Compassionate use of a novel ß-lactam enhancer-based investigational antibiotic cefepime/zidebactam (WCK 5222) for the treatment of extensively-drug-resistant NDM-expressing Pseudomonas aeruginosa infection in an intra-abdominal infection-induced sepsis patient: a case report.

Infections in critically-ill patients caused by extensively-drug-resistant (XDR)-Pseudomonas aeruginosa are challenging to manage due to paucity of effective treatment options. Cefepime/zidebactam, which is currently in global Phase 3 clinical development (Clinical Trials Identifier: NCT04979806, registered on July 28, 2021) is a novel mechanism of action based ß-lactam/ ß-lactam-enhancer combination with a promising activity against a broad-range of Gram-negative pathogens including XDR P. aeruginosa. We present a case report of an intra-abdominal infection-induced sepsis patient infected with XDR P. aeruginosa and successfully treated with cefepime/zidebactam under compassionate use. The 50 year old female patient with past-history of bariatric surgery and recent elective abdominoplasty and liposuction developed secondary pneumonia and failed a prolonged course of polymyxins. The organism repeatedly isolated from the patient was a New-Delhi metallo ß-lactamase-producing XDR P. aeruginosa resistant to ceftazidime/avibactam, imipenem/relebactam and ceftolozane/tazobactam, susceptible only to cefepime/zidebactam. As polymyxins failed to rescue the patient, cefepime/zidebactam was administered under compassionate grounds leading to discharge of patient in stable condition. The present case highlights the prevailing precarious scenario of antimicrobial resistance and the need for novel antibiotics to tackle infections caused by XDR phenotype pathogens.

Bone mass in newborns and its predictors.

OBJECTIVE: Optimal bone mass (a function of foetal programming and adequate intrauterine bone mineral accrual) is essential for prevention of osteoporosis. The present study was planned with the objectives to describe newborn bone mass (NBBM) and study the associated factors. DESIGN: Observational study Patients: Singleton pregnant women ≤16 weeks gestation. MEASUREMENTS: Maternal factors and antenatal events: Dietary assessment (3 days-24-h diet recalls at ≤16 and 32-34 weeks), fetal femoral volume (FFV) assessment at 19 and 34 weeks, serum 25 hydroxyvitamin D (S.25OHD) and placental weight. Newborn anthropometric parameters, cord S.25OHD & IGF-1 level and NBBM by DXA (whole-body bone mineral content (BMC), bone mineral density (BMD) and bone area). RESULTS: Total 224 subjects were studied: 198 full-term and 26 preterm. The mean BMC, BMD and bone area for term newborns was 46.5 g (95% confidence interval [CI]: 45.35-47.66), 0.209 g/cm2 (95% CI: 0.206-0.212) and 221.6 cm2 (95% CI: 218.52-224.62), respectively. The mean placental weight was 403.2 ± 75.01 g (n = 72) while FFV was 0.71 ± 0.28 ml (19 weeks; n = 59) and 4.4 ± 1.17 ml (34 weeks; n = 33). Factors significantly associated with NBBM -gestational age at delivery, gestational weight gain, FFV at 19 weeks, placental weight, third-trimester maternal serum albumin and newborn anthropometric parameters (univariable analysis) and newborn birth weight, placental weight and FFV at 19 weeks (multivariable analysis). CONCLUSION: This study described NBBM among term newborns and birth weight, second-trimester FFV and placental weight were the associated factors.

Efficacy of ormeloxifene versus oral contraceptive in the management of abnormal uterine bleeding due to uterine leiomyoma.

