STRIDER（西地那非治疗预后不良的早期胎儿生长受限）：一项国际性随机安慰剂对照试验的联合会研究。
STRIDER (Sildenafil TheRapy in dismal prognosis early onset fetal growth restriction): an international consortium of randomised placebo-controlled trials.
机构信息
Academisch Medisch Centrum, Meibergdreef 9, 1105, AZ, Amsterdam, The Netherlands.
University College Cork, Cork, Ireland.
出版信息
BMC Pregnancy Childbirth. 2017 Dec 28;17(1):440. doi: 10.1186/s12884-017-1594-z.
BACKGROUND
Severe, early-onset fetal growth restriction due to placental insufficiency is associated with a high risk of perinatal mortality and morbidity with long-lasting sequelae. Placental insufficiency is the result of abnormal formation and function of the placenta with inadequate remodelling of the maternal spiral arteries. There is currently no effective therapy available. Some evidence suggests sildenafil citrate may improve uteroplacental blood flow, fetal growth, and meaningful infant outcomes. The objective of the Sildenafil TheRapy In Dismal prognosis Early onset fetal growth Restriction (STRIDER) collaboration is to evaluate the effectiveness of sildenafil versus placebo in achieving healthy perinatal survival through the conduct of randomised clinical trials and systematic review including individual patient data meta-analysis.
METHODS
Five national/bi-national multicentre randomised placebo-controlled trials have been launched. Women with a singleton pregnancy between 18 and 30 weeks with severe fetal growth restriction of likely placental origin, and where the likelihood of perinatal death/severe morbidity is estimated to be significant are included. Participants will receive either sildenafil 25 mg or matching placebo tablets orally three times daily from recruitment to 32 weeks gestation.
DISCUSSION
The STRIDER trials were conceived and designed through international collaboration. Although the individual trials have different primary outcomes for reasons of sample size and feasibility, all trials will collect a standard set of outcomes including survival without severe neonatal morbidity at time of hospital discharge. This is a summary of all the STRIDER trial protocols and provides an example of a prospectively planned international clinical research collaboration. All five individual trials will contribute to a pre-planned systematic review of the topic including individual patient data meta-analysis.
TRIAL REGISTRATIONS
New Zealand and Australia: ACTRN12612000584831 . Registered 30/05/2012. Canada: NCT02442492 . Registered 05/05/2015. Ireland: CT 900/572/1 . Registered 15/07/2015. The Netherlands: NCT02277132 . Registered 29/09/2014. United Kingdom: ISRCTN39133303 . Registered 31/07/2014.
背景
由于胎盘功能不全导致的严重早期胎儿生长受限与围产期死亡率和发病率的高风险相关，并伴有长期的后遗症。胎盘功能不全是由于胎盘的异常形成和功能导致母体螺旋动脉重塑不足所致。目前尚无有效的治疗方法。一些证据表明，西地那非枸橼酸盐可能改善胎盘血流、胎儿生长和有意义的婴儿结局。西地那非治疗不良预后早期胎儿生长受限（STRIDER）合作的目的是通过开展随机临床试验和系统评价，包括个体患者数据荟萃分析，评估西地那非与安慰剂在实现健康围产儿生存方面的有效性。
方法
已启动了五项全国/两国多中心随机安慰剂对照试验。纳入的研究对象为 18-30 周患有严重胎儿生长受限（可能为胎盘源性）、围产期死亡/严重发病率风险高的单胎妊娠孕妇。参与者将从招募到 32 孕周时，每天口服 25 毫克西地那非或匹配的安慰剂片剂 3 次。
讨论
STRIDER 试验是通过国际合作构思和设计的。虽然出于样本量和可行性的原因，各个试验的主要结局不同，但所有试验都将收集一套标准结局，包括出院时无严重新生儿发病率的生存情况。这是所有 STRIDER 试验方案的摘要，并提供了一个前瞻性计划的国际临床研究合作的范例。所有五项单独的试验都将为包括个体患者数据荟萃分析的预先计划的系统综述做出贡献。
试验注册
新西兰和澳大利亚：ACTRN12612000584831。于 2012 年 5 月 30 日注册。加拿大：NCT02442492。于 2015 年 5 月 5 日注册。爱尔兰：CT 900/572/1。于 2015 年 7 月 15 日注册。荷兰：NCT02277132。于 2014 年 9 月 29 日注册。英国：ISRCTN39133303。于 2014 年 7 月 31 日注册。
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