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Search / Trial NCT06048510

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

Launched by UNIVERSITY HOSPITAL, BORDEAUX · Sep 15, 2023

Trial Information

Current as of June 26, 2025

Recruiting

Keywords

Skin Autofluorescence Glycated Albumin, Hb A1c Glycation Biomarkers Macrosomia Gestational Diabetes Mellitus

ClinConnect Summary

This clinical trial is studying new ways to predict gestational diabetes mellitus (GDM) and macrosomia, which is when a baby is born larger than normal. GDM can lead to complications during pregnancy, so finding better screening methods is important. The trial is comparing two new tests—skin autofluorescence and glycated albumin—with the standard test known as HbA1c to see which one is better at identifying women at risk for these conditions early in their pregnancy.

To join the study, women need to be at least 18 years old, be pregnant with one baby (or twins if one has been reduced), and be less than 28 weeks along in their pregnancy. Participants will need to provide consent and be part of a social security scheme. If you decide to participate, you may undergo additional testing to help researchers understand these new markers better. This trial aims to improve the care of pregnant women by finding better ways to predict and manage potential health issues for both mothers and their babies.

Gender

ALL

Eligibility criteria

  • 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.

About University Hospital, Bordeaux

The University Hospital of Bordeaux is a leading academic medical center dedicated to advancing healthcare through innovative research and clinical excellence. As a prominent sponsor of clinical trials, the institution integrates cutting-edge scientific inquiry with patient care, fostering an environment that encourages collaboration among multidisciplinary teams. With a commitment to improving treatment outcomes and enhancing patient safety, the University Hospital of Bordeaux plays a pivotal role in the development of new therapies and medical technologies, contributing significantly to the global medical community.

Locations

Bordeaux, , France

Patients applied

0 patients applied

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported