METHODOLOGY: This prospective, randomized, controlled trial enrolled pregnant females undergoing LSCS after spinal anesthesia. The participants were randomized into two groups: a novel 3D device group and a traditional wedge group. Primary outcome measures included the incidence of SHS, while secondary outcomes included maternal hemodynamic parameters, fetal outcomes, feasibility, ease of use, and the safety profile of the devices.
RESULTS: Baseline characteristics were well balanced between the two groups. Although some differences in maternal hemodynamic parameters were noted, the incidence of SHS was significantly lower in the novel 3D device group than that in the traditional wedge group. Fetal outcomes did not differ significantly between the groups. The novel 3D device demonstrated high compatibility with various patient anatomies and was easy to integrate into routine practice. The adverse event profiles were similar between the groups.
CONCLUSION: This study highlights the potential of a novel 3D-printed uterine displacement device for preventing SHS during LSCS, thereby improving maternal and fetal outcomes. Future research should further validate these findings and explore the long-term implications of the maternal and neonatal outcomes.
METHODS AND ANALYSIS: This is a protocol for a cluster randomised controlled trial that aims to evaluate the impact of the PRIME programme on participants' clinical outcomes and explore participants' and pharmacists' views towards its implementation. This protocol describes the development of the PRIME programme and mobile app, its feasibility and implementation in community pharmacy settings. 16 pharmacies from two states in Malaysia will be randomised to the intervention arm or standard care. The study will include overweight or obese adults with pre-diabetes. During each follow-up visit at the pharmacy, intervention participants will receive in-depth counselling from pharmacists after reviewing their self-monitoring data recorded in the PRIME app. They will also receive pre-diabetes education through the app and join a peer support chatgroup. The primary clinical outcome includes changes in body weight at 6 months, while the secondary clinical outcomes include changes in blood glucose profile, lipid profile, blood pressure and adiposity measures. The sustainability of the PRIME programme will be accessed using a follow-up questionnaire, while participants' engagement with the intervention will be evaluated using attendance rate and the app data. Focus group discussions and one-to-one interviews will be conducted for process evaluation. This study will inform the impact of community pharmacists-led digital health intervention in pre-diabetes management.
ETHICS AND DISSEMINATION: This study has been registered with clinicaltrials.gov (NCT04832984) and approved by the Monash University Human Research Ethics Committee (Project ID: 27512).
TRIAL REGISTRATION NUMBER: clinicaltrials.gov (NCT04832984).
RESULTS: An investigation on the adherence, invasion and intracellular survival of bacterial strains within the bovine aortic endothelial cell line (BAEC) were carried out. The potential vaccine strain, P. multocida B:2 GDH7, was significantly better (p ≤ 0.05) at adhering to and invading BAEC compared to its parent strain and to P. multocida B:2 JRMT12 and survived intracellularly 7 h post treatment, with a steady decline over time. A dual reporter plasmid, pSRGM, which enabled tracking of bacterial movement from the extracellular environment into the intracellular compartment of the mammalian cells, was subsequently transformed into P. multocida B:2 GDH7. Intracellular trafficking of the vaccine strain, P. multocida B:2 GDH7 was subsequently visualized by tracking the reporter proteins via confocal laser scanning microscopy (CLSM).
CONCLUSIONS: The ability of P. multocida B:2 GDH7 to model bactofection represents a possibility for this vaccine strain to be used as a delivery vehicle for DNA vaccine for future multivalent protection in cattle and buffaloes.