p<0.001), total cetrotide dose (aOR: 0.82; p<0.001), and total utilizable embryos (aOR:1.11; p=0.029) were statistically significant. CONCLUSIONS: Having an elevated serum progesterone level on the day of hCG trigger was associated with lower pregnancy rates, but this is still not a robust marker to predict live births. More good quality evidence is needed.

Prognostic Significance of HE4 Tissue Expression in Serous Epithelial Ovarian Carcinoma.

Neerja BhatlaBackground Human Epididymis protein 4 (HE4) is expressed in ovarian cancer. Preoperative serum testing is still not widely available. This pilot study aimed to investigate the magnitude of expression of HE4 in tissue sections of serous epithelial ovarian carcinoma, its correlation with clinical outcome, and the feasibility of HE4 immunohistochemistry as a prognostic marker. Materials and Method In this ambispective study, immunohistochemistry (IHC) was used to evaluate tissue sections of ovarian serous epithelial carcinoma at primary cytoreductive surgery. On HE4 immunohistochemistry (IHC), the magnitude of HE4 expression was assessed categorically as high or low HE4 expression and semiquantitatively by the H-score, and correlated with clinical outcome in terms of survival status, progression-free survival, and overall survival. Results Of 32 cases, most ( n = 31, 96.8%) were positive for HE4 IHC. The mean age was 49 ± 8.2 years; 29 (90.6%) patients were in FIGO stage IIIC; 25 (78.9%) had ≥1cm residual disease after surgery; 31 (96.8%) received adjuvant chemotherapy, either 3-weekly ( n = 25, 81.2%) or dose-dense weekly ( n = 6, 18.8%) regimen. The majority ( n = 31, 96.8%) had a high-grade tumor, of whom 19 (59.4%) had high HE4 expression and 13(40.6%) patients had H-score in the range of 5 to 8. The mean H-score was 6.97 ± 3.61 (range 0 to 12). The overall survival of the study population at 64 months was 36.65% (95% CI: 8.59-66.34), with median overall survival of 59 months. A new scoring system was developed combining categorical HE4 expression and serum CA-125 levels; the combination of HE4 expression with postoperative CA-125 levels was found to be the best prognostic marker for overall survival ( p = 0.05). A composite score of 2 identified patients with poor progression-free survival (HR 4.64, p = 0.039) and overall survival (HR 5.45, p = 0.05). Conclusion The new composite scoring system using HE4 IHC with postoperative serum CA-125 levels offers an extremely useful option for prognosticating patients with serous epithelial ovarian carcinoma than serum CA-125 alone. This is useful where preoperative records are not available to the treating clinician.

Continuous Glucose Monitoring System Profile of Women with Gestational Diabetes Mellitus Missed Using Isolated Fasting Plasma Glucose-Based Strategies Alternative to WHO 2013 Criteria: A Cross-Sectional Study.

INTRODUCTION: The aim of the study was to evaluate the differences in the continuous glucose monitoring system (CGMS)-based glycemic parameters between women with normoglycemia and early gestational diabetes mellitus (GDM) identified on the basis of mild fasting plasma glucose elevation (FPG, 5.1-5.5 mmol/L) and/or post-load plasma glucose elevation (PLG, 1-h ≥ 10.0 mmol/L or 2-h ≥ 8.5 mmol/L). METHODS: This cross-sectional study included women with singleton pregnancy (8+0 to 19+6 weeks of gestation) and normoglycemia or GDM per World Health Organization (WHO) 2013 criteria. We evaluated the glycemic parameters of clinical interest using blinded CGMS evaluation and reported them per standard methodology proposed by Hernandez et al. RESULTS: A total of 87 women (GDM, n = 38) were enrolled at 28.6 ± 4.5 years. Among women with GDM, 10 (26.3%) had isolated mild FPG elevation (5.1-5.5 mmol/L), 10 (26.3%) had isolated PLG elevation (1-h ≥ 10.0 mmol/L or 2-h ≥ 8.5 mmol/L), and 7 (18.4%) had a combination of both. The remaining 11 (28.9%) had elevated FPG (≥ 5.6 mmol/L) with or without PLG elevation. Thus, when an isolated FPG cutoff ≥ 5.6 mmol/L is used to diagnose GDM, 27 (71.0%) women would be perceived as normoglycemic. Such women had significantly higher CGMS parameters of clinical interest, such as 24-h mean glucose, fasting glucose, 1-h and 2-h postprandial glucose (PPG), 1-h PPG excursion, and peak PPG. CONCLUSIONS: An isolated FPG threshold, especially the higher cutoff ≥ 5.6 mmol/L, can potentially miss a large proportion of women (nearly three-fourths) diagnosed with GDM per WHO 2013 criteria. Eventually, such women fare significantly differently from normoglycemic women in various CGMS parameters of clinical interest.

Comparing maternal outcomes in spontaneous singleton pregnancies versus in vitro fertilization conception: Single-center 10-year cohort study.

