Early Diagnosis of Gestational Diabetes Mellitus (EDoGDM) study: a protocol for a prospective, longitudinal cohort study.
Early Diagnosis of Gestational Diabetes Mellitus (EDoGDM) study: a protocol for a prospective, longitudinal cohort study.
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DOI：
10.1136/bmjopen-2016-012315
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发表时间：
2016-11-21
期刊：
影响因子：
2.9
通讯作者：
Wang Z
中科院分区：
文献类型：
--
作者：
Liu B;Xu Y;Zhang Y;Cai J;Deng L;Yang J;Zhou Y;Long Y;Zhang J;Wang Z
低风险孕妇妊娠期糖尿病 (GDM) 的诊断基于妊娠 24 至 28 周之间的口服葡萄糖耐量试验 (OGTT)。然而，没有足够的证据说明为什么在这个时间段进行测试。此外，胎儿可能在当前测试时间范围之前暴露于高血糖，这使得早期给药具有潜在的优势。本研究的主要目的是探讨妊娠 18-20 周时进行的 OGTT 对 GDM 的诊断价值。该研究结果可能为孕妇进行 OGTT 最有益的时间提供科学见解。作为一项前瞻性纵向队列研究，妊娠糖尿病早期诊断 (EDoGDM) 研究将招募 570 名符合下述纳入和排除标准的孕妇。 OGTT 将在妊娠 18 至 20 周（早期 OGTT）和妊娠 24-28 周（常规 OGTT）之间进行。将收集母亲及其后代的临床和实验室信息进行分析。描述孕18-20周GDM的患病率，研究早期OGTT诊断GDM的敏感性、特异性、阳性预测值和阴性预测值。将比较通过早期或定期 OGTT 诊断的组之间与高血糖相关的临床结果。本研究经中山大学附属第一医院伦理委员会批准（批准号：2016-042）。所有参与者均需签署知情同意书。这项研究的结果将在同行评审的期刊上传播。 NCT02740283。
A diagnosis of gestational diabetes mellitus (GDM) in low-risk pregnant women is based on an oral glucose tolerance test (OGTT) between 24 and 28 gestational weeks. However, there is insufficient evidence for why the test is performed in this time period. Moreover, the fetus may be exposed to hyperglycaemia prior to the current testing time frame, making earlier administration potentially advantageous. The main purpose of the present study is to investigate the GDM diagnostic value of an OGTT performed at 18–20 gestational weeks. The results of the study may provide scientific insight into the most beneficial time of OGTT for pregnant women. As a prospective, longitudinal cohort study, the Early Diagnosis of Gestational Diabetes Mellitus (EDoGDM) study will recruit 570 pregnant women who meet the inclusion and exclusion criteria outlined below. OGTTs will be performed between 18 and 20 gestational weeks (early OGTT) and 24–28 gestational weeks (regular OGTT). Clinical and laboratory information of the mother and their offspring will be collected for analysis. The prevalence of GDM at 18–20 gestational weeks will be described, and the sensitivity, specificity, positive predictive value and negative predictive value of early OGTT on diagnosis of GDM will be studied. Clinical outcomes associated with hyperglycaemia will be compared between groups diagnosed by early or regular OGTT. The study was approved by The Ethical Committees of The First Affiliated Hospital of Sun Yat-sen University (number 2016-042). Signed informed consent will be obtained from all participants. The results of this study will be disseminated in peer-reviewed journals. NCT02740283.
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影响因子：
16.2
作者：
American Diabetes Association
通讯作者：
American Diabetes Association
影响因子：
6.1
作者：
Glueck, CJ;Goldenberg, N;Sherman, A
通讯作者：
Sherman, A
影响因子：
7.2
作者：
通讯作者：
--
DOI：
10.1016/s0020-7292(15)30033-3
发表时间：
2015-10-01
影响因子：
3.8
作者：
Hod, Moshe;Kapur, Anil;Divakar, Hema
通讯作者：
Divakar, Hema
DOI：
10.1016/0002-9378(82)90349-0
发表时间：
1982-01-01
影响因子：
9.8
作者：
CARPENTER, MW;COUSTAN, DR
通讯作者：
COUSTAN, DR