New Markers of Glycation to Predict Gestational Diabetes Mellitus and Macrosomia.
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 800
- 试验地点
- 1
- 主要终点
- Incidence of GDM diagnosed during pregnancy.
研究概览
简要总结
Gestational diabetes mellitus (GDM) increases the risk of macrosomia and other adverse pregnancy outcomes. Screening strategies are debated: universal vs. selective, and macrosomia may begin before the time of screening, suggesting that glycation markers may have an interest. The objective of this trail is to compare novel markers: skin autofluorescence and glycated albumin, to HbA1c (reference) as predictors of GDM, macrosomia and other adverse outcomes, in pregnant women.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 99 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age ≥ 18 years
- •Singleton pregnancy (or twin pregnancy reduced spontaneously or medically before 14 weeks of amenorrhea)
- •Gestational age at inclusion <28 weeks of amenorrhea
- •Participant affiliated with or beneficiary of a social security scheme
- •Collection of patient consent.
排除标准
- •Gestational age at inclusion ≥ 28 weeks of amenorrhea
- •Multiple pregnancy
- •Known diabetes prior to pregnancy
- •History of bariatric surgery
- •Expected delivery in another maternity unit not participating in the study
- •Person deprived of liberty by judicial or administrative decision
- •Guardianship or curatorship
- •Participant not affiliated or not benefiting from a social security scheme.
研究组 & 干预措施
Pregnant women
Pregnant women, with gestational age at inclusion <28 weeks of amenorrhea, with or without risk factors for GDM will be included in the first consultation at the Maternity Hospital (Bordeaux University Hospital).
Determination of glycation markers (HbA1c, glycated albumin, and skin autofluorescence).
干预措施: Pregnant women (Diagnostic Test)
结局指标
主要结局
Incidence of GDM diagnosed during pregnancy.
时间窗: At trimester 1
The primary outcome is the incidence of GDM diagnosed during pregnancy after inclusion in the trial. The measure is performed by fasting blood glucose:≥ 0.92 g/L and \< 1.26 g/L,or based on the result of the 75g OGTT performed at 24-28 weeks of amenorrhea, if glycemia at time 0 ≥ 92 mg/dL (5.06 mmol/L) and/or time 60min ≥ 180 mg/dL (9.9 mmol/L) and/or time 120min ≥153 mg/dL (8.42 mmol/L).
次要结局
- Neonatal morbidity 2(Between the day of delivery and the following day)
- Neonatal morbidity 4(Between the day of delivery and the following day)
- Fetal morbidity(Between the day of delivery and the following day)
- Obstetrical outcome(Between the day of delivery and the following day)
- Maternal morbidity(Between the day of delivery and the following day)
- Neonatal morbidity 1(Between the day of delivery and the following day)
- Neonatal morbidity 3(Between the day of delivery and the following day)