Protocol for a Diagnostic Accuracy Study of Polymerase Chain Reaction for Detecting Group B <i>Streptococcus</i>Colonisation in Early Labour or with Spontaneous Ruptured Membranes

Background: Group B Streptococcus [GBS] is a bacterium which transiently colonises the genital tract and can be transmitted from mother to baby at birth. Babies colonised with GBS can develop early-onset group B streptococcus disease [EOGBSD] which can lead to extended hospital stay, disability and death. One of the primary methods for determining which women are most likely to be GBS positive at the time of birth is antenatal universal culture-based screening. Recently Polymerase Chain Reaction [PCR] screening has emerged as a point-of-care method for screening women during the intrapartum period. This study will compare the diagnostic accuracy of this new technology and antenatal culture-based screening at 35 to 37 weeks gestational age, with the reference standard of formal culture-based testing in labour. Methods: This prospective observational study will take place in an Australian hospital. Consecutive women with one or more live fetuses, intending to have a vaginal birth will be asked to participate. Planned screening for GBS colonisation using microbiological culture on a self-collected specimen will occur at 35 to 37 completed weeks gestational age as per our usual hospital policy. A PCR GBS test by Xpert GBS (Cepheid) will be performed on admission to labour ward or at the time of rupture of membranes. The reference standard will be a formal GBS culture on a combined lower vaginal and perianal swab. The sensitivity, specificity, positive and negative predictive values, and positive and negative likelihood ratios will be estimated for both antenatal screening and the intrapartum Xpert GBS (Cepheid) point-of-care test and compared to the reference standard. Results: It is expected that the study will be completed by mid to late 2020. Conclusion: This study has the potential to improve the accuracy of GBS screening of pregnant women and therefore health outcomes for mothers and babies. There is also the potential for a cost savings to the health system.

期刊与学术会议论文摘要中报告随机对照试验的CONSORT声明：说明与详述

背景:对于与随机对照试验(randomized controlled trial,RCT)有关的学术会议论文或期刊中发表的文章来说,清楚、明了、信息量充足的摘要是十分重要的,因为读者经常仅仅根据报告的摘要对一个临床试验作出评价。为此,我们需要对"临床试验报告的统一标准(Consolidated Standards of Reporting Trials,CONSORT)声明"进行扩充,制定一个期刊与学术会议论文摘要中报告RCT的必备条目清单。今后在任何期刊发表的论文或学术会议论文摘要中,作者对RCT结果的报告都要包含这些内容。方法与结果:我们根据现有的质量评价工具和基于经验的证据总结出一个条目清单。运用三轮修正式德尔菲法(modified-Delphi process)进行条目筛选。邀请共计109人参与电子网络调查,反馈率为61%。调查结果于2007年1月在加拿大蒙特贝罗举行的CONSORT小组会议中公布,与会的26人中有临床试验实施人员、统计学家、流行病学家以及生物医学编辑。经过讨论最终确定条目,随后对其进行修订以保证这些条目体现了会议期间以及会后的讨论思路。摘要CONSORT建议RCT报告的摘要需要有一个结构化的格式,其中应该包括具体的试验目的、试验设计(随机分配的方法、盲法或遮蔽等)、研究对象(对象描述、随机分组的样本量以及用于分析的样本量)、每组实施的干预、实施的干预对主要疗效结果的影响及其危害、试验结论、试验注册名称和编号以及资金来源。本文对每一条能够找到例子的纳入条目都配有良好报告范例、基本原理以及证据等,十分明了易懂,因此我们建议与清单同时使用。结论:摘要CONSORT旨在改善期刊与学术会议中发表的论文摘要的质量,这将有助于摘要提供详尽清晰的信息,这些信息能够帮助读者对试验的有效性和试验结果的适用性做出正确的评价。

出生前反复暴露于皮质激素的新生儿的呼吸窘迫综合征:一项随机化对照试验

Background: The efficacy and safety of repeat doses ofprenatal corticosteroids remains uncertain. Our aim was to establish whether repeat prenatal corticosteroids given to women at risk of preterm birth can reduce neonatal morbidity without harm. Methods: In this hospital-basedstudy, 982 women who remained at risk of preterm birth at less than 32 weeks’ gestation, 7 or more days after receiving a first course of prenatal corticosteroids,were randomly assigned to receive a repeat intramuscular dose of either 11.4 mg betamethasone (as Celestone Chronodose), or saline placebo. This was repeated every week the woman remained undelivered, at less than 32 weeks’ gestation, and at risk of preterm birth. Primary outcomes were occurrence and severity of neonatal respiratory distress syndrome, use and duration of oxygen and mechanical ventilation, and weight, length, and head circumference at birth and hospital discharge. Statistical analyses were on an intention to treat basis. This study is registered as an International Standard Randomised Controlled Trial, number ISRCTN48656428. Findings:Fewer babies exposed to repeat corticosteroids had respiratory distress syndrome (33%vs 41%; relative risk 0.82,95%CI 0.71-0.95, P=0.01) and fewer had severe lung disease(12%vs 20%; relative risk 0.60, 95%CI 0.46-0.79,P=0.0003) than those in the placebo group. In keeping with these benefits, babies exposed to repeat corticosteroids needed less oxygen therapy (P=0.03), and shorter duration of mechanical ventilation (P=0.01). Mean weight,length, and head circumference at birth and hospital discharge did not differ between treatment groups. Z-scores for weight (P=0.04) and head circumference (P=0.03) at birth were lower in the babies who received repeat corticosteroids although at the time of hospital discharge Z-scores did not differ between treatment groups (P=0.29 for weight, P=0.48 for head circumference). Interpretation:Exposure to repeat doses of antenatal corticosteroids reduces neonatal morbidity. Pending long-term outcome results, the short-term benefits for the babies in our study support the use of repeat doses of corticosteroids in women who remain at risk of very preterm birth 7 or more days after an initial course.

