An interventional study of Pregnant women in Macrosomia, Fetal and Gestational Diabetes Mellitus in Pregnancy, sponsored by University Hospital, Bordeaux. Recruiting at 1 site in France. Open to participants aged 18 Years to 99 Years. Per ClinicalTrials.gov, last updated 2026-01-15.
Sponsored by University Hospital, Bordeaux · Not applicable, Interventional, and Prevention
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.
Exclusion criteria:
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).
Diagnostic Test: Pregnant 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.
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
Fetal morbidity
Incidence of fetal death in utero
Time frame: Between the day of delivery and the following day
Obstetrical outcome
Incidence of labor induction, caesarean section, instrumental delivery.
Time frame: Between the day of delivery and the following day
Maternal morbidity
Documentation of maternal morbidity diagnosis
Time frame: Between the day of delivery and the following day
Neonatal morbidity 1
Incidence of macrosomia (by birth weight ≥ 4,000g and Large for Gestational Age if ≥ 90th centiles according to sex and gestational age)
Time frame: Between the day of delivery and the following day
Neonatal morbidity 2
Documentation of neonatal morbidity diagnosis
Time frame: Between the day of delivery and the following day
Neonatal morbidity 3
Hospitalization in neonatology or neonatal intensive care unit
Time frame: Between the day of delivery and the following day
Neonatal morbidity 4
Presence of anoxic-ischemic encephalopath or neonatal seizure
Time frame: Between the day of delivery and the following day
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University Hospital, Bordeaux