Naturalistic Evaluation of ERAS Bundle Implementation Feasibility in Elective Cesarean Deliveries of Tertiary Care Hospital in a Low-Middle-Income Country.

The present study assessed whether applying enhanced recovery after surgery (ERAS) guidelines for cesarean delivery is feasible in the tertiary care setting with an add-on objective to identify barriers to successful implementation. The cross-sectional study included women undergoing elective CS and willing to participate. The study attempted to understand barriers to ERAS implementation through timely interviewing study participants. Sixty-two patients participated in the study. Antenatal and fetal complications were observed in 39(63%) and 32(51%) participants. The study observed that at least 80% of the proposed components could be applied to 71% of the study population. All 15 components could be applied to 7(11.2%) patients, and at least 50% could be applied to 58(94%) patients. The least applied component was minimizing starvation by taking clear liquids until 2 hrs before surgery in 26(42%) patients due to waiting hours outside the operation-theater (OT). When fitness-for-discharge was assessed against the percent components of ERAS implemented, the area under the curve (AUC) value was 0.75, with a specificity value of 95.65% and a positive predictive value of 94.12%. In the postoperative ERAS bundle, fitness-for-discharge on day-two was statistically associated with early and frequent breastfeeding (p = 0.000) and prevention of intra-op hypotension (p = 0.03). In conclusion, the primary barriers to implementing ERAS were resource limitations in the form of single functional OT and limited doctors.

Comparison of Vaginal Dinoprostone Pessary With Transcervical Balloon Catheter Plus Vaginal Misoprostol for Pre-induction Cervical Ripening: A Randomized Trial.

Aims and Objectives To compare the safety and efficacy of dinoprostone pessary with Foley plus vaginal misoprostol for cervical ripening. Materials and Methods We randomized 115 women to the pessary or Foley plus misoprostol group. Pessary was inserted for 24 hours, and in the Foley plus misoprostol group, intravaginal misoprostol 25 mcg was administered along with trans-cervical Foley insertion and repeated every six hours to a maximum dose of 100 mcg. Singleton pregnancies requiring labor induction at more than 34 weeks with a Bishop score of <6 were included. Study outcomes included induction-delivery interval (IDI), mode of delivery, change in the Bishop score, need for oxytocin augmentation, and patient discomfort as assessed by visual analog score. Results The IDI was similar between the groups (pessary vs Foley plus misoprostol; 21.27 vs 21.10 hours, p = 0.9). The mean change in the Bishop score and need for augmentation with oxytocin was significantly more in the Foley plus misoprostol group compared to pessary (2.72 vs 1.94, p = 0.001; 89.7% vs 57.9%, p = 0.0001). Pessary was better tolerated compared to Foley plus misoprostol (VAS 7.8 vs 6.68, p = 0.0001). Mode of delivery and maternal and neonatal outcomes showed no difference. Conclusion There was no significant difference between pessary and Foley plus misoprostol in the IDI and mode of delivery. Pessary was better tolerated, and augmentation with oxytocin was required less often. Foley plus misoprostol caused a faster change in the Bishop score, but oxytocin augmentation was used more often. Maternal and neonatal outcomes were similar.

Acute kidney injury and it's outcome following maternal near miss event: A prospective observational study from a tertiary care hospital.

Purpose: Haemorrhage, preeclampsia and sepsis are the leading causes of renal dysfunction in women with a maternal nearmiss(MNM) complication. The study aimed to assess the prevalence, pattern and follow up of these women. Methods: This was a hospital based prospective observational study, conducted over one year. All women with a MNM leading to acute kidney injury (AKI) were analysed for fetomaternal outcomes and renal function at 1 year of followup. Results: The incidence of MNM was 43.04 per 1000 livebirths. 18.2% women developed AKI. 51.1% women developed AKI in the puerperal period. Most common cause of AKI was haemorrhage seen in 38.3% women. The majority of women had s.creatinine between 2.1 to 5 mg/dl and 44.68% required dialysis. 80.8% women recovered fully when the treatment was initiated within 24 h. One patient underwent renal transplant. Conclusion: Early diagnosis and treatment of AKI results in full recovery.

