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.

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.

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.

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.

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.

Pazopanib based oral metronomic therapy for platinum resistant/refractory epithelial ovarian cancer: A phase II, open label, randomized, controlled trial.

BACKGROUND: Treatment of patients with platinum resistant/refractory epithelial ovarian cancer (EOC) is an unmet need. We evaluated the role of oral metronomic therapy in this setting. PATIENTS AND METHODS: Between October 2017 and September 2019 seventy five patients with platinum resistant/refractory EOC were enrolled. Patients received oral etoposide (50 mg, day 1 to 14, cyclophosphamide 50 mg, day 1 to 28, every 4 weeks (Arm A, n = 38). Patients in Arm- B (n = 37) received Pazopanib (400 mg once daily) in addition to etoposide and cyclophosphamide. Quality of life (QoL) was evaluated using the EORTC questionnaire. Serum VEGF and PDGF were estimated at baseline, after 3rd and 6th cycle. The primary endpoint was progression free survival (PFS). Secondary endpoints were overall survival (OS), toxicity and QoL. RESULTS: Patients characteristics were well matched. Median PFS was higher in arm B, 5.1 months (95% CI 3.13 to10.33) compared to 3.4 months (95% CI 3.0 to 6.53) in arm A, p = 0.045. Median OS has 'not reached' in Arm B compared to 11.2 months (95% CI, 5.66 - not reached) in arm A, p = 0.032. Therapy was tolerated well; oral mucositis (p = 0.36) and fatigue (p = 0.08) being more in arm B. QoL assessment revealed modest improvement in 'symptom scales' in Arm B. Serum VEGF and PDGF levels decreased with therapy in both arms (Arm A-p < 0.0001, Arm B-p < 0.016). CONCLUSION: Addition of pazopanib to etoposide and cyclophosphamide could be a novel oral combination for metronomic therapy for platinum resistant/refractory EOC. TRIAL REGISTRATION: CTRI/2017/10/010219.

Radiological evaluation of metastatic lymph nodes in carcinoma cervix with emphasis on their infiltrative pattern.

Background & objectives: Imaging has been added to the International Federation of Gynecology and Obstetrics (FIGO) 2018 staging system of cervical carcinoma. This study was performed to assess the impact of imaging in staging and to ascertain the prevalence and pattern of nodal metastasis on contrast-enhanced computed tomography (CECT) in patients with cervical carcinoma who were treated based on FIGO 2009 staging system. Methods: This retrospective study was conducted to evaluate all patients with biopsy-proven cervical carcinoma who underwent CECT of abdomen at a tertiary cancer centre in north India from April 2017 to April 2019 and for whom either baseline or follow up scans were available. In patients with enlarged or necrotic lymph nodes, the location, size and pattern of infiltration of adjacent organs were recorded. Results: A total of 602 patients of cervical carcinoma had undergone CT during the study period, of whom 138 (22.9%) underwent CT at baseline and 464 (77.1%) patients during follow up. The FIGO (2009) stage distribution at the time of presentation was stage IB: 109 (18.1%); stage IIA: 14 (2.3%), stage IIB: 118 (19.6%), stage IIIA: 12 (2%), stage IIIB: 277 (46%), stage IVA: 20 (3.3%) and stage IVB: 52 (8.6%). Ninety of the 138 (65.22%) patients underwent a stage shift according to the FIGO 2018 because of the presence of enlarged lymph nodes at baseline scan. Sixteen (2.7%) patients had infiltrative nodal masses most commonly involving the blood vessels (n=14) followed by ureter (n=8), bones (n=5), muscle and bowel (n=3, each). The majority (14/16) of these patients presented with vague abdominal pain, discomfort and vomiting, while two had bone pain. Interpretation & conclusions: CECT at baseline helps in accurately assessing the stage in cervical carcinoma. It helps in the identification of lymph node metastasis in cervical carcinoma, which is crucial for guiding accurate management.

Analysis of Multimerin 1 (MMRN1) expression in ovarian cancer.

