Community Screening for High-Risk Human Papilloma Virus Infection using Self-Sampling and 'Point-Of-Care' Test.

OBJECTIVE: HR-HPV types 16 and 18 are responsible for pre-invasive and invasive lesions of the cervix, accounting for 70-80% of the total subtypes. The aim of this study was to investigate the prevalence of high-risk HPV subtypes 16 and 18 in self-collected vaginal samples using real-time micro-PCR and to study the acceptability of self-sampling. METHODS: Eligible women (30-65 years) were screened from a semi-urban area of Uttarakhand (India) using self-sampling. High-risk HPV genotypes (16/31 and 18/45) were tested using real-time micro-PCR technique with results available in one hour. The positive results were validated by standard RT-PCR for high-risk HPV 16, 18, separately and for 12 other high-risk genotypes, combined. Ease of the procedure, level of comfort, and recommendation to other women were studied and the acceptability of self-sampling was analyzed using the Likert scale. RESULT: Of 975 eligible women screened, 45 participants tested positive for HR-HPV (16/31,18/45) using real-time micro-PCR with a prevalence of 4.6%. Positive samples were further tested through routine RT-PCR and 60% were found to be HR-HPV 16 and 18 positive. For self-sampling, 96.72% (n=943) participants were 'very satisfied' and 94.15% (n=918) found self-sampling to be 'very comfortable' and 88.51% (n=863) stated that they will strongly recommend this test to other eligible women in the community. CONCLUSION: We conclude that HR-HPV testing with limited genotyping showed a prevalence of 4.6%, 60% of these were HPV 16/18 positive. Point of care testing was feasible in the community and self-sampling was acceptable.

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.

Comparison of Human Epididymis Protein 4, Cancer Antigen 125, and Ultrasound Prediction Model in Differentiating Benign from Malignant Adnexal Masses.

Background: This study aimed to compare the diagnostic performance of carcinogenic antigen (CA) 125, (HE)-4 (Human epididymis protein 4), and ultrasound (International Ovarian Tumor Analysis [IOTA]) Simple Rules individually and to derive a composite score in the differentiating ovarian cancer from benign ovarian mass. Subjects and Methods: Consecutive patients (n = 100) with pelvic mass admitted during February 2018-August 2019 were included prospectively. Patients with either known case of epithelial ovarian cancer (EOC) or metastatic EOC were excluded. The primary outcome was to assess the sensitivity and specificity of CA-125, HE-4, and IOTA Simple Rules in predicting benign from malignant mass independently, while secondary outcome was derivation of a new model incorporating these variables using multivariate logistic regression analysis to predict benign from malignant lesions. Receiver operator curve (ROC) was drawn to redefine the best-performing cutoff values and difference between area under the ROC (AUROC) were compared by DeLong's method. Results: Out of 100 cases of adnexal mass selected, the sensitivity and specificity of CA-125 were 73.8% and 77.6%, HE-4 were 90.5% and 87.9%, and IOTA Simple Rules were 92.9% and 81.0%. CA-125, HE-4, and IOTA Simple Rules were independently associated with the likelihood of malignancy/borderline (P < 0.001). The area under the curve for the "composite score" (AUC = 0.93) was the highest and was significantly better than that of CA-125 (AUC = 0.786) (P = 0.004 using DeLong's test) and comparable with HE-4 (AUROC = 0.90; P = 0.128 using DeLong's Test). Conclusion: The sensitivity and specificity of HE-4 and IOTA Simple Rules for predicting malignant ovarian tumor was better than those of CA-125. The diagnostic performance of "composite score" was comparable to those of either HE-4 or IOTA Simple Rules and significantly better than CA-125.

Implementing the Practice of Birth Companion in Labor During the COVID-19 Pandemic: A Quality Improvement Endeavor in India.

