Effect of prenatal exposure to maternal cortisol and psychological distress on infant development in Bengaluru, southern India: a prospective cohort study.

BACKGROUND: The mental health status of a pregnant woman and its consequent impact on foetal well being is not given much importance compared to the risk imposed by obstetric complications and medical conditions. Maternal psychological distress is a major public health problem and needs timely detection and intervention to prevent any adverse pregnancy outcome. There is ample evidence from literature that justifies the association of prenatal maternal mental stress and elevated cortisol with delayed infant motor and cognitive development; evidence from India being rather limited. The study aim is to prospectively assess the association of maternal psychological distress and cortisol level with motor and cognitive development of the infant. METHODS: A sample of 2612 eligible pregnant women who have been registered for antenatal care at selected public sector hospitals in Bengaluru will be recruited after obtaining written informed consent. They will be assessed for the presence of maternal psychological distress in the form of depression and anxiety using appropriate scales and saliva samples will be collected for cortisol estimation during early, mid and late pregnancy. Follow up visits after delivery will be done on day 10, 3 months, 8 months and 12 months. The Bayley Scales of Infant and Toddler Development [BSID] (Third edition) will be used to measure both motor and mental milestones in terms of Psychomotor Development Index (PDI) and Mental Development Index (MDI). Logistic regression model will be used to determine the association between the exposure variables and outcomes which will be reported as Odd's Ratio (OR) and 95% confidence intervals (CI). DISCUSSION: Our study findings could add to the growing evidence that maternal psychological distress during pregnancy adversely influences growth and development in the offspring and subsequent development of the child. While maternal anxiety and depression can be measured by using self reporting instruments, estimation of maternal endogenous cortisol levels could serve as a biomarker of prenatal psychological stress. Findings from this study could be used to focus upon the burden of mental health problems during pregnancy and to consider steps to scale up prenatal mental health services in health care settings

Sociodemographic, obstetric and psychological determinants of obesity among women in early to mid-pregnancy in South India

Background: Worldwide, the occurrence of obesity has markedly increased over the past decades with serious public health consequences. Obese pregnant women are more likely to develop hypertension, pre-eclampsia and gestational diabetes, resulting in obstetric complications which in turn may contribute to an increase in adverse child outcomes and maternal mortality. The present study was done to determine the prevalence of obesity and its association with socio-demographic variables, obstetric history and mental health. Methods: This study was nested within an ongoing cohort study, CASCADE, in a public hospital in Bangalore. The study participants comprised of 280 pregnant women who were 18 years of age and above, with a gestational age of less than 24 weeks, enrolled between a period of August 1st, 2017 until April 30th, 2018. Weight and height were measured using calibrated devices to calculate the body mass index. Results: The prevalence of obesity was observed to be 33.9% among the pregnant mothers. Obesity was found to be significantly associated with age, history of abortion, gravidity on multivariate logistic regression. No association was found with depression and anxiety. Conclusions: Obesity is an important health concern among urban pregnant women in the region of South India. The prevalence is much higher than that reported in other studies. Increasing age, multigravidity and past history of abortion were significantly associated with maternal obesity.</ns4:p

The prevalence and determinants of pregnancy-related anxiety amongst pregnant women at less than 24 weeks of pregnancy in Bangalore, Southern India.

Background: A pregnant woman undergoes physiological as well as psychological changes during this phase of life during which anxiety is a commonly faced mental condition. There is sufficient evidence on the association of pregnancy specific anxiety with adverse pregnancy outcomes. Studies on anxiety during pregnancy from low and middle income countries are limited. Methods: This study included 380 pregnant women, having a confirmed pregnancy of less than 24 weeks without any obstetric complication, who were availing of antenatal care at a public sector hospital in Bangalore city. Pregnancy-related thoughts (PRT) scale was used to screen for anxiety. Details pertaining to sociodemographic data, obstetric history, psychosocial factors including social support, marital discord, domestic violence, consanguinity, history of catastrophic events, history of mental illness, current presence of depression and anxiety was obtained by means of electronic data capture using an Android-based App. Results: Out of 380 pregnant women, 195 (55.7%) were found to have pregnancy-related anxiety. Lower socioeconomic status, low social support and depression emerged as significant determinants of anxiety. Conclusion: The prevalence of anxiety was fairly high in the study population and isp therefore an important public health concern. Pregnancy-related anxiety must be identified early during routine antenatal care to prevent any untoward pregnancy outcomes

Effectiveness of a novel mobile health (Peek) and education intervention on spectacle wear amongst children in India: Results from a randomized superiority trial in India.

