Actively Recruiting
New Markers of Glycation to Predict Gestational Diabetes Mellitus and Macrosomia
Led by University Hospital, Bordeaux · Updated on 2026-01-15
800
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
Sponsors
U
University Hospital, Bordeaux
Lead Sponsor
S
Société Francophone du Diabète
Collaborating Sponsor
AI-Summary
What this Trial Is About
Gestational diabetes mellitus (GDM) during pregnancy increases the risk of having a large baby (macrosomia) and other complications for both mother and child. This trial is designed to compare new markers of sugar damage in the body, such as skin autofluorescence and glycated albumin, with the traditional HbA1c test. Researchers want to see how well these markers predict GDM, macrosomia, and related pregnancy outcomes in women before 28 weeks of pregnancy. Pregnant women under 28 weeks of gestation, with or without risk factors for GDM, will be enrolled during their first consultation at the maternity hospital. The study will measure glycation markers including HbA1c, glycated albumin, and skin autofluorescence to assess their potential as early predictors. This is an interventional diagnostic study without placebo or masking. Participants will be monitored mainly during the first trimester for the development of GDM. The study will also track various maternal, fetal, and neonatal health outcomes from delivery day to the following day. The primary outcome is the incidence of GDM diagnosed during pregnancy. Safety and health of mother and baby will be evaluated closely around the time of delivery. The trial is expected to continue through September 2028.
CONDITIONS
Brief Title
New Markers of Glycation to Predict Gestational Diabetes Mellitus and Macrosomia.
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 years or older
- Singleton pregnancy or twin pregnancy reduced before 14 weeks of amenorrhea
- Gestational age less than 28 weeks of amenorrhea at inclusion
- Affiliated with or beneficiary of a social security scheme
- Provided patient consent to participate
You will not qualify if you...
- Gestational age 28 weeks or more at inclusion
- Multiple pregnancy (not reduced before 14 weeks)
- Known diabetes before pregnancy
- History of bariatric surgery
- Expected delivery at a maternity unit not participating in the study
- Person deprived of liberty by judicial or administrative decision
- Under guardianship or curatorship
- Not affiliated with or benefiting from a social security scheme
AI-Screening
AI-Powered Screening
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Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 28 weeks of gestation at inclusion
Participants undergo determination of glycation markers such as HbA1c, glycated albumin, and skin autofluorescence to assess risk of gestational diabetes mellitus.
1 visit (in-person)
Duration - From day of delivery to the following day
Participants are assessed for fetal, obstetrical, maternal, and neonatal morbidity around the time of delivery.
1 visit (in-person)
Trial Site Locations
Total: 1 location
1
Hopital Pellegrin
Bordeaux, France, 33000
Actively Recruiting
Research Team
F
FOUSSARD NINON, Dr
R
RIGALLEAU VINCENT, Pr
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
PREVENTION
Number of Arms
1
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