Study protocol: 'a large cohort study of postnatal events in a not-for-profit referral centre in Vellore, South India'.

INTRODUCTION: In a large developing country, with diverse population characteristics and differential access to healthcare, it is important to identify factors that influence postnatal health. This knowledge will help frame recommendations to enhance universal postnatal care. METHODS AND ANALYSIS: A prospective cohort study will be conducted by recruiting all participants who deliver in a referral centre in South India during a 1-year period after written consent is obtained from them. In addition to clinical information pertaining to their delivery and demographics, details of physical health, mental health socioeconomic status and emotional support will also be collected. Every participant will be followed up physically and/or by telephonic consultation at 3, 9 and 18 months of their postnatal period to reassess their status and that of their babies. As there are several independent and dependent variables requiring multivariate analysis, a sample size of 10 000 is considered adequate. Any unplanned visits to a health facility will be enquired into and documented for analysis.During data analysis, the effect of Caesarean section, high-risk characteristics and gestational age of the baby at delivery on various outcome measures and postnatal status will be evaluated. Interpretation of the large volume of collected data will help frame recommendations to improve postnatal care ETHICS AND DISSEMINATION: The study is approved by the Institutional Review Boards (Research and Ethics Committees) of Christian Medical College, Vellore, Tamil Nadu, India (IRB 12178 date 24 June 2020).Women are provided with a detailed information sheet and written consent is obtained. They are reassured that their care will not be compromised if they do not consent to the study. Data will be available on the clinical trial portal to assist in the dissemination of results after the project is published. TRIAL REGISTRATION NUMBER: CTRI/2022/03/041343.

The Impact of Secondary Hypertension in Pregnancy on Maternal and Fetal Outcomes: A 42-Month Observational Study from South India.

Objectives: To examine the prevalence, etiology, and clinical outcomes of secondary hypertension in pregnancy in a high-risk tertiary care hospital. Study Design: This retrospective study used data from patient records between January 2015 and July 2018. Of 52,293 pregnant women admitted during this period, those with hypertension were included. Patient demographics, diagnosis of secondary hypertension, investigations, suspected etiologies of secondary hypertension, maternal and neonatal outcomes and discharge conditions were included. Main Outcome Measures: The prevalence of secondary hypertension and causes were measured. Univariate followed by multivariate analyses were done to look for associated maternal and neonatal outcomes. Results: Among patients with chronic hypertension in pregnancy, 13.7% had secondary causes, of which renal and cardiac causes were the commonest. The incidence of severe pre-eclampsia (40.5%) among patients with secondary hypertension was higher in patients with systolic blood pressures more than 140 mm of Hg than in those with systolic blood pressures lower than 140 mm of Hg (odds ratio [OR]: 4.92, confidence interval [CI]: 1.7-14.16, p: 0.002) irrespective of etiology. Pre-eclampsia predisposed to maternal acute kidney injury (OR: 1.23, CI: 1.04-1.45, p: 0.003), low birthweight (OR: 4.69, CI: 1.44-11.9, p: 0.006), preterm delivery (OR: 4.69, CI: 1.78-12.34, p: 0.001), and neonatal death (OR: 5.19, CI: 0.97-27.6, p: 0.04). Conclusion: The prevalence of hypertension in pregnancy was 10.3%; among them, the prevalence of secondary hypertension was 1.46%. Uncontrolled secondary hypertension was associated with poor maternal and neonatal outcomes. Strict control of blood pressure in secondary hypertension in pregnancy ensured better outcomes.

A retrospective study analyzing indications and outcomes of mid-trimester emergency cervical cerclage in a tertiary care perinatal centre over half a decade.

