New Markers of Glycation to Predict Gestational Diabetes Mellitus and Macrosomia.
NCT ID: NCT06048510
Last Updated: 2023-12-22
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
800 participants
INTERVENTIONAL
2023-12-18
2025-04-30
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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NA
SINGLE_GROUP
PREVENTION
NONE
Study Groups
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Pregnant women
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).
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.
Interventions
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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.
Eligibility Criteria
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Inclusion Criteria
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
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.
18 Years
99 Years
ALL
No
Sponsors
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Société Francophone du Diabète
OTHER
University Hospital, Bordeaux
OTHER
Responsible Party
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Locations
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Hopital Pellegrin
Bordeaux, , France
Countries
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Central Contacts
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Facility Contacts
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FOUSSARD NINON, Dr
Role: primary
MILAN LEA
Role: backup
Other Identifiers
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CHUBX 2022/26
Identifier Type: -
Identifier Source: org_study_id