Department of Obstetrics and Gynaecology, University Medical Centre Utrecht, Utrecht, the Netherlands.
BMC Pregnancy Childbirth. 2012 Dec 27;12:164. doi: 10.1186/1471-2393-12-164.
Hyperglycemia in pregnancy is associated with poor perinatal outcome. Even if pregnant women with diabetes are monitored according to current guidelines, they do much worse than their normoglycaemic counterparts, marked by increased risks of pre-eclampsia, macrosomia, and caesarean section amongst others. Continuous Glucose Monitoring (CGM) is a new method providing detailed information on daily fluctuations, used to optimize glucose control. Whether this tool improves pregnancy outcome remains unclear. In the present protocol, we aim to assess the effect of CGM use in diabetic pregnancies on pregnancy outcome.
METHODS/DESIGN: The GlucoMOMS trial is a multicenter open label randomized clinical trial with a decision and cost-effectiveness study alongside. Pregnant women aged 18 and over with either diabetes mellitus type 1 or 2 on insulin therapy or with gestational diabetes requiring insulin therapy before 30 weeks of gestation will be asked to participate. Consenting women will be randomly allocated to either usual care or complementary CGM. All women will determine their glycaemic control by self-monitoring of blood glucose levels and HbA1c. In addition, women allocated to CGM will use it for 5-7 days every six weeks. Based on their CGM profiles they receive dietary advice and insulin therapy adjustments if necessary. The primary outcome measure is rate of macrosomia, defined as a birth weight above the 90th centile. Secondary outcome measures will be birth weight, composite neonatal morbidity, maternal outcome and costs. The analyses will be according to the intention to treat principle.
With this trial we aim at clarifying whether the CGM improves pregnancy outcome when used during diabetic pregnancies.
Nederlands Trial Register: NTR2996.
妊娠期间的高血糖与围产期结局不良有关。即使根据当前指南监测患有糖尿病的孕妇，她们的情况也比血糖正常的孕妇差得多，表现为子痫前期、巨大儿和剖宫产等风险增加。连续血糖监测（CGM）是一种新方法，可提供关于日常波动的详细信息，用于优化血糖控制。这种工具是否能改善妊娠结局仍不清楚。在本方案中，我们旨在评估 CGM 在糖尿病妊娠中的使用对妊娠结局的影响。
方法/设计：GlucoMOMS 试验是一项多中心开放标签随机临床试验，同时进行决策和成本效益研究。将邀请年龄在 18 岁及以上、正在接受胰岛素治疗的 1 型或 2 型糖尿病孕妇或在 30 孕周前需要胰岛素治疗的妊娠期糖尿病孕妇参加。同意参加的女性将被随机分配到常规护理或补充 CGM 组。所有女性将通过自我监测血糖水平和 HbA1c 来确定其血糖控制情况。此外，分配到 CGM 的女性将每六周使用 CGM 监测 5-7 天。根据他们的 CGM 图谱，他们将获得饮食建议和必要时的胰岛素治疗调整。主要结局指标是巨大儿（定义为出生体重高于第 90 百分位）的发生率。次要结局指标将是出生体重、新生儿复合发病率、产妇结局和成本。分析将根据意向治疗原则进行。
通过这项试验，我们旨在阐明 CGM 在糖尿病妊娠期间使用时是否能改善妊娠结局。
荷兰试验注册处：NTR2996。