Usage of postpartum intrauterine contraceptive device (postpartum-IUD) after an increase in the institutional delivery rate in India: time to re-visit the effect of timing of counselling on its acceptance.

PURPOSE: While increase in institutional deliveries brings an opportunity to counsel women for postpartum family planning (PPFP), its uptake remains low. Reasons for poor acceptance of postpartum intrauterine contraceptive device (postpartum-IUD), and its relation with the timing of counselling need to be investigated. METHODS: Women attending the antenatal clinic, reporting in labour, and within 48 h of delivery respectively were invited to participate. Eligible women were asked about awareness and choice for PPFP. After counselling, acceptance for PPFP was compared with the baseline. Acceptance and continuation of postpartum-IUD were compared between women counselled in the antenatal, intrapartum, and postpartum periods. RESULTS: Only 23% of 360 women were aware of postpartum-IUD. After counselling, acceptance for PPFP increased from 14% to 97% and for postpartum-IUD, from 0.5% to 33.9%. Acceptance of postpartum-IUD among women counselled in the antenatal, intrapartum and postpartum period was 45%, 35% and 21.7% respectively. Acceptance was higher among the antenatal-counselling group than the postpartum-counselling group (OR 0.45; CI 0.22-0.94; p = 0.03). CONCLUSION: Counselling, irrespective of its timing, improves acceptance for PPFP. Acceptance and continuation of postpartum-IUD are higher following counselling in antenatal period. All eligible women should be counselled irrespective of 'when' they approach the facility.

Acceptance for postpartum-IUD is maximum when women are counselled in the antenatal period. With a surge in institutional deliveries, the opportunity to counsel women in the intrapartum and postpartum period should not be missed as this also increases acceptance for PPFP and postpartum-IUD.

Legal Limits Relaxed: Time to Look at Other Barriers Faced by Women Seeking Termination of Pregnancy for Fetal Anomalies.

Introduction Advancements in prenatal diagnostic techniques have led to an increase in demand for termination of pregnancy for fetal anomalies (TOPFA). While relaxation in the legal gestational age limits across various countries relieves an important barrier, there is a need to identify the reasons that lead to delays in seeking abortion for fetal anomalies, because abortion-related complications increase with gestational age. Methods In this hospital-based qualitative study, antenatal women referred to a tertiary care institute in North India because of major fetal anomalies were explained about the study. Those women who fulfilled the inclusion criteria were recruited after taking consent. Details of antenatal care and prenatal tests were recorded. An in-depth inquiry was made into the reasons for the delay in prenatal tests, the delay in the decision for abortion, and specific problems that they faced in seeking TOPFA. Results Out of 80 women who met the inclusion criteria and consented to participate, more than 75% had received antenatal care in public healthcare facilities. Less than 50% of women received folic acid in the first trimester while 26% had first contact with healthcare facilities in the second trimester. Only 21 women underwent screening for common aneuploidies. Second-trimester anomaly scan was delayed in 35 women due to women-centered reasons (n = 17) or provider-centered (n = 19) reasons. Only 37.5% of women were counseled about fetal anomalies by their primary care provider. Owing to delay at multiple levels, 40 women (50%) could receive counseling about fetal abnormality for the first time after 20 weeks. These women could not be offered abortion because this study was carried out before the amendments in the Medical Termination of Pregnancy Act in India. The older act allowed abortion up to 20 weeks of gestation. Seventeen women could obtain permission for an abortion from a court of law. Arrangements for travel and stay and dependence on family members were the main problems faced by women seeking TOPFA. Conclusions Delay in diagnosis of a fetal anomaly due to delay in seeking antenatal care, irregular follow-up, and lack of pre-test counseling are the major reasons for the delay in the decision for abortion. This is further compounded by inadequate post-test counseling. Lack of awareness, failure or delay in counseling, need to travel to another facility for abortion, dependence on family members, and financial issues are the major barriers.

