New Markers of Glycation to Predict Gestational Diabetes Mellitus and Macrosomia.

University Hospital, Bordeaux800 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

PREVENTION

Masking

NONE

Enrollment

800

Conditions

Macrosomia, Fetal Gestational Diabetes Mellitus in Pregnancy

Interventions

Gestational Diabetes Mellitus increases the risk of adverse pregnancy outcomes (such as macrosomia). The lack of early clinical symptoms leads to screen pregnant women for GDM, and the strategies of screening are a matter of debate. Interventions to control glucose levels in women with GDM have demonstrated efficacy in terms of macrosomia. However, macrosomia may start before the time of screening, suggesting that markers of glycation may have interest : skin autofluorescence, glycated albumin.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 99 Years

Medical Language ↔ Plain English

Inclusion criteria: 1. Age ≥ 18 years 2. Singleton pregnancy (or twin pregnancy reduced spontaneously or medically before 14 weeks of amenorrhea) 3. Gestational age at inclusion \<28 weeks of amenorrhea 4. Participant affiliated with or beneficiary of a social security scheme 5. Collection of patient consent. Exclusion criteria: 1. Gestational age at inclusion ≥ 28 weeks of amenorrhea 2. Multiple pregnancy 3. Known diabetes prior to pregnancy 4. History of bariatric surgery 5. Expected delivery in another maternity unit not participating in the study 6. Person deprived of liberty by judicial or administrative decision 7. Guardianship or curatorship 8. Participant not affiliated or not benefiting from a social security scheme.

Outcomes

Primary Outcomes

Incidence of GDM diagnosed during pregnancy.

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).

Time frame: At trimester 1