Implementing the WHO Labour Care Guide to reduce the use of Caesarean section in four hospitals in India: protocol and statistical analysis plan for a pragmatic, stepped-wedge, cluster-randomized pilot trial.

BACKGROUND: The World Health Organization (WHO) Labour Care Guide (LCG) is a paper-based labour monitoring tool designed to facilitate the implementation of WHO's latest guidelines for effective, respectful care during labour and childbirth. Implementing the LCG into routine intrapartum care requires a strategy that improves healthcare provider practices during labour and childbirth. Such a strategy might optimize the use of Caesarean section (CS), along with potential benefits on the use of other obstetric interventions, maternal and perinatal health outcomes, and women's experience of care. However, the effects of a strategy to implement the LCG have not been evaluated in a randomised trial. This study aims to: (1) develop and optimise a strategy for implementing the LCG (formative phase); and (2) To evaluate the implementation of the LCG strategy compared with usual care (trial phase). METHODS: In the formative phase, we will co-design the LCG strategy with key stakeholders informed by facility assessments and provider surveys, which will be field tested in one hospital. The LCG strategy includes a LCG training program, ongoing supportive supervision from senior clinical staff, and audit and feedback using the Robson Classification. We will then conduct a stepped-wedge, cluster-randomized pilot trial in four public hospitals in India, to evaluate the effect of the LCG strategy intervention compared to usual care (simplified WHO partograph). The primary outcome is the CS rate in nulliparous women with singleton, term, cephalic pregnancies in spontaneous labour (Robson Group 1). Secondary outcomes include clinical and process of care outcomes, as well as women's experience of care outcomes. We will also conduct a process evaluation during the trial, using standardized facility assessments, in-depth interviews and surveys with providers, audits of completed LCGs, labour ward observations and document reviews. An economic evaluation will consider implementation costs and cost-effectiveness. DISCUSSION: Findings of this trial will guide clinicians, administrators and policymakers on how to effectively implement the LCG, and what (if any) effects the LCG strategy has on process of care, health and experience outcomes. The trial findings will inform the rollout of LCG internationally. TRIAL REGISTRATION: CTRI/2021/01/030695 (Protocol version 1.4, 25 April 2022).

The new WHO Labour Care Guide (LCG) is an innovative partograph that emphasises women-centred, evidence-based care during labour and childbirth. Together with clinicians working at four hospitals in India, we will develop and test a strategy to implement the LCG into routine care in labour wards of these hospitals. We will use a randomised trial design where this LCG strategy is introduced sequentially in each of the four hospitals, in a random order. We will collect data on all women giving birth and their newborns during this period and analyse whether the LCG strategy has any effects on the use of Caesarean section, women's and newborn's health outcomes, and women's experiences during labour and childbirth. While the trial is being conducted, we will also collect qualitative and quantitative data from doctors, nurses and midwives working in these hospitals, to understand their perspectives and experiences of using the LCG in their day-to-day work. In addition, we will collect economic data to understand how much the LCG strategy costs, and how much money it might save if it is effective. Through this study, our international collaboration will generate critical evidence and innovative tools to support implementation of the LCG in other countries.

Effects of the WHO Labour Care Guide on cesarean section in India: a pragmatic, stepped-wedge, cluster-randomized pilot trial.

Cesarean section rates worldwide are rising, driven by medically unnecessary cesarean use. The new World Health Organization Labour Care Guide (LCG) aims to improve the quality of care for women during labor and childbirth. Using the LCG might reduce overuse of cesarean; however, its effects have not been evaluated in randomized trials. We conducted a stepped-wedge, cluster-randomized pilot trial in four hospitals in India to evaluate the implementation of an LCG strategy intervention, compared with routine care. We performed this trial to pilot the intervention and obtain preliminary effectiveness data, informing future research. Eligible clusters were four hospitals with >4,000 births annually and cesarean rates ≥30%. Eligible women were those giving birth at ≥20 weeks' gestation. One hospital transitioned to intervention every 2 months, according to a random sequence. The primary outcome was the cesarean rate among women in Robson Group 1 (that is, those who were nulliparous and gave birth to a singleton, term pregnancy in cephalic presentation and in spontaneous labor). A total of 26,331 participants gave birth. A 5.5% crude absolute reduction in the primary outcome was observed (45.2% versus 39.7%; relative risk 0.85, 95% confidence interval 0.54-1.33). Maternal process-of-care outcomes were not significantly different, though labor augmentation with oxytocin was 18.0% lower with the LCG strategy. No differences were observed for other health outcomes or women's birth experiences. These findings can guide future definitive effectiveness trials, particularly in settings where urgent reversal of rising cesarean section rates is needed. Clinical Trials Registry India number: CTRI/2021/01/030695 .

Determinants of inhalant (whitener) use among street children in a South Indian city.

A cross-sectional study was conducted in the year 2008 among 174 children in observation homes in Hyderabad, India, to estimate the distribution of inhalant (whitener) use among this population. Data were collected using an instrument developed for this purpose. About 61% of the children were boys and their mean age was 12.2 years (range 5-18 years). Whitener use was found in 35% of the children along with concurrent use of other substances. Peer pressure was the commonest cause reported for initiating substance use. The high prevalence is an important concern for the Indian policymakers given the large number of street children in Indian cities.

