Elective induction of labor versus expectant management at 39 weeks among low-risk nulliparous pregnant women: A randomized controlled trial in India (ELITE-39 trial).

OBJECTIVE: The aim of the present open label randomized controlled trial was to compare the rate of cesarean section (CS) after elective induction with that of expectant management in low-risk nulliparous women at 39 weeks. METHODS: This randomized controlled trial from a tertiary maternity care center enrolled low risk nulliparous pregnant women at 38-38+4 weeks between April 1, 2019 and December 31, 2021. Participants were randomized into either the elective induction group (e-IOL) or the expectant management (EM) group though computer generated block randomization. The primary outcome was cesarean rate and the secondary outcome include adverse maternal and perinatal outcome between e-IOL and EM groups. We performed intention to treat analysis. RESULTS: A total of 360 women were enrolled into the present study. Analysis was performed for 179 women in the e-IOL group and 180 women in the EM group. The baseline demographic characteristics including Bishop score were comparable between the groups. The CS rate in both groups was 17.3% (31/179) and 25% (45/180), which is comparable (P = 0.08). There was one intrapartum stillbirth in the e-IOL group, and two babies succumbed in the neonatal period in the EM group. The maternal and perinatal outcomes between the groups were not found to be significantly different. CONCLUSION: Elective induction of low-risk nulliparous women at 39 weeks was not associated with increased cesarean section rate. The maternal and perinatal outcomes were comparable. Large, multicentric real time randomized controlled trials are needed to understand the benefit of elective induction in low-risk nulliparous women. This should include centers with large volume of deliveries especially from emerging countries also.

Proteinuria in predicting adverse outcomes in women with severe features of pre-eclampsia from a developing country: A prospective cohort study.

OBJECTIVE: To study the adverse maternal and perinatal outcomes in women with severe pre-eclampsia (SPE) among different ranges of proteinuria. METHODS: This prospective cohort study was conducted in Jawaharlal Institute of Postgraduate Medical Education and Research, India. After obtaining informed written consent, the 202 singleton women fulfilling the criteria of severe features of pre-eclampsia were stratified based on the value of urine protein-creatinine ratio (UPCR) as mild, moderate, severe, and massive proteinuria during pregnancy. Clinical outcomes were assessed and patients were followed up until 12 weeks postpartum to identify persistent proteinuria and hypertension. RESULTS: Of the 202 women with SPE, adverse maternal outcomes were seen in 34.65% (n = 70) and adverse perinatal outcomes in 75.74% (n = 153). The demographic and clinical factors were similar among women with increasing severity of proteinuria, except for mean systolic blood pressure, serum creatinine and total serum protein. UPCR was found to have a significant correlation with composite adverse perinatal outcome (P < 0.001) and individual outcomes of neonatal intensive care unit admission for >48 h (P = 0.01) and neonatal sepsis (P = 0.02) but not adverse maternal outcomes (P = 0.201). The optimum UPCR cutoff for adverse perinatal outcomes was 1.6 (sensitivity, 73.2%; specificity, 52.7%). In addition, 14.85% of the women had a persistently elevated UPCR and 3.96% had hypertension at 3 months postpartum. CONCLUSION: In women with SPE, severe and massive proteinuria were related to composite adverse perinatal outcome but not composite adverse maternal outcome. Moreover, antenatal 24-h proteinuria was significantly associated with persistent proteinuria. Significant proteinuria in women with SPE poses a risk for chronic renal dysfunction, requiring follow-up.

Association between common mental disorder and glycemic control in women with gestational diabetes: A mixed-method study.

Background: Gestational diabetes mellitus (GDM) is associated with an increased risk of mental health disorders among pregnant women. Poor mental health can negatively impact glycemic control in women with GDM, leading to adverse outcomes for both the mother and the baby. Aim: To determine the prevalence of common mental disorder (CMD) in women with GDM and its association with poor glycemic control. Additionally, to explore the reasons and coping strategies for CMD in women with GDM. Methods: A sequential explanatory mixed-method study was conducted among 351 women with GDM visiting a tertiary care hospital. The prevalence of CMD was assessed using Generalized Anxiety Disorder-7 (GAD-7), Patient Health Questionnaire-9 (PHQ-9), and Perceived Stress Scale (PSS). Glycemic control was determined based on two-hour postprandial blood glucose levels. In-depth interviews were conducted with six women who screened positive for CMD and had poor glycemic control. Data were analyzed using SPSS v23 and stats v12. Chi-square test and Poisson regression were performed, and adjusted prevalence ratios (aPRs) were reported. Results: The prevalence of CMD was found to be 19.08% (95% CI: 15.32%-23.52%), with 18.2% (95% CI: 14.5%-22.6%) anxiety symptoms 8.3% (95% CI: 5.8%-11.6%) depressive symptoms and stress each. CMD was significantly related to poor glycemic control (aPR: 1.58; 95% CI: 1.23-2.03; P value <0.001). The qualitative analysis revealed individual, family, health, and facility factors influencing mental health and glycemic control. Conclusion: Common mental health disorders are prevalent in women with GDM. It has a negative association with glycemic control. Implementing a routine screening program in the ANC clinic can aid in early identification and prompt management of the CMD and its associated complications.