Randomized crossover trial of 'Roll-over' technique of abdominal paracentesis versus standard technique in suspected malignant ascites.

BACKGROUND: The sensitivity of single abdominal paracentesis for diagnosis of peritoneal carcinomatosis (PC) varies from 40-70%. We hypothesized that rolling-over the patient before paracentesis might improve the cytological yield. RESEARCH DESIGN AND METHODS: This was a single center pilot study with a randomized cross-over design. We compared the cytological yield of fluid obtained by roll-over technique (ROG) with standard paracentesis (SPG) in suspected PC. In the ROG group, patients were rolled side-to-side thrice, and the paracentesis was done within 1 minute. Each patient served as their own control, and the outcome assessor (cytopathologist) was blinded. The primary objective was to compare the tumor cell positivity between SPG and ROG groups. RESULTS: Of 71 patients, 62 were analyzed. Of 53 patients with malignancy-related ascites, 39 had PC. Most of the tumor cells were adenocarcinoma (30, 94%) with one patient each having suspicious cytology and one having lymphoma. The sensitivity for diagnosis of PC was (31/39) 79.49% in SPG group and (32/39) 82.05% in ROG group (p = 1.00). The cellularity was similar between both the groups (good cellularity in 58% of SPG and 60% of ROG, p = 1.00). CONCLUSIONS: Rollover paracentesis did not improve the cytological yield of abdominal paracentesis. TRIAL REGISTRATION: CTRI/2020/06/025887 and NCT04232384.

Prenatal diagnosis for hemophilia A (intron 22 inversion) reveals a rare association with Klinefelter syndrome with diagnostic difficulties in molecular interpretation.

Hemophilia A is an X-linked recessive disorder caused by genetic abnormalities in the F8 . Klinefelter syndrome is sex chromosome aneuploidy caused by nondisjunction during meiosis in the germ cells or mitotic cell divisions in the early embryonic cells. We here report an intriguing case of a prenatal diagnosis where a rare association of hemophilia A and Klinefelter syndrome was found in a fetus. This case highlights the diagnostic difficulty where the inverse-PCR for intron 22 inversion defect leading to hemophilia A did not amplify. Indirect molecular testing was done using multiallelic extragenic variable number tandem repeat (VNTR) DXS52 (St14) and polymorphic markers. The interpretation was further complicated by the presence of Klinefelter syndrome. This case highlights the challenges faced when such rare combinations are found during prenatal diagnosis.

Prospective assessment of mental and physical health of maternal near-miss women: A low-middle-income country's experience.

Background: Traumatic birth experience is an unaddressed arena, especially in Asian women, with several societal stigmas lingering around. Aim: A study was undertaken to simultaneously assess the post-partum mental and physical health follow-up of maternal near-miss (MNM) women and compare it with women of uneventful deliveries. Materials and Methods: The prospective cohort study enrolled 88 MNM women (case cohort) and 80 women with an uneventful peri-partum period (control cohort) at the same time. The participants were followed up with Edinburgh Postnatal Depression Scale (EDPS), PTSD Checklist - Civilian Version (PLC-C), and a 36-item short-form-survey form over 6 months after the delivery. Results: The case group had higher mean EPDS and PLC-C scores, with poor quality of life (QOL) performance, compared to the control group at 6 weeks and 3 months, and 6 months follow-up (P < 0.05). At the sixth-week follow-up visit, the study observed that 28 (31.8%) women from the case group required a psychiatry consultation compared to the control group with only two (2.5%) participants (P < 0.001). At 3 months, an evident difference was noted on various QOL parameters, such as limitations due to physical health and emotional problems, energy fatigue, general health, and health change parameters between the two groups (P < 0.05). The difference persisted at 6-month follow-up as well for limitations due to physical health, energy fatigue, and general health parameters only (P < 0.05). Conclusion: There is an urgent need for a multi-departmental collaborative approach at the hospital level and policy-making decisions at higher levels for the mental health of Asian women facing MNM events.