BACKGROUND: Uncorrected refractive errors can be corrected by spectacles which improve visual functioning, academic performance and quality of life. However, spectacle wear can be low due to teasing/bullying, parental disapproval and no perceived benefit.Hypothesis: higher proportion of children with uncorrected refractive errors in the schools allocated to the intervention will wear their spectacles 3-4 months after they are dispensed. METHODS: A superiority, cluster-randomised controlled trial was undertaken in 50 government schools in Hyderabad, India using a superiority margin of 20%. Schools were the unit of randomization. Schools were randomized to intervention or a standard school programme. The same clinical procedures were followed in both arms and free spectacles were delivered to schools. Children 11-15 years with a presenting Snellen visual acuity of <6/9.5 in one or both eyes whose binocular acuity improved by ≥2 lines were recruited.In the intervention arm, classroom health education was delivered before vision screening using printed images which mimic the visual blur of uncorrected refractive error (PeekSim). Children requiring spectacles selected one image to give their parents who were also sent automated voice messages in the local language through Peek. The primary outcome was spectacle wear at 3-4 months, assessed by masked field workers at unannounced school visits. www.controlled-trials.com ISRCTN78134921 Registered on 29 June 2016. FINDINGS: 701 children were prescribed spectacles (intervention arm: 376, control arm: 325). 535/701 (80%) were assessed at 3-4 months: intervention arm: 291/352 (82.7%); standard arm: 244/314 (77.7%). Spectacle wear was 156/291 (53.6%) in the intervention arm and 129/244 (52.9%) in the standard arm, a difference of 0.7% (95% confidence interval (CI), -0.08, 0.09). amongst the 291 (78%) parents contacted, only 13.9% had received the child delivered PeekSim image, 70.3% received the voice messages and 97.2% understood them. INTERPRETATION: Spectacle wear was similar in both arms of the trial, one explanation being that health education for parents was not fully received. Health education messages to create behaviour change need to be targeted at the recipient and influencers in an appropriate, acceptable and accessible medium. FUNDING: USAID (Childhood Blindness Programme), Seeing is Believing Innovation Fund and the Vision Impact Institute

Prenatal Depression and Its Associated Risk Factors Among Pregnant Women in Bangalore: A Hospital Based Prevalence Study

BACKGROUND The most common psychological problem that affects a woman during her perinatal period worldwide is depression. The risk of prenatal depression increases significantly as pregnancy progresses and clinically significant depressive symptoms are common in mid and late trimesters. Studies from various countries around the world have shown a prevalence rate ranging from as low as 4% to as high as 81%. The prevalence of depression in India is shown to vary from 9.18% in one study to 36.75 % reported in another. There is paucity of research on depression during the prenatal period, especially in India. Given this background, the present study aimed to assess the prevalence of prenatal depression and its associated risk factors among pregnant women in Bangalore, Southern India. METHODS: The study was nested within an on-going cohort study. The study participants comprised of pregnant women attending the antenatal clinic at Jaya Nagar General Hospital (Sanjay Gandhi Hospital) in Bangalore. The data was collected using standardised questionnaires. Edinburgh Postnatal Depression Scale (EPDS), Multidimensional Scale of Perceived Social Support Scale (MSPSS), Revised Dyadic Adjustment Scale, The Modified Conflict Tactics scale, Modified Kuppuswamy socio economic scale, Pregnancy related anxiety Scales were used. RESULTS: Of the 280 pregnant mothers, the proportion of them who screened positive for prenatal depression was 35.7%. Presence of domestic violence was found to impose a five times higher and highly significant risk of developing prenatal depression among the respondents. Pregnancy related anxiety was also found to be a positive predictor of prenatal depression. Presence of catastrophic events in the past one year was found to impose a two times higher and significant risk of developing prenatal depression among the respondents. CONCLUSION: The present study showed a higher prevalence of prenatal depression among the study participants which is suggestive of the public health importance in the study region. Health care plans therefore can include screening and diagnosis of prenatal depression in the antenatal care along with other health care facilities provided

What makes the pregnant women revisit public hospitals for research? Participant engagement and retention trial in a public hospital (PERTH): an RCT protocol.