维生素C和维生素E与子痫前期和围生期并发症之间相关性的研究

BACKGROUND: Supplementation with antioxidant vitamins has been proposed to reduce the risk of preeclampsia and perinatal complications, but the effects of this intervention are uncertain. METHODS: We conducted a multicenter, randomized trial of nulliparous women between 14 and 22 weeks of gestation. Women were assigned to daily supplementation with 1000 mg of vitamin C and 400 IU of vitamin E or placebo (microcrystalline cellulose) until delivery. Primary outcomes were the risks of maternal preeclampsia, death or serious outcomes in the infants (on the basis of definitions used by the Australian and New Zealand Neonatal Network), and delivering an infant whose birth weight was below the 10 th percentile for gestational age. RESULTS: Of the 1877 women enrolled in the study, 935 were randomly assigned to the vitamin group and 942 to the placebo group. Baseline characteristics of the two groups were similar. There were no significant differences between the vitamin and placebo groups in the risk of preeclampsia (6.0 percent and 5.0 percent, respectively; relative risk, 1.20; 95 percent confidence interval, 0.82 to 1.75), death or serious outcomes in the infant (9.5 percent and 12.1 percent; relative risk, 0.79; 95 percent confidence interval, 0.61 to 1.02), or having an infant with a birth weight below the 10th percentile for gestational age (8.7 percent and 9.9 percent; relative risk, 0.87; 95 percent confidence interval, 0.66 to 1.16). CONCLUSIONS: Supplementation with vitamins C and E during pregnancy does not reduce the risk of preeclampsia in nulliparous women, the risk of intrauterine growth restriction, or the risk of death or other serious outcomes in their infants.

维生素C、维生素E与围生期并发症及先兆子痫风险

BACKGROUND: Supplementation with antioxidant vitaminshas been proposed to reduce the risk of preeclampsia and perinatal complications, but the effects of this intervention are uncertain. METHODS: We conducted a multicenter, randomized trial of nulliparous women between 14 and 22 weeks of gestation. Women were assigned to daily supplementation with 1000 mg of vitamin C and 400 IU of vitamin E or placebo (microcrystalline cellulose) until delivery. Primary outcomes were the risks of maternal preeclampsia, death or serious outcomes in the infants (on the basis of definitions used by the Australian and New Zealand Neonatal Network), and delivering an infant whose birth weight was below the 10th percentile for gestational age. RESULTS: Of the 1877 women enrolled in the study, 935 were randomly assigned to the vitamin group and 942 to the placebo group.Baseline characteristics of the two groups were similar.There were no significant differences between the vitaminand placebo groups in the risk of preeclampsia (6.0 percent and 5.0 percent, respectively; relative risk, 1.20;95 percent confidence interval, 0.82 to 1.75), death or serious outcomes in the infant (9.5 percent and 12.1 percent;relative risk, 0.79; 95 percent confidence interval,0.61 to 1.02), or having an infant with a birth weight below the 10th percentile for gestational age (8.7 percent and 9.9 percent; relative risk, 0.87; 95 percent confidence interval,0.66 to 1.16). CONCLUSIONS: Supplementation with vitamins C and E during pregnancy does not reduce the risk of preeclampsia in nulliparous women, the risk of intrauterine growth restriction, or the risk of death or other serious outcomes in their infants.

Male obesity and subfertility, is it really about increased adiposity？

The prevalence of overweight and obesity in reproductive-aged men is increasing worldwide, with 〉70% of men 〉18 years classified as overweight or obese in some western nations. Male obesity is associated with male subfertility, impairing sex hormones, reducing sperm counts, increasing oxidative sperm DNA damage and changing the epigenetic status of sperm. These changes to sperm function as a result of obesity, are further associated with impaired embryo development, reduced live birth rates and increased miscarriage rates in humans. Animal models have suggested that these adverse reproductive effects can be transmitted to the offspring; suggesting that men＇s health at conception may affect the health of their children, in addition to higher adiposity, male obesity is associated with comorbidities, including metabolic syndrome, hypercholesterolemia, hyperleptinemia and a pro-inflammatory state, all which have independently been linked with male subfertility. Taken together, these findings suggest that the effects of male obesity on fertility are likely multifactorial, with associated comorbidities also influencing sperm, pregnancy and subsequent child health.