Proportion and determinants of tuberculosis among human immunodeficiency virus-positive patients attending the antiretroviral therapy center attached to a Medical College in South India.

BACKGROUND: The human immunodeficiency virus/acquired immunodeficiency syndrome (HIV/AIDS) pandemic has caused a re-emergence of tuberculosis (TB). In persons infected with both HIV and TB, the lifetime risk of developing TB disease is 50-70% compared to 10% in HIV-negative individuals. India has world's 3(rd) highest HIV burden and is also one of the countries endemic for TB, so the country faces a dual epidemic of HIV and TB. OBJECTIVES: To find out the proportion and determinants of TB in HIV-positive subjects. SUBJECTS AND METHODS: This study was undertaken at the ART center from June 01, 2012, to May 31, 2013. HIV-positive subjects aged above 15 years who had been on antiretroviral therapy (ART) for more than 6 months were included in the study. Nonprobability purposive sampling was adopted. A predesigned semi-structured questionnaire was used to obtain data. RESULTS: A total of 536 HIV-positive people were interviewed, 58.8% of whom were males, 79.1% were Hindu, 61.0% had up to high school education, and 57% were unskilled laborers. About 63% were married, 40% were from the upper lower class, and 60% were from urban areas. For the majority (89.1%), the probable mode of transmission of HIV was by the heterosexual route. TB co-infection was present in 38.4% subjects. The most common form of TB was extra-pulmonary in subjects on antituberculous treatment (47.3%) and among old cases (57.6%). On bivariate analysis, 136 (42.4%) married subjects and those from rural areas were more commonly affected by TB compared to subjects who were unmarried and from urban areas with odds ratio (OR): 1.555, confidence interval (CI): 1.077-2.246 and OR: 1.523, CI: 1.061-2.185, respectively. The proportion of TB was high among subjects who lived in overcrowded houses 130 (44.2%), and who had a habit of alcohol use compared to others with OR: 1.731, CI: 1.734-2.179 and OR: 1.524, CI: 1.045-2.223, respectively. Logistic regression analysis showed that TB among people living with HIV/AIDS was highest in persons living in overcrowded houses (OR: 1.706, CI: 1.185-2.458) and those who consumed alcohol (OR: 1.605, CI: 1.090-2.362). CONCLUSIONS: Demographic factors like male gender, middle age, living in the rural areas, consumption of alcohol, and living in overcrowded houses were found with a higher proportion of TB. The use of highly active ART appeared to progressively decrease but did not completely eliminate the risk of TB.

Awareness about pictorial warnings on tobacco products and its impact on tobacco consumers in Bellary, India.

BACKGROUND: In India, 800,000-900,000 people will die annually due to diseases attributable to tobacco. The government of India has taken several measures, including legislation to control tobacco intake. Display of pictorial warnings on tobacco products was one of the legislative measures taken under The Cigarettes and Other Tobacco Products Act (COTPA) enacted in 2003, intended to discourage the consumption of tobacco. OBJECTIVES: 1) To study the factors influencing awareness among tobacco consumers about the pictorial warnings used on tobacco products; 2) To study the impact of the current pictorial warnings on tobacco consumers. MATERIALS AND METHODS: A cross sectional study was conducted from January 2011 to June 2011 at Bellary city, Karnataka. Data were collected with pre-tested and pre-designed semi-structured proforma. Univariate and multivariate analyses were conducted using Epi-info version 3.4.3. RESULTS: In our study out of 600 subjects 435 (72.5%) had seen the pictorial warnings. Among them 111 (25.5%) had interpreted correctly and 63 (14.5%) had given a thought/ tried to reduce or quit tobacco consumption. Younger age group, better educational status, people from urban area, upper socio economic class, lesser duration (< 5 years) of tobacco usage were found to have significant association with awareness about pictorial warnings on tobacco products. However, the impact of pictures on reducing/quitting tobacco consumption was very low. CONCLUSION: Awareness and its impact on tobacco consumption are poor among our study subjects. There is an urgent need for reconsideration for more effective pictorial warnings.

A study of prevalence of type 2 diabetes mellitus among urban adults of Ballari, India.

Background: Diabetes is a major lifestyle disorder, the prevalence of which is increasing globally. India has the unfortunate privilege of being the “Diabetes capital” of the world, more concerning is the fact that diabetes prevalence over the past 4 decades has increased fourfold. Indian studies have shown the prevalence rate of diabetes mellitus to be 2.4% in rural and 4 to 11% among urban dwellers due to industrialization and urbanization. There is a paucity of such data in the state and none in Ballari city hence this present study was undertaken to find out the prevalence of type 2 D in urban population of Ballari city. Methods: This is a cross sectional study conducted in urban wards of Ballari city. The sample of 1412 adults aged above 20 years were included in the study. Cluster sampling technique adopted to select the wards and systematic random sampling was used to select the subjects. Ethical clearance was obtained and written informed consent from respective subjects. Data was collected using pre designed and pretested semistructured questionnaire. Questionnaire included information regarding socio-demographic profile and blood glucose level was measured by glucometer. Results: The overall prevalence was found to be 12.7% and prevalence of diabetes mellitus was 15.6% in males and 10.1% in case of females. Conclusions: The prevalence of diabetes mellitus in Ballari city was 12.7%.