Objective We aim to implement the practice of birth companions (BC) (from 0% to 90%) during labor to provide respectful maternity care (RMC) during the coronavirus disease 2019 (COVID-19) pandemic. Methods This was a prospective quality improvement (QI) study conducted in the Department of Obstetrics and Gynecology at All India Institute of Medical Sciences (AIIMS), Rishikesh, India. The methodology given by the World Health Organization (WHO)'s Point of Care Continuous Quality Improvement (POCQI) manual was followed, and standard tools of quality improvement were used to attain the objective. Results The QI team conducted a cause and effect analysis to understand the reasons why birth companions were not allowed during childbirth. The Pareto principle derived at three most important causes of the problem: absence of a defined policy, ignorance of guidelines promoting BC even during the pandemic, and relatives could enter wards only after a negative reverse transcriptase polymerase chain reaction (RTPCR) report, which could take up to 48 hours. Multiple change ideas were tested by means of Plan-Do-Study-Act (PDSA) cycles that were successful in bringing about desired change and improvement in the delivery of quality healthcare. Conclusion QI methodology was effective in promoting and achieving more than 90% birth companionship in labor and thus helpful in providing respectful maternity care even during the COVID-19 pandemic.

Maternal-Fetal Characteristics of Pregnant Women With Severe COVID Disease and Maternal-Neonatal Characteristics of Neonates With Early-Onset SARS-CoV-2 Infection: A Prospective Data Analysis.

Introduction COVID-19 and its mutants have significantly impacted the health care system, claiming numerous lives and adding to the morbidity. The data are scarce to describe the effect of disease severity on pregnancy outcomes, the possibility of mother-to-child transmission, and neonatal outcomes of COVID-positive babies. This study aimed to report the maternal and fetal characteristics of pregnant women with severe COVID disease as well as maternal and neonatal characteristics of neonates with early-onset SARS-CoV-2 infection. Materials and methods This is a prospective data analysis of pregnant women with severe COVID disease and neonates with early-onset SARS-CoV-2 infection. The disease parameters including demographic data, clinical presentation, investigations, management, and maternal and neonatal outcomes were recorded and analyzed. Results India has faced three waves till now. At the study center, a total of 165 (60, 68, and 37 in the first, second, and third waves, respectively) COVID-positive pregnant women were admitted during all three waves. No severe COVID disease with pregnancy was noted in the first and third waves. During the second wave (March to June 2021), 15 pregnant women were found to have severe COVID disease. All of them had COVID-related symptoms, with the majority requiring supplementary oxygen at presentation. Nine of these women had intrauterine fetal demise at admission. Nearly 73% were in their second trimester, and the rest were in the third trimester. There was raised total leukocyte count and alanine transaminase in 73% and raised aspartate transaminase in all cases. All of them were admitted to the intensive care unit. Two women in their third trimester had a termination of pregnancy by cesarean section, and one of the neonates had early neonatal death due to perinatal asphyxia. Both the neonates were COVID-19 positive. Eleven women with critical illness succumbed to the disease. No neonate was found to have early-onset SAR-CoV-2 infection during the first and third waves. Only 11 neonates tested positive for SARS-CoV-2 at the time of birth during the second wave. None of them had any COVID-related symptoms. Preterm birth was reported in four cases. The average Apgar scores at 1 and 5 minutes were 6.9 and 8.09, respectively. The average birth weight was 2,551.81 grams. All neonates were initially kept in the neonatal intensive care unit. Out of 11, four neonates required treatment in the form of positive-pressure ventilation, chest compressions, high-flow nasal oxygen, and non-invasive and invasive ventilation. Neonatal mortality was documented in two cases. Six mothers had one or more positive results in either amniotic fluid, placental membrane, or vaginal or cervical swab, highlighting the possibility of antepartum or intrapartum transmission. Conclusion Severe COVID disease during pregnancy was associated with high rates of intrauterine fetal demise and maternal mortality. Raised liver enzymes might be taken as a predicting factor for severe disease. On the other hand, early-onset neonatal SARS-CoV-2 infection is mostly asymptomatic and has a good prognosis. Additionally, mother-to-child transmission of SARS-CoV-2 is possible in the antepartum and intrapartum periods.

Impact of Pregnancy on Susceptibility and Severity of COVID-19: A Hospital-Based Prospective Observational Study.

