Preoperative vaginal cleansing with chlorhexidine and cetrimide solution for reduction of postoperative infectious morbidity at a tertiary care center in North India: A prospective cohort study.

OBJECTIVE: To determine the effect of preoperative vaginal cleansing with chlorhexidine and cetrimide solution on postoperative infectious morbidity. METHODS: This prospective cohort study was conducted over a period of 18 months in the Department of Obstetrics and Gynecology, Vardhman Mahavir Medical College and Safdarjung Hospital, New Delhi, India. Women undergoing cesarean section were alternately allotted to study and control groups. Women with chorioamnionitis, antepartum hemorrhage, rupture of membranes for more than 24 h, and fever in the preoperative period were excluded. The study group received preoperative vaginal cleansing with antiseptic solution (7.5% chlorhexidine w/v and 15% cetrimide w/v); the control group did not receive vaginal cleansing. Both groups were followed for the presence of any infectious morbidity until they were discharged from the hospital. RESULTS: Age, body mass index (calculated as weight in kilograms divided by the square of height in meters), gestational age, and the parity of the women in the study and control groups were comparable (n = 760). The rate of endometritis was lower in the study group, but the difference was not statistically significant (P = 0.054). Post-cesarean febrile morbidity and wound sepsis were significantly lower in the study group (P = 0.017 and P = 0.02, respectively). On subgroup analysis, women in the study group with rupture of the membranes before cesarean delivery had lower wound sepsis and a reduced duration of hospital stay. Women in the study group with emergency cesarean delivery showed a significant reduction in wound sepsis, febrile morbidity, and length of hospital stay. CONCLUSION: Preoperative vaginal cleansing with chlorhexidine and cetrimide solution before a cesarean section reduces postoperative infectious morbidity.

Carle's obstetric early warning score as a screening tool for critical care admission.

BACKGROUND OBJECTIVES: Early warning systems (EWS) involve serial observations (track) with criteria (trigger) to timely identify patients at risk of complications. Carle designed a statistically based clinically modified obstetric early warning score (Carle's OEWS). This study evaluated Carle's OEWS and its individual components for predicting admission to the obstetric critical care unit (OCCU). Maternal near-miss and maternal mortality were the secondary outcomes. METHODS: A prospective observational study was conducted among 1250 pregnant women with a period of gestation ≥28 week admitted in the labour wards of a tertiary centre over 18 months. The physiological parameters of OEWS were recorded and aggregate score was calculated at admission and at regular intervals thereafter, till discharge or OCCU admission. RESULTS: The area under receiver operating characteristic (ROC) curve of OEWS was 0.975 for predicting OCCU admission, 0.971 for near-miss, and 0.996 for predicting maternal mortality and was significant for all outcomes. All individual parameters, except diastolic blood pressure, had a significant relative risk for predicting OCCU requirement. INTERPRETATION CONCLUSIONS: Carle's OEWS is a useful screening tool for predicting obstetric OCCU admission and can be routinely used in labour wards to ensure timely intervention.

Ultrasonographic Assessment of Body Fat Index for Prediction of Gestational Diabetes Mellitus and Neonatal Complications.

OBJECTIVES: To assess maternal pre-peritoneal fat and subcutaneous fat at 16-20 weeks gestation by ultrasound. Thus, calculate body fat index (BFI) and determine its cut-off value for prediction of gestational diabetes mellitus (GDM) and neonatal subcutaneous adiposity. METHODS: A cohort study was conducted in 200 pregnant women with singleton fetus during anomaly scan using BFI where they were screened for GDM at 24-28 weeks gestation by oral glucose tolerance test. Labour and neonatal outcomes were recorded. The receiver operating characteristic curve was used to determine the cut-offs for BFI, pre-peritoneal fat thickness, and subcutaneous fat thickness in order to predict GDM. RESULTS: The area under receiver operating characteristic curve for BFI was 0.967 (95% CI 0.932-0.987) with a sensitivity of 97.3%, specificity of 89.57%, negative predictive value of 99.3%, and diagnostic accuracy of 91% at a BFI cut-off of 0.88. The study analysis demonstrated BFI to be statistically superior to BMI > 22.9 kg/m2 for prediction of GDM. BFI > 0.88 was a risk factor for developing neonatal subcutaneous adiposity. CONCLUSIONS: BFI is a practical and convenient non-invasive screening tool to predict GDM and neonatal subcutaneous adiposity.

Comparison of Diabetes in Pregnancy Study Group India (DIPSI) and WHO criteria for diagnosis of gestational diabetes by assessment of fetomaternal outcomes.

