RecruitingNot Applicable

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

France800 participantsStarted 2023-12-18

Plain-language 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.

Who can participate

Age range18 Years – 99 Years

SexALL

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Inclusion criteria

✓. 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 criteria

✕. 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.

What they're measuring

Incidence of GDM diagnosed during pregnancy.

Timeframe: At trimester 1

Trial details

NCT IDNCT06048510

SponsorUniversity Hospital, Bordeaux

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2028-09

Contact for this trial

FOUSSARD NINON, Dr

5.57.65.60.78 ninon.foussard@u-bordeaux.fr

View on ClinicalTrials.gov More Macrosomia, Fetal trials