OBJECTIVE:  Pregnancy is a transient state of immunosuppression. The objective of this study was to ascertain whether pregnant women are more susceptible to coronavirus disease 2019 (COVID-19) than non-pregnant women and the impact of pregnancy on the severity of COVID-19 and associated morbidity and mortality. METHODS:  A prospective observational study was performed at All India Institute of Medical Sciences (AIIMS) Rishikesh for a period of two months. A total of 42 and 33 COVID-19 positive women were included in the obstetric and non-obstetric cohorts respectively. RESULTS:  Baseline characteristics were similar in both groups. Approximately 48% of the obstetric cohort had no COVID-19-related symptoms. Whereas, 100% of the non-obstetric cohort was symptomatic and had a significantly higher number of patients presenting with fever, cough, and breathlessness. The obstetric cohort had a significantly higher incidence of mild disease (p=0.009). In the obstetric cohort, the mean gestational age was 32.59 ± 2.57 weeks, with patients spread across all trimesters. Most of the patients with severe disease were in their second trimester. There was no difference in intensive care unit (ICU) admission, duration of ICU stay, duration of hospital stay, and mortality among both groups. A significantly smaller number of patients in the obstetric cohort required ventilatory support (p=0.0002). The maternal mortality rate was 16.67%. All of them had severe diseases requiring ICU admission. The cause of death was attributed to severe COVID pneumonia with septic shock in all cases. The mortality rate was comparatively higher (27.27%) in the non-obstetric group. CONCLUSION:  Pregnancy, unlike other immunocompromised conditions, does not seem to affect the prognosis of COVID-19 in terms of disease severity or mortality.

Clinical spectrum and outcome of pregnancy with liver diseases - A prospective study.

Objective: Liver diseases constitute a family of diseases in pregnancy which are less often studied individually. Spectrum of liver diseases directly or indirectly related to pregnancy comprise 3% of all pregnancies. The biggest challenge is to arrive at a diagnosis in such cases. With this study we aimed to study the prevalence of different Liver diseases in pregnancy in our population and its effect on fetomaternal outcome. Material and Methods: This was a prospective observational study carried out from March 2018 to March 2020. A total of 184 pregnant women with diagnosis of some form of liver disease as evident from their symptoms, signs or biochemical investigations were included in study cohort. Result: Primigravida accounted for majority of study cohort (44.02%). Approximately 90.21% belonged to 20-35 yrs. Age group. Intrahepatic cholestasis of pregnancy (IHCP) was the most common liver ailment (66.84%) followed by viral hepatitis (10.32%), Hyperemesis gravidarum (7.06%) and HELLP syndrome (6.52%). There was one case of Acute fatty liver of pregnancy (0.54%), four cases of Pre-eclampsia with liver dysfunction (2.17%), seven cases of Jaundice in pregnancy (3.80%) and 3 cases of pre-existing liver diseases (1.63%). 5 cases (2.71%) of antepartum eclampsia, 5 cases (2.71%) of postpartum eclampsia and 1 case (0.54%) of post-partum HELLP was seen. 33.33% patients were delivered early by induction or caesarean section because of liver dysfunction.14.67% required blood or blood products transfusion.1.63% had postpartum hemorrhage.1.08% mothers required intensive care admissions. Neonatal outcome was poor with 6.41% being growth restricted, 9.61% premature, 8.97% were intrauterine dead fetuses, 2.56% had early neonatal deaths and 7.05% needed neonatal intensive care unit admissions. Conclusion: Timely admission, quick diagnosis and appropriate management of patients with liver diseases in pregnancy can make a significant difference in mortality and morbidity rates due to liver ailments in pregnancy.

Obstetric and perinatal outcomes in pregnant women with COVID-19: an interim analysis.

The coronavirus disease (COVID-19) has affected the health-care system worldwide. The effect of COVID-19 on obstetric and perinatal outcomes is yet to be completely ascertained. A hospital-based prospective observational study was conducted at the Department of Obstetrics & Gynecology, AIIMS Rishikesh from July to December 2020. A total of 60 COVID-positive pregnant women were included. Obstetric and perinatal outcomes were compared with 60 COVID-negative pregnant women. A subgroup comparison was also performed between symptomatic and asymptomatic pregnant women with COVID-19. Majority of COVID-positive pregnant women were asymptomatic (81.7%). Eleven patients were symptomatic, out of which 9 (15%) had mild disease and only 2 (3.3%) had severe pneumonia. There was an increased likelihood of early pregnancy loss (5%), oligohydramnios (21.7%), preterm birth (31.7%), and cesarean section (53.3%). The occurrence of preterm birth was significantly higher in symptomatic women than asymptomatic women (p = .01). Oligohydramnios was significantly more frequent in COVID-positive than COVID-negative pregnant women (p = .048). Preterm birth and cesarean rate were slightly higher in COVID-positive group but the difference was not statistically significant. Other obstetric outcomes were comparable in both groups. The majority of women with COVID-19 infection in pregnancy remain asymptomatic or have mild symptoms. Still, it may lead to maternal death and poor fetal outcomes in form of early pregnancy loss, prematurity, oligohydramnios, intrapartum fetal distress, and increased cesarean rate. Therefore, COVID-19 preventive measures should be strictly implemented and followed.