OBJECTIVE: To evaluate fetomaternal outcomes in women who are normoglycemic by Diabetes in Pregnancy Study Group India (DIPSI) but have gestational diabetes mellitus (GDM) by WHO criteria versus those who are normoglycemic by both DIPSI and WHO criteria. METHODS: This was a prospective, cohort study. A total of 635 women participated. They underwent a 2-h non-fasting oral glucose tolerance test (OGTT) and results were interpreted by DIPSI. Out of 635 women, 52 were lost to follow up and 33 were diagnosed as GDM by DIPSI and excluded from the study. The remaining 550 women, after 72 h from the first test, underwent a 75-g fasting-OGTT and results were interpreted using WHO 2013 criteria. Results of the second test were blinded till delivery. The 550 women were followed for fetomaternal outcomes. Participants with normal DIPSI and normal WHO 2013 OGTT were labeled group 1. Participants with normal DIPSI but abnormal WHO 2013 OGTT were labeled group 2. Fetomaternal outcomes were compared between these groups. RESULTS: Occurrence of GDM by DIPSI was 5.1%, by WHO 2013 criteria it was 10.5%. Composite fetomaternal outcomes occurred more commonly in women with a normal DIPSI but an abnormal WHO 2013 test. Out of 550 women, 492 had normal DIPSI and normal WHO 2013 test. Out of this 492, 116 (23.6%) women had adverse fetomaternal outcomes. Fifty-eight women out of 550 had a normal DIPSI but an abnormal WHO 2013 test. Thirty-seven (63.8%) women out of 58 had adverse fetomaternal outcomes. We found statistically significant association between adverse fetomaternal outcome and GDM by WHO 2013 test (with normal DIPSI test). CONCLUSION: WHO 2013 has superior diagnostic value compared with DIPSI criteria for diagnosis of GDM.

Prediction of complications of pre-eclampsia using the fullPIERS high risk predictive model.

OBJECTIVE: To determine the predicted probability percentage of complications in women with pre-eclampsia using the Pre-eclampsia Integrated Estimate of Risk (fullPIERS) model within the first 24 h after admission and assess the model's predictive value for complications of pre-eclampsia. METHODS: This was a prospective cohort study in which the fullPIERS model was applied to 256 pregnant women with pre-eclampsia within the first 24 h after admission. These women were then followed for 48 h to 7 days for maternal and fetal complications. Reciever operating characteristics (ROC) curves were generated to assess the performance of the fullPIERS model for adverse outcomes of pre-eclampsia. RESULTS: Of the 256 women enrolled in the study, 101 women (39.5%) developed maternal complications, 120 women (46.9%) developed fetal complications, and 159 women (62.1%) developed both. With an area under the ROC curve of 0.843 (95% confidence interval 0.789-0.897), the fullPIERS model had good discriminating ability to predict complications at any time point between 48 h and 7 days after admission. The sensitivity and specificity of the model at a ≥5.9% cut-off value for predicting adverse maternal outcomes were 60% and 97%, respectively; they were 44% and 96%, respectively, for predicting combined fetomaternal complications with a cut-off value of 4.9%. CONCLUSIONS: The fullPIERS model performs reasonably well in predicting adverse maternal and fetal outcomes in women with pre-eclampsia.

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

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

Anxiety and depression among women with COVID-19 infection during childbirth-experience from a tertiary care academic center.