Adherence to medical nutrition therapy and it's challenges among antenatal women with gestational diabetes mellitus in South India- A sequential explanatory mixed-method study.

BACKGROUND: Globally, one in ten pregnant women have diabetes; out of which, 90% contribute to gestational diabetes mellitus (GDM). Medical Nutrition Therapy (MNT) is the cornerstone for GDM treatment yet adherence to MNT among the masses is not adequately monitored as part of the routine antenatal services. The study aimed to estimate the proportion of adherence to MNT and determine the factors related toadherence among antenatal women with GDM. This study also explores the facilitators, barriers, and possible suggestions for improving adherence. MATERIALS AND METHODS: This facility-based sequential explanatory mixed-method study was conducted among 341 antenatal women with GDM at, Puducherry. The study was conducted in 2021. Dietary adherence was evaluated using Perceived Dietary Adherence Questionnaire and based on the scores obtained they were selected for in-depth interviews to explore the facilitators and barriers. Collected data wereanalysed by Chi-square test using STATA version 16. RESULTS: Out of 341 participants, the proportion of participants adherent to MNT was 135 (39.6%) with 95% CI of 34%-44%. Thepredictors for poor adherence were unemployment (PR: 0.65; 95%CI: 0.48-0.88) and good adherence was antenatal women in the 2nd trimester (PR: 1.541; 95%CI: 1.18-2.025). Barrierstonon-adherence were financial crisis, lack of awareness ofthe need for MNT, and joint family pressure. CONCLUSIONS: About two-thirds of antenatal women with GDM are non-adherent to MNT. Unemployment and period of gestation were found to be theirdeterminants. Appropriate action has to be implemented for improving the adherence rate.

Maternal and perinatal outcome of women with early-onset severe pre-eclampsia before 28 weeks: Is expectant management beneficial in a low-resource country? A prospective observational study.

OBJECTIVE: To study the maternal and perinatal outcomes in women with severe pre-eclampsia before 28 weeks of pregnancy. METHODS: A descriptive study from a tertiary care center. All consecutive women with severe pre-eclampsia withonset before 28 weeks of pregnancy were included. The details were collected in a predesigned structured proforma prospectively. RESULTS: The study cohort included 145 women with a mean maternal age of 26.97 ± 5.36 years (range 19-47 years). The mean duration of prolongation of pregnancy was 13.04 ± 10.57 days (range 1-51 days). A total of 29.7% (n = 43) of women had at least one major adverse maternal outcome, and the most common was HELLP (hemolysis, elevated liver enzymes, low platelet count) syndrome (n = 24,16.6%), followed by eclampsia (n = 12,8.3%). The stillbirth rate was high (n = 103,68.7%), and most occurred in the antepartum period. Of 47 (31.3%) neonates born alive, only eight (17.02%;8/47) survived up to 28 days of life. Fetal growth restriction with Doppler abnormalities and neonatal sepsis were the most common reasons for perinatal mortality. CONCLUSION: Expectant management should not be considered routinely when the onset of severe pre-eclampsia is before 25+6 weeks of pregnancy. Between 26 and 27+6 weeks it can be offered under close monitoring and the perinatal survival depends on the neonatal services available in their facility.

Predictors of adverse maternal outcome in jaundiced pregnant women identified as having pregnancy-specific liver disease (P-sLD).

We aimed to study the factors including model for end stage liver disease (MELD) score in predicting mortality in women with pregnancy-specific liver diseases (P-sLD). A total of 154 women with clinical jaundice were studied of which 138 women were diagnosed with P-sLD. The most common P-sLD was HELLP syndrome (51.9%) followed by acute fatty liver of pregnancy (AFLP) (17.5%). The mean age was 26.3 ± 4.7 years and the mean gestational age was 35.1 ± 4.2 weeks. The maternal death rate was 26.8% and the most common cause was coagulopathy followed by sepsis. The mean MELD score among non survivors was 25.98 ± 8.17 compared to 17.29 ± 8.12 among survivors (p value .00). On univariate analysis, gestational age at admission, presence of hypertension, the platelet count, serum creatinine, INR and MELD score were found to significant. The AUC for INR (0.82) and MELD score (0.77) was better than platelet count (0.72) and serum creatinine (0.67). On multivariate analysis, only the INR and presence of AKI were found to be significantly associated with maternal mortality. The performance of INR was better than MELD score in predicting mortality in women with P-sLD. Additional factors like platelet count may be incorporated in to MELD score for the prediction of mortality in pregnant women.IMPACT STATEMENTWhat is already known on this subject? Pregnancy-specific liver disorders (P-sLD) have significant effect on maternal and foetal outcome, often considered as a spectrum of disease with significant overlap of clinical and laboratory parameters. MELD score is used reliably outside the pregnancy to predict mortality may not be good in pregnant women. There are only few studies that looked at the factors predictive of adverse maternal outcome.What do the results of this study add? Though we have demonstrated that MELD score was significantly high among non-survivors, serum bilirubin an important component of MELD score was not found to be significant. The other factors which were found to be significant on univariate analysis include gestational age at admission, hypertension and platelet count. However, international normalised ratio (INR) and acute kidney injury (AKI) were the factors independently associated with mortality.What are the implications for clinical practice and/or further research? The utility of MELD score in P-sLD should be studied prospectively in different populations. Moreover, the feasibility of developing a simple model which incorporates platelet count in addition to other components of MELD score should also be explored in future studies.