We studied the indications, success rate, perinatal outcomes and maternal complications following mid-trimester emergency cervical cerclage. All women undergoing mid-trimester emergency cerclage at our centre during 2014-2019 were included in this retrospective study.There were 46 women in our cohort. Mean cervical length was 1.5 cm (SD ± 0.7), and 52.1% of them had bulging membranes. The mean gestational age at cerclage was 23.35 weeks (SD ± 3.341). Three were loss to follow up.Out of 43 pregnancies (23 singletons and 20 twins) analyzed, 37/43, 86.4% had livebirths. Success rate in the singletons and twins were 91.3% and 80% respectively. Maternal complications were seen in 56.5% of patients. Composite neonatal morbidity was significantly more in the twin group (p-value 0.04).Overall live birth rate was 86.4% with similar success rates in singleton and multiple pregnancies. Although, evidence for beneficial effect of prophylactic cerclage in multiple gestation is lacking, emergency cerclage may have a role in twin gestation.

Placenta accreta spectrum: Management and outcomes in a tertiary centre in India: An observational cross-sectional study.

Our observational cross-sectional study looked at the risk factors, diagnosis, management and outcomes of placenta accrete spectrum at the Christian Medical College and Hospital, Vellore, India, between January 2013 and December 2018. A total of 21 cases of placenta accrete spectrum are described among whom a preop diagnosis was available in 14 cases. A previous history of Caesarean section and placenta previa was present in 90%. Caesarean hysterectomy was carried out in 80%, but none of those managed conservatively required interval hysterectomy. Urinary tract injury was the most common surgical complication, seen in over 50%. The mean blood loss was 3.5 l and 14 patients required intensive care unit admission, but no maternal mortality ensued. Thus, we conclude that the conservative management in carefully selected cases is feasible.

Maternal and Perinatal Outcomes of Influenza in Pregnancy after Treatment with Oseltamivir.

CONTEXT: Influenza infection in pregnancy causes 4%-8% case fatality and five times more perinatal mortality. Influenza is a major contributor to mortality in developing countries; however, the morbidity has largely been underestimated. Public health interventions for prevention are also lacking. AIMS: This study aimed to determine the seasonality of influenza in pregnant Indian women and to estimate the maternal and perinatal morbidity after treatment with oseltamivir. SETTINGS AND DESIGN: This was a prospective observational cohort study, conducted in a tertiary hospital. SUBJECTS AND METHODS: Pregnant women with ILI (influenza-like illness) were recruited into Cohort 1 (polymerase chain reaction [PCR] positive) and Cohort 2 (PCR negative). Gestational age-matched asymptomatic controls formed Cohort 3. Women in Cohort 1 received oseltamivir for 5 days. The incidence of small-for-gestational age (SGA) and preterm birth were the primary outcomes. Maternal and neonatal morbidity formed the secondary outcomes. STATISTICAL ANALYSIS: Unmatched (Cohort 1 and 2) and matched analysis (Cohort 1 and 3) were done. Student's t-test and Chi-square test were used to compare between variables. RESULTS: Year-round incidence of influenza was recorded. Severe illness was more in Cohort 1 compared to Cohort 2 (36.2% vs. 6.3%; P < 0.001). SGA was comparable in all the cohorts (13%). Preterm birth (7.8% vs. 3.3%; P < 0.08; relative risk-2.75) was considerably high in Cohort 1. Secondary maternal and neonatal outcomes were similar between the groups. CONCLUSION: Influenza in pregnancy showed year-round incidence and increased maternal and neonatal morbidity despite treatment with oseltamivir. We suggest the need for newer interventions to curtail the illness in pregnancy.

An Integrated System for Fetal Scalp Visualization, Blood Collection and Analysis.

KEY MESSAGE: The new NB scope aids in better visualization of the scalp and blood collection and analysis at bed side. OBJECTIVE: Caesarean section rates and inherent complications are on the rise all over the world. One way to avoid a caesarean is to measure fetal scalp blood lactate levels. The methods available to visualize fetal scalp, obtain the blood sample and perform the blood test are separate, cumbersome and expensive, needing a certain level of expertise. We propose a device that incorporates all the steps of obtaining a fetal scalp blood lactate into one sleek, easy to use device. METHODS: The initial design, 3-D print and was tried on mannequin. After ethics committee approval, the prototype was experimented on patients in labour with singleton live fetus in cephalic presentation with no evidence of distress. RESULTS: There were (n = 9) patients recruited. There were (n = 5) primigravida and (n = 4) multigravida all of whom were in active labour. Parity did not seem to influence ease of instrumentation. Of the (n = 9) mothers (n = 2) had meconium-stained liquor and the rest (n = 7) had clear liquor, meconium-stained liquor did not affect visualization. The mean time taken to collect the sample was 184.11(± 33.04) seconds. CONCLUSION: The Neeraj-Bhaskar (NB) scope is an easy to use, affordable device that can be used time and again to decide on cases where emergency caesarean section can be avoided due to fetal distress.

