Prevention of nodules and enhancement of antibody response to genetically engineered recombinant vaccine against Human Chorionic Gonadotropin (hCG) for contraception.

OBJECTIVE: Human Chorionic Gonadotropin (hCG) plays a crucial role in embryo implantation and in maintenance of pregnancy. An immuno-contraceptive approach involves the use of a recombinant hCGß-LTB vaccine formulated with adjuvant Mycobacterium indicus pranii (MIP), to prevent pregnancy without disturbing ovulation, hormonal profiles, and menstrual cycles in women. The present work in mice was designed to address issues encountered in clinical trials conducted with hCGß-LTB vaccine, with focus on two primary concerns. Firstly, it aimed to determine the optimal vaccine dosage required to induce a high level of anti-hCG antibodies. Secondly, it aimed to assess the safety profile of the vaccine, specifically injection site reactions in the form of nodules, observed in some of the subjects. METHODS AND RESULTS: Studies undertaken indicate that a 2 µg dose of the protein version of the vaccine, administered in mice through the intramuscular route, can induce high anti-hCG titres. Furthermore, administering a booster dose enhances the antibody response. Our findings suggest that the concentration and frequency of administration of the adjuvant MIP can also be reduced without compromising vaccine efficacy. CONCLUSION: The issue of nodule formation at the injection site can be mitigated either by administering the vaccine along with MIP intramuscularly or injecting hCG vaccine and MIP at separate intradermal sites. Thus, protein vaccine administered at a 2µg dose via the intramuscular route addresses both efficacy and safety concerns.

The Phase I/II clinical trials initiated with the recombinant hCG vaccine in women revealed inadequate antibody titres in all subjects, alongside the development of nodules at the injection sites in some participants. Studies were undertaken in mice to propose potential strategies for mitigating injection site reactions and enhancing the antibody response. It was concluded that the optimum dose of the protein version of the vaccine to get high antibody titres, is 2 µg administered intramuscularly while upholding safety standards.

Borderline tumours of ovary and fertility preservation-Outcomes from a tertiary care center in India.

OBJECTIVE: Borderline ovarian tumors (BOT) are characterized by atypical epithelial proliferation without stromal invasion and majority are diagnosed in women of reproductive age group desirous of fertility preservation. METHODS: A retrospective review of medical records of patients diagnosed with BOT and on regular follow up at the All India Institute of Medical Sciences New Delhi, during a nine-year study period from March 2014 to March 2023 was performed. Surgical treatment was classified as radical or fertility sparing surgery (FSS). Surgical staging was defined as complete, partial or un-staged. RESULTS: Median age of 91 women was 34 years. Follow up period ranged from 4 to 222 months (median 77 months). Among 68 premenopausal women, 31 (46 %) underwent radical surgery and FSS in 37 (54 %) cases. Median time to conception in 29 women with future fertility wishes was 13 months (range, 4 to38 m). Seven of 29 cases (29 %) required ovulation induction. The pregnancy rate was 82.7 % and live birth rate was 80 %. Eight cases (8.7 %) had a recurrence (7- un-staged, 1- partially staged) and median time to recur was 36 months. There was no significant difference in recurrence between cystectomy/oophorectomy. Ovary was the site of recurrence in all surgically salvaged cases except peritoneal cavity in 1 case with mortality. Relapse free survival at 5 and 10 years in FSS and radical surgery group were similar. CONCLUSION: FSS is a safe procedure and should be considered in young patients desirous of future fertility along with a comprehensive peritoneal staging. Reproductive outcomes are excellent.

To assess the analgesic efficacy of adjuvant magnesium sulfate added with ropivacaine over ropivacaine alone as a continuous infiltration in total abdominal hysterectomy wound: A randomized controlled trial.

Background and Aims: Magnesium sulfate (MgSO4) has been demonstrated to have analgesic property in various clinical settings. This study explores if addition of MgSO4 to ropivacaine increases its analgesic efficacy when infiltrated continuously in the postsurgical wound following total abdominal hysterectomy. Material and Methods: This randomized controlled trial was conducted at a tertiary care referral hospital in New Delhi, India. Fifty-two patients were randomized into two groups to receive the intervention of which 48 were able to complete the study. The first group (n = 26) received 0.25% ropivacaine infiltration and the second group (n = 26) received 0.25% ropivacaine with 5% MgSO4 at the incision site for 48 h postoperatively. Primary objective was to compare the total postoperative opioid (morphine) consumption by the study participants in both the groups and the secondary objectives were pain scores at rest and at movement, patient satisfaction score, and wound quality of life on the 7th postoperative day among the two groups. Results: Both the groups were comparable in their demographic characteristics. The median morphine consumed at 48 h postoperatively was 16.5 [0-77] mg in the ropivacaine group and 13[1-45] mg in the ropivacaine with MgSO4 group and the difference was statistically insignificant (P = 0.788). There was no statistical difference between the groups with respect to the pain scores, patient satisfaction, or wound quality of life at 7 days. Conclusion: The addition of MgSO4 to ropivacaine does not confer any additional postoperative analgesic benefits over ropivacaine alone in continuous wound infiltration following total abdominal hysterectomy.

Comparative study on complications and difficulties in laparoscopy in female genital tuberculosis cases versus non-tuberculosis cases.

BACKGROUND AND OBJECTIVE: Female genital tuberculosis (FGTB) is an important type of extrapulmonary tuberculosis (TB) associated with morbidity especially infertility in developing countries. Laparoscopy may be difficult and hazardous in FGTB. The aim of the study was to observe the difficulties and complications of laparoscopy in FGTB cases. MATERIALS AND METHODS: It was a prospective study over 12 years' period on 412 cases of diagnostic laparoscopy performed on FGTB cases with infertility. All patients underwent history taking and clinical examination and endometrial sampling for acid-fast bacilli (AFB) microscopy, culture, polymerase chain reaction (PCR), gene Xpert (last 212 cases) and histopathological evidence of epithelioid granuloma. Another 412 cases of diagnostic laparoscopy in the absence of FGTB performed during same time were taken as controls from the pool of non-TB cases. Various difficulties and complications were noted in both groups and statistical analysis was done. RESULTS: Mean age, parity, body mass index and duration of infertility were 26.8 versus 25.4 years, 0.32 versus 0.28, 23.15 versus 25.28 Kg/m 2 and 4.15 versus 5.12 years, respectively. Primary and secondary infertility was seen in 78.6% and 20.38% of cases in the study group and 74.75% and 25.24% in the control group, respectively. Endometrial biopsy showed AFB microscopy in 5.3%, culture in 6.3%, epithelioid granuloma in 15.77% and on peritoneal biopsy granuloma in 6.55%, positive PCR in 368 (89.32%) and positive gene Xpert in 38 out of 212 (17.92%, out of last 212 cases). Definite findings of FGTB were seen in 171 (41.50%) cases. Probable findings of FGTB were seen in 241 (58.49%) cases. Various complications were difficulty in the creation of pneumoperitoneum or insertion of trocar and cannula in 16.74% and 13.10% of cases as compared to 1.94% and 1.69% in the control group. Excessive bleeding was seen in 5.09% versus 0.97% cases, respectively. Various injuries observed were bowel injury in 1.69% versus 0.24% cases (small bowel in 1.21% vs. 0.24%, large bowel in 0.48% vs. 0.1%), while bladder injury was seen in 0.97% versus 0.24% cases, subacute intestinal obstruction was seen in 5.8% versus 0.72% cases respectively while flare up of TB was seen in 5.09% versus 0% in cases and controls, respectively. Wound infection was seen in 8.48% versus 1.25% cases, respectively. INTERPRETATION AND CONCLUSION: FGTB is associated with increased complications and difficulties as compared to laparoscopy in other cases.

Role of Placental Vascularization Indices and Shear Wave Elastography in Fetal Growth Restriction.

Objective: To evaluate the role of placental vascularisation indices using 3D-Power Doppler and placental elasticity using Shear Wave Elastography (SWE) in Fetal Growth Restricted (FGR) pregnancies and to assess their correlation with perinatal outcomes. Methods: This prospective case-control study was conducted from June 2018-2020. Thirty women with FGR and thirty controls (24-36 weeks) underwent grayscale and Doppler ultrasonography followed by measurement of vascularisation indices and SWE from the central and peripheral parts of fetal and maternal surfaces of the placenta. Participants were followed till delivery and perinatal outcomes were noted. Results: Vascularisation indices were significantly reduced among FGR vs. controls: Vascularisation Index (VI): 20.90 ± 5.46 vs. 31.49 ± 3.89, Flow Index (FI): 26.29 ± 1.70 vs. 30.85 ± 2.02, Vascularisation- Flow Index (VFI): 7.06 ± 2.42 vs. 12.37 ± 2.43, p < 0.001. The mean placental SWE (17.36 ± 1.50 kPa) in FGR pregnancies was significantly higher as compared to controls (4.14 ± 1.14 kPa), p < 0.001. Neonatal polycythaemia and hyperbilirubinemia were significantly increased in FGR pregnancies with higher SWE value. Receiver operating characteristic curve-based cut-off of VI for intensive care requirement was 23.0 (sensitivity: 75%, specificity: 71%) and for tachypnea was 22.8 (73% sensitivity and specificity). The cut-off of FI for low birth weight was 25.7 (sensitivity: 69.6%, specificity: 71.4%). Conclusion: This study demonstrates that increased placental stiffness and reduced vascularisation in FGR indicate possible placental pathology. Both modalities help in predicting perinatal complications. Hence, vascularisation indices and SWE reflect the extent of placental insufficiency and can be useful adjuncts in diagnosis.

Expression of DKK1 in Endometrial Endometrioid Carcinoma and Its Correlation with Wnt/ß-catenin Signalling Pathway.

Objectives: Endometrial cancer is the most prevalent form of cancer affecting female reproductive organs. The most common histologic type, endometrioid carcinoma, accounts for 75-80% of all endometrial cancer cases. Studies on DKK1 expression profiles and their inhibitory role in the Wnt signalling pathway in the genesis and development of endometrial carcinoma are scarce. This study aimed to investigate DKK1 expression in endometrial carcinoma and its correlation with the Wnt/ß-catenin pathway. Methods: A total of 160 formalin-fixed paraffin-embedded samples were included in this study (50 cases of endometrial atypical hyperplasia, 50 cases of endometrioid endometrial carcinoma, 30 cases of proliferative endometrium and 30 cases of secretory endometrium). The expression patterns of DKK1, E-cadherin, ß-catenin and c-Myc in endometrial atypical hyperplasia and carcinoma were investigated and compared with that of proliferative and secretory endometrium. Immunohistochemistry and analysis were performed from July 2018 to June 2020. Results: A decreasing pattern of immunopositivity for DKK1, E-cadherin and ß-catenin from proliferative/secretory endometrium to endometrial atypical hyperplasia and endometrioid carcinoma was found. Increasing c-Myc immunopositivity was noted from proliferative/secretory endometrium to endometrial atypical hyperplasia and endometrioid carcinoma. Moreover, decreasing DKK1 immunopositivity was well correlated with E-cadherin, ß-catenin and c-Myc immunopositivity. Conclusion: Decreasing DKK1 positivity from benign endometrium to endometrioid carcinoma suggests a negative regulatory function of DKK1 in endometrioid carcinoma. DKK1 is downregulated in the Wnt signalling pathway in endometrioid endometrial carcinoma. Therefore, DKK1 is promising as a biomarker for screening endometrioid carcinoma. Future studies should examine the reactivation of the DKK1 gene, which may be a valuable strategy for antagonising the Wnt signalling pathway.

Blended Teaching Methodology of E-learning and Simulation Training in Obstetrics and Gynecology for Undergraduate Medical and Nursing Trainees.

Context The concept of simulation-based teaching has become a standard practice for health education in the present era. However, there is a paucity of literature on integrating simulation-based teaching in the conventional training of undergraduate medical and nursing students. Aim To explore the effectiveness and benefits of e-learning along with low-fidelity simulation in obstetrics and gynecology among undergraduate medical and nursing students at a tertiary care center in India. Methodology It was a prospective study conducted on 53 final-year undergraduate medical students and 61 final-year undergraduate nursing students. All students underwent a knowledge-based pre-test followed by exposure to an e-learning module on four selected obstetrics and gynecology skills, namely, conducting normal delivery, episiotomy suturing, pelvic examination, and insertion of intrauterine device. Students practiced these four skills on low-fidelity simulators. After this, they underwent a post-test assessment and gave feedback. A focused group discussion was conducted to explore their experiences. Results There was a statistically significant difference between the pre-test and post-test knowledge scores of all the students (p =< 0.001). Students found this teaching strategy useful and reported an increase in self-assessed confidence. Focused group discussion revealed various themes like improved satisfaction and ability to practice repeatedly without fear of harming patients. Conclusions Based on the results, this teaching methodology should be integrated as an adjunct method of teaching in the undergraduate curriculum from the first year itself, which will motivate students to participate in clinical care and will result in quality improvement of health care.

Fertility and pregnancy in chronic myeloid leukemia: real-world experience from an Indian tertiary care institution.

Chronic myeloid leukemia (CML) management during pregnancy is challenging. In this retrospective study, hospital records of CML patients treated between 2000 and 2021 were screened to identify patients who tried to conceive/got pregnant (planned and unplanned) on TKIs (tyrosine kinase inhibitors)/were pregnant at CML onset/fathered a child. We found ninety-three pregnancies involving thirty-three women and thirty-eight men, and they were analyzed for the pregnancy outcomes and the strategies utilized for CML management during pregnancy and the pre-conception period. There were two women and four men with primary infertility and five women with secondary infertility. TKIs were discontinued before conception in four planned pregnancies and at the time of recognition of pregnancy in unplanned pregnancies (n = 21). Unplanned pregnancy outcomes were two miscarriages, eight elective terminations, and eleven live births. Planned pregnancies led to four healthy babies. Outcomes of pregnancies at CML onset (n = 17) were six live births, one stillbirth, five elective terminations, and five abortions. Except for one child with congenital micro-ophthalmia, no other child born to the women on TKI had any malformations. Thirty-eight men fathered 51 healthy children. All but two patients (one planned and one unplanned pregnancy) lost their hematological responses during pregnancy and gained their previous best response after restarting TKI. In women who were pregnant at CML onset, complete cytological remission (CCYR) was achieved between 7 and 24 months (median:14 months) after starting TKI. During pregnancy, intermittent hydroxyurea ± TKI (in the second and third trimesters) was used to keep WBCs less than 30,000/mm3. Outcomes of pregnancies in CML patients can be optimized with our approach. TKIs (Imatinib and Nilotinib) can be safely used in the second and third trimesters. Delayed initiation or interruption of TKI during pregnancy does not negatively affect response to TKIs.

Laparoscopic evaluation of female genital tuberculosis in infertility: An observational study.

Background & objectives: Female genital tuberculosis (FGTB) is an important variety of extrapulmonary TB causing significant morbidity, especially infertility, in developing countries like India. The aim of this study was to evaluate the laparoscopic findings of the FGTB. Methods: This was a cross-sectional study on 374 cases of diagnostic laparoscopy performed on FGTB cases with infertility. All patients underwent history taking and clinical examination and endometrial sampling/biopsy for acid-fast bacilli, microscopy, culture, PCR, GeneXpert (only last 167 cases) and histopathological evidence of epithelioid granuloma. Diagnostic laparoscopy was performed in all the cases to evaluate the findings of FGTB. Results: Mean age, parity, body mass index and duration of infertility were 27.5 yr, 0.29, 22.6 kg/m2 and 3.78 years, respectively. Primary infertility was found in 81 per cent and secondary infertility in 18.18 per cent of cases. Endometrial biopsy was positive for AFB microscopy in 4.8 per cent, culture in 6.4 per cent and epithelioid granuloma in 15.5 per cent. Positive peritoneal biopsy granuloma was seen in 5.88 per cent, PCR in 314 (83.95%) and GeneXpert in 31 (18.56%, out of last 167 cases) cases. Definite findings of FGTB were seen in 164 (43.86%) cases with beaded tubes (12.29%), tubercles (32.88%) and caseous nodules (14.96%). Probable findings of FGTB were seen in 210 (56.14%) cases with pelvic adhesions (23.52%), perihepatic adhesions (47.86%), shaggy areas (11.7%), pelvic adhesions (11.71%), encysted ascites (10.42%) and frozen pelvis in 3.7 per cent of cases. Interpretation & conclusions: The finding of this study suggests that laparoscopy is a useful modality to diagnose FGTB with a higher pickup rate of cases. Hence it should be included as a part of composite reference standard.

SCOPE: Surveillance of COVID-19 in pregnancy- results of a multicentric ambispective case-control study on clinical presentation and maternal outcomes in India between April to November 2020.

OBJECTIVE: To determine the clinical manifestations, risk factors, treatment modalities and maternal outcomes in pregnant women with lab-confirmed COVID-19 and compare it with COVID-19 negative pregnant women in same age group. DESIGN: Multicentric case-control study. DATA SOURCES: Ambispective primary data collection through paper-based forms from 20 tertiary care centres across India between April and November 2020. STUDY POPULATION: All pregnant women reporting to the centres with a lab-confirmed COVID-19 positive result matched with controls. DATA QUALITY: Dedicated research officers extracted hospital records, using modified WHO Case Record Forms (CRF) and verified for completeness and accuracy. STATISTICAL ANALYSIS: Data converted to excel files and statistical analyses done using STATA 16 (StataCorp, TX, USA). Odds ratios (ORs) with 95% confidence intervals (CI) estimated using unconditional logistic regression. RESULTS: A total of 76,264 women delivered across 20 centres during the study period. Data of 3723 COVID positive pregnant women and 3744 age-matched controls was analyzed. Of the positive cases 56·9% were asymptomatic. Antenatal complications like preeclampsia and abruptio placentae were seen more among the cases. Induction and caesarean delivery rates were also higher among Covid positive women. Pre-existing maternal co-morbidities increased need for supportive care. There were 34 maternal deaths out of the 3723(0.9%) positive mothers, while covid negative deaths reported from all the centres were 449 of 72,541 (0·6%). CONCLUSION: Covid-19 infection predisposed to adverse maternal outcomes in a large cohort of Covid positive pregnant women as compared to the negative controls.

Central nervous system metastasis from epithelial ovarian cancer- predictors of outcome.

Management of central nervous system (CNS) metastases from epithelial ovarian cancer (EOC) is an unmet need. We analyzed data on 41 such patients to evaluate predictors of outcome. Between January, 2010 and December 2020, among 1028 patients with EOC treated at our institute 41 (3.98%) developed CNS metastasis. Median age of patients was 48 years, ranging from 22 to 75 years. Primary outcome measure was progression free survival (PFS). Overall survival (OS), and analysis of prognostic factors were secondary outcome measures. An intention to treat analysis was done. We also performed review the literature (n=2253) as regards to clinicopathological and radiological features, treatment received, survival outcomes and prognostic factors. Median time from diagnosis of EOC to CNS metastasis was 27 months (range: 0 to 101 months). 33(80.5%) patients had FIGO stage III-IV at baseline and serous carcinoma (75.6%) was common pathology subtype. Thirteen (31.7%) patients had isolated CNS metastasis and 28 (68.3%) had intra-abdominal disease in addition. Nineteen (46.3%) patients achieved complete response post treatment with surgery, radiation and chemotherapy. Median PFS and OS from the time of CNS metastasis is 12 (range:1 to 51) months and 33 (range: 1 to 71) months, respectively. Absence of extracranial disease and lower serum CA-125 at diagnosis of CNS metastasis were predictive of superior PFS and OS on multivariate analysis. CNS metastasis is a late event in EOC, post multiple lines of treatment. Patients with disease limited to brain and treated with surgical resection and chemoradiation have best outcome.

SMARCA4-deficient Undifferentiated Uterine Sarcoma: Clinicopathological Features of an Emerging Entity.

SMARCA4-deficient undifferentiated uterine sarcoma is a recently described molecularly defined entity among the subset of aggressive undifferentiated uterine tumors. Mutation in the SMARCA4 gene is a key driver alteration, as also seen in small cell carcinoma of ovary, hypercalcemic type (SCCOHT) and thoracic undifferentiated carcinoma. Limited number of cases of SMARCA4-deficient undifferentiated uterine sarcoma has been reported in literature. We hereby describe a case of this distinct entity in a 52-year-old woman. Histomorphological examination showed sheets of monomorphic epithelioid cells with a variable proportion of cells displaying rhabdoid features, brisk mitotic activity, and lymphovascular invasion. A panel of immunohistochemical markers was required to exclude the differential diagnoses. The tumor was microsatellite stable. Loss of SMARCA4 expression and intact expression of INI1 in tumor cells by immunohistochemistry (IHC) confirmed the diagnosis of SMARCA4- deficient undifferentiated uterine sarcoma. The patient had a rapidly progressive clinical course.

Use of 'Printed Investigation Sheet' as Checklist in Admitted Antenatal Patients: A Quality Improvement Initiative.

Background: The study was conducted to establish use of printed investigation sheets as checklists for timely workup and clinical evaluation of antenatal women with medical diseases; admitted in maternity ward, by third day of their hospital admission. This was aimed to standardize care, avoid repeated blood sampling of patients, avoid delay in starting the treatment and help teams perform optimally by systematic use of quality improvement (QI) tools. Methods: The present study was conducted in the Department of Obstetrics and Gynaecology at a tertiary care teaching hospital using point-of-care quality improvement methodology systematically. A QI team was made who formulated an aim statement, conducted a root-cause analysis, performed plan-do-study-act (PDSA) cycles. The outcome was measured as complete clinical evaluation of antenatal women with anaemia, hypertension, and/or diabetes by third day of admission in the maternity ward. Results: The baseline data showed that median percentage of patients with complete clinical evaluation was only 29.2%. After a root-cause analysis with fishbone tool, three PDSA cycles were conducted to achieve the target of 80%. After the third PDSA cycle, complete clinical evaluation in anaemia, hypertension, diabetes showed an improving trend with a median of 75%. Conclusion: Adopting simple principles of quality improvement, initiating use of printed investigation sheets as checklist can streamline and expedite clinical evaluation of antenatal patients with medical problems so as to avoid unnecessary delay in initiating the management in busy maternity wards.

Can portable Colposcopes Replace Standard-of-care Colposcopes? A Crossover Trial of Two Portable Colposcopes with a Standard-of-Care Video Colposcope.

BACKGROUND: Screen positive women need to be triaged by colposcopy which is a major challenge in low-middle income countries. Portable colposcopes may overcome many challenges, reduce referrals and enable a single visit approach. This study assessed the performance of portable colposcopes and potential to reduce referral. METHOD: This crossover randomised study enrolled women aged 25 to 65 years with abnormal screening result or cervical symptoms. All women underwent visual inspection with acetic acid (VIA), HPV test, colposcopy with two portable colposcopes (Gynocular®, Gynius, Sweden, and Pocket® transvaginal colposcope, Duke University, NC, USA) and a standard video colposcope, and biopsy. Colposcopic Swede score agreement between portable and video colposcopes, as well as agreement of Swede score with histology were calculated for each device. The potential impact of portable colposcopes in a single visit approach was assessed based on the final diagnosis. RESULTS: Among 250 subjects, 27(10.80%) had high-grade cervical intraepithelial neoplasia (CIN2+) lesions. Swede scores for Pocket and Gynocular colposcopes were similar to video colposcope in 248 (99.20%) and 247 (98.80%) subjects, respectively (agreement scores 0.9969 and 0.9954, respectively). At a Swede score cut-off of ≥5, all three devices had identical sensitivity, specificity, positive and negative predictive value of 96.30%, 92.30%, 60.50% and 99.50,. Ablative treatment offered at field setting would result in optimal treatment in 52.0% and 85.1% cases when screened with VIA and HPV test respectively; using Pocket colposcope could improve this to 94.0% and 95.9%, respectively. Overtreatment and referral rates reduced from 46.8% and 12.4% to 4.8% and 6.0%, respectively, when VIA test is followed by triage with pocket colposcope. These outcomes were comparable to screening with HPV followed by colposcopy triage. CONCLUSIONS: Pocket colposcope performed comparably to the video colposcope. Used by healthcare providers in the field setting, they can augment the results of VIA significantly.

Early-Stage epithelial ovarian cancer: Predictors of survival.

Background: One fifth of patients with epithelial ovarian cancers (EOC) present at an early stage (FIGO stage I & II). However, there is scarcity of literature on the outcomes and its predictors. The aim of the study was to assess relapse free survival (RFS), overall survival (OS) and its predictors in early stage EOC. Patients and Methods: In this retrospectively study, we included all patients with early-stage EOC diagnosed between January 2010 and December 2018. Patients with synchronous malignancies were excluded. Clinical profile, clinico-pathological characteristics and treatment details were recorded. Patient underwent initial surgery followed by adjuvant chemotherapy in high-risk disease. Patients with stage IC, or stage II or clear cell histology or high-grade histology irrespective of stage/histological subtype were defined as high-risk disease. Fertility sparing surgery (FSS) [unilateral salpingo-oopherectomy with complete surgical staging] was performed in patient willing to preserve fertility. Primary objective was to assess RFS and OS in all patients with early stage EOC. Secondary objectives were to assess RFS and OS in early stage EOC with high-risk disease, predictors of RFS and OS, and outcomes of FSS. Survival probabilities were estimated according to Kaplan-Meier and compared by the log rank test. Cox's regression model was used to analyze the significance of various factors affecting relapse free survival (RFS) and overall survival (OS). Results: 195 patients with early stage EOC were recruited with median age of 47 years (range, 16-80 years). FIGO stage I and stage II were seen in 72 % and 18 % patients respectively. Serous subtype was reported in 58 % and high-grade histology in 66 %. 184 patients (94.0%) underwent optimal staging surgery, including 27 (14%) with fertility sparing surgery (FSS). 133 (91.7 %) of 145 patients with high-risk disease received adjuvant chemotherapy (paclitaxel and carboplatin), while 12 (8.3 %) patients opted to remain on observation. At median follow up of 56 months (95 % CI, 46-64 months), 49 (25 %) patients relapsed [including 3 of 27 (11.1 %) who underwent FSS], 18 patients died of progressive disease, while 31 patients were alive and disease free. Estimated OS at 5 years is 87.6 % (95 % CI 79.9-92.5) and RFS is 73.2 % (95 % CI 64.7-80.0). On multivariate analysis tumor grade was predictive of RFS (HR 2.9, p < 0.04) and OS (HR 9.4, p < 0.02). Conclusions: This study confirms the excellent outcome for patients with early stage EOC. Histological grade of tumor is a significant predictor of OS and RFS. FSS is feasible in selected patients with early EOC.

Outcome in women undergoing uterine artery embolization for arterio-venous malformation diagnosed post-pregnancy-A retrospective study.

Objective: To analyse the outcome of patients with symptomatic arterio-venous malformation (AVM), formed following pregnancy and managed by uterine artery embolization (UAE). Materials and Methods: This retrospective study was conducted after ethical approval and included 15 patients presenting with abnormal uterine bleeding following pregnancy, who were suspected to have an AVM which later was confirmed by angiography and managed with UAE. Presenting symptoms, post-UAE complications and subsequent fertility outcomes were noted. Follow-up period ranged from 6 months to 2.5 years. Results: The mean age was 28.4±3.82 years and mean parity was 1.3. Out of 15 cases, 9 (60%) presented after abortion, 4 (26.6%) after normal vaginal delivery and 2 (13.3%) after cesarean delivery; of these 10/15 (66.7%) patients had a history of curettage. The most common presenting symptom was continuous bleeding per-vaginum since the antecedent pregnancy in 9/15 (60%) patients and 6/15 (40%) patients had irregular bleeding. The mean duration of symptoms was 91±85.7 (30-360) days. For UAE, embolic agents used were polyvinyl alcohol (PVA) particles (300-500 µm) in 2 (13.3%), 30% glue injection in 3 (20%), the combination of PVA with glue injection in 4 (26.6%) and PVA with gelfoam in 6 (40%) patients. After UAE, bleeding responded within 3.6±0.97 (3-6) days in all but one patient who required repeat UAE one month later. All women resumed their normal menstrual cycle in 31.3±5.2 (24-42) days. Ten patients desired conception, of whom 5 (50%) conceived within 13.2±5.1 (6-19) months after UAE. Two women carried pregnancy to term, one underwent preterm cesarean for growth restriction with oligohydramnios. One patient had postpartum hemorrhage, which was managed medically. One had spontaneous abortion at 6 weeks gestation and the other is 13 weeks pregnant at present. Conclusion: UAE is an effective treatment modality for the management of symptomatic post-pregnancy AVMs.

Establishing communication with relatives of admitted obstetrical patients with COVID-19 infection during COVID-19 pandemic: A quality improvement initiative.