Impact of covid 19 pandemic on severe maternal outcomes -An observational study from a referral institute of India.

Introduction: Covid 19 pandemic has taken the world by storm. As far as maternal health is concerned, it has been affected both directly and indirectly. Not only are the women getting affected by COVID disease but also the health services are suffering in terms of availability, approachability and access. The study aimed to analyze the change in the trends of maternal near and maternal mortality comprising severe maternal outcome (SMO) between 2019 and 2020 in the department of obstetrics and gynaecology of our hospital due to COVID pandemic. Methods: This retrospective study was conducted in the Obstetrics and Gynaecology department of Post Graduate Institute of Medical Education and Research (PGIMER), Chandigarh. The maternal death review data and maternal near miss statistics were analysed. This included assessing the change in the number of maternal deaths and obstetric near miss, their respective causes, and case fatality rate specific to COVID during pregnancy. Results: The total births decreased from 6056 in 2019-4140 in 2020 whereas women with severe maternal outcomes increased from 4.6% in 2019 to 6.5% in 2020(p value < 0.001). The incidence of nearmiss increased significantly from 3.5% in 2019 to 5.1% in 2020(p value < 0.0001) and maternal mortality ratio increased from 1122 per 1 lakh births to 1425 per 1 lakh births. Haemorrhage was the most common cause of maternal near miss with 45.8% in 2019 and an increase to 50.2% in 2020. The percentage of illiterate patients with near miss statistically reduced in 2020(p value - 0.004). Average hospital stay also reduced from 16.5+/-2.1 days to 12.6+/-6.3 days (p value < 0.0001). The average time taken to reach the hospital, however, increased from 27+/-3 h to 36+/-4 h (p value < 0.0001). The rate of direct maternal deaths increased from 45.6% to 52.5% between 2019 and 2020(p-value-0.434). Conclusion: Covid 19 pandemic has affected both maternal mortality and morbidity. Keeping the current situation in mind, it becomes increasingly important to develop patient education via electronic media and teleconsultations. One-stop portals and helplines which involve multidisciplinary teams should be available to all such pregnancies.

Pattern of non-communicable diseases during pregnancy and their effect on feto-maternal outcome: A prospective observational study.

OBJECTIVE: To assess patterns of non-communicable diseases (NCDs) and pregnancy outcomes of women in a tertiary care hospital. METHODS: This was a prospective observational study, conducted over 1 year. All NCDs in women who delivered or aborted were studied. Maternal and neonatal outcomes were noted. RESULTS: In all, 1003 NCDs occurred in 894 women. Chronic hypertension was the commonest, involving 309 (30.8%) women. Others included cardiovascular (159, 15.9%), neurological (142, 14.2%), endocrine (115, 11.5%), autoimmune (76, 7.6%), chronic kidney (48, 4.8%), and chronic respiratory (43, 4.3%) diseases, psychiatric disorders (38, 3.8%), cancers (20, 2.0%), and chronic liver disease (18, 1.8%). Most (599, 67.0%) were diagnosed before pregnancy and 145 (16.2%), 81 (9.1%), and 69 (7.7%) were diagnosed in the first, second, and third trimesters, respectively. Maternal deaths occurred in 6 (0.7%) women and near miss in 19 (2.1%) women. Only 9 (1.5%) women with NCD diagnosed before pregnancy had maternal near miss or death, compared with 16 (5.4%) diagnosed during pregnancy (P < 0.001). Of live births, 281 (35.3%) were low birth weight, 49 (6.1%) were very low birth weight, and 24 (3.0%) were extremely low birth weight. CONCLUSION: Chronic hypertension was the commonest NCD, which along with cardiovascular and neurological disorders constituted around 60% of all NCDs. One-third of NCDs were initially diagnosed during pregnancy. Maternal morbidity was lower if NCDs were diagnosed before pregnancy.

Neonatal outcomes following prophylactic administration of phenylephrine or noradrenaline in women undergoing scheduled caesarean delivery: A randomised clinical trial.