BACKGROUND: Pregnancy and postpartum are vulnerable periods for mental health problems and distress. Studies conducted worldwide have highlighted the role of the COVID-19 pandemic in adding to the rates of depression and anxiety in the perinatal period. However, there are very few reports on mothers who were identified as having COVID-19 infection at the time of childbirth. OBJECTIVE: Our study aimed to find the prevalence of depression and anxiety among pregnant women who were admitted for labor and tested positive for COVID-19 infection. We also aimed to study the association of various sociodemographic, social support, and obstetrical factors and that of COVID-19-related worries with depression and anxiety. STUDY DESIGN: The study was conducted at the obstetrics inpatient setting in a public hospital in New Delhi, which had a separate designated COVID-19 block. Pregnant and postpartum women >18 years of age who were admitted to the COVID-19 maternity ward for delivery were included for this study. The women were interviewed within the first week of admission and after 6 to 8 weeks of childbirth. The sociodemographic and obstetrical details and COVID-19-related worries and concerns were assessed. Depression and anxiety were assessed using the Patient Health Questionnaire version 9 and the Generalized Anxiety Disorder 7-item Scale, respectively.The normally distributed variables are expressed as mean±standard deviation and continuous variables with skewed distribution as median (interquartile range). The categorical data presented as proportions of categorical variables were compared using the chi-square or the Fischer exact test. All the tests are 2-sided, with a significance level of 5%. The data were analyzed using the SPSS software version 24. The rates of depression and anxiety were calculated and univariate analysis was done to identify the factors associated with moderate and severe anxiety and depression using various sociodemographic and obstetrical variables, the total COVID anxiety scale scores, and the social support score. RESULTS: The mean age of the women was 26.86 years (±4.31). Of the 243 women assessed using the Patient Health Questionnaire version 9, 168 (69.13%) had mild depressive disorder, and 29 (11.3%) had moderate depressive disorder. Of the 187 women who were assessed at the 6-weeks follow-up, 31 (16.57%) had minimal depression, 131 (70.05%) had mild depression, and 25 (13.36%) had moderate depression. Mild anxiety was seen in 121 cases (49.79%) and 13 (5.34%) had moderate anxiety symptoms. Women reported several worries, especially about the stigma of COVID-19 infection, support for infant care, and access to infant health services. CONCLUSION: Screening for common mental illnesses with the timely identification of associated risk factors should be done, with a liaison between obstetricians and mental health professionals. Obstetricians can address and reassure pregnant women regarding concerns about contracting the infection, worries about the possible effects of COVID-19 on the fetus and the newborn, and concerns about future consultations. In case the worries are out of proportion and necessitate intervention by mental health professionals, referral services should be made available. Hence, identifying and addressing the mental health concerns will help provide the optimum perinatal care during the pandemic.

A review of conventional and sustained-release formulations of oral natural micronized progesterone in obstetric indications.

BACKGROUND: Exogenous progesterone is a treatment option for obstetric indications associated with reduced progesterone activity. Oral natural micronized progesterone (NMP) is effective, although it requires multiple daily doses and may cause adverse events due to its active metabolites. A sustained-release formulation of NMP (NMP-SR) has been developed to overcome the limitations of conventional oral NMP. METHODS: This narrative review examines the available evidence for oral NMP and NMP-SR in several obstetric indications of interest. RESULTS: Literature searches identified 17 studies of oral NMP (luteal phase support during assisted reproduction, prevention of threatened miscarriage, prevention of preterm delivery), and clinical studies supporting use of NMP-SR (luteal phase support during intrauterine insemination, maintenance of high-risk pregnancy). Oral NMP was effective for luteal phase support during in vitro fertilization and intrauterine insemination, prevention of threatened miscarriage, and prevention of preterm delivery. NMP-SR was comparable to dydrogesterone for luteal phase support during intrauterine insemination and effectively maintained high-risk pregnancies. Oral NMP-SR was well tolerated. CONCLUSIONS: By releasing progesterone gradually and circumventing first-pass metabolism, NMP-SR elicits the desired therapeutic effect with benefits over conventional oral NMP in terms of bioavailability, once-daily dosing and improved tolerability. Oral NMP-SR appears to be a valuable option for treating obstetric conditions associated with insufficient progesterone exposure.

Clinical Profile, Viral Load, Maternal-Fetal Outcomes of Pregnancy With COVID-19: 4-Week Retrospective, Tertiary Care Single-Centre Descriptive Study.

OBJECTIVE: The COVID-19 pandemic raises a major concern about its severity in pregnancy, maternal-fetal outcomes, and risk of vertical transmission. We report a retrospective descriptive study of the clinical course and maternal-fetal outcomes of pregnant women with COVID-19. METHODS: This is a single-centre, retrospective study performed in a tertiary care hospital for pregnant women with COVID-19 in India. The medical records of all women who delivered in the COVID19 facility from May 5, 2020, to June 5, 2020, were reviewed independently. Data extracted from the records included demographic characteristics, obstetric details, comorbidities, disease severity, investigations, management, and information on neonates (birthweight, Apgar score, and perinatal complications). RESULTS: Among 348 women tested for SARS-CoV-2, 57 women (16.3%) were confirmed as positive based on quantitative reverse transcriptase polymerase chain reaction of the nasopharyngeal specimen. Most women (45; 78.9%) had a mild infection with favourable maternal-fetal outcomes. Three maternal deaths were associated with comorbidities. Five neonates tested positive for SARS-CoV-2, remained hemodynamically stable, and were subsequently discharged. CONCLUSIONS: A majority of pregnant women with COVID-19 had mild disease and recovered with good perinatal outcomes. Women with comorbidities may have an increased risk of severe morbidity and mortality. The cycle threshold signifying the viral load and degree of infectivity can modify management during pregnancy. Long-term outcomes and the potential mother-to-child vertical/horizontal transmission need further study.