BACKGROUND: Cohort studies have public health importance as they effectively provide evidence on determinants of health from a life course perspective. Researchers often confront the poor follow-up rates as a major challenge in the successful conduct of cohort studies. We are currently recruiting in a birth cohort study, titled as "Maternal Antecedents of Adiposity and Studying the Transgenerational role of Hyperglycemia and Insulin" (MAASTHI) in a public hospital; with the aim of assessing maternal glycemic levels on the risk of adverse fetal outcomes. Nested within the ongoing cohort, the proposed trial aims to evaluate the effectiveness of two interventions in improving the follow-up in the cohort study in a public hospital. METHODS: A randomized trial of 795 pregnant women, with 265 women each in three arms observed through pregnancy, until their baby is 14 weeks old. The comparator group receives a standard leaflet, with details on the importance of glucose testing and regular follow up in pregnancy. Intervention arm-1 will receive the standard leaflet plus individualized messages, through an Interactive Voice Response (IVR) system; a type of computer-linked telephone intervention system to remind the participants about the lab test and follow-up dates. Intervention arm- 2 will have the opportunity to attend Mother and Baby Affairs (MBA) workshops, which will provide information on Gestational Diabetes Mellitus (GDM) screening and management to pregnant women and personalized counselling services. The outcome of interest is the difference in the proportion of participants completing follow-up at different points in time, among three arms. DISCUSSION: Between the two interventions (IVR and MBA), the study results would uncover the contextually specific, timely intervention, which can increase the proportion of pregnant women followed up in public hospitals. If effective, this study will provide information on an effective intervention, useful in ensuring the success of longitudinal follow-up in the public hospitals. TRIAL REGISTRATION: NCT03088501 , Date Registered: 16/03/2017

Family-led rehabilitation after stroke in India: a randomised controlled trial

Background: Most people with stroke in India have no access to organised rehabilitation services. The effectiveness of training family members to provide stroke rehabilitation is uncertain. Our primary objective was to determine whether family-led stroke rehabilitation, initiated in hospital and continued at home, would be superior to usual care, in a low resource setting. Methods: The Family-led Rehabilitation after Stroke in India (ATTEND) trial was a prospectively randomised open trial with blinded endpoints (PROBE) conducted across 14 hospitals in India. Patients (and their caregivers) were randomised to intervention or usual care by site Coordinators, using a secure web-based system, with minimisation by site and stroke severity. The intervention group received additional structured rehabilitation training, commenced in hospital and continued at home for up to 2 months. The primary outcome was death or dependency, defined by scores 3 to 6 on the modified Rankin scale (range, 0 [no symptoms] to 6 [death]) as assessed by blinded observers at six months. Secondary outcomes included any serious adverse event, hospital length of stay, activities of daily living, health-related quality of life, anxiety and depression, and caregiver strain. All analyses were intention to treat. Registration: Clinical Trials Registry-India (CTRI/2013/04/003557); Australian New Zealand Clinical Trials Registry (ACTRN12613000078752); and Universal Trial Number (U1111-1138-6707) Findings: A total of 1,250 patients were randomised (623 intervention and 627 control) between 13 January 2014 and 12 February 2016. At six months, 285 of 607 (47·0%) participants in the intervention group were dead or dependent compared to 287 of 605 (47·4%) in the control group (odds ratio 0·98; 95% confidence Interval 0·78 to 1·23, P = 0·87). No significant differences were observed in any of the secondary or safety outcomes. Interpretation: Family-led rehabilitation did not reduce death or dependency after stroke

Evaluating the Effectiveness of Interventions to Improve the Follow-up Rate for Children With Visual Disabilities in an Eye Hospital in Nepal: Nonrandomized Study

Background: Monitoring ocular morbidity among pediatric patients requires regular follow-up visits. We found that the follow-up rate was poor among children in our setting. Therefore, we intended to assess the effectiveness of 2 interventions—(1) counseling and (2) SMS text messaging and phone calls—to improve the follow-up rates. Objective: This study aimed to evaluate the effectiveness of 2 interventions, counseling and SMS and phone calls group, as well as a routine standard care for improving the follow-up rate of pediatric patients. Methods: A Nonrandomized, quasiexperimental design was used. Children (aged 0-16 years) with ocular conditions requiring at least 3 follow-up visits during the study period were included. A total of 264 participants were equally allocated to the 3 intervention groups of (1) counseling, (2) SMS and phone calls, and (3) routine standard care group. A 20-minute counseling session by a trained counselor with the provision of disease-specific leaflets were given to those in the counseling group. For the second intervention group, parents of children received an SMS text 3 days before and a phone call 1 day before their scheduled follow-up visits. Participants allocated for the routine standard care group were provided with the existing services with no additional counseling and reminders. Participants attending 3 follow-ups within 2 days of the scheduled visit date were considered compliant. The difference in and among the proportion of participants completing all 3 follow-up visits in each group was assessed. Results: The demographic characteristics of the participants were similar across the study groups. Only 3% (8/264) of participants completed all 3 follow-up visits, but overall compliance with the follow-up, as defined by the investigators, was found to be only 0.76% (2/264). There was no statistically significant difference in the proportion of follow-up between the intervention groups. However, the proportion of participants attending the first and second follow-ups, as well as the overall total number of follow-ups, was more in the SMS and phone-call group followed by the counseling group. Conclusions: We did not find any evidence on the effectiveness of our interventions to improve the follow-up rate. The primary reason could be that this study was conducted during the COVID-19 pandemic. It could also be possible that the intensity of the interventions may have influenced the outcomes. A rigorously designed study during the absence of any lockdown restrictions is warranted to evaluate intervention effectiveness. The study also provides useful insights and highlights the importance of designing and systematically developing interventions for improving the follow-up rate and ensuring a continuum of care to children with visual disabilities in Nepal and similar contexts. Trial Registration: ClinicalTrials.gov NCT04837534; https://clinicaltrials.gov/ct2/show/NCT04837534 International Registered Report Identifier (IRRID): RR2-10.2196/3157

Risk factors for orofacial clefts in India:A case-control study

BACKGROUND: Orofacial clefts (OFC) are linked with several genetic and environmental factors. The aim of this study was to explore the association of potential risk factors with OFCs in India. METHODS: This was a hospital-based, matched case-control (1:4 ratio; matching done for parity) study conducted in Hyderabad, Bengaluru, and Delhi-National Capital Region. Cases (nonsyndromic clefts) were recruited from treatment centers, while controls (live births) were recruited from maternity centers. Information on exposures was collected during personal interviews. Exposures of interest included folic acid supplementation during the peri-conceptional period, consanguineous marriage, exposure to drugs, infections during pregnancy, family history of OFC, and dietary factors. RESULTS: A total of 785 participants were included in the study: 157 cases and 628 controls. A family history of cleft lip/palate (adjusted odds ratio [AOR], 15.48; 95% confidence interval [CI], 4.36-54.96; p value = 0.001), exclusive vegetarianism (AOR, 4.47; 95% CI, 1.83-10.98; p value = 0.001), and delayed first conception (AOR, 2.55, 95% CI, 1.25-5.21, p = 0.01) were found to be strongly associated with higher risk of OFCs. Supplementation with folic acid during first 3 months of pregnancy was not found to be protective against OFCs (AOR, 1.24; 95% CI, 0.59-2.58; p value = 0.56). CONCLUSION: Our study confirmed the importance of family history as a risk factor for OFC. Our study did not show an association with folic acid supplementation but was underpowered to detect small effects. Our finding of higher risk among vegetarians requires replication. Birth Defects Research 109:1284-1291, 2017. © 2017 The Authors. Birth Defects Research Published by Wiley Periodicals, Inc

Family-led rehabilitation after stroke in India (ATTEND): a randomised controlled trial

Background: Most people with stroke in India have no access to organised rehabilitation services. The effectiveness of training family members to provide stroke rehabilitation is uncertain. Our primary objective was to determine whether family-led stroke rehabilitation, initiated in hospital and continued at home, would be superior to usual care, in a low resource setting. Methods: The Family-led Rehabilitation after Stroke in India (ATTEND) trial was a prospectively randomised open trial with blinded endpoints (PROBE) conducted across 14 hospitals in India. Patients (and their caregivers) were randomised to intervention or usual care by site Coordinators, using a secure web-based system, with minimisation by site and stroke severity. The intervention group received additional structured rehabilitation training, commenced in hospital and continued at home for up to 2 months. The primary outcome was death or dependency, defined by scores 3 to 6 on the modified Rankin scale (range, 0 [no symptoms] to 6 [death]) as assessed by blinded observers at six months. Secondary outcomes included any serious adverse event, hospital length of stay, activities of daily living, health-related quality of life, anxiety and depression, and caregiver strain. All analyses were intention to treat. Registration: Clinical Trials Registry-India (CTRI/2013/04/003557); Australian New Zealand Clinical Trials Registry (ACTRN12613000078752); and Universal Trial Number (U1111-1138-6707) Findings: A total of 1,250 patients were randomised (623 intervention and 627 control) between 13 January 2014 and 12 February 2016. At six months, 285 of 607 (47·0%) participants in the intervention group were dead or dependent compared to 287 of 605 (47·4%) in the control group (odds ratio 0·98; 95% confidence Interval 0·78 to 1·23, P = 0·87). No significant differences were observed in any of the secondary or safety outcomes. Interpretation: Family-led rehabilitation did not reduce death or dependency after stroke