A cluster randomized controlled trial of an electronic decision-support system to enhance antenatal care services in pregnancy at primary healthcare level in Telangana, India: trial protocol.

BACKGROUND: India contributes 15% of the total global maternal mortality burden. An increasing proportion of these deaths are due to Pregnancy Induced Hypertension (PIH), Gestational Diabetes Mellitus (GDM), and anaemia. This study aims to evaluate the effectiveness of a tablet-based electronic decision-support system (EDSS) to enhance routine antenatal care (ANC) and improve the screening and management of PIH, GDM, and anaemia in pregnancy in primary healthcare facilities of Telangana, India. The EDSS will work at two levels of primary health facilities and is customized for three cadres of healthcare providers - Auxiliary Nurse Midwifes (ANMs), staff nurses, and physicians (Medical Officers). METHODS: This will be a cluster randomized controlled trial involving 66 clusters with a total of 1320 women in both the intervention and control arms. Each cluster will include three health facilities-one Primary Health Centre (PHC) and two linked sub-centers (SC). In the facilities under the intervention arm, ANMs, staff nurses, and Medical Officers will use the EDSS while providing ANC for all pregnant women. Facilities in the control arm will continue to provide ANC services using the existing standard of care in Telangana. The primary outcome is ANC quality, measured as provision of a composite of four selected ANC components (measurement of blood pressure, blood glucose, hemoglobin levels, and conducting a urinary dipstick test) by the healthcare providers per visit, observed over two visits. Trained field research staff will collect outcome data via an observation checklist. DISCUSSION: To our knowledge, this is the first trial in India to evaluate an EDSS, targeted to enhance the quality of ANC and improve the screening and management of PIH, GDM, and anaemia, for multiple levels of health facilities and several cadres of healthcare providers. If effective, insights from the trial on the feasibility and cost of implementing the EDSS can inform potential national scale-up. Lessons learned from this trial will also inform recommendations for designing and upscaling similar mHealth interventions in other low and middle-income countries. CLINICALTRIALS: gov, NCT03700034, registered 9 Oct 2018, https://www. CLINICALTRIALS: gov/ct2/show/NCT03700034 CTRI, CTRI/2019/01/016857, registered on 3 Mar 2019, http://www.ctri.nic.in/Clinicaltrials/pdf_generate.php?trialid=28627&EncHid=&modid=&compid=%27,%2728627det%27.

Prospective cohort study of surgical site infections following single dose antibiotic prophylaxis in caesarean section at a tertiary care teaching hospital in Medchal, India.

BACKGROUND: Caesarean section (CS) is considered to be a life-saving operative intervention for women and new-borns in certain antepartum and intrapartum conditions. Caesarean delivery may be accompanied by several complications including surgical site infections (SSI). However, there is a significant lack of uniformity in the administration of antibiotics for preventing surgical site infections (SSI) following caesarean deliveries. The present study was conducted to determine the incidence of post CS SSI following the adoption of single-dose antibiotic prophylaxis as recommended by WHO at a tertiary care teaching hospital in Medchal, India. Also, to identify the risk factors of SSI and reported the bacteriological profiles and the antimicrobial susceptibility pattern of the culture positive isolates. MAIN OBJECTIVES: To estimate the incidence of surgical site infections (SSI's) according to CDC criteria following WHO-recommended single-dose antibiotic prophylaxis for caesarean section at a tertiary care teaching hospital in Medchal, India. METHODS: A prospective hospital-based study was conducted between June 2017 and December 2019, in which women who underwent caesarean delivery were followed up for 30 days post-delivery. Clinical details were collected using a structured questionnaire, and participants were followed up weekly after discharge to document any signs and symptoms of SSI. Symptomatic patients were requested to come to the hospital for further investigation and treatment. Standard microbiological tests were conducted to detect microorganisms and their antibiotic sensitivity. RESULTS: The study included 2,015 participants with a mean age of 24.1 years. The majority were multigravida (n = 1,274, 63.2%) and underwent emergency caesarean delivery (n = 1,232, 61.1%). Ninety two participants (4.6%, 95% CI: 3.7% to 5.6%) developed surgical site infections, with 91 (98.9%) having superficial and 1 (1.1%) having a deep infection. Among those who developed an SSI, 84 (91.3%) did so during their hospital stay, while 8 (8.7%) developed an SSI at home. The adjusted relative risk (a RR) for developing an SSI was 2.5 (95% CI: 1.4 to 4.6; power 99.9%) among obese women and 2.3 (95% CI: 1.1 to 4.7; power 100%) among women aged 25 years or younger. Microbial growth in culture was observed from 55 (75.8%) out of total 66 samples. The most common organisms identified were Staphylococcus aureus (n = 7(12.3%)23, 46.0%), Klebsiella sp. (n = 13, 26.0%), and Escherichia coli (n = 12, 24.0%). CONCLUSION: The rate of SSI following caesarean deliveries subjected to single dose antibiotic prophylaxis was low. Young women and obese women were at high risk of developing SSI.

