足月时不成比例的宫内生长干预试验：DIGITAT。
Disproportionate Intrauterine Growth Intervention Trial At Term: DIGITAT.
作者信息
Boers Kim E, Bijlenga Denise, Mol Ben W J, LeCessie Saskia, Birnie Erwin, van Pampus Marielle G, Stigter Rob H, Bloemenkamp Kitty W M, van Meir Claudia A, van der Post Joris A M, Bekedam Dick J, Ribbert Lucy S M, Drogtrop Addie P, van der Salm Paulien C M, Huisjes Anjoke J M, Willekes Christine, Roumen Frans J M E, Scheepers Hubertina C J, de Boer Karin, Duvekot Johannes J, Thornton Jim G, Scherjon Sicco A
机构信息
Department of Obstetrics and Gynaecology, Leiden University Medical Center, The Netherlands.
出版信息
BMC Pregnancy Childbirth. 2007 Jul 10;7:12. doi: 10.1186/1471-2393-7-12.
BACKGROUND
Around 80% of intrauterine growth restricted (IUGR) infants are born at term. They have an increase in perinatal mortality and morbidity including behavioral problems, minor developmental delay and spastic cerebral palsy. Management is controversial, in particular the decision whether to induce labour or await spontaneous delivery with strict fetal and maternal surveillance. We propose a randomised trial to compare effectiveness, costs and maternal quality of life for induction of labour versus expectant management in women with a suspected IUGR fetus at term.
METHODS/DESIGN: The proposed trial is a multi-centre randomised study in pregnant women who are suspected on clinical grounds of having an IUGR child at a gestational age between 36+0 and 41+0 weeks. After informed consent women will be randomly allocated to either induction of labour or expectant management with maternal and fetal monitoring. Randomisation will be web-based. The primary outcome measure will be a composite neonatal morbidity and mortality. Secondary outcomes will be severe maternal morbidity, maternal quality of life and costs. Moreover, we aim to assess neurodevelopmental and neurobehavioral outcome at two years as assessed by a postal enquiry (Child Behavioral Check List-CBCL and Ages and Stages Questionnaire-ASQ). Analysis will be by intention to treat. Quality of life analysis and a preference study will also be performed in the same study population. Health technology assessment with an economic analysis is part of this so called Digitat trial (Disproportionate Intrauterine Growth Intervention Trial At Term). The study aims to include 325 patients per arm.
DISCUSSION
This trial will provide evidence for which strategy is superior in terms of neonatal and maternal morbidity and mortality, costs and maternal quality of life aspects. This will be the first randomised trial for IUGR at term.
TRIAL REGISTRATION
Dutch Trial Register and ISRCTN-Register: ISRCTN10363217.
背景
约80%的宫内生长受限（IUGR）婴儿为足月出生。他们的围产期死亡率和发病率有所增加，包括行为问题、轻度发育迟缓以及痉挛性脑瘫。治疗存在争议，尤其是关于是否引产或在严密监测胎儿和母亲的情况下等待自然分娩的决策。我们提议进行一项随机试验，以比较足月疑似IUGR胎儿的妇女引产与期待治疗在有效性、成本和母亲生活质量方面的差异。
方法/设计：拟进行的试验是一项多中心随机研究，对象为临床怀疑在孕36⁺⁰至41⁺⁰周有IUGR胎儿的孕妇。在获得知情同意后，妇女将被随机分配至引产组或进行母婴监测的期待治疗组。随机分组将通过网络进行。主要结局指标将是综合的新生儿发病率和死亡率。次要结局指标将是严重的母亲发病率、母亲生活质量和成本。此外，我们旨在通过邮寄调查问卷（儿童行为检查表-CBCL和年龄与发育阶段问卷-ASQ）评估两年时的神经发育和神经行为结局。分析将按意向性分析进行。生活质量分析和偏好研究也将在同一研究人群中进行。包含经济分析的卫生技术评估是这项所谓的Digitat试验（足月不成比例宫内生长干预试验）的一部分。该研究旨在每组纳入325例患者。
讨论
这项试验将为哪种策略在新生儿和母亲发病率及死亡率、成本和母亲生活质量方面更具优势提供证据。这将是第一项针对足月IUGR的随机试验。
试验注册
荷兰试验注册库和ISRCTN注册库：ISRCTN10363217
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