New Markers of Glycation to Predict Gestational Diabetes Mellitus and Macrosomia.
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Pregnant women.
- Who it may be relevant to
- Registry conditions: Macrosomia, Fetal, Gestational Diabetes Mellitus in Pregnancy. Basic parameters: 18 years — 99 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- France
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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.
Interventions
- Diagnostic test 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
Primary outcome measures
- Incidence of GDM diagnosed during pregnancy. [Time frame: At trimester 1]
Secondary outcome measures (7)
- Fetal morbidity [Time frame: Between the day of delivery and the following day]
- Obstetrical outcome [Time frame: Between the day of delivery and the following day]
- Maternal morbidity [Time frame: Between the day of delivery and the following day]
- Neonatal morbidity 1 [Time frame: Between the day of delivery and the following day]
- Neonatal morbidity 2 [Time frame: Between the day of delivery and the following day]
- Neonatal morbidity 3 [Time frame: Between the day of delivery and the following day]
- Neonatal morbidity 4 [Time frame: Between the day of delivery and the following day]
Eligibility criteria
Inclusion criteria
- Age ≥ 18 years
- Singleton pregnancy (or twin pregnancy reduced spontaneously or medically before 14 weeks of amenorrhea)
- Gestational age at inclusion <28 weeks of amenorrhea
- Participant affiliated with or beneficiary of a social security scheme
- Collection of patient consent.
Exclusion criteria
- Gestational age at inclusion ≥ 28 weeks of amenorrhea
- Multiple pregnancy
- Known diabetes prior to pregnancy
- History of bariatric surgery
- Expected delivery in another maternity unit not participating in the study
- Person deprived of liberty by judicial or administrative decision
- Guardianship or curatorship
- Participant not affiliated or not benefiting from a social security scheme.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Prevention
Study locations
France · 1 center
- Hopital Pellegrin — Bordeaux
Identifiers
NCT: NCT06048510 · CHUBX 2022/26