Impact of prepregnancy body mass index on adverse pregnancy outcomes: analysis from the Longitudinal Indian Family hEalth cohort study.

BACKGROUND: Both high and low maternal prepregnancy body mass index can lead to suboptimal fetal growth and risk of pregnancy complications. In developed countries, nearly half of all women of childbearing age are either overweight or obese, and most data linking maternal body mass index and adverse pregnancy complications are limited to these populations. OBJECTIVE: This study aimed to prospectively evaluate the relationships between prepregnancy body mass index and adverse pregnancy outcomes using the Longitudinal Indian Family hEalth (LIFE) study. STUDY DESIGN: We modeled the relationships between prepregnancy body mass index and adverse pregnancy outcomes such as low birthweight, preterm birth, cesarean delivery, intrauterine growth restriction, miscarriage, and fetal death among 675 women aged 15 to 35 years with singleton pregnancies in the Longitudinal Indian Family hEalth study, a population-based prospective pregnancy cohort study conducted in Telangana, India. Prepregnancy body mass index was calculated as weight in kilograms divided by height in meters squared and was classified into 4 categories using the World Health Organization recommendations for Asian adults. Prepregnancy body mass index was assessed at a mean of 12.3 months before pregnancy. Odds ratios and 95% confidence intervals of adverse pregnancy outcomes were modeled and adjusted for confounders. RESULTS: Obese women had a 3-fold increased risk of cesarean delivery (odds ratio, 3.13; 95% confidence interval, 1.56-6.29) compared with normal-weight women. Those who were overweight also had a marginally increased risk of cesarean delivery, albeit not statistically significant (odds ratio, 1.17; 95% confidence interval, 0.61-2.24). Underweight women had a modestly increased risk of low birthweight, compared with normal-weight women (odds ratio, 1.12; 95% confidence interval, 0.71-1.77), although results were not significant. Conversely, obese (odds ratio, 0.71; 95% confidence interval, 0.28-1.77) and overweight (odds ratio, 0.61; 95% confidence interval, 0.24-1.51) women had a marginally decreased risk of low birthweight. CONCLUSION: Our data suggest that women with elevated prepregnancy body mass index may have a higher risk of adverse pregnancy outcomes, especially cesarean delivery. Although this study has limited generalizability, our findings are generalizable to rural to periurban regions of India. Further studies exploring the translatability of these findings to other populations are needed. In addition, targeted prepregnancy intervention studies and programs that include counseling on optimization of preconception health and lifestyle modification for improvement of subsequent pregnancy outcomes among overweight and obese women are needed.

Consanguineous Marriage and Early Pregnancy Loss in Rural to Peri-Urban India.

Background: Consanguineous marriage (CM) has been linked to spontaneous abortion (SAB), although studies have largely been cross-sectional and likely underestimated early loss. We aimed to determine the relationships between CM and SAB in a prospective pregnancy cohort study in Telangana State, India. Methods: Data from 661 participants aged 15-35 years in the Longitudinal Indian Family hEalth (LIFE) study actively followed for pregnancy and pregnancy loss were analyzed. SAB was classified as early (< 8) or late (8-22) weeks gestation. We used logistic regression to model the relationships between CM, defined by first-cousin marriage, and SAB, adjusted for maternal age. Results: Women in CM were at a modestly increased risk of any (ORadj 1.15, 95% CI 0.69, 1.91) and early (ORadj 2.03, 95% CI 0.85, 4.83) SAB compared to women in non-CM, although results were not statistically significant. There was no relationship between CM and late SAB. Conclusion: Among couples in southern India, there was a modest increase in early but not late SAB among CMs which may be explained by the expected influence of chromosomal abnormalities and lethal homozygous recessive disease on early loss. Pre- and Peri-marital Health Counseling that addresses this risk may be warranted. Supplementary Information: The online version contains supplementary material available at 10.1007/s13224-021-01498-7.