NCT06048510 New Markers of Glycation to Predict Gestational Diabetes Mellitus and Macrosomia.
| NCT ID | NCT06048510 |
| Status | Recruiting |
| Phase | — |
| Sponsor | University Hospital, Bordeaux |
| Condition | Macrosomia, Fetal |
| Study Type | INTERVENTIONAL |
| Enrollment | 800 participants |
| Start Date | 2023-12-18 |
| Primary Completion | 2028-09 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 800 participants in total. It began in 2023-12-18 with a primary completion date of 2028-09.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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.
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.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT06048510 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 99 Years, studying Macrosomia, Fetal. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06048510 currently recruiting?
Yes, NCT06048510 is actively recruiting participants. Contact the research team at ninon.foussard@u-bordeaux.fr for enrollment information.
Where is the NCT06048510 trial being conducted?
This trial is being conducted at Bordeaux, France.
Who is sponsoring the NCT06048510 clinical trial?
NCT06048510 is sponsored by University Hospital, Bordeaux. The trial plans to enroll 800 participants.