BACKGROUND: There is limited evidence to support the use of noradrenaline over phenylephrine during elective caesarean section with regards to its impact on foetal acidosis. Concerns regarding a deleterious effect of noradrenaline on foetal blood gas analysis because of its ß-mimetic activity cannot currently be ruled out by data from randomised controlled trials. OBJECTIVE: We hypothesised that noradrenaline would be associated with higher umbilical artery base excess values and less foetal acidosis compared with phenylephrine. This study aimed to observe the effect of prophylactic infusions of phenylephrine or noradrenaline in low-risk elective caesarean delivery on umbilical artery blood gas analysis. DESIGN: A prospective, randomised, double-blind trial. SETTING: Labour room operating theatre of tertiary care hospital in Northern India from April 2020 to November 2020. PATIENTS: Full-term, nonlabouring pregnant women, scheduled for elective caesarean delivery under spinal anaesthesia. INTERVENTION: Equipotent prophylactic infusions of either phenylephrine 100 µg min-1 or noradrenaline 5 µg min-1 were administered to maintain maternal SBP between 90 and 110% of baseline using a predefined algorithm. MAIN OUTCOME MEASURE: The primary outcome was umbilical artery base excess in noradrenaline versus the phenylephrine group. The incidence of foetal acidosis defined as umbilical artery base excess less than -6 mmol l-1 was also assessed for noradrenaline versus phenylephrine. RESULTS: Median [IQR] umbilical artery base excess was significantly higher in the noradrenaline group: -5.4 [-6.6 to -4.03] versus -6.95 [-9.02 to -4.53] in the phenylephrine group (P = 0.014). No significant difference in the incidence of foetal acidosis was observed between noradrenaline and phenylephrine groups: 36 versus 54% (P 0.07); difference 18% (95% CI, -1.4 to 35.6%). CONCLUSION: Prophylactic noradrenaline 5 µg min-1 infusion resulted in higher base excess values compared with phenylephrine 100 µg min-1 infusion. A comparable incidence of foetal acidosis was observed in women receiving either noradrenaline or phenylephrine. Maternal bradycardia was more pronounced with phenylephrine while targeting blood pressure goals. CTRI: CTRI/2020/03/023986.

Identification of At-risk Pregnant Population for Over-the-Counter Drug Usage in Low-Resource Settings.

OBJECTIVE: Nearly 1.5 billion people of an Asian country are living their lives without a country-specific over-the-counter (OTC) drug list. A study was planned to assess the understanding and practice of OTC medication consumption in the pregnant population. METHODS: A questionnaire-based cross-sectional study evaluating different perspectives on OTC drug consumption was planned in around 500 pregnant women attending tertiary care outpatient antenatal clinics. The association of knowledge, attitude and practice versus indications, knowledge regarding harmful effects possible, reasons for choosing OTC medication, the practice of consulting nonmedical persons and drug interactions with the disease or prescription medications was determined. Regression analysis was performed in statistical software R. RESULTS: Seven percent (36/516) of pregnant women were found to consume oral antimicrobials without prescription. Local chemist consultation was the most common channel (72.48%) to procure the OTC medicines. Participants with good knowledge score showed an odds ratio (OR) of 1.87 (95% C.I.; 1.28-2.73), 1.6 (95% C.I.; 0.99-2.63), 1.66 (95% C.I.; 1.14-2.42) and 2.66 (95% C.I.; 1.49-4.89) for self-medication encouragement tendency possible, restricting sale of OTC medications, the habit of reading drug leaflets and understanding the potentially harmful effects, with OTC drugs, respectively. Right-attitude participants showed an OR of 1.89 (95% C.I.; 1.29-2.80) and 1.8 (95% C.I.; 1.19-2.76) for identifying knowledge of acetaminophen overdose and liver damage link as well as the disease symptom masking possibility with OTC, respectively. Participants with insufficient knowledge and attitude scores showed an association with more OTC antacid-antiemetics and analgesic use, respectively. CONCLUSION: Antenatal pregnant women need to be guided on avoiding OTC antimicrobial usage. Both obstetricians and regulators have to play an active role in educating pregnant women and contributing to developing country-specific OTC drug lists with the guidelines. SUPPLEMENTARY INFORMATION: The online version contains supplementary material available at 10.1007/s13224-021-01481-2.