Obstetric and perinatal outcomes in pregnant women with Takayasu's arteritis: single centre experience over five years

Objective: To study obstetric and perinatal outcomes among pregnant women with Takayasu arteritis (TA), attending our hospital for pregnancy and childbirth between January 2011 to December 2016. Material and Methods: Retrospective study was carried out by abstracting clinical charts on all pregnant women with TA who underwent antenatal care and/or delivery in our hospital during this period. American College of Rheumatology criteria was used for diagnosis of TA. Sixteen women with TA were included in the study. Maternal demographic data, stage of disease, complications related to disease, details of treatment taken prior to pregnancy, pregnancy outcomes, and neonatal outcomes were studied. Results: Forty-four percentage (7/16) belonged to type 5 angiographic type, however the same proportion (7/16) had undergone surgical corrections prior to pregnancy and the majority (15/16) were on medical management. Only three women (19%) were diagnosed during pregnancy. Most did not have active disease measured by Kerr's criteria (n=12; 75%), and Indian Takayasu clinical activity scores A. Chronic hypertension was the commonest antenatal complication (56.2%), nearly one-third had growth restricted babies and 25% had preterm labour. There were no cardiovascular events, no maternal deaths, nor fetal or neonatal deaths. Two-thirds of our women were delivered by caesarean section. Conclusion: Preconceptional counselling is of paramount importance in women with TA. Good maternal and fetal outcomes are observed with close antenatal surveillance and multidisciplinary care. Pregnancy should be planned during disease remission, with good antenatal care, close monitoring of clinical symptoms, early diagnosis and treatment of complications.

Decoding stillbirths using the Relevant Condition at Death classification: Study from the developing world

Objective: To determine the stillbirth rate in 2017 at Christian Medical College, a tertiary care perinatal center in South India, and to identify causes for the various stillbirths that occurred using the Relevant Condition at Death (ReCoDe) classification. Material and Methods: Medical records of the women with stillbirths between January 1st, to December 31st, 2017, were retrieved and analyzed using the SPSS software (IBM, version 23). The study was approved by the institutional review board (minute no: 11273, retro dated: 28/3/2018). Results: Of the total 14696 deliveries between January 1st, 2017, to December 31st, 2017, there were 247 stillbirths, a rate of 16.8 per 1000 births. Maternal factors: 156 (64.2%) women were booked and the rest were un-booked. Hypertensive disorders of pregnancy were detected in 27.5% (n=67). A greater number of un-booked women had gestational hypertension as compared with booked women (41% vs 24%, p=0.005). Fetal characteristics: still births secondary to lethal congenital anomalies were seen in 18.2% (n=45). Lethal congenital anomalies were diagnosed 10 times more in the booked patients than un-booked ones (24.7% vs 2.3%, p=0.001). Obstetric factors: one or two previous miscarriages were seen in 29.5% cases. Seventeen women (6.9%) had a prior stillbirth. ReCoDe Classification: we were able to successfully classify 84.2% of the stillbirths, leaving 15.78% unclassified. Fetal growth restriction secondary to uteroplacental insufficiency was found in 25.9% cases. Of the placental causes, abruption accounted for 10.9% of cases. Medical co-morbidities were seen in 46.5% pregnancies. Conclusion: The ReCoDe method of classifying stillbirths is useful in the developing world. It helped to elucidate the cause for stillbirths in 84.2% of cases. The majority of cases in our set were due to fetal growth restriction, hypertensive disorders of pregnancy, and uteroplacental insufficiency. Stillbirths can be prevented by a comprehensive antenatal care system, early recognition, and close monitoring of high-risk pregnancies.