OBJECTIVE: A successful assisted reproductive technique (ART) cycle is not flawless, and several studies have reported high incidences of maternal complications, but the association is inconclusive. In addition, the racial and ethnic effects of the Asian population undergoing ART on maternal outcomes is not well studied. This study attempts to compare various maternal outcome parameters ART and spontaneously conceived singleton pregnancies from a single high volume tertiary care centre. METHODS: A retrospective cohort study from a single tertiary infertility center was conducted from January 2011 to September 2020. The study included 1125 IVF conceived singletons (AP group) and 7193 spontaneous conceived singletons (SP group). The groups were compared using the Pearson Chi-square test and the adjusted odds ratio calculated using multivariate analysis. RESULTS: Maternal outcomes like gestational hypertension, pre-eclampsia, gestational diabetes (GDM), oligohydramnios, chorioamnionitis, operative, and instrumental delivery were significantly different in the two groups (p<0.05). The AP group had a significantly increased risk of GDM (aOR 1.093; 95% CI 1.076-1.110) and pregnancy-induced hypertension (PIH) (aOR 1.577; 95% CI 1.288-1.930) as compared to the SP group. IVF significantly increases the risk of abruption by 2 times (p=0.028), and independently increases the risk of caesarean section by 3.1-fold (p<0.001). But overall the IVF is the protective factor for oligohydramnios (p=0.024). CONCLUSIONS: ART increases the likelihood of pregnancy-related maternal complications, such as PIH, GDM, abruption, chorioamnionitis, and an increased rate of caesarean delivery. Thus, all patients undergoing ART procedures should receive pre-conceptional counselling regarding the associated obstetric risks and consider ART pregnancy as a high-risk pregnancy.

Serum Bile Acids in Intrahepatic Cholestasis of Pregnancy (ICP), Versus Pregnant and Nonpregnant Controls in Asian Indian Women and a Proposed Scoring to Optimize Management in ICP.

Objectives: This prospective clinical trial was conducted to assess serum bile acids (BA) levels in women with intrahepatic cholestasis of pregnancy (ICP) compared to both pregnant and non-pregnant controls; and evaluate perinatal outcome in relation to bile acid levels. A scoring is proposed based on biochemical markers to optimize management in ICP cases. Materials and Methods: Serum bile-acids(BA) were assessed in 71 intrahepatic-cholestasis of pregnancy(ICP) cases (group-I), versus 50 pregnant (group-II) and 35 non-pregnant (group-III) controls. Ursodeoxycholic acid (UDCA) was administered in ICP group. Baseline bilirubin (SB), aminotransferases (AT), alkaline-phosphatase were sent in groups I & II. Investigations were repeated in group-I after 4 weeks. Perinatal complications were noted. Results: Mean BA in group-I was 75.92 ± 39.9 µmol/L which reduced to 41.3 ± 15.4 µmol/L(45.6%, p < 0.001) with UDCA. Mean BA was 29.2 ± 5.7 and 5.9 ± 1.8 µmol/L in group-II and group-III. UDCA significantly reduced itching-score. Rate of fetal distress linearly increased with the increasing baseline levels of serum BA, AT and SB: from 2.5 to 100% at BA < 40 and ≥ 200 µmol/L, (p = 0.008); from 16.1 to 100% at AT < 100 and ≥ 500 IU/mL(p = 0.016); and from 6.8 to 100% at SB < 0.8 and > 5 mg/dL (p = 0.001); respectively. Their baseline levels were divided into 5 groups in correlation to fetal distress. Serum BA < 40, 40-80, 80-120, 120-200, ≥ 200 µmol/L; AT < 100,100-200,200-500, ≥ 500 IU/mL; and SB < 0.8, 0.8-1.0, 1.1-2, 2.1-5 and > 5 mg/dL. Nutan ICP scoring was proposed with a score 0 to 4 given to each parameter and score-based management protocol was suggested for fetal surveillance and delivery. Conclusions: SBA are higher in Asian Indian pregnant women. Levels > 30 µmol/L can be taken as a cut off for diagnosing ICP in Asian-Indian women. Adopting higher cut-offs for this geographic part will avoid over-diagnosing ICP and iatrogenic early termination of pregnancy. Suggested scoring will help clinicians in optimizing the time of delivery on an individualized basis.

Continuous glucose monitoring system profile of women diagnosed as gestational diabetes mellitus by International Association of Diabetes and Pregnancy Study Groups criteria and labeled as normoglycemic by alternate criteria in early pregnancy.

