Lower versus Higher Glycemic Criteria for Diagnosis of Gestational Diabetes
Lower versus Higher Glycemic Criteria for Diagnosis of Gestational Diabetes
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DOI：
10.1056/nejmoa2204091
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发表时间：
2022-08-18
影响因子：
158.5
通讯作者：
McKinlay, Christopher J.
中科院分区：
文献类型：
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作者：
Crowther, Caroline A.;Samuel, Deborah;McKinlay, Christopher J.
背景 尽管诊断标准尚不清楚，但妊娠糖尿病的治疗可改善母婴健康。 方法 我们以 1:1 的比例随机分配妊娠 24 至 32 周的妇女，使用较低或较高的血糖诊断标准来评估妊娠糖尿病。较低血糖标准是空腹血糖水平至少为 92 毫克每分升（≥ 5.1 毫摩尔每升），1 小时水平至少为 180 毫克每分升（≥ 10.0 毫摩尔每升），或 2 小时水平至少为 153 毫克每分升（≥ 8.5 毫摩尔每升）。较高的血糖标准是空腹血糖水平至少为 99 毫克每分升（≥ 5.5 毫摩尔每升）或 2 小时血糖水平至少为 162 毫克每分升（≥ 9.0 毫摩尔每升）。主要结局是出生大于胎龄婴儿（根据芬顿世界卫生组织标准，出生体重超过第 90 个百分位数）。次要结局是孕产妇和婴儿健康。 结果 共有 4061 名女性接受了随机分组。 2022 名低血糖标准组女性中有 310 名 (15.3%) 被诊断出妊娠糖尿病，2039 名高血糖组女性中有 124 名 (6.1%) 被诊断出妊娠糖尿病。在低血糖标准组女性所生的 2019 名婴儿中，有 178 名 (8.8%) 为大胎龄儿，在高血糖标准组女性所生的 2031 名婴儿中，有 181 名 (8.9%) 为大胎龄儿（调整后相对风险，0.98；95% 置信区间，0.80 至1.19；P=0.82)。引产、使用卫生服务、使用药物和新生儿低血糖在低血糖标准组中比在高血糖标准组中更常见。两个试验组的其他次要结局的结果相似，并且不良事件的组间没有显着差异。在两组血糖测试结果介于较低和较高血糖标准之间的女性中，接受妊娠期糖尿病治疗的女性（195 名女性）与未接受妊娠期糖尿病治疗的女性（178 名女性）相比，对孕产妇和婴儿的健康有益，其中大于胎龄儿的数量较少。血糖标准。 （由新西兰健康研究委员会和其他机构资助；GEMS 澳大利亚新西兰临床试验注册号，ACTRN12615000290594。）
Background Treatment of gestational diabetes improves maternal and infant health, although diagnostic criteria remain unclear.Methods We randomly assigned women at 24 to 32 weeks' gestation in a 1:1 ratio to be evaluated for gestational diabetes with the use of lower or higher glycemic criteria for diagnosis. The lower glycemic criterion was a fasting plasma glucose level of at least 92 mg per deciliter (>= 5.1 mmol per liter), a 1-hour level of at least 180 mg per deciliter (>= 10.0 mmol per liter), or a 2-hour level of at least 153 mg per deciliter (>= 8.5 mmol per liter). The higher glycemic criterion was a fasting plasma glucose level of at least 99 mg per deciliter (>= 5.5 mmol per liter) or a 2-hour level of at least 162 mg per deciliter (>= 9.0 mmol per liter). The primary outcome was the birth of an infant who was large for gestational age (defined as a birth weight above the 90th percentile according to Fenton-World Health Organization standards). Secondary outcomes were maternal and infant health.Results A total of 4061 women underwent randomization. Gestational diabetes was diagnosed in 310 of 2022 women (15.3%) in the lower-glycemic-criteria group and in 124 of 2039 women (6.1%) in the higher-glycemic-criteria group. Among 2019 infants born to women in the lower-glycemic-criteria group, 178 (8.8%) were large for gestational age, and among 2031 infants born to women in the higher-glycemic-criteria group, 181 (8.9%) were large for gestational age (adjusted relative risk, 0.98; 95% confidence interval, 0.80 to 1.19; P=0.82). Induction of labor, use of health services, use of pharmacologic agents, and neonatal hypoglycemia were more common in the lower-glycemic-criteria group than in the higher-glycemic-criteria group. The results for the other secondary outcomes were similar in the two trial groups, and there were no substantial between-group differences in adverse events. Among the women in both groups who had glucose test results that fell between the lower and higher glycemic criteria, those who were treated for gestational diabetes (195 women), as compared with those who were not (178 women), had maternal and infant health benefits, including fewer large-for-gestational-age infants.Conclusions The use of lower glycemic criteria for the diagnosis of gestational diabetes did not result in a lower risk of a large-for-gestational-age infant than the use of higher glycemic criteria. (Funded by the Health Research Council of New Zealand and others; GEMS Australian New Zealand Clinical Trials Registry number, ACTRN12615000290594.)