Midwifery Education Program, Ryerson University, Toronto, Canada.
Department of Pediatrics, Mount Sinai Hospital, Toronto, Canada.
J Matern Fetal Neonatal Med. 2021 Jun;34(11):1814-1821. doi: 10.1080/14767058.2019.1650907. Epub 2019 Aug 13.
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 ( GR-1 and 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 [ = 73] and placebo group [ = 66]). Of these, 113 were included in the final analysis (probiotic group [ = 57] and placebo group [ = 56]). Baseline characteristics between groups were similar with the exception of gestational age ( < .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%; = .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.
目的：B 组链球菌（GBS）阴道/直肠定植与早发型 GBS 疾病（EOGBSD）有关，EOGBSD 是新生儿发病率和死亡率的主要原因。在加拿大，为妊娠 35-37 周的孕妇提供 GBS 定植的普遍筛查，对于筛查阳性者提供产时抗生素预防（IAP）。普遍筛查和 IAP 治疗并未消除所有 EOGBSD 病例，且 IAP 已被记录存在副作用。益生菌补充剂已被提议作为降低 GBS 定植的一种可能方法。
材料和方法：入组时年龄>18 岁且<45 岁、妊娠<25 周的孕产妇女被随机分配口服 GR-1 和 RC-14 两种益生菌胶囊或安慰剂，每日 2 粒，持续 12 周，于妊娠 23-25 周时开始。主要目的是确定更大规模研究的可行性。还评估了两组孕妇在 35-37 周时 GBS 阴道/直肠定植的发生率。
结果：共 139 名孕产妇女被随机分配（益生菌组 [n=73]和安慰剂组 [n=66]）。其中，113 人被纳入最终分析（益生菌组 [n=57]和安慰剂组 [n=56]）。组间基线特征相似，但妊娠年龄不同（<.01）。入组率较低，为 12%，但平均依从率为 87%。纳入/排除标准过于严格，对于更大规模的拟议研究，需要对研究设计进行更改。两组阴道/直肠 GBS 定植率无显著差异（15.8%比 21.43%； = .48）。益生菌组未记录到不良反应。
结论：这是安大略省首次由助产士主导的涉及天然保健品的试验。尽管口服益生菌治疗是可行的，但与安慰剂相比，其降低 GBS 定植率的效果并不优越。需要进行一项充分的、随机对照试验来评估两种益生菌菌株的有效性。
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