Evaluate the Effectiveness of Enhanced Recovery After Surgery Versus Conventional Approach in Benign Gynecological Surgeries: A Randomized Controlled Trial.

Objective This study aimed to evaluate the effectiveness of enhanced recovery after surgery (ERAS) model versus conventional approach in benign gynecological surgeries (incorporating various routes of surgery). Methods This was a randomized controlled trial wherein patients undergoing gynecological surgery for benign indications from January 2019 to July 2020 were recruited and randomized into ERAS and conventional protocol groups using block randomization. The intended primary outcome was to compare the median length of hospital stay in both groups. "Fit for discharge" criteria were used to assess the length of stay as patients who belonged to hilly terrain with limited transportation facilities stayed for a longer duration. Results A total of 180 patients were recruited and 90 each was randomized into ERAS and conventional protocol groups. The difference in length of hospital stay between ERAS (36 hours, range 24-96 hours) and conventional group (72 hours, range: 24-144 hours) was significant (p<0.01). A statistically significant difference was noted in the time for recovery of bowel function and tolerance for diet in the ERAS group. No significant difference in complications and readmission (within 30 days) rate was seen between the two groups. Quality of life as assessed by the World Health Organization Quality of Life Brief Version (WHO-QOL BREF) on the day of discharge and day 30 was higher in the ERAS group in physical and psychological domains, while no difference was seen in environmental and social domains. Conclusion This study as an institutional experience strengthens the existing evidence regarding the efficacy of ERAS in reducing hospital stay and improving quality of life compared to the conventional perioperative management protocol.

Correlation of Homeostatic Model Assessment-Insulin Resistance, Anti-Mullerian Hormone, and BMI in the Characterization of Polycystic Ovary Syndrome.

OBJECTIVE: To evaluate the correlation of homeostatic model assessment-insulin resistance (HOMA-IR), anti-Mullerian hormone (AMH), and BMI and to compare their values across the different phenotypes in polycystic ovary syndrome (PCOS) women of the reproductive age group. STUDY DESIGN: A total of 307 PCOS-diagnosed women were included in the study and further classified in different phenotypes. BMI, HOMA-IR, and serum AMH values were noted and their association with different phenotypes was seen. The correlation of these variables was also noted. RESULTS: Phenotype D was the most common phenotype followed by type A, type B, and type C. A total of 265 women had an AMH value of ≥4 mg/ml with the highest value in phenotype A followed by D, C, and B. HOMA-IR and BMI values did not vary significantly among different phenotypes. HOMA-IR and BMI had a statistically significant positive correlation and serum AMH was negatively correlated with HOMA-IR, but no significant correlation was seen between serum AMH and BMI. The biochemical parameters like luteinizing hormone (LH), follicle-stimulating hormone (FSH), LH: FSH ratio, and serum testosterone showed no correlation with phenotypes or any other clinical parameter. CONCLUSION: HOMA-IR and BMI showed a statistically significant positive correlation indicating the need for lifestyle modification and weight reduction in PCOS women, which can further help in decreasing insulin resistance. A strong correlation of serum AMH levels and phenotypes shows the importance of serum AMH levels for classifying different PCOS phenotypes.

Intraoperative and Postoperative Complications in Gynaecological Surgery: A Retrospective Analysis.

Background and objective Surgical complications can arise either intraoperatively or postoperatively. The factors that lead to complications in gynaecological surgeries could be both patient-related or surgeon-related. In this study, we aimed to identify the frequency of intraoperative and postoperative complications in gynaecological surgeries conducted at our institution and to evaluate various risk factors that may predispose patients to these complications. Materials and methods  This was a retrospective analysis of women undergoing gynaecological surgeries in the Department of Obstetrics and Gynaecology at a tertiary centre in Uttarakhand, India from February 2016 to December 2019. Demographic characteristics, comorbidities, and perioperative complications of these women were recorded. Results A total of 389 women undergoing gynaecological surgeries were included in the study cohort. Of note, 94 of these had perioperative complications, accounting for 24.16% of the total cases. The most common route of surgery associated with complications was open abdominal surgery (34.66%). The operating time in most surgeries ranged from two to three hours (48.93%), and the average duration of hospital stay after surgery was 10.79 + 7.91 days. Intraoperative and postoperative complication rates were 5.91% and 19.28% respectively. Of these, surgical site infections (SSIs) (10.28%) and fever (5.39%) were the most common complications observed. Independent parameters like age, parity, route of surgery, operative time, preoperative duration of hospital stay, and preoperative blood transfusion were significantly associated with perioperative complications. Conclusions Surgical complications were more frequently seen in abdominal cases compared to other routes. Knowledge of centre-specific surgical outcome data can help in providing patients with better preoperative counselling.

