研究方案 OPPTIMUM——孕激素预防早产能否改善结局？
Trial protocol OPPTIMUM-- does progesterone prophylaxis for the prevention of preterm labour improve outcome?
机构信息
University of Edinburgh MRC Centre for Reproductive Health, The Queen's Medical Research Institute, 47 Little France Crescent, Edinburgh, EH16 4TY, UK.
出版信息
BMC Pregnancy Childbirth. 2012 Aug 6;12:79. doi: 10.1186/1471-2393-12-79.
BACKGROUND
Preterm birth is a global problem, with a prevalence of 8 to 12% depending on location. Several large trials and systematic reviews have shown progestogens to be effective in preventing or delaying preterm birth in selected high risk women with a singleton pregnancy (including those with a short cervix or previous preterm birth). Although an improvement in short term neonatal outcomes has been shown in some trials these have not consistently been confirmed in meta-analyses. Additionally data on longer term outcomes is limited to a single trial where no difference in outcomes was demonstrated at four years of age of the child, despite those in the "progesterone" group having a lower incidence of preterm birth.
METHODS/DESIGN: The OPPTIMUM study is a double blind randomized placebo controlled trial to determine whether progesterone prophylaxis to prevent preterm birth has long term neonatal or infant benefit. Specifically it will study whether, in women with singleton pregnancy and at high risk of preterm labour, prophylactic vaginal natural progesterone, 200 mg daily from 22 - 34 weeks gestation, compared to placebo, improves obstetric outcome by lengthening pregnancy thus reducing the incidence of preterm delivery (before 34 weeks), improves neonatal outcome by reducing a composite of death and major morbidity, and leads to improved childhood cognitive and neurosensory outcomes at two years of age. Recruitment began in 2009 and is scheduled to close in Spring 2013. As of May 2012, over 800 women had been randomized in 60 sites.
DISCUSSION
OPPTIMUM will provide further evidence on the effectiveness of vaginal progesterone for prevention of preterm birth and improvement of neonatal outcomes in selected groups of women with singleton pregnancy at high risk of preterm birth. Additionally it will determine whether any reduction in the incidence of preterm birth is accompanied by improved childhood outcome.
TRIAL REGISTRATION
ISRCTN14568373.
背景
早产是一个全球性问题，其发病率因地点而异，为 8%至 12%。几项大型试验和系统评价表明，孕激素在有单胎妊娠（包括宫颈短或既往早产史的孕妇）的高危妇女中，可有效预防或延迟早产。虽然一些试验显示短期新生儿结局有所改善，但荟萃分析并未一致证实这一点。此外，关于长期结局的数据仅限于一项试验，该试验在四年时未显示出儿童结局的差异，尽管“孕激素”组的早产发生率较低。
方法/设计：OPPTIMUM 研究是一项双盲随机安慰剂对照试验，旨在确定孕激素预防早产是否对新生儿有长期益处。具体而言，它将研究在有单胎妊娠且早产风险高的妇女中，预防性阴道给予天然孕激素（200mg/天），从 22-34 孕周开始，与安慰剂相比，是否通过延长妊娠时间（从而降低早产发生率）来改善产科结局，是否通过减少死亡和主要发病率的复合终点来改善新生儿结局，以及是否在 2 岁时改善认知和神经感觉结局。该研究于 2009 年开始招募，计划于 2013 年春季结束。截至 2012 年 5 月，60 个地点已有超过 800 名妇女被随机分配。
讨论
OPPTIMUM 将提供进一步的证据，证明阴道孕激素在预防早产和改善高危单胎妊娠妇女的新生儿结局方面的有效性。此外，它将确定早产发生率的任何降低是否伴随着儿童结局的改善。
试验注册
ISRCTN84362674。
Zotero 插件