AIMS/INTRODUCTION: We aimed to evaluate and compare continuous glucose monitoring system (CGMS)-based glycemic parameters in women in early pregnancy (<20 weeks of gestation) who were classified as: (i) gestational diabetes mellitus (GDM) by the International Association of Diabetes and Pregnancy Study Groups (IADPSG), but normoglycemia by alternate (UK National Institute for Health and Care Excellence, Canadian Diabetes Association and Diabetes in Pregnancy Study group of India) criteria; and (ii) normoglycemia by both (IADPSG and alternate) criteria. MATERIAL AND METHODS: In this cross-sectional study, eligible women underwent standard 75-g oral glucose tolerance test, followed by the placement of a CGMS. Glycemia-related parameters were calculated using the standard approach for CGMS data in pregnancy. RESULTS: We enrolled 96 women at 14.0 ± 3.2 weeks of gestation. Of the women diagnosed as GDM by IADPSG criteria, 34.2%, 26.3% and 44.7% were classified as normoglycemic by UK National Institute for Health and Care Excellence, Canadian Diabetes Association and Diabetes in Pregnancy Study group of India criteria, respectively. Mean 1-h postprandial glucose and time above range were significantly higher in women who were GDM by IADPSG, but normoglycemia by Canadian Diabetes Association criteria, compared with women with normoglycemia using both criteria. Similarly, mean 1-h postprandial glucose, 2-h postprandial glucose, peak postprandial glucose, 1-h postprandial glucose excursion and time above range were significantly higher in women who were not identified as GDM by the UK National Institute for Health and Care Excellence criteria. Finally, women missed by the Diabetes in Pregnancy Study group of India criteria had significantly higher mean 1-h postprandial glucose, 2-h postprandial glucose, peak postprandial glucose, postprandial glucose excursion, 24-h glucose and time above range parameters. CONCLUSIONS: More than one-quarter of women diagnosed as GDM by IADPSG criteria are not identified by alternate criteria. Such women are significantly different from normoglycemic women in terms of several CGMS-based glycemic parameters of clinical significance.

Obstetrics outcome in pulmonary tuberculosis.

BACKGROUND: To evaluate the maternal and perinatal outcome in pulmonary tuberculosis cases as compared to low risk pregnancies in a tertiary referral hospital. METHODS: A total of 15 cases of pulmonary tuberculosis over a period of two years who delivered in our unit was studied in the retrospective study. The maternal and perinatal outcome in them was compared with 191 low risk pregnancies who delivered at the same time in the hospital after taking into account inclusion and exclusion criteria. RESULTS: The mean age and mean parity was 25.73 ± 2.85 and 28.75 ± 3.11, 2.1 and 1.9 in the 2 groups. Symptoms of pulmonary tuberculosis were cough (100%), chest pain (80%), expectoration (100%), hemoptysis (33.3%), fever (93.33%), anorexia (86.66%) and loss of weight (80%). Symptoms in study patients were significantly more common in study patients. The presence of associated medical problems was similar in the 2 groups. The prevalence of oligoamnios, gestational diabetes mellitus, antepartum hemorrhage and intrahepatic cholestasis was similar in the 2 groups. Prevalence of preterm labor was 53.33% in study group which was significantly higher than in controls (8.9%). Risk of premature rupture of membrane was also significantly higher in the study groups (53.33%) as compared to control groups (8.9%). Mean gestational age was also significantly lower (36.2 weeks) in study group as compared to 38.6 weeks in control group. The incidence of cesarean delivery was similar in the 2 groups (26.66% vs 28.79%). The mean birth weights was 2308.6 gm in the study group as compared to 2707.56 gm in control group. Fetal growth restrictions and Respiratory distress syndrome in babies was significantly higher in study group than in control group. Low APGAR score (<8) was also higher (33.3%) in study group as compared to control group (2.61%). CONCLUSION: Pulmonary tuberculosis during pregnancy is associated with increased perinatal morbidity, low birth weight, poor APGAR and increased respiratory distress rates.

Knowledge, attitude, perceptions, and concerns of pregnant and lactating women regarding COVID-19 vaccination: A cross-sectional survey of 313 participants from a tertiary care centre of North India.

AIM: The study aimed to assess the knowledge, attitude, perceptions, and concerns of pregnant and lactating women regarding COVID-19 vaccination. METHODS: A cross-sectional survey was conducted using a pre-validated questionnaire to assess the knowledge, attitude, perceptions, and concerns about COVID 19 vaccination among pregnant and lactating women. RESULTS: Most (90%) of the study participants(n =313) agreed that it was essential to get vaccinated for COVID-19 and were aware that pregnant (72.2%) or lactating women (65.2%) are eligible for vaccination. There was a significant positive association between willingness to pay for the vaccine and the socio-economic status (p<0.01). Women residing in rural areas wanted to wait to see the effect of the vaccine on other pregnant and lactating women (p<0.001). The major factors associated with vaccine hesitancy were unforeseen future effects of vaccines on the foetus (58.6%) and rapid development and approval of vaccine without including pregnant and lactating women in vaccine trials (53.6%). These factors were positively associated with socioeconomic status (p<0.05) and residence (p<0.01) CONCLUSION: The safety concerns regarding the COVID-19 vaccine is a major reason for vaccine hesitancy. The policymakers should advocate, investigate, and publicize relevant data on vaccine efficacy and safety among these women.