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澳大利亚妊娠期糖尿病后母亲糖尿病预防计划(MAGDA-DPP)产后干预:一项随机对照试验研究方案的更新

Mothers After Gestational Diabetes in Australia Diabetes Prevention Program (MAGDA-DPP) post-natal intervention: an update to the study protocol for a randomized controlled trial.

作者信息

Shih Sophy T F, Davis-Lameloise Nathalie, Janus Edward D, Wildey Carol, Versace Vincent L, Hagger Virginia, Asproloupos Dino, O'Reilly Sharleen L, Phillips Paddy A, Ackland Michael, Skinner Timothy, Oats Jeremy, Carter Rob, Best James D, Dunbar James A

机构信息

Greater Green Triangle University Department of Rural Health, Flinders University, PO Box 423, 3280 Warrnambool, VIC, Australia.

出版信息

Trials. 2014 Jun 30;15:259. doi: 10.1186/1745-6215-15-259.

Abstract

BACKGROUND

The Mothers After Gestational Diabetes in Australia Diabetes Prevention Program (MAGDA-DPP) is a randomized controlled trial (RCT) that aims to assess the effectiveness of a structured diabetes prevention intervention for women who had gestational diabetes.

METHODS/DESIGN: The original protocol was published in Trials (http://www.trialsjournal.com/content/14/1/339). This update reports on an additional exclusion criterion and change in first eligibility screening to provide greater clarity. The new exclusion criterion "surgical or medical intervention to treat obesity" has been added to the original protocol. The risks of developing diabetes will be affected by any medical or surgical intervention as its impact on obesity will alter the outcomes being assessed by MAGDA-DPP. The screening procedures have also been updated to reflect the current recruitment operation. The first eligibility screening is now taking place either during or after pregnancy, depending on recruitment strategy.

TRIAL REGISTRATION

Australian New Zealand Clinical Trials Registry ANZCTRN 12610000338066.

摘要

背景

澳大利亚妊娠糖尿病后母亲糖尿病预防项目(MAGDA-DPP)是一项随机对照试验(RCT),旨在评估针对患有妊娠糖尿病的女性进行结构化糖尿病预防干预的有效性。

方法/设计:原始方案发表于《试验》杂志(http://www.trialsjournal.com/content/14/1/339)。本次更新报告了一项额外的排除标准以及首次资格筛查的变化,以提供更清晰的说明。新的排除标准“用于治疗肥胖的手术或医学干预”已添加到原始方案中。任何医学或手术干预都会影响患糖尿病的风险,因为其对肥胖的影响会改变MAGDA-DPP所评估的结果。筛查程序也已更新,以反映当前的招募操作。首次资格筛查现在根据招募策略在孕期或产后进行。

试验注册

澳大利亚新西兰临床试验注册中心ANZCTRN 12610000338066。

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