Western Sydney University, Sydney, NSW
Robinson Research Institute, University of Adelaide, Adelaide, SA.
Med J Aust. 2018 Nov 5;209(9):405-406. doi: 10.5694/mja17.01129. Epub 2018 May 28.
Gestational diabetes mellitus (GDM) causes adverse pregnancy outcomes that can be averted by treatment from 24-28 weeks' gestation. Assessing and treating women for overt diabetes in pregnancy (ODIP) at the first antenatal clinic booking is now recommended in international guidelines. As a consequence, women with milder hyperglycaemia are being diagnosed and treated for early GDM, but randomised controlled trial (RCTs) assessing the benefits and harms of such treatment have not been undertaken. The Treatment Of Booking Gestational diabetes Mellitus (TOBOGM) study is a multi-centre RCT examining whether diagnosing and treating GDM diagnosed at booking improves pregnancy outcomes. Methods and analysis: 4000 adult pregnant women (< 20 weeks' gestation) at risk of ODIP will be recruited from 12 hospital antenatal booking clinics and referred for an oral glucose tolerance test (OGTT). 800 women with hyperglycaemia (ie, booking GDM) according to the 2014 Australasian Diabetes-in-Pregnancy Society criteria for pregnant women at 24-28 weeks' gestation will be randomised to immediate treatment for GDM (intervention) or to no treatment (control), pending the results of a second OGTT at 24-28 weeks' gestation. Antenatal and GDM care will otherwise follow local guidelines. Randomisation will be stratified by site and OGTT glycaemic risk strata. The primary pregnancy outcome is a composite of respiratory distress, phototherapy, birth trauma, birth before 37 weeks' gestation, stillbirth or death, shoulder dystocia, and birthweight ≥ 4.5 kg. The primary neonatal outcome is neonatal lean body mass. The primary maternal outcome is pre-eclampsia. Ethics approval: South Western Sydney Local Health District Research and Ethics Office (reference, 15/LPOOL/551). Dissemination of results: Peer-reviewed publications, scientific meetings, collaboration with research groups undertaking comparable studies, discussions with guideline groups and policy makers.
Australian New Zealand Clinical Trials Registry, ACTRN12616000924459.
妊娠糖尿病（GDM）可导致不良妊娠结局，通过在 24-28 孕周进行治疗可以预防这些结局。目前，国际指南建议在第一次产前门诊预约时评估和治疗显性孕期糖尿病（ODIP）。因此，更多患有较轻高血糖的女性被诊断为早期 GDM 并接受治疗，但尚未进行评估这种治疗的益处和危害的随机对照试验（RCT）。TOBOGM 研究是一项多中心 RCT，旨在检验在初诊时诊断和治疗 GDM 是否可以改善妊娠结局。
该研究将从 12 家医院产前门诊预约处招募 4000 名有发生 ODIP 风险的成年孕妇（<20 孕周），并进行口服葡萄糖耐量试验（OGTT）。800 名 24-28 孕周时根据 2014 年澳大拉西亚妊娠糖尿病学会标准诊断为高血糖（即初诊 GDM）的孕妇将根据 24-28 孕周时的第二次 OGTT 结果随机分为 GDM 即刻治疗组（干预组）或不治疗组（对照组）。否则，将遵循当地指南进行产前和 GDM 护理。随机分组将按地点和 OGTT 血糖风险分层进行分层。主要妊娠结局是呼吸窘迫、光疗、产伤、<37 孕周分娩、死胎或死亡、肩难产和出生体重≥4.5kg。主要新生儿结局是新生儿瘦体重。主要产妇结局是子痫前期。
南西悉尼地方卫生区研究和伦理办公室（参考号，15/LPOOL/551）。
同行评议的出版物、科学会议、与正在进行类似研究的研究小组合作、与指南制定小组和政策制定者的讨论。
澳大利亚和新西兰临床试验注册中心，ACTRN12616000924459。