Ten units intravenous oxytocin over 2-4 h is as effective as 30 units over 8-12 h in preventing postpartum hemorrhage after cesarean section: A randomized controlled trial.

OBJECTIVES: Currently, recommended high-dose oxytocin regimen for the prevention of postpartum hemorrhage (PPH) following cesarean delivery (CD) is associated with maternal side effects frequency of which is greater with a higher cumulative dose and rapid administration of oxytocin. Here, we evaluated the efficacy of single-dose intravenous oxytocin over 2-4 h (total = 10 units) with oxytocin maintenance infusion for 8-12 h (total = 30 units) in postoperative CD women for the prevention of PPH. METHODS: The current double-blinded randomized controlled trial was carried out in a tertiary care institute in Southern India. The primary outcome measures included the following: (a) the need for additional uterotonics to control PPH and (b) significant deterioration of vital signs as assessed by pulse rate and blood pressure in the postoperative period. The secondary outcome measures were as follows: (a) significant difference (≥10% between preoperative and postoperative packed cell volume) and (b) need for blood transfusion. RESULTS AND CONCLUSIONS: Two hundred and seventy-one women were randomized into Group A (oxytocin = 10 units; n = 135) and Group B (oxytocin = 30 units; n = 136). Both the groups were comparable with regard to demographic characteristics. There was no difference in any of primary or secondary outcome measures in the two groups. Thus, low-dose oxytocin regimen is as effective as high-dose oxytocin regimen in the prevention of PPH in postoperative CD women.

Large for Gestational Age Births Among South Indian Women: Temporal Trend and Risk Factors from 1996 to 2010.

BACKGROUND/PURPOSE: Mean birth weight is a good health indicator for any population. In the recent past, there have been many reports in the West indicating that there has been an increase in the proportion of large for gestational age (LGA) babies. The objective is to describe the change in the incidence of LGA babies from 1996 to 2010 in South India and the maternal risk factors. METHODS: A rotational sampling scheme was used, i.e., the 12 months of the year were divided into 4 quarters and a month was from each quarter was selected rotationally. All deliveries for that month were considered. Only deliveries that occurred between 28 and 42 weeks of pregnancy were considered. The association between risk variables was studied using multivariable logistic regression. RESULTS: There were 35,718 deliveries that occurred during these 15-year-study period in the gestational age 28-42 weeks were registered through the outpatient clinics. The incidence of LGA was 9.4 % that has mostly remained at the same level. The incidence of LGA in mothers with gestational diabetes was 6.7, 3 and 17.6 % in overweight, obese and gestational l diabetes mothers. Overweight, obesity in pregnant women and cesarean section were significant risk factors. CONCLUSION: Unlike in Western countries, where the incidence of LGA babies has spiraled upward, has remained nearly at the same level over one and a half decades, in South India. The risk factors for giving birth to LGA babies in South India were similar to other studies.

Risk Factors for Stress During Antenatal Period Among Pregnant Women in Tertiary Care Hospital of Southern India.

BACKGROUND: The well-being of an infant may be affected when the mother is subjected to psychosocial stress during her pregnancy. Mothers exposed to stressful conditions were more prone for preterm birth than those without any stress. In this study perceived stress has been used as an indicator of levels of stress. There are very few studies published from developing countries on the levels of perceived stress and its causes in pregnant women. MATERIALS AND METHODS: This study employed a cross-sectional assessment of pregnant women attending the outpatient services of a tertiary care hospital for regular antenatal check-up. Women not known to have any risk factors at 28 weeks to 34 weeks of pregnancy who agreed to participate in the study were interviewed to assess the perceived stress score. RESULTS: Among the total patients 57.7% were primigravida and the mean score on perceived stress scale was 13.5±5.02. The majority of the group (102; 65.4%) scored higher than the mean value of total score on the perceived stress scale. Unplanned pregnancy and husband's employment status were associated with high levels of perceived stress in multivariate analysis in this set of women. CONCLUSION: Individual as well as pregnancy related factors can contribute to perceived stress in pregnant women. With the established relationship between maternal mental health, pregnancy outcome and infant growth, the assessment and management of stress early in the pregnancy is crucial.

A Case Control Study to Evaluate the Association between Primary Cesarean Section for Dystocia and Vitamin D Deficiency.

BACKGROUND: Milder forms of vitamin D deficiency could be responsible for poor muscular performance causing dysfunctional labor. The aim of our research was to study the association between vitamin D deficiency and primary cesarean section. MATERIALS AND METHODS: This was a case control study. Forty six women who delivered by primary cesarean section with dystocia as primary or secondary indication after 37 weeks of gestation were taken as cases and a similar number of women who delivered vaginally were taken as controls. Vitamin D deficiency was diagnosed when the serum 25(OH)D level was ≤20 ng/ml and this was compared between cases and controls. RESULTS: Median serum (OH) vitamin D levels was 23.3ng/ml among women who delivered by cesarean section and 26.2ng/ml among controls (p=0.196). Baseline characteristics were similar in both groups except for a strong association between Body Mass Index (BMI) and cesarean section, (29.7kg/m(2) in cases and 25.9kg/m(2) in controls p=0.001) seen in multivariate analysis. Vitamin D deficiency was seen in 34.8% of cases and 21.7% of controls (p=0.165). CONCLUSION: This small case control study did not show a significant association between vitamin D deficiency and primary cesarean section.

Carbapenem Resistant Organisms: An Unusual Aetiology for Puerperal Sepsis.

Puerperal infection is a common complication of labour. It occurs universally and is usually responsive to first line antibiotics. However, resistance to first line antibiotics and even second line antibiotics is becoming more wide spread. We report a case of puerperal infection caused by carbapenem resistant organisms leading to prolonged fever and hospitalisation. A 28-year-old primigravida, following caesarean section done elsewhere, for elevated blood pressure presented with high grade fever. The patient was treated with antibiotic to which she failed to respond. She underwent laparotomy twice and only improved after Colistin was combined with Meropenam, based on urine and pus culture reports.

Small for gestational age births among South Indian women: temporal trend and risk factors from 1996 to 2010.

BACKGROUND: The birth weight and gestational age at birth are two important variables that define neonatal morbidity and mortality. In developed countries, chronic maternal diseases like hypertension, diabetes mellitus, renal disease or collagen vascular disease is the most common cause of intrauterine growth restriction (IUGR). Maternal nutrition, pregnancy induced hypertension, chronic maternal infections, and other infections such as cytomegalovirus, parvovirus, rubella and malaria are the other causes of IUGR. The present study examines the secular trend of Small for Gestational Age (SGA) over 15 years and risk factors for SGA from a referral hospital in India. METHODS: Data from 1996 to 2010 was obtained from the labour room register. A rotational sampling scheme was used i.e. 12 months of the year were divided into 4 quarters. Taking into consideration all deliveries that met the inclusion criteria, babies whose birth weights were less than 10(th) percentile of the cut off values specific for gestational ages, were categorized as SGA. Only deliveries of live births that occurred between 22 and 42 weeks of pregnancy were considered in this study. Besides bivariate analyses, multivariable logistic regression analysis was done. Nagelkerke R(2) statistics and Hosmer and Lemeshow chi-square statistics were used as goodness of fit statistics. RESULTS: Based on the data from 36,674 deliveries, the incidence of SGA was 11.4% in 1996 and 8.4% in 2010. Women who had multiple pregnancies had the higher odds of having SGA babies, 2.8 (2.3-3.3) times. The women with hypertensive disease had 1.8 (1.5-1.9) times higher odds of having SGA. Underweight women had 1.7 (1.3 - 2.1) times and anaemic mothers had 1.29 (1.01 - 1.6) times higher odds. The mothers who had cardiac disease were 1.4 (1.01 - 2.0) times at higher odds for SGA. In teenage pregnancies, the odds of SGA was 1.3 (1.1 - 1.5) times higher than mothers in the age group 20 to 35 years. CONCLUSIONS: There is a significant reduction in the incidence of SGA by 26% over 15 years. The women with the above modifiable risk factors need to be identified early and provided with health education on optimal birth weight.