Holmes V A, Young I S, Maresh M J A, Pearson D W M, Walker J D, McCance D R
Department of Medicine, Queen's University Belfast, Belfast, UK.
Int J Gynaecol Obstet. 2004 Oct;87(1):66-71. doi: 10.1016/j.ijgo.2004.06.015.
Rates of pre-eclampsia in women with type 1 diabetes are two to four times higher than in normal pregnancies. Diabetes is associated with antioxidant depletion and increased free radical production, and an increasing body of evidence suggests that oxidative stress and endothelial cell activation may be relevant to disease pathogenesis in pre-eclampsia. The Diabetes and Pre-eclampsia Intervention Trial (DAPIT) aims to establish if pregnant women with type 1 diabetes supplemented with vitamins C and E have lower rates of pre-eclampsia and endothelial activation compared with placebo treatment.
DAPIT is a randomised multicentre double-blind placebo-controlled trial that will recruit 756 pregnant women with type 1 diabetes from 20 metabolic-antenatal clinics in the UK over 4 years. Women are randomised to daily vitamin C (1000 mg) and vitamin E (400 IU) or placebo at 8-22 weeks of gestation until delivery. Maternal venous blood is obtained at randomisation, 26 and 34 weeks, for markers of endothelial activation and oxidative stress and to assess glycaemic control. The primary outcome of DAPIT is pre-eclampsia. Secondary outcomes include endothelial activation (PAI-1/PAI-2) and birthweight centile.
1型糖尿病女性患先兆子痫的几率比正常妊娠女性高两到四倍。糖尿病与抗氧化剂消耗及自由基生成增加有关，越来越多的证据表明氧化应激和内皮细胞激活可能与先兆子痫的疾病发病机制相关。糖尿病与先兆子痫干预试验（DAPIT）旨在确定与安慰剂治疗相比，补充维生素C和E的1型糖尿病孕妇先兆子痫发生率及内皮激活率是否更低。
DAPIT是一项随机多中心双盲安慰剂对照试验，将在4年时间里从英国20家代谢产前诊所招募756名1型糖尿病孕妇。孕妇在妊娠8至22周随机分组，每日服用维生素C（1000毫克）和维生素E（400国际单位）或安慰剂，直至分娩。在随机分组时、26周和34周采集孕妇静脉血，检测内皮激活和氧化应激标志物，并评估血糖控制情况。DAPIT的主要结局是先兆子痫。次要结局包括内皮激活（PAI - 1/PAI - 2）和出生体重百分位数。