Robotic-Assisted Hysterectomy for Benign Indications of Uteri Less Than Fourteen Weeks Size Versus More Than Fourteen Weeks Size: A Comparative Study.

Objectives This study was conducted to evaluate the feasibility of robotic hysterectomy for benign indications in patients with small size (<14 weeks) versus large size (>14 weeks) uterus. Methods This prospective study was conducted in a single centre from August 2018 to January 2020 in the Department of Obstetrics and Gynecology at All India Institute of Medical Sciences, Rishikesh (Uttarakhand). Surgical outcomes of 216 patients who underwent a robotic hysterectomy in our institution for benign indications were analysed. Women opting for definitive surgical management by minimally invasive technique were divided into two groups according to the size of the uterus less than 14 weeks (group 1) versus more than equal to 14 weeks (group 2). Data collected in both groups included intra-operative and post-operative parameters, length of hospital stay and morbidity if any. Results The demographic profile was comparable in both groups. The mean estimated blood loss was 180.78 ±68.0 ml (range, 10-340 ml) in group 1 and 253.49 ±57ml (range, 60-360 ml) in group 2 (p-value < 0.0001). However, the fall in haemoglobin level after 24 hours of surgery was not statistically significantly different between the two groups. The total duration of surgery in group 1 was 97.86 ± 12.0 minutes (range, 78-132 minutes) and in group 2 was 116.60 ± 15.4 minutes (range, 97-156 minutes), the difference being statically significant (p-value < 0.0001, 95% CI 103±2.1). Console time in group 1 was 43.84 ±6.0 minutes (range, 34-57 minutes) and in group 2 53.22 ±5.5 minutes (range, 44-66 minutes), the difference being statistically significant (p-value < 0.0001, 95% CI 46.57±0.97). There was no difference observed in terms of intra-operative and post-operative complications between the two groups. Conclusion The total duration of surgery and estimated blood loss were directly proportional to the size of the uterus. However, complication rate, hospital stay and requirement of post-op analgesia were comparable in both groups. Robotic surgery in a larger uterus is a feasible option in terms of better surgical outcomes and postoperative course. Thus, robotic hysterectomy in women with a large uterus is a suitable approach in the narrow region of the pelvis.

Women's experiences and perception of symptomatic pelvis organ prolapse: A Cross sectional study from Uttarakhand, India.

BACKGROUND: Pelvic Organ Prolapse (POP) negatively affects the health of a woman in terms of physical, social and emotional wellbeing. OBJECTIVE: The aim of this study was to elucidate the experience of living with prolapse and its impact on daily life. METHODS: Women undergoing surgery for pelvic organ prolapse were interviewed to evaluate their sociodemographic profile with subsequent impact on their daily life. RESULTS: Among the 45 cases with POP, 80% belonged to rural areas. Mean age of study group was 53.68 years. Young age at marriage (mean age 17.31), early first child birth (mean age being 20.5 years) and increased parity (86.66% had parity 3 and above) with majority of children born at home under supervision of untrained dais (77.78%) could probably attribute to their prolapse. Approximately 51% thought that prolapse occurs as a result of hard manual work and 64% cases considered it non treatable. POP was associated with poor quality of life in terms of physical, social and sexual life. Decreased sexual frequency was seen in 86.67% cases. 50% cases reported bladder problems. Sense of incomplete evacuation was seen in nearly 35% and constipation was reported by 37%. CONCLUSION: Though there exists a social stigma associated with pelvic organ prolapse, this study showed that in majority, it was the woman herself who delayed medical help. Health care providers should take initiative in educating women regarding prolapse and to make them aware that it is a treatable condition which can improve their quality of life.