AIM: To compare ormeloxifene with combined oral contraceptive (COC) in abnormal uterine bleeding (AUB) due to leiomyoma (AUB-L). METHODS: Fifty women with AUB-L were randomized after informed consent and institute ethics clearance. Group I (n = 25) was given ormeloxifene (a SERM i.e. selective estrogen receptor modulator) 60 mg twice per week and group II (n = 25) was given COC (ethinyl estradiol 30 µg with desogestrel 150 µg) on days 1-21 for 6 months. Menstrual blood loss was assessed on pictorial blood loss assessment chart (PBAC) score and leiomyoma volume was assessed on ultrasound. Fibroids were classified according to FIGO-PALM-COEIN classification for AUB where leiomyomas were further sub-classified as types 0 to 8 according to their location. Follow up was done at 1, 3, 6 and 9 months. RESULTS: Mean PBAC score reduced by 81% with ormeloxifene (group I) compared with 43.8% for COC (group II). After 6 months, 18 patients (72%) in group I had PBAC score in the non-menorrhagic range (<100) compared with only two (8%) in group II. In group I, PBAC score in FIGO-PALM-COEIN leiomyoma types 2, 3, 4, 5, 6 reduced by 90.2%, 82.5%, 93.3%, 56.4% and 100%, respectively and 14 (56%) developed amenorrhea; compared with reduction of 64%, 27.5%, 25.9% in types 4, 5 and 6, respectively in group II. Dysmenorrhea visual analog scale score decreased in both groups. Mean leiomyoma volume increased in both groups: by 25.7% with ormeloxifene versus 16.9% with COC; only grade 2 leiomyoma in group I reduced by 44%. One patient in group II with grade 2 leiomyoma discontinued treatment at 3 months. Seven patients (28%) developed ovarian cyst in group I with no other major adverse effect in either group. CONCLUSION: Ormeloxifene with its convenient twice-weekly dosage schedule was effective in treating AUB-L, with 72% of patients responding to 6-month treatment compared with 8% with COC, even though leiomyoma volume increased insignificantly with both ormeloxifene and COCs.

Maternal complications in pregnancy with diabetes.

Maternal complications of diabetes in pregnancy include obstetric complications such as pre-eclampsia, preterm labour, polyhydramnios, increased operative delivery and increased infective morbidity. These can be minimized with optimal glycaemic control. Additionally, pregnancies with overt/pregestational diabetes may have diabetes related complications such as hypoglycaemia, worsening of retinopathy, nephropathy and diabetic ketoacidosis. Women with pre-existing diabetic vasculopathy should be managed with multi-disciplinary approach with maternal and foetal surveillance to detect any deterioration. Such patients have a poor pregnancy outcome. Gastropathy and coronary artery disease in diabetics is a contraindication to pregnancy.

Third Trimester foetal complications in pregnancy with diabetes.

Diabetes in pregnancy starts affecting the foetus even in the pre-conception period. The complications encountered in third trimester are foetal macrosomia and intrauterine foetal demise; birth of a macrosomic baby further leads to shoulder dystocia, birth trauma, brachial plexus injury. Additionally, pregnancies with overt/pregestational diabetes may be complicated with foetal growth restriction, congenital abnormalities diagnosed in third trimester and foetal hypertrophic obstructive cardiomyopathy. Even minor degrees of hyperglycaemia is associated with adverse pregnancy outcome. Optimizing maternal glycaemic control and foetal surveillance is crucial for optimizing the perinatal outcome and minimizing aforesaid complications. The management of macrosomia is controversial regarding timing and mode of delivery, but most authorities agree for primary caesarean if estimated foetal weight at the end of pregnancy is 4500 gram or more.

Fetomaternal outcomes in pregnant women with congenital heart disease: a comparative analysis from an apex institute.

OBJECTIVE: With advancements in cardiac surgical interventions during infancy and childhood, the incidence of maternal congenital heart disease (CHD) is increasing. This retrospective study compared fetal and cardiac outcomes in women with and without CHD, along with a sub-analysis between cyanotic versus non-cyanotic defects and operated versus non-operated cases. METHODS: A 10-year data were retrospectively collected from pregnant women with CHD and a 1:1 ratio of pregnant women without any heart disease. Adverse fetal and cardiac outcomes were noted in both groups. Statistical significance was set at P<0.05. RESULTS: A total of 86 pregnant women with CHD were studied, with atrial septal defects (29.06%) being the most common. Out of 86 participants, 27 (31.39%) had cyanotic CHD. Around 55% of cases were already operated on for their cardiac defects. Among cardiovascular complications, 5.8% suffered from heart failure, 7.0% had pulmonary arterial hypertension, 8.1% presented in New York Heart Association functional class IV, 9.3% had a need for intensive care unit admission, and one experienced maternal mortality. Adverse fetal outcomes, including operative vaginal delivery, mean duration of hospital stay, fetal growth restriction, preterm birth (<37 weeks), low birth weight (<2,500 g), 5-minute APGAR score <7, and neonatal intensive care unit admissions, were significantly higher in women with CHD than in women without heart disease. CONCLUSION: Women with CHD have a higher risk of adverse fetal and cardiac outcomes. The outcome can be improved with proper pre-conceptional optimization of the cardiac condition, good antenatal care, and multidisciplinary team management.

