Antiplatelets for prevention of pre-eclampsia: an individual patient data review
Antiplatelets for prevention of pre-eclampsia: an individual patient data review
批准号:
nhmrc : 253636
负责人:
A/Pr Christine Roberts
金额:
$18.27万
依托单位国家:
澳大利亚
项目类别:
NHMRC Project Grants
财政年份:
2003
资助国家:
澳大利亚
项目状态:
已结题
起止时间:
2003-01-01 至 2005-12-31
中文摘要
高血压是一种常见的妊娠并发症,每年约有20,000名澳大利亚妇女受到影响。虽然大多数孕妇和她们的宝宝都很健康,但先兆子痫(即高血压和尿液中的蛋白质)是一个更严重的问题。10-15%的孕产妇死亡与严重先兆子痫有关。胎儿和新生儿死亡率也有所上升。母婴发病率高主要是由于妊娠相关并发症、产科干预措施增加、胎儿生长受限和早产。到目前为止,我们还没有安全有效的方法来预防这种危及生命的疾病。已知血小板聚集(参与血液凝固)是该疾病的一部分,并可能导致母亲和胎盘循环紊乱。抗血小板药物,特别是低剂量阿司匹林,可能预防或延缓先兆子痫的发展。一些试验和Cochrane对所有试验(涉及3万多名妇女)的系统评价表明,先兆子痫、早产和围产期死亡可以减少。然而,目前还不清楚哪些女性会受益,怀孕期间应该在什么时候开始治疗,以及服用多少剂量的阿司匹林既有效又安全。这一建议的个体患者数据审查从原始研究者处收集所有参与试验的女性的数据,包括关于潜在危害的缺失信息。这项建议是对资源的良好投资,以获得妇女和保健专业人员在决定是否使用阿司匹林时所需的信息。来自所有初级试验的国际研究人员已经形成了一个合作组织来监督该项目:围产期抗血小板国际研究审查(PARIS)合作组织。此外,通过国际合作将确保获得最高质量的数据,以及在实践中对结果的认可和实施。
英文摘要
High blood pressure is a common complication of pregnancy affecting ~20,000 Australian women each year. Although most women and their babies do well, pre-eclampsia, defined as high blood pressure together with protein in the urine is a more serious problem. Severe pre-eclampsia is associated with 10-15% of maternal deaths. Fetal and newborn baby deaths are also increased. Mother and baby morbidity is high principally due to the associated complications in pregnancy, increased obstetric interventions, fetal growth restriction and preterm birth. As yet we have no safe and effective way of preventing this life threatening condition. Aggregation of platelets (involved in blood clotting) is known to be part of the disease and could lead to the disturbances in the circulation of the mother and the placenta. Antiplatelet agents, low dose aspirin in particular, might prevent or delay the development of pre-eclampsia. Some trials and a Cochrane systematic review of all trials (involving over 30,000 women) suggest that pre-eclampsia, preterm birth and perinatal death could be reduced. However, it is still not clear which women will benefit, when in pregnancy the treatment should start and what dose of aspirin is both effective and safe. This proposed individual patient data review in which data on all women who have been entered in trials is gathered from the original investigators, including missing information on potential harms. This proposal represents a good investment of resources to obtain the information needed by women and health professional to make decisions about the use of aspirin. International investigators from all the primary trials have already formed a collaboration to oversee the project: the Perinatal Antiplatelet Review of International Studies (PARIS) Collaboration Furthermore, working through an international collaboration will ensure the highest quality in data availability, as well endorsement and implementation of the results in practice.
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