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

University Hospital of Bordeaux

Status: Enrolling

Conditions: Gestational Diabetes Mellitus in Pregnancy; Macrosomia, Fetal

Treatments: Diagnostic Test: Pregnant women

Study type: Interventional

Funder types: Other

Identifiers

NCT06048510

CHUBX 2022/26

Details and patient eligibility

About

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.

Enrollment: 800 estimated patients

Sex: All

Ages: 18 to 99 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Prevention

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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800 participants in 1 patient group

Pregnant women

Experimental group

Description:

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).

Treatment:

Diagnostic Test: Pregnant women