Low dose mifepristone in medical management of uterine leiomyoma - an experience from a tertiary care hospital from north India.

BACKGROUND & OBJECTIVES: Uterine myoma is a common indication for hysterectomy in India. An effective medical treatment option may reduce hysterectomy associated morbidity. This study was undertaken to evaluate efficacy and safety of low dose mifepristone in medical management of myoma and to compare two doses - 10 vs. 25 mg/day. METHODS: In this randomized clinical trial, women with symptomatic myoma or myoma>5 cm were included. Uterine size >20 wk, fibroids >15 cm were excluded. Pictorial blood loss assessment chart (PBAC) score was used to assess menstrual-blood-loss and visual analog scale (VAS) for other symptoms. Haemogram, liver function test, ultrasound with doppler and endometrial histology was performed. Patients were randomized and were given oral mifepristone as 25 mg/day in group 1 and 10 mg/day in group 2 for 3 months. Patients were followed at 1, 3 and 6 months. RESULTS: Seventy patients in group 1 and 73 in group 2 completed treatment. Mean PBAC score reduced from 253 to 19.8 and from 289.2 to 10.4 at 1 and 3 months in groups 1 and 2, respectively. At 3 months, 67 of 70 (95.7%) patients of group 1 and 66 of 73 (90.4%) of group 2 developed amenorrhoea which reverted after median 34 (range 4-85) days. Mean myoma volume decreased by 35.7 per cent (from 176.8 to 113.7 cm 3 ) and 22.5 per cent (from 147.6 to 114.4 cm 3 ) at 3 months in groups 1 and 2, respectively. Side effects seen were leg cramps in 7 of 70 (10%) and 5 of 73 (6.8%) and hot-flushes in 5 of 70 (7.1%) and 5 of 73 (6.8%) in groups 1 and 2, respectively. Repeat endometrial-histopathology did not reveal any complex hyperplasia or atypia in either group. INTERPRETATION & CONCLUSIONS: Mifepristone (10 and 25 mg) caused symptomatic relief with more than 90 per cent reduction in menstrual blood. Greater myoma size reduction occured with 25 mg dose. Amenorrhoea was developed in 90-95 per cent patients which was reversible. It can be a reasonable choice for management of uterine leiomyoma as it is administered orally, cost-effective and has mild side effects.

Synchronous Bilateral Torsion of Nonpathological Ovaries in an Adolescent Girl with Unilateral Recurrence.

Synchronous bilateral ovarian torsion is rare that too in nonpathological ovaries. To the best of our knowledge, this is the second case of synchronous bilateral ovarian torsion of nonpathological ovaries in adolescents. A 14-year-old girl presented with pain lower abdomen, vomiting, and constipation for the last 10 days. Ultrasonography (USG) suggested bilateral ovarian torsion without any ovarian pathology. Emergency laparoscopy confirmed bilateral ovarian torsion with necrosed-looking ovaries, and detorsion was done. During follow-up period, she had intermittent mild pain abdomen, and on USG, her left ovary returned to normal size, but her right ovary had been bulky throughout without any cyst. At around 10 months, the patient presented with severe abdomen pain. This time only right ovarian torsion was there. Laparoscopic bilateral ovarian detorsion with bilateral ovarian ligament plication was done. Ovarian torsion can be bilateral, even in nonpathological ovaries. Ovarian fixation should be done in these cases to prevent recurrent torsion.

An evaluation of Composite Reference Standard (CRS) for diagnosis of Female Genital Tuberculosis.

