Reproductive Endocrinology Research Center, Research Institute for Endocrine Sciences, Shahid Beheshti University of Medical Sciences, Tehran, Iran.
Non-Communicable Diseases Research Center, Endocrinology and Metabolism Population Sciences Institute, Tehran University of Medical Sciences, Tehran, Iran.
Front Endocrinol (Lausanne). 2023 Jun 2;14:1155007. doi: 10.3389/fendo.2023.1155007. eCollection 2023.
The aim of the study was to investigate the effect of treatment on pregnancy outcomes among women who had fasting plasma glucose (FPG) 5.1-5.6 mmol/l in the first trimester of pregnancy.
We performed a secondary-analysis of a randomized community non-inferiority trial of gestational diabetes mellitus (GDM) screening. All pregnant women with FPG values range 5.1-5.6 mmol/l in the first trimester of gestation were included in the present study (n=3297) and classified to either the (i) intervention group who received treatment for GDM along with usual prenatal care (n=1,198), (ii) control group who received usual-prenatal-care (n=2,099). Macrosomia/large for gestational age (LGA) and primary cesarean-section (C-S) were considered as primary-outcomes. A modified-Poisson-regression for binary outcome data with a log link function and robust error variance was used to RR (95%CI) for the associations between GDM status and incidence of pregnancy outcomes.
The mean maternal age and BMI of pregnant women in both study groups were similar. There were no statistically significant differences in the adjusted risks of adverse pregnancy outcomes, including macrosomia, primary C-S, preterm birth, hyperbilirubinemia, preeclampsia, NICU-admission, birth trauma, and LBW both groups.
It is found that treating women with first-trimester FPG values of 5.1-5.6 mmol/l could not improve adverse pregnancy outcomes including macrosomia, Primary C-S, Preterm birth, hypoglycemia, hypocalcemia, preeclampsia, NICU admission, Birth trauma and LBW. Therefore, extrapolating the FPG cut-off point of the second trimester to the first -which has been proposed by the IADPSG, might therefore not be appropriate.
https://www.irct.ir/trial/518, identifier IRCT138707081281N1.
本研究旨在探讨在妊娠早期空腹血糖（FPG）为 5.1-5.6mmol/l 的女性中，治疗对妊娠结局的影响。
我们对妊娠期糖尿病（GDM）筛查的社区非劣效性随机临床试验进行了二次分析。本研究纳入了所有妊娠早期 FPG 值在 5.1-5.6mmol/l 范围内的孕妇（n=3297），并将其分为（i）干预组，该组接受 GDM 治疗以及常规产前护理（n=1198），（ii）对照组，该组接受常规产前护理（n=2099）。巨大儿/胎儿大于胎龄（LGA）和初次剖宫产（C-S）为主要结局。采用基于泊松回归的二元结局数据模型，对数链接函数和稳健误差方差，以 RR（95%CI）来评估 GDM 状态与妊娠结局之间的关联。
两组孕妇的平均年龄和 BMI 相似。两组孕妇不良妊娠结局的调整风险无统计学差异，包括巨大儿、初次 C-S、早产、高胆红素血症、子痫前期、NICU 入院、产伤和 LBW。
发现治疗妊娠早期 FPG 值为 5.1-5.6mmol/l 的女性并不能改善不良妊娠结局，包括巨大儿、初次 C-S、早产、低血糖、低钙血症、子痫前期、NICU 入院、产伤和 LBW。因此，将 IADPSG 提出的 2 期 FPG 切点外推至 1 期可能并不合适。
https://www.irct.ir/trial/518，标识符 IRCT138707081281N1。
