Consensus Statement No. 434: Simulation in Obstetrics and Gynaecology.

OBJECTIVE: To provide a comprehensive and current overview of the evidence for the value of simulation for education, team training, patient safety, and quality improvement in obstetrics and gynaecology, to familiarize readers with principles to consider in developing a simulation program, and to provide tools and references for simulation advocates. TARGET POPULATION: Providers working to improve health care for Canadian women and their families; patients and their families. OUTCOMES: Simulation has been validated in the literature as contributing to positive outcomes in achieving learning objectives, maintaining individual and team competence, and enhancing patient safety. Simulation is a well-developed modality with established principles to maximize its utility and create a safe environment for simulation participants. Simulation is most effective when it involves interprofessional collaboration, institutional support, and regular repetition. BENEFITS, HARMS, AND COSTS: This modality improves teamwork skills, patient outcomes, and health care spending. Upholding prescribed principles of psychological safety when implementing a simulation program minimizes harm to participants. However, simulation can be an expensive tool requiring human resources, equipment, and time. EVIDENCE: Articles published between 2003 and 2022 were retrieved through searches of Medline and PubMed using the keywords "simulation" and "simulator." The search was limited to articles published in English and French. The articles were reviewed for their quality, relevance, and value by the SOGC Simulation Working Group. Expert opinion from relevant seminal books was also considered. VALIDATION METHODS: The authors rated the quality of evidence and strength of recommendations using the Grading of Recommendations Assessment, Development and Evaluation (GRADE) approach. See online Appendix A (Tables A1 for definitions and A2 for interpretations of strong and conditional [weak] recommendations). INTENDED AUDIENCE: All health care professionals working to improve Canadian women's health, and relevant stakeholders, including granting agencies, physician/nursing/midwifery colleges, accreditation bodies, academic centres, hospitals, and training programs.

Effectiveness of oral intake of Lactobacillus rhamnosus GR-1 and Lactobacillus reuteri RC-14 on Group B Streptococcus colonization during pregnancy: a midwifery-led double-blind randomized controlled pilot trial.

OBJECTIVE: Group B streptococcus (GBS) vaginal/rectal colonization in pregnancy has been associated with early-onset GBS disease (EOGBSD), a leading cause of neonatal morbidity and mortality. In Canada, universal screening for GBS colonization is offered to pregnant people at 35-37 weeks' gestation and those who test positive are offered intrapartum antibiotic prophylaxis (IAP). Universal screening and treatment with IAP have not eradicated all cases of EOGBSD, and IAP has documented side effects. Probiotic supplements have been proposed as a possible way to reduce GBS colonization. MATERIALS AND METHODS: Pregnant midwifery clients >18 years of age and <45 years of age and with a gestational age of <25 weeks at the time of enrolment were randomly assigned to receive two capsules of probiotics (Lactobacillus rhamnosus GR-1 and Lactobacillus reuteri RC-14) or placebo orally daily for 12 weeks at 23-25 weeks' gestation. The primary aim was to determine the feasibility of a larger study. The rate of GBS vaginal/rectal colonization at 35-37 weeks' gestation was also assessed in both groups. RESULTS: In total, 139 pregnant midwifery clients were randomized (probiotic group [N = 73] and placebo group [N = 66]). Of these, 113 were included in the final analysis (probiotic group [N = 57] and placebo group [N = 56]). Baseline characteristics between groups were similar with the exception of gestational age (p < .01). The recruitment rate was low at 12%, but the mean compliance rate was 87%. The eligibility/ineligibility criteria were too strict and changes to the study design will be required for the larger proposed study. The rates of vaginal/rectal GBS colonization did not differ significantly between groups (15.8 versus 21.43%; p = .48). No adverse effects were documented in the probiotic group. CONCLUSION: This was the first midwifery-led trial involving a natural health product in the province of Ontario. Although treatment with oral probiotics is feasible, the results were not superior to placebo in reducing the rate of GBS colonization. An adequately powered, randomly controlled trial is required to assess the effectiveness of the two probiotic strains.