BACKGROUND: Female genital tuberculosis (FGTB) is a common cause of infertility in developing countries. Its diagnosis is difficult due to its paucibacillary nature, with no single test having high sensitivity and specificity. This study is to share the experience of using Composite Reference Standard (CRS) for the diagnosis of FGTB. METHODS: This is a prospective study conducted between September 2017 to June 2019, over 100 infertile females found to have FGTB on composite reference standard which consisted of acid-fast bacilli on microscopy or culture, histopathological evidence of epithelioid granuloma, positive gene Xpert on endometrial sample or definite or probable finding of FGTB on laparoscopy. RESULTS: A total of 100 infertile women (78% primary, 22% secondary) found to have FGTB on CRS were enrolled in this study. Mean age, body mass index, parity and duration of infertility were 28.2 years, 23.17 kg/m2, 0.24 ± 0.12 and 2.41 years respectively. Various symptoms were scanty menses (16%), irregular cycle (7%), dysmenorrhea (11%), pelvic pain (11%). Various signs were vaginal discharge (65%), adnexal mass (6%), tubo-ovarian mass on ultrasound (15%), abnormal hysterosalpingography findings (57.14%), positive polymerase chain reaction test (65%) and abnormal hysteroscopy (82.2%). The positive findings on CRS were positive AFB on microscopy or culture (3%), positive gene Xpert (28%) (done in some cases), epithelioid granuloma on histopathology (13%), definite findings on laparoscopy like tubercles, caseous nodules and beaded tubes in (57.19%) patients while probable findings of FGTB like straw colored fluid in POD, extensive dense pelvic, peri-tubal, peri-ovarian adhesions; hydrosalpinx; tubo-ovarian mass; thick fibrosed tubes; mid tubal block; peri hepatic adhesions (Fitz Hugh Curtis Syndrome); hyperemia of tubes/blue uterus on chromotubation were seen in (48.8%) patients. All patients found to be positive on CRS were given 6 months of anti-tubercular therapy. CONCLUSION: This study demonstrates the high reliability of use of composite reference standard for diagnosis of FGTB.

Imaging features of accessory cavitated uterine mass (ACUM): a peculiar yet correctable cause of dysmenorrhea.

Accessory cavitated uterine mass (ACUM) is a rare form of developmental mullerian anomaly which causes chronic pelvic pain, dysmenorrhea and infertility in young females. It is a non-communicating, accessory cavity within an otherwise normal uterus, lined by functional endometrium and surrounded by myometrium-like smooth muscle cells which imparts it uterus-like appearance. USG and MRI are the imaging modalities which help in reaching the diagnosis. Knowledge of this entity and awareness of its imaging features can help diagnose this often underdiagnosed and surgically correctable cause of dysmenorrhea.

Awareness Regarding Medicolegal Aspects of Medical Services Among Reproductive Age Women: A Population-Based Cross-Sectional Study.

INTRODUCTION: The government has implemented various laws to regulate medical practice and improve the quality of health care services. This study evaluated the general population's awareness of various medicolegal aspects related to the medical profession.   Methods: A cross-sectional study was conducted. Knowledge of laws and ethics related to medical practice was assessed based on a well-structured questionnaire including 25 items. Women were categorized based on their score into low (below 50th percentile), medium (50th -75th percentile), and high (above 75th percentile) awareness.    Results: A total of 334 women were recruited. The mean age of the women in the study was 30.29±6.58 SD years; most women were between 20-30 (56.28%). Most women were graduates (33.23%), followed by postgraduates (29.04%). The majority of women were unemployed (housewives: 64.67%, students: 4.49%), followed by skilled workers (22.75%), semi-professional, and professionals (8.08%). High awareness about the various medicolegal aspects was seen in 25.1% of women, while 29.04% had medium awareness and 45.80% had low awareness. It was also seen that the women with higher education(p=0.002) and those employed (0.001) had better knowledge. Further, graduate housewives had better awareness than non-graduate housewives.   Conclusion: Education and self-independence significantly affected awareness of medicolegal issues among our women. Assuring the right to education and empowering women with self-independence will go a long way in ensuring active participation in medical decision-making.

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.

A case series of melioidosis: An underdiagnosed infection.

Melioidosis is an infection caused by Burkholderia pseudomallei. It is a non notifiable disease and is not included in Integrated Disease Surveillance Program by National Center of Disease Control. India is predicted to have highest burden of disease with an estimated mortality of 32,000 per year. Melioidosis presents with a wide range of clinical manifestations like pneumonia, liver and splenic abscess, septicemia etc. This wide spectrum of presentation and mimicry with other infections leads to its misdiagnosis or underdiagnosis. The only source of disease burden in India is few case reports and the true burden and distribution of disease still needs to be assessed. We, hereby, report a case series of four cases aged 28 years, 53 years, 33 years and 22 years. All cases had different clinical presentation ranging from abdominal wall abscess to septicemia and neurological manifestations making the diagnosis challenging. Three of the four cases were discharged after complete recovery while one case went leave against medical advice. To our knowledge this is the first series describing complete recovery of three out of four cases. This case series will help the physicians to raise their index of clinical suspicion of melioidosis in high risk patients presenting with various findings thus improving the chances of correct diagnosis and treatment.

Comparison of Accuracy of Freestyle Libre Pro and Medtronic iPro2 Continuous Glucose Monitoring Systems in Pregnancy.

