Palatnik Anna, Mele Lisa, Landon Mark B, Reddy Uma M, Ramin Susan M, Carpenter Marshall W, Wapner Ronald J, Varner Michael W, Rouse Dwight J, Thorp John M, Sciscione Anthony, Catalano Patrick, Saade George R, Caritis Steve N, Sorokin Yoram
Department of Obstetrics and Gynecology, Northwestern University, Chicago, IL.
George Washington University Biostatistics Center, Washington, DC.
Am J Obstet Gynecol. 2015 Oct;213(4):560.e1-8. doi: 10.1016/j.ajog.2015.06.022. Epub 2015 Jun 11.
The purpose of this study was to examine the association between gestational age (GA) at the time of treatment initiation for gestational diabetes mellitus (GDM) and maternal and perinatal outcomes.
We conducted a secondary analysis of a multicenter randomized treatment trial of mild GDM in which women with mild GDM were assigned randomly to treatment vs usual care. The primary outcome of the original trial, as well as this analysis, was a composite perinatal adverse outcome that included neonatal hypoglycemia, hyperbilirubinemia, hyperinsulinemia, and perinatal death. Other outcomes that were examined included the frequency of large for GA, birthweight, neonatal intensive care unit admission, gestational hypertension/preeclampsia, and cesarean delivery. The interaction between GA at treatment initiation (stratified as 24-26, 27, 28, 29, and ≥30 weeks of gestation) and treatment group (treated vs routine care), with the outcomes of interest, was used to determine whether GA at treatment initiation was associated with outcome differences.
Of 958 women whose cases were analyzed, those who initiated treatment at an earlier GA did not gain an additional treatment benefit compared with those who initiated treatment at a later GA (probability value for interaction with the primary outcome, .44). Similarly, there was no evidence that other outcomes were improved significantly by earlier initiation of GDM treatment (large for GA, P = .76; neonatal intensive care unit admission, P = .8; cesarean delivery, P = .82). The only outcome that had a significant interaction between GA and treatment was gestational hypertension/preeclampsia (P = .04), although there was not a clear cut GA trend where this outcome improved with treatment.
Earlier initiation of treatment of mild GDM was not associated with stronger effect of treatment on perinatal outcomes.
本研究旨在探讨妊娠期糖尿病（GDM）开始治疗时的孕周（GA）与孕产妇及围产期结局之间的关联。
我们对一项轻度GDM多中心随机治疗试验进行了二次分析，该试验将轻度GDM女性随机分配至治疗组与常规护理组。原始试验以及本次分析的主要结局是围产期不良复合结局，包括新生儿低血糖、高胆红素血症、高胰岛素血症及围产期死亡。所检查的其他结局包括大于孕周胎儿的发生率、出生体重、新生儿重症监护病房收治率、妊娠期高血压/子痫前期及剖宫产。治疗开始时的孕周（分层为妊娠24 - 26周、27周、28周、29周及≥30周）与治疗组（治疗组与常规护理组）之间的交互作用以及感兴趣的结局，用于确定治疗开始时的孕周是否与结局差异相关。
在分析的958例女性病例中，与在较晚孕周开始治疗的女性相比，在较早孕周开始治疗的女性并未获得额外的治疗益处（与主要结局的交互作用概率值为0.44）。同样，没有证据表明更早开始GDM治疗能显著改善其他结局（大于孕周胎儿，P = 0.76；新生儿重症监护病房收治率，P = 0.8；剖宫产，P = 0.82）。孕周与治疗之间存在显著交互作用的唯一结局是妊娠期高血压/子痫前期（P = 0.04），尽管在该结局随治疗改善方面没有明确的孕周趋势。
更早开始轻度GDM治疗与治疗对围产期结局的更强效果无关。
