Identifying new markers to predict gestational diabetes and large babies.
New Markers of Glycation to Predict Gestational Diabetes Mellitus and Macrosomia.
NA · University Hospital, Bordeaux · NCT06048510
This study is testing new ways to predict gestational diabetes and large babies in pregnant women by looking at specific markers in their blood to see if they work better than the usual tests.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 800 (estimated) |
| Ages | 18 Years to 99 Years |
| Sex | All |
| Sponsor | University Hospital, Bordeaux (other) |
| Locations | 1 site (Bordeaux) |
| Trial ID | NCT06048510 on ClinicalTrials.gov |
What this trial studies
This study aims to evaluate new glycation markers, specifically skin autofluorescence and glycated albumin, as predictors of gestational diabetes mellitus (GDM) and macrosomia in pregnant women. It compares these novel markers to the traditional HbA1c measurement to determine their effectiveness in identifying risks for adverse pregnancy outcomes. The study will involve pregnant women who are less than 28 weeks into their pregnancy and will assess their glycation levels to improve screening strategies for GDM. The goal is to enhance early detection and management of these conditions.
Who should consider this trial
Good fit: Ideal candidates for this study are pregnant women aged 18 years and older, with a singleton pregnancy and less than 28 weeks of gestation.
Not a fit: Patients who have known diabetes prior to pregnancy or are beyond 28 weeks of gestation will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved screening methods for gestational diabetes and better outcomes for mothers and infants.
How similar studies have performed: While the use of glycation markers in this context is innovative, similar studies have shown promise in identifying risks associated with gestational diabetes.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Bordeaux
- Hopital Pellegrin — Bordeaux, France (RECRUITING)
Study contacts
- Study coordinator: FOUSSARD NINON, Dr
- Email: ninon.foussard@u-bordeaux.fr
- Phone: 5.57.65.60.78
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Macrosomia, Fetal, Gestational Diabetes Mellitus in Pregnancy, skin autofluorescence, glycated albumin,, HbA1c, glycation biomarkers, macrosomia, gestational diabetes mellitus