There are limited data on head-to-head performance of Freestyle Libre Pro (FSL-Pro) and blinded Medtronic iPro2 continuous glucose monitoring system in pregnancy. In this prospective observational study, women with hyperglycemia in pregnancy (n = 42) underwent simultaneous FSL-Pro and Medtronic iPro2 sensor insertion and self-monitoring of blood glucose using Contour Plus meter (reference). The overall mean absolute relative difference (MARD) for iPro2 and FSL-Pro systems were 8.0% ± 9.2% and 19.0% ± 12.7%, respectively. At hypoglycemic range, both sensors performed less accurately (MARD: 18.0% and 16.8%, respectively), whereas iPro2 showed higher accuracy at euglycemic (8.2% and 19.3%, respectively) and hyperglycemic (6.8% and 18.0%, respectively) ranges. On Bland-Altman analysis, iPro2 and FSL-Pro underestimated glucose by 0.01 and 1.09 mmol/L, respectively. The ISO criteria were fulfilled for 88.5% and 44.9% of all values, respectively. To conclude, iPro2 was more accurate; however, both sensors demonstrated inaccuracy at hypoglycemic range, highlighting the need for refinements in the current generation of sensors to address this problem.

Laparoscopic-assisted uterovaginal anastomosis in congenital atresia of uterine cervix: follow-up study.

STUDY OBJECTIVE: To study the efficacy, safety, and functional outcomes of laparoscopic-assisted uterovaginal anastomosis with placement of a silicone tube as stent in congenital cervical atresia. DESIGN: Descriptive study (Canadian Task Force classification II-3). SETTING: Tertiary care referral hospital. PATIENTS: Fourteen consecutive patients (mean [SD] age, 15.2 [2.0] years) with congenital absence of a uterine cervix, associated with partial or complete vaginal aplasia. INTERVENTIONS: Laparoscopic-assisted uterovaginal anastomosis with placement of a silicone stent was performed to treat cervical agenesis. In cases with associated vaginal aplasia, modified McIndoe vaginoplasty was performed concomitantly. Follow-up assessment was performed at 1, 3, and 6 months, and then yearly. MEASUREMENTS AND MAIN RESULTS: Of 14 patients with congenital cervical anomalies, cervical dysgenesis was observed in 5 (35.7%), and cervical agenesis in 9 (64.2%). All patients with cervical agenesis also had a partial or complete noncanalized vagina. The procedure was successfully completed in all patients. Main outcome measures were functional capability and postoperative complications. Mean (SD) follow-up after surgery was 3.8 (1.2) years. Postoperatively, all but 1 patient (92.8%) experienced regular menses, with complete relief of cyclical abdominal pain. One patient underwent hysterectomy because of genital infection and re-stenosis. Concomitant vaginoplasty was performed in 9 patients (64.2%) with associated vaginal aplasia, and vaginal length was 6.5 (1.2) cm at 6-month follow-up. Five patients (35.7%) are sexually active, and report it to be satisfactory. Pregnancy has been achieved in 3 of the 5 patients (60%). CONCLUSIONS: Laparoscopic-assisted uterovaginal anastomosis may be considered the treatment of choice in patients with cervical agenesis, and radical treatment such as hysterectomy can be averted. The procedure is successful insofar as resumption of menstrual function. However, long-term reproductive outcome in these young girls will require further follow-up.

The Impact of the COVID-19 Pandemic on the Psychological Well-being of Healthcare Workers in Obstetrics and Gynaecology: An Observational Study at an Apex Institute.

Background and objective The coronavirus disease 2019 (COVID-19) pandemic has affected the health, social, and economic sectors all over the world. With a view to assessing the impact of COVID-19 on the mental health of healthcare workers (HCWs), we conducted a study to find out the incidence and severity of depression, anxiety, and post-traumatic stress disorder (PTSD) among HCWs. Material and methods This was an observational cross-sectional study conducted in the Department of Obstetrics and Gynaecology in collaboration with the Department of Psychiatry at AIIMS, New Delhi from March 2021 to June 2021. One hundred HCWs working in the Department of Obstetrics and Gynaecology were surveyed using a set of semi-structured interview schedules and structured questionnaires distributed via email or manually. The structured questionnaire included the demographic profile; other baseline information; the 42-item Depression, Anxiety, and Stress Scale (DASS-42); and the Impact of Event Scale-Revised (IES-R) instrument. Data analysis was carried out using the statistical package STATA version 14.0 (StataCorp LLC, College Station, TX). Results A total of 100 HCWs participated in the study, out of which 39 (39%), 45 (45%), and 16 (16%) were doctors, nursing staff, and supporting staff, respectively. Overall, 92 (92%) of the participants were women, and the mean age of the participants was 29.87 ±4.85 years. Out of the 100 participants, 17 (17%), 25 (25%), 13 (13%), and two (2%) participants had depression, anxiety, stress, and PTSD, respectively. Occupation-wise, among the nursing staff, doctors, and supporting staff, the incidence of depression was 24.4%, 15.4%, 0.0%, respectively; the anxiety rate was 33.3%, 25.6%, and 0.0%, respectively; and the rate of stress was 17.8%, 12.8%, and 0.0%, respectively. The IES-R score was significantly higher among unmarried as compared to married participants (2.70 ±7.935 vs. 1.60 ±3.583, p=0.000). Participants living in joint families had a higher DASS-42 score (DASS-D: 4.00 ±5.299 vs. 3.77 ±7.727, p=0.889; DASS-A: 4.31 ±4.398 vs. 4.12 ±7.496, p=0.905; DASS-S: 4.08 ±4.816 vs. 3.88 ±7.567, p=0.016) and lower IES-R score (1.31 ±4.922 vs. 2.66 ±9.947, p=0.752) as compared to those living in nuclear families. Depression (4.86 ±8.165 vs. 2.00 ±4.388, p=0.054), anxiety (5.31 ±7.538 vs. 2.14 ±4.704, p=0.024), stress (5.20 ±7.651 vs. 1.67 ±4.733, p=0.014) and PTSD (3.61 ±10.900 vs. 1.44 ±2.634, p=0.245) were all higher among HCWs having exposure to COVID-19 more than 10 hours per week compared to participants with an exposure of less than 10 hours per week. The participants having psychiatric illness in the family showed significantly higher mean values for DASS-42 (DASS-D: 20.00 ±26.870 vs. 3.50 ±6.264, p=0.001; DASS-A: 18.50 ±20.506 vs. 3.88 ±6.215, p=0.002; DASS-S: 18.00 ±21.213 vs. 3.64 ±6.346, p=0.003) as compared to those without any psychiatric illness in the family. Conclusion Based on our findings, occupational and environmental factors at the workplace play a key role in mental health outcomes, and COVID-19 has had a significant impact on the mental health of HCWs. Furthermore, we have also observed that effective planning can significantly reduce mental stress.

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

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

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.

Efficacy of myo-inositol and d-chiro-inositol combination on menstrual cycle regulation and improving insulin resistance in young women with polycystic ovary syndrome: A randomized open-label study.

OBJECTIVE: To compare the effect of myo-inositol and d-chiro-inositol in combination (MI + DCI) with combined hormonal contraceptive (CHC) on menstrual cycle regulation in young Indian women with polycystic ovary syndrome (PCOS). METHODS: Seventy young women with PCOS aged 15-24 years with delayed cycles were randomized into two groups and were treated for 6 months with MI + DCI (550 + 150 mg, 3.6:1 ratio) twice a day and CHC (ethinyl estradiol 20 µg + drospirenone 3 mg) once a day. RESULTS: Spontaneous menses resumed in 28 (84.85%) young women on MI + DCI, compared with withdrawal bleeding in 34 (100%) on CHC. The mean cycle length reduced with both MI + DCI (124.54 ± 8.08 to 57.75 ± 3.00 days, P < 0.001) and CHC (105.88 ± 7.96 to 30.53 ± 2.95 days, P < 0.001). Regular menstrual cycles were established in 9 (27.27%) young women with MI + DCI (P = 0.001) and 30 (88.23%) with CHC (P < 0.001). Three months after stopping the treatment, 24 young women (85.71%) on MI + DCI and 25 (73.53%) on CHC continued to have spontaneous cycles. Anti-Müllerian hormone decreased with both the drugs (P = 0.001), whereas luteinizing hormone (P = 0.001) and testosterone (P = 0.04) decreased with CHC and homeostatic model assessment of insulin resistance (P < 0.001) with MI + DCI. CONCLUSION: Myo-inositol and d-chiro-inositol in combination (3.6:1 ratio) are effective in regularizing menstrual cycles and improving insulin resistance. TRIAL REGISTRATION: Clinical Trials Registry of India (CTRI/2018/03/012643). http://ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=20969&EncHid=&userName=myo-inositol.

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.