Ovarian cancer, the most lethal gynecological cancer, is the fifth most common cause of cancer-related deaths in women. A cost-effective and non-invasive early screening method for ovarian cancer is required to reduce the high mortality rate. Saliva is a clinically informative unique fluid, which is useful for novel approaches to prognosis, clinical diagnosis, and monitoring for non-invasive detection of disease. Multimerin1 (MMRN1) is a di-sulfide linked homo-polymeric glycoprotein from EMILIN family. Altered expression of MMRN1 has been reported in hepatocellular carcinoma, cervical cancer, and ovarian cancer. But, its role in epithelial ovarian cancer (EOC) is not clear and well documented. In this study, expression of Multimerin 1 was validated in saliva and tissues of EOC patients and age-matched controls by western blotting, ELISA, RT-PCR, and immunohistochemistry. Significant over expression of MMRN1 was observed by western blot and ELISA in saliva samples of EOC patients. The average concentration of MMRN1 in the saliva of healthy controls was 28.7 pg/ml (SE ± 1.76), 42.53 pg/ml (SE ± 4.06) in low grade and 52.91 pg/ml (SE ± 4.24) with p < 0.01 in high-grade EOC. Upregulated cytoplasmic expression of MMRN1 was observed in EOC tissue by immunohistochemistry. Our results suggest that MMRN1 expression is associated with EOC progression and MMRN1 may be potential biomarker candidates for early-stage EOC detection however further experiments are required in a large cohort to establish this proposition. Also, saliva can be explored as a novel medium for ovarian cancer diagnosis.

Predictors of chemotherapy resistance & relapse in gestational trophoblastic neoplasia.

BACKGROUND & OBJECTIVES: Gestational trophoblastic neoplasia (GTN) is a chemosensitive malignancy with an excellent cure rate. The primary objective of the present study was to determine the predictors of chemoresistance and disease relapse, and the secondary objective was to appraise the WHO/FIGO risk scoring and course of disease in women with GTN. METHODS: In this retrospective study, case records of women treated for GTN from January 2011 to June 2019 were reviewed. For the purpose of comparison, sub-stratification of FIGO/WHO low risk group (≤6) into low (0-4) and intermediate (5-6) risk was done. Similarly, WHO high risk (≥7) group was sub-stratified into high (7-12) and ultra-high risk (≥13) groups. RESULTS: Case records of 116 patients were included: 51.7 per cent (60/116) were of low risk disease and 48.2 per cent (56/116) were of high risk disease. Chemoresistance developed in 28.4 per cent (33/116) and relapse in 10.3 per cent (12/116) cases. Risk of chemoresistance was higher in low risk (0-6) while risk of relapse was more in high risk (≥7) group. On sub-stratification, chemoresistance was more with intermediate [0-4: 28.5% (10/35), 5-6: 44% (11/25), 7-12: 22.5% (9/40), ≥13: 18.7% (3/16)] and relapse with ultra-high risk score [0-4: 5.7% (2/35), 5-6: 4% (1/25), 7-12:10% (4/40), ≥13: 31.2% (5/16)]. Age, myometrial invasion, serum beta-human chorionic gonadotropin and tumour size were not related to chemoresistance or relapse. INTERPRETATION & CONCLUSIONS: WHO risk score and presence of metastatic disease predict the probability of developing chemotherapy resistance and disease relapse. Risk of chemotherapy resistance was higher in women with intermediate-risk score (5-6), and risk of relapse was more in those with ultra-high risk score (≥13).

Facility preparedness for an obstetric unit during the Covid-19 pandemic.

Covid-19 infection has placed health systems under unprecedented strain and foresight for preparedness is the key factor to avert disaster. Every facility that provides obstetric service needs a certain level of preparedness to be able to handle at least Covid-suspect pregnant women awaiting test reports, who need to be managed as Covid-positive patients till reports are available. Thus, these facilities need to have triage areas and Covid-suspect labour rooms. Healthcare facilities can have designated areas for Covid-positive patients or have referral linkages with designated Covid-positive hospitals. Preparation includes structural reorganization with setting up a Covid-suspect and Covid-positive facility in adequate space, as well as extensive training of staff about infection control practices and rational use of personal protective equipment (PPE). A systematic approach involving five essential steps of making standard operating procedures, infrastructural reorganization for a triage area and a Covid-suspect labour ward, procurement of PPE, managing the personnel and instituting appropriate infection control practices can ensure uninterrupted services to patients without compromising the safety of healthcare providers.

Oral metronomic chemotherapy for recurrent & refractory epithelial ovarian cancer: A retrospective analysis.

Background & objectives: Advanced epithelial ovarian cancer (EOC) is associated with dismal outcome and progression-free survival (PFS) shortens with each subsequent relapse. For patients with recurrent and platinum refractory disease, therapeutic options are limited. Oral metronomic therapy (OMT) is associated with symptomatic relief and stable response in a significant proportion of patients. We retrospectively evaluated the outcome of patients with EOC treated with OMT at a tertiary care hospital in north India. Methods: Between January 2011 to December 2017, 36 EOC patients received OMT. Patients' median age was 50 yr (range, 38-81 yr) and they had received a median of two lines of prior chemotherapy. OMT regimen included a combination of cyclophosphamide, etoposide (VP-16) and celecoxib with or without pazopanib along with supportive care. Response rates and outcomes were ascertained using the Gynecological Cancer Intergroup Guidelines. The toxicity was graded according to the Common Terminology Criteria for Adverse Events v.4.03. Results: The median CA-125 before initiating OMT was 160 U/ml (range, 42.23-5330 U/ml). The median interval between last chemotherapy and starting OMT regimen was 159 days (range, 1-1211 days). The overall response rate was 50 per cent. The median progression-free survival (PFS) was 8.2 months [95% confidence interval (CI): 5.03-10.33], and the median overall survival was 38 months (95% CI: 25.6-NR). Patients who received two lines of chemotherapy before OMT (P=0.052) and those who received pazopanib-based OMT (P=0.0513) had better PFS. Interpretation & conclusions: For patients with relapse and refractory EOC, OMT could be a reasonable option. A combination of oral etoposide (VP-16) and pazopanib needs further evaluation in a large number of patients in a randomized trial.

Quantitative Sonoelastographic Assessment of the Normal Uterus Using Shear Wave Elastography: An Initial Experience.

OBJECTIVES: To describe the sonoelastographic characteristics of the normal endometrium, myometrium, and cervix and to assess their variability with age and different menstrual phases. METHODS: A total of 56 women were enrolled in this prospective study, who underwent transvaginal ultrasound examinations, including B-mode imaging and shear wave elastography. The elasticity parameters (in kilopascals) of the normal endometrium, myometrium, and cervix were studied. The variability of the mean elasticity value of the endometrium in different menstrual phases and age groups was analyzed. The variability of the mean elasticity of the cervix across different age groups was also studied. RESULTS: The mean age of the participants was 40 years (range, 25-69 years). The normal mean elasticity values ± SDs were 25.54 ± 8.56 kPa for the endometrium, 40.24 ± 8.59 kPa for the myometrium, and 18.90 ± 4.22 kPa for the cervix. A mean endometrial-to-myometrial elasticity ratio was calculated, which was found to be 0.65 ± 0.22. There was no significant difference in the mean endometrial elasticity values for women in different menstrual phases (P = .176) or in different age groups (P = .376). There was no significant difference in the mean cervical elasticity with age (P = .192). CONCLUSIONS: Shear wave elastography is a promising adjunct to ultrasound for the evaluation of the uterus, and the results from this study may provide normal data, which may further help in diagnosing various uterine diseases.

Successful Pregnancy Outcome after Coiling of Ruptured Intracranial Aneurysm.

Rupture of intracranial aneurysm is a serious condition, prompt diagnosis and treatment may prevent potentially lethal complications in pregnancy and otherwise. Clipping and endovascular coiling are treatment modalities available. We accessed outcome of a pregnancy with ruptured intracranial aneurysm managed with endovascular coiling. We report a pregnant woman who suffered from SAH due to rupture of posterior cerebral artery aneurysm in third trimester. Endovascular coiling with Guglielmi detachable coil (GDC) followed by caesarean section done. She required coiling twice in pregnancy.