Factors associated with the outcome of TOLAC after one previous caesarean section: a retrospective cohort study.

The factors associated with the outcome of trial of labour after one previous Caesarean Section; a retrospective cohort study. A retrospective observational study was performed on all eligible consecutive singleton pregnancies planned for trial of labour after one previous Caesarean Section (TOLAC) over a period of 18 months to study the success rate of vaginal birth after Caesarean Section (VBAC) and to find out the factors associated with successful and failed TOLAC. All of the data were entered in electronic format and the data was analysed in detail. Of the 1324 women studied, the VBAC rate was 65.3% and the incidence of scar rupture was 0.5%. The composite adverse maternal (postpartum haemorrhage and intensive care admission) and foetal outcome (still birth, 5-minute APGAR <7 and NICU admission) was more in the failed TOLAC group. Various demographic, clinical and obstetric factors were studied in detail between the successful and failed TOLAC groups. The favourable Bishop Score (>4) was independently associated with successful TOLAC (OR 4.3; 95% CI 3.3-5.6 p < .001). Maternal age of >30 years, (OR 0.57; 95% CI 0.41-0.79; p = .001), labour induction (OR 0.43; 95% CI 0.33-0.56; p < .001) and estimated foetal weight of >3500 g (0.31; 95% CI 0.14-0.6; p = .002) were the factors independently associated with failed TOLAC. Previous indication for a Caesarean Section and previous vaginal delivery were not found to be independently associated with the outcome of TOLAC. The predictive models for TOLAC need to be used cautiously and the risk assessment should be done on an individual basis.IMPACT STATEMENTWhat is already known on this subject? TOLAC is a reasonable strategy in Obstetrics especially after one Caesarean Section to minimise the morbidity associated with rising Caesarean Section. However, the maternal and foetal morbidity are more following unsuccessful TOLAC. The factors which predict the outcome of TOLAC are multifactorial which include maternal demographic factors, previous obstetric factors like indication for Caesarean Section, intraoperative complications, inter-pregnancy interval, current obstetric factors such as gestational age, Bishop Score before delivery, labour factors and foetal factors, e.g. sex and foetal size.What do the results of this study add? We tried to include all the possible factors which probably influence TOLAC and found only Bishop Score, maternal age, foetal size and labour induction were the factors independently associated with the outcome of TOLAC. A Bishop Score of >4 admission was the greatest predictor of successful TOLAC (OR 4.3). Similarly, labour induction and foetal size of >3.5 kg were associated with 60% and 70% less chance of VBAC, respectively.What are the implications of these findings for clinical practice and/or further research? The factors found to be associated with successful and failed TOLAC may be utilised to develop a predictive model. More so, prospective studies are needed to test such predictive models.

Raised blood glucose due to heterozygous glucokinase gene mutation (GCK-MODY) diagnosed for the first time in pregnancy: The dilemmas and successful management - Case report and review of literature.

Glucokinase mutation (GCK-MODY) is frequently misdiagnosed as either type I or type II diabetes mellitus, especially if presented for the first time during pregnancy. Generally GCK-MODY affects 1-2% of individuals with a diagnosis of diabetes. The defect in the glucose sensing mechanism in GCK-MODY results in a higher set point for maintenance of glucose homeostasis. Treatment is not recommended outside the pregnancy; however, in pregnancy, fetal abdominal circumference helps to decide about the likelihood of the fetus having inherited the condition and therefore whether insulin is required in pregnancy. We present a case in which GCK-MODY was diagnosed for the first time after pregnancy; the subsequent pregnancy was uneventful. Genetic testing is mandatory to establish the diagnosis. Here the implications of MODY and its subtypes, along with the pattern of inheritance and management aspects are discussed.

Is SARS-CoV-2 Transmitted Through Breastfeeding?

There are concerns regarding the transmission of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) from mother to child during this COVID pandemic. This descriptive study was done to check the possible transmission of the virus through breastfeeding in the Indian context. RT-qPCR for SARS-CoV-2 was done in breast milk samples from 30 COVID-positive mothers. Paired oropharyngeal swabs of the same neonates were also sent for RT-PCR at 48 h and on day 5 of life. All the breast milk samples were negative for SARS-CoV-2 except one. A repeat sample of breast milk from the same mother was also negative when rechecked the next day. All the paired neonatal oropharyngeal swabs were also negative for SARS-CoV-2. The authors could not find evidence for transmission of SARS-CoV-2 from mother to child through breastmilk in the population studied.