RecruitingNot ApplicableNCT06048510

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

Sponsor

University Hospital, Bordeaux

Enrollment

800 participants

Start Date

Dec 18, 2023

Study Type

INTERVENTIONAL

Conditions

Gestational Diabetes Mellitus in Pregnancy Macrosomia, Fetal

Summary

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.

Eligibility

Min Age: 18 YearsMax Age: 99 Years

Inclusion Criteria5

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.

Exclusion Criteria8

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.

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Interventions

DIAGNOSTIC_TESTPregnant women

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.