Frontline use of bevacizumab in ovarian cancer: Experience from India.

Background: Ovarian cancer is the second most common gynaecological malignancy in India. Despite relatively high response rates to first-line carboplatin and paclitaxel-based chemotherapy in epithelial ovarian cancer (EOC), the majority of patients experience multiple relapses and finally become resistant. Vascular endothelial growth factor (VEGF) promotes progression of ovarian cancer. Bevacizumab, a recombinant humanized monoclonal antibody directed against VEGF-A is an anti-angiogenesis agent. Data on the use of bevacizumab for EOC from India are not available. We, therefore, studied the use of bevacizumab in ovarian cancer. Methods: In this prospective, non-randomized study, 10 patients who received bevacizumab were compared with 20 age- and stage-matched controls. After maximal surgical debulking, patients in the bevacizumab arm received bevacizumab 15 mg/kg i.v. on day 1 every 3 weeks followed by paclitaxel and carboplatin from cycle 1. After 6 cycles, bevacizumab was continued for 1 year. Controls received paclitaxel 1 75 mg/m2 and carboplatin only for 4-8 cycles. The outcome measures were adverse effects and progression-free survival. Results: Haematological toxicity (i.e. neutropenia, thrombocytopenia and anaemia) was similar in both arms. Hypertension (40% v. 10%, p = 0.04) and bleeding-related complications (50% v. 0%, p = 0.002) were more in the bevacizumab arm. However, gastrointestinal (GI) perforations were not increased. The median progression-free survival was similar in both arms; 26 months versus 21 months (p = 0.57). Conclusion: In this small group of patients, addition of bevacizumab increased the toxicity of chemotherapy.

Pregnancy with massive splenomegaly: A case series.

Background: Pregnancy with massive splenomegaly is a rare entity and is associated with increased risk to both mother and foetus. There is paucity of studies in the literature to guide clinicians for the management of this condition. Methods: We reviewed the course of pregnancy, maternal and foetal outcomes of 5 pregnant women with massive splenomegaly who were managed in our unit during 2015-16. Results: All 5 women had anaemia and thrombocytopenia, and had different causes for splenomegaly. One patient had chronic malaria, 2 had portal hypertension with cirrhosis and the remaining 2 had non-cirrhotic portal hypertension. Life-threatening complications were present in 2 patients; one of them had severe pre-eclampsia complicated by pulmonary oedema, cardiac arrest and the other patient developed spontaneous bacterial peritonitis. Intrauterine growth restriction and meconium-stained liquor were the most common perinatal complications. Two patients had vaginal delivery and 3 required emergency caesarean section. Postpartum haemorrhage was present in 2, and the hospital stay was prolonged in all the patients. All mothers and babies were discharged in a satisfactory condition. Conclusion: Pregnancy with massive splenomegaly poses a challenge because of diverse aetiology and potentially adverse outcomes. Multidisciplinary care in a tertiary centre can help optimize the outcome.

Androgen Receptor Expression in Endometrial Stromal Sarcoma: Correlation With Clinicopathologic Features.

Endometrial stromal sarcoma (ESS) is a rare neoplasm comprising only 0.2% to 1% of all uterine malignancies and occurs in women between 42 and 59 yr of age. ESSs frequently express estrogen receptor (ER) and progesterone receptor (PR). However, the published literature contains scant data on the expression and therapeutic/prognostic role of androgen receptor (AR) in ESSs. We undertook this study to characterize the expression of AR along with ER and PR in ESSs and correlate it with clinicopathologic features. The clinical details, slides, and blocks of 25 tumors from 24 patients (September 2010 to February 2016) were retrieved. The diagnosis and grade of ESS were reviewed and immunohistochemistry performed with anti-ER, PR, and AR antibodies. Ages ranged from 18 to 50 yr, with a mean age of 36 yr. Low-grade ESS (LGESS) and high-grade ESS (HGESS) were diagnosed in 15 and 9 patients, respectively. An 18-yr-old woman who initially had LGESS suffered a pelvic recurrence; that exhibited high-grade morphology. Our patients, especially those with HGESS, were much younger compared with published worldwide data. ER, PR, and AR immunoreactivity was observed in 14 (93.3%), 12 (80%), and 11 (73.3%) LGESSs, respectively. This is in contrast to HGESSs, in which 5 (50%) tumors had a triple-negative hormonal profile. AR, like ER and PR, was more frequently expressed in LGESS as compared with HGESS. Whether AR, in addition to ER and PR receptor status, may help guide adjuvant hormonal therapy needs further elucidation.