OBJECTIVES: To establish communication with relatives of obstetrical patients with coronavirus disease 2019 (COVID-19) admitted to an isolation ward by systematic use of quality improvement tools during the COVID-19 pandemic as there were many challenges in communicating with relatives. METHODS: The study was conducted in the Department of Obstetrics and Gynecology at a tertiary-care teaching hospital based on four systematic steps of Point of Care Improvement methodology. After identifying the problem, a quality improvement team was constituted, which formed a specific aim. After root-cause analysis with fishbone tool, three Plan-Do-Study-Act (PDSA) cycles with various interventions were planned. RESULTS: The outcome was measured as percentage of relatives of obstetrical patients admitted to the hospital with COVID-19 who were counseled about vital patient-related information. The baseline percentage of counseling of relatives of COVID-19-positive obstetrical patients admitted to the hospital was 14% per day. After three PDSA cycles, the target of 66.5% was achieved. CONCLUSION: Communication with the relatives of COVID-19-positive obstetrical patients admitted to isolation wards in the hospital could be easily streamlined without any additional resources using the principles of quality improvement during the COVID-19 pandemic.

Hysteroscopic observations in 348 consecutive cases of female genital tuberculosis: A prospective study.

STUDY OBJECTIVE: To evaluate the hysteroscopic findings in female genital tuberculosis. DESIGN: It was a prospective study of hysteroscopic findings performed on 348 cases of female genital tuberculosis (FGTB). SETTING: It was a prospective cross-sectional study in a tertiary referral centre. PATIENTS: A total of 348 patients with infertility with FGTB on various tests. INTERVENTION: A total of 348 patients of infertility found to have FGTB on various investigations were enrolled in the study. A detailed history was taken. Clinical examination, endometrial sampling and diagnostic laparoscopy were performed was also performed in selected cases. All patients underwent hysteroscopy as part of evaluation for infertility and tuberculosis (TB) findings. MEASUREMENTS AND MAIN RESULTS: The mean age, parity, body mass index and duration of infertility was 28.2 years, 0.31,23.1kg/m2 and 3.44 years respectively. Infertility was primary in 81.03% and secondary in 18.96% cases. Diagnosis of FGTB was made by endometrial aspirate findings of positive AFB on microscopy (4.02%), positive culture (4.88%), positive PCR (83.90%), epithelioid granuloma (14.65%), positive AFB on microscopy or culture of peritoneal cytology (1.14%) or epithelioid granuloma on peritoneal biopsy (1.72%), definitive findings of TB on laparoscopy (41.95%) or probable findings of TB on laparoscopy (58.05%). Various hysteroscopic findings observed were normal findings (28.16%), pale endometrial cavity (54.31%), features of active TB (7.47%), features of chronic TB (19.54%), features of TB sequelae like obstructed ostia (both ostia in 13.79%, one ostia 14.94%, periostial fibrosis; (bilateral 4.59%, unilateral 5.17%), endometrial glands atrophy (12.35%), small shrunken cavity (6.32%), distorted cavity (5.17%), various grades of intrauterine adhesions (29.88%). Hysteroscopy in FGTB was associated with increased difficulties and complications like failed procedures, difficult visualisation, false passage and uterine perforation. CONCLUSION: Hysteroscopy is useful modality to detect endometrial TB but is associated with increased difficulty and complications.

Transvaginal Shear Wave Elastography for Assessment of Endometrial and Subendometrial Pathologies: A Prospective Pilot Study.

OBJECTIVE: To assess the role of shear wave elastography (SWE) in characterizing different endometrial and subendometrial pathologies. METHODS: Seventy-three women with pathologically proven endometrial and subendometrial pathologies were enrolled in this prospective study and assessed with transvaginal SWE. The elasticity values (in kiloPascals), and the ratio of mean elasticity of the endometrial lesion to myometrial elasticity (E/M ratio) were compared in different pathologies. RESULTS: There was a statistically significant difference (P <.001) in the mean, minimum, and maximum elasticity of the pathologies as well as the E/M ratio (P <.00001). In the analysis of the subgroups, the mean elasticity of endometrial polyp was statistically significantly lower than other subgroups (P <.01), while submucosal leiomyoma and focal adenomyoma had significantly higher values than other subgroups (P <.01). No statistically significant difference was noted in the mean elasticity of carcinoma and hyperplasia (P-.19). CONCLUSION: SWE is a potential adjunct to ultrasound that provides an additional paradigm to characterize endometrial and subendometrial masses.