Clinical profile, viral load, management and outcome of neonates born to COVID 19 positive mothers: a tertiary care centre experience from India.

Despite rapidly evolving knowledge about COVID 19 infection, routes of perinatal COVID 19 transmission and viral load in mother neonate dyad remain uncertain. Data were analysed to describe the clinicodemographic profile and viral load in neonates born to COVID 19 positive mothers. Of 2947 deliveries, 69 mothers were COVID 19 positive (2.3%), with 1 abortion, 2 macerated stillbirths and 2 fresh stillbirths as pregnancy outcomes. Of 65 tested neonates, 10.7% (7) were confirmed COVID 19 positive by RTPCR (reverse transcriptase-polymerase chain reaction). Viral load (cycle threshold, Ct of E, RDRp) in neonates was comparable with the Ct reported from adults; however, neonates had milder clinical manifestations. All 7 neonates who tested positive for COVID 19 were subsequently discharged. Six of the 7 neonates were asymptomatic and 1 neonate needed respiratory support (indication being prematurity) which resolved after 48 h. Maternal and neonatal comparison of Ct of E and RdRp gene was statistically non-significant (25.97 vs 19.68, p = 0.34 and 26.5 vs 25.0, p = 0.84). Viral loads of mothers with COVID 19 positive neonates compared with mothers with COVID 19 negative neonates for E and RdRp gene were also statistically non-significant (25 vs 27.19, p = 0.63 and 19.6 vs 27.6, p = 0.08). The majority (93%) of neonates tested later than 48 h (roomed in with mother and breastfed) tested negative.Conclusion: The study supports milder manifestation in COVID 19 positive neonates. Risk of transmission from COVID 19 positive mother to neonate by rooming-in and breastfeeding is low. In this study on a limited number of neonates, maternal viral load was not found to be associated with the positivity status or severity of the illness of neonate. What is Known: • Neonates born to COVID 19 positive mothers are at risk of COVID 19 infection. What is New: • Risk of transmission of COVID 19 from mother to neonate, with rooming-in and breastfeeding, appears low. • In this study on a limited number of neonates, maternal viral load of COVID 19 (E and RdRp cycle thresholds) was not associated with severity of illness or COVID 19 positivity in neonates.

Obstetric Early Warning Score for Prognostication of Critically Ill Obstetric Patient.

INTRODUCTION: Obstetric early warning score (OEWS) has been used conventionally for early identification of deteriorating obstetric patients in the labor room and ward settings. This study was conducted to determine if this simple clinical score could be used for prognosticating a critically ill patient in the ICU setting instead of sequential organ failure assessment score (SOFA) and acute physiology and chronic health evaluation (APACHE II) score. MATERIALS AND METHODS: A cohort study was conducted at Obstetrics Critical Care Unit, Vardhman Mahavir Medical College and Safdarjung Hospital, New Delhi. A total of 250 obstetric patients were recruited after informed consent. The OEWS, SOFA, and APACHE II scores were calculated within 24 hours of admission. The patients were followed to study the maternal outcome. RESULTS: The area under receiver operator characteristic (AUROC) curve of OEWS, SOFA, and APACHE II for prediction of maternal mortality was 0.894 (95% CI, 0.849-0.929), 0.924 (95% CI, 0.884-0.954), and 0.93 (95% CI, 0.891-0.958), respectively. The standardized mortality ratio (SMR) for OEWS, SOFA, and APACHE II was 66.3, 62.5, and 69.15%, respectively. CONCLUSION: Obstetric early warning score is as effective as the conventional SOFA and APACHE II to prognosticate the obstetric patient. Since OEWS is based only on clinical criteria, it can be done immediately on admission and can help in early allocation of appropriate manpower and resources for optimum outcome. CLINICAL SIGNIFICANCE: The clinical application of this study will help intensivists to prognosticate the critically ill obstetric patients immediately following admission to the critical care unit. HOW TO CITE THIS ARTICLE: Khergade M, Suri J, Bharti R, Pandey D, Bachani S, Mittal P. Obstetric Early Warning Score for Prognostication of Critically Ill Obstetric Patient. Indian J Crit Care Med 2020;24(6):398-403.