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首页> 外文期刊>Human Reproduction >A feasibility trial of screening women with idiopathic recurrent miscarriage for high uterine natural killer cell density and randomizing to prednisolone or placebo when pregnant
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A feasibility trial of screening women with idiopathic recurrent miscarriage for high uterine natural killer cell density and randomizing to prednisolone or placebo when pregnant

机译：筛查特发性反复流产妇女子宫自然杀伤细胞密度高并在怀孕时随机分配泼尼松龙或安慰剂的可行性试验

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STUDY QUESTION: Is it feasible to screen women with idiopathic recurrent miscarriage (RM) for high uterine natural killer (uNK) cell density and then randomize them to prednisoione or placebo when pregnant? SUMMARY ANSWER: It was feasible to recruit women with idiopathic RM into a 'screen and treat' trial despite their desire for active medication. WHAT IS KNOWN ALREADY: Clinical trials of immunotherapy in women with idiopathic RM have failed to substantiate efficacy in preventing miscarriage. Preimplantation uNK cell density is higher in women with RM and can be reduced with prednisolone. STUDY DESIGN, SIZE, DURATION: InapilotRCT, 160 eligible women were screened with an endometrial biopsy and those with high uNK cell density were invited to return when pregnant for randomization to prednisolone (20 mg for 6 weeks, 10 mg for 1 week, 5 mg for 1 week) or identical placebo tablets. Randomization was by random number generation and patients, clinicians and outcome assessors were blinded to allocation. The study size and duration was determined by funding, which was for a feasibility trial, for 2 years, sufficient to screen 150 women and randomize 40 women. The outcome measures were recruitment rate, women's perspectives, compliance, live birth and miscarriage rates and pregnancy complications. PARTICIPANTS/MATERIALS, SETTING, METHODS: The trial was advertised nationally in the UK. Women who attended research clinics run by one consultant (SQ) with three or more consecutive idiopathic miscarriages were included. Women's perspectives of the trial were sought through a questionnaire. The endometrium was sampled 5-9 days afterthe LH surge, stained using immunohistochemistry for CD56 and the sub-epithelial region analysed with image analysis. Women with a high uNK cell density (> 5%) were invited to contact the clinic at 4-6 weeks gestation for randomization. Compliance with medication was assessed using a daily log, and side effects recorded by the women in a diary and on a structured proforma completed in the clinic at the end of the first trimester. All women had ultrasound scans every 2 weeks until 14 weeks' gestation and growth scans at 28 and 34 weeks' gestation in addition to routine antenatal care and a follow-up in person or by telephone 6 weeks after delivery. MAIN RESULTS AND THE ROLE OF CHANCE: Despite the fact that 85% of women said they would prefer the active treatment, the trial recruitment occurred at the planned rate. Eligible women (n = 160) attended the research clinics and had the uNK test, 72 were screen positive and 40 returned when pregnant for randomization. Compliance with medication was reported to be 100%. The active treatment was associated with side effects of insomnia and flushing. The live birth rate was 12/20 (60%) with prednisolone and 8/20 (40%) with placebo (Risk Ratio 1.5, 95% confidence interval (Cl) 0.79-2.86, absolute difference 20% Cl-10%, +50%), and hence, this was not significant. There were no pregnancy complications or serious adverse fetal outcomes.LIMITATIONS, REASONS FOR CAUTION: This was a feasibility trial so of insufficient size to assess efficacy or safety. There was inconsistency in the start date of the trial medication and this may have affected the outcome in the active treatment group. WIDER IMPLICATIONS OF THE FINDINGS: It was feasible to recruit women with idiopathic RM into a'screen and treat' trial despite their desire for active medication. Our data also suggest that in future trials the primary outcome measure is live birth rate after 24 weeks gestation. STUDY FUNDING/COMPETING INTEREST(s): Moulton charitable trust funded this study. There are no competing interests. TRIAL REGISTRATION NUMBER: Current Controlled Trials No: ISRCTN28090716.
机译：研究问题：是否可以筛查特发性反复流产（RM）妇女的高子宫自然杀伤（uNK）细胞密度，然后在怀孕时将其随机分配给泼尼松龙或安慰剂？总结答案：征集患有特发性RM的女性，尽管他们希望使用主动药物，也可以进行“筛查和治疗”试验。已经知道的是：特发性RM妇女的免疫疗法临床试验未能证实预防流产的功效。患有RM的女性，植入前的uNK细胞密度更高，泼尼松龙可以降低。研究设计，大小，时间：InapilotRCT，对160例符合条件的妇女进行了子宫内膜活检，并邀请怀孕时uNK细胞密度高的妇女随机返回泼尼松龙（20 mg，6周，10 mg，1周，5 mg） 1周）或相同的安慰剂片剂。随机化是通过随机数的产生而进行的，患者，临床医生和结果评估者对分配不知情。研究规模和持续时间由一项为期两年的可行性试验资金决定，足以筛选150名妇女并随机分配40名妇女。结果指标是招募率，妇女的观点，依从性，活产和流产率以及妊娠并发症。参与者/材料，环境，方法：该试验在英国全国进行广告宣传。包括参加由一名顾问（SQ）运营的研究诊所并连续三次或更多次自然流产的妇女。通过调查表征询了妇女对审判的看法。 LH激增后5-9天取样子宫内膜，用免疫组织化学法对CD56染色，并用图像分析法分析上皮下区域。 uNK细胞密度高（> 5％）的妇女应在妊娠4-6周时联系诊所进行随机分组。使用每日记录来评估对药物的依从性，并由妇女在孕早期在日记中以及在诊所完成的结构化形式上记录下女性的副作用。所有妇女每两周进行一次超声波扫描，直到妊娠14周为止。除常规的产前护理以及分娩后6周内亲自或电话随访外，所有妇女均在妊娠28和34周时进行了生长扫描。主要结果和机会：尽管有85％的妇女表示愿意接受积极治疗，但仍按计划的比例招募了试验人员。符合条件的妇女（n = 160）进入研究诊所并接受了uNK测试，其中72例筛查呈阳性，40例因随机分组而返回。据报道对药物的依从性为100％。积极的治疗与失眠和潮红的副作用有关。泼尼松龙的活产率为12/20（60％），安慰剂为8/20（40％）（风险比1.5，95％置信区间（Cl）0.79-2.86，绝对差异20％Cl-10％，+ 50％），因此这并不重要。没有妊娠并发症或严重的胎儿不良后果。局限性，警告原因：这是一项可行性试验，因此规模不足以评估疗效或安全性。试验药物的开始日期不一致，这可能已经影响了积极治疗组的结果。结果的更广泛含义：尽管他们希望使用活性药物，也可以招募患有特发性RM的妇女参加“筛查和治疗”试验。我们的数据还表明，在未来的试验中，主要结果指标是妊娠24周后的活产率。研究资金/竞争兴趣：Moulton慈善信托基金资助了这项研究。没有利益冲突。试用注册号：电流控制试验编号：ISRCTN28090716。

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