Efficacy of metformin in improving glycaemic control & perinatal outcome in gestational diabetes mellitus: A non-randomized study.

BACKGROUND & OBJECTIVES: Gestational diabetes mellitus (GDM) can cause adverse perinatal outcome if not treated. Although insulin therapy has been the main treatment modality over decades but considering its cost and parenteral mode of administration, it does not seem to be appropriate, especially in low-resource settings. The objective of this study was to evaluate the role of metformin in GDM and know its efficacy as well as adverse effect on foetus and mother. METHODS: All pregnant women with GDM who were not controlled on medical nutrition therapy and required metformin therapy were included in the study. Careful monitoring of blood sugar was done. Development of any maternal or foetal complications and adverse effect were recorded. RESULTS: A total of 2797 pregnant women were screened, of whom 233 (8.3%) were found to have GDM. Of the 64 women with GDM (28.7%) who required metformin therapy, majority (93.8%) achieved blood sugar control, whereas three (4.7%) women failed. Caesarean section rate was 54 per cent, and 15.6 per cent neonates were large for gestational age. Only two (3.1%) women had gastrointestinal side effects which were minor and got resolved with time. No case of hypoglycaemia or perinatal mortality was reported. INTERPRETATION & CONCLUSIONS: Our findings indicate that metformin may be used as a safe and effective oral hypoglycaemic agent in GDM, especially in low-resource settings where cost, storage and compliance are logistic issues. However, long-term follow up studies are needed to solve issues related to its safety in pregnancy.

Surgical Scar Site Recurrence in Patients With Cervical Cancer on 18F-FDG PET-CT: A Case-Control Study.

PURPOSE: The purpose of this study was to assess the role of fluorine 18 ((18)F)-fluorodeoxyglucose positron emission tomography-computed tomography ((18)F-FDG PET-CT) in evaluating various parameters in patients with surgical scar site recurrence in cervical carcinoma. METHODS: Data of all patients with cervical cancer (n = 329) who underwent PET-CT at our institute between 2005 and 2013 was reviewed. Of these 329 patients, 132 patients who were surgically treated and underwent restaging/follow-up PET-CT were included in the present study for final analysis. Tumor recurrence at the abdominal surgical scar site was looked for. Abnormal uptakes suggestive of active disease at other sites were also noted. Maximum standardized uptake value was measured for all the lesions. Patients with scar site recurrence were taken as cases (n = 6), whereas the remaining patients served as controls (n = 126). Comparison with conventional imaging modalities was made wherever available. Histopathological examination was always sought for. RESULTS: The incidence of scar site recurrence after surgery was found to be 4.5% (6/117). A total of 56 of 132 patients had recurrent disease, including 6 patients with scar site recurrence. All of the patients with scar site recurrence also had recurrent disease at other sites (local, nodal, or distant). Conventional imaging modalities were available in 4 of these 6 patients and detected scar site recurrence in 3 of those 4 patients. In patients with scar site recurrence, the mean ± SD time to scar site recurrence was 14.0 ± 10.9 months (median, 10 months; range, 7-36 months). Significant difference was seen between cases and control for International Federation of Genecology and Oncology stage (P = 0.001) and nodal recurrence (P = 0.007). Additionally, age, nodal recurrence, distant recurrence, and scar site recurrence were significantly associated with death. CONCLUSIONS: Scar site recurrence carries a poor prognosis, and the incidence is much higher than previously known when PET-CT is used as a modality for its detection.