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 .

An epidemiological study on dog bite and its management in Bellary, Karnataka.

Animal bites are common childhood occurrences. Dog bites remain constant problem in our country because of the increasing dog population. To know the pattern of dog bites in children, the morbidity Pattern, the circumstances of dog bites, ascertain the first aid measures and Vaccination practiced by people after dog bites and the compliance with vaccination and adverse reactions due to vaccination, this cross sectional descriptive study was carried put on children who were dog bite victims attending VIMS hospital, Bellary during Feb 2011 to Nov 2011. Out of 536 participants 71% were males and 29% were females. 35% of the participants belongs to 10-12 yr age group. Majority of the victims belongs to upper lower and lower class of socio economic group. 42% of children were bitten over lower limbs and 43.8% of the victims had some local treatment immediately. 77% of the victims were received anti-rabies vaccine and only 11% of the dogs were vaccinated against rabies.

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.