A Quality Improvement Study on Improving Communication between Health-Care Provider and Laboring Woman: A Step toward Respectful Maternity Care.

BACKGROUND: Effective communication between health-care providers (HCP) and women during labor is a key component for providing dignified and consented maternity care. The quality improvement (QI) study was planned to improve the communication skills of HCP to provide dignified and consented care in the labor ward. METHODOLOGY: This study was conducted at the labor ward of a tertiary care hospital. To assess the magnitude of nondignified and nonconsented care, baseline data were collected from the women who had normal vaginal delivery through interviews using a prestructured questionnaire. The HCPs were also interviewed about the reasons for nondignified and nonconsented care. Various change ideas were tested through the plan-do-study-act cycle to sensitize the HCP with World Health Organization recommendations on intrapartum communication. RESULTS: There was a marked improvement in communication between HCP and women in labor, i.e., addressing the woman by her name (100%), consent before each clinical examination (93%), and providing information about the progress of labor after each examination (50%). CONCLUSION: A QI approach is feasible and effective as a behavior change intervention to provide dignified and consented care in the existing settings.

Discordant immunohistochemistry in an unusual MLH1 gene variant in a case of Lynch syndrome.

Immunohistochemistry for mismatch repair proteins and microsatellite instability testing are recommended screening methods for Lynch syndrome. They have a good sensitivity and specificity, allowing for directed genetic testing and diagnosis. We report a case of Lynch syndrome with retained MMR protein expression who later showed an MLH1 gene variant on genetic testing (Next Generation Sequencing) requested because of the clinical presentation of metachronous colonic and endometrial carcinoma. This report makes the case for strong clinical suspicion and directed genetic testing despite initial screen negative results.

'Rollover' abdominal paracentesis versus standard technique: protocol of a crossover randomized comparative trial.

The sensitivity of single abdominal paracentesis for diagnosis of peritoneal carcinomatosis in patients with malignant ascites is 40-70%. Tumor cells shed from the peritoneum settle preferentially in certain recesses of the peritoneum. We aim to compare the standard technique of abdominal paracentesis versus a rollover technique in a randomized crossover study to assess the cytological yield in patients suspected to have peritoneal carcinomatosis. Each patient will serve as their own control and the outcome assessor (cytopathologist) will be blinded to the method of paracentesis performed. The primary objective will be to compare the tumor cell positivity between the standard paracentesis group and the rollover group among enrolled patients. Clinical Trial registration: CTRI/2020/06/025887 and NCT04232384.

Lay abstract Existing methods of diagnosing cancer-related ascites are dependent on microscopic evaluation of fluid obtained from the ascites. However, this may not diagnose all such cases because the fluid may not contain many tumor cells. This may be due to the settling of tumor cells in certain inaccessible locations of the peritoneum (the lining of the abdominal cavity). This trial will look at whether rolling the patient from side to side could be helpful in increasing the chances of finding tumor cells in the ascites.

COVID-19 Pandemic and Infertility: Gynecological Dilemma from an Indian Perspective.

As the emaciated healthcare system is attempting to break the tide of the novel coronavirus pandemic across the globe, the highest cost of this fight is being borne by the third world countries. India is currently experiencing the peak incidence of COVID-19 cases. For the last 9 months, non-emergency services including OPDs have been suspended in majority of the hospitals to divert resources for combatting emergency medical care during this deadly pandemic. This temporary pause and containment could be detrimental to even patients suffering from malignancy. During this critical hour, commencement of infertility treatments including assisted reproductive technologies (ART) will add to additional burden upon the crippled medical fraternity. Fate of thousands of patients seems to hang by a fine thread now. In the resource-poor countries, it is our duty to divert maximum medical power to curtail this contagious pandemic rather than focusing on non-urgent treatment services.