Division of Maternal Fetal Medicine and the Division of Clinical Research, Department of Obstetrics and Gynecology, and the Bernard Becker Medical Library, Washington University School of Medicine in St. Louis, St. Louis, Missouri; the Departments of Medicine and Obstetrics, Gynecology, and Reproductive Biology, Diabetes Unit, Massachusetts General Hospital and Harvard Medical School, Boston, Massachusetts; and the Department of Obstetrics and Gynecology, Warren Alpert Medical School at Brown University, Providence, Rhode Island.
Obstet Gynecol. 2022 Nov 1;140(5):712-723. doi: 10.1097/AOG.0000000000004943. Epub 2022 Oct 5.
To estimate short-term maternal and neonatal outcomes with one-compared with two-step testing for gestational diabetes mellitus (GDM).
A systematic review of randomized controlled trials (RCTs) and observational studies comparing one-step and two-step GDM testing strategies before September 2021 was conducted. We searched Ovid Medline (1946-), EMBASE (1947-), Scopus (1960-), Cochrane Central, and ClinicalTrials.gov . The primary outcome was rate of large-for-gestational age (LGA) neonates. Secondary outcomes were clinically relevant outcomes for GDM that were selected a priori.
Titles, abstracts, and manuscripts were screened, selected, and reviewed by the first two authors. Four RCTs (24,966 patients) and 13 observational studies (710,677 patients) were analyzed.
TABULATION, INTEGRATION, AND RESULTS: Pooled relative risks (RRs) were calculated with 95% CIs using random-effects models and were plotted graphically with forest plots. Study heterogeneity was evaluated using Cochran Q and Higgins I 2 tests. The quality of studies that met the inclusion criteria was evaluated with the Downs and Black checklist. Publication bias was assessed by using asymmetry of funnel plots and Harbord's test. There was no difference in the rate of LGA neonates (pooled RR 0.95; 95% CI 0.88-1.04) by testing strategy among RCTs, but patients who underwent one-step testing were more likely to be diagnosed with GDM (pooled RR 2.13; 95% CI 1.61-2.82) and treated with diabetes medications (pooled RR 2.24; 95% CI 1.21-4.15). One-step testing was associated with higher rates of neonatal intensive care unit (NICU) admission (pooled RR 1.12; 95% CI 1.00-1.26) and neonatal hypoglycemia (pooled RR 1.23; 95% CI 1.13-1.34). In analysis of high-quality RCTs and observational studies, one-step testing was associated with a lower rate of LGA neonates (pooled RR 0.97; 95% CI 0.95-0.98), but higher rates of GDM diagnosis, treatment, NICU admission, and neonatal hypoglycemia.
Despite a significant increase in GDM diagnosis and treatment with one-step testing, there is no difference in rate of LGA neonates compared with two-step testing among RCTs.
PROSPERO, CRD42021252703.
评估一步法与两步法检测妊娠期糖尿病(GDM)的短期母婴结局。
对截至 2021 年 9 月的随机对照试验(RCT)和观察性研究进行了系统评价,比较了一步法和两步法 GDM 检测策略。我们检索了 Ovid Medline(1946-)、EMBASE(1947-)、Scopus(1960-)、Cochrane 中央和 ClinicalTrials.gov。主要结局是巨大儿(LGA)的发生率。次要结局是预先选择的 GDM 的临床相关结局。
由前两名作者筛选、选择和审查标题、摘要和手稿。对 4 项 RCT(24966 例患者)和 13 项观察性研究(710677 例患者)进行了分析。
表格、整合和结果:使用随机效应模型计算具有 95%置信区间的合并相对风险(RR),并使用森林图以图形方式绘制。使用 Cochran Q 和 Higgins I 2 检验评估研究异质性。使用 Downs 和 Black 清单评估符合纳入标准的研究的质量。使用漏斗图不对称和 Harbord 检验评估发表偏倚。在 RCT 中,检测策略之间 LGA 新生儿的发生率没有差异(合并 RR 0.95;95%CI 0.88-1.04),但一步法检测的患者更有可能被诊断为 GDM(合并 RR 2.13;95%CI 1.61-2.82)并接受糖尿病药物治疗(合并 RR 2.24;95%CI 1.21-4.15)。一步法检测与新生儿重症监护病房(NICU)入院率(合并 RR 1.12;95%CI 1.00-1.26)和新生儿低血糖症(合并 RR 1.23;95%CI 1.13-1.34)较高相关。在对高质量 RCT 和观察性研究的分析中,一步法检测与 LGA 新生儿的发生率较低(合并 RR 0.97;95%CI 0.95-0.98)相关,但 GDM 诊断、治疗、NICU 入院和新生儿低血糖症的发生率较高。
尽管一步法检测会显著增加 GDM 的诊断和治疗,但与两步法检测相比,RCT 中 LGA 新生儿的发生率没有差异。
PROSPERO,CRD42021252703。