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

Study Overview
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Brief Summary
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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.

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

Conditions
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Macrosomia, Fetal, Gestational Diabetes Mellitus in Pregnancy

Intervention / Treatment
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* Diagnostic Test: Pregnant women


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 99 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Pregnant women<br>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). | Diagnostic Test: Pregnant women<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of GDM diagnosed during pregnancy. | The primary outcome is the incidence of GDM diagnosed during pregnancy after inclusion in the trial. The measure is performed by fasting blood glucose:≥ 0.92 g/L and < 1.26 g/L,or based on the result of the 75g OGTT performed at 24-28 weeks of amenorrhea, if glycemia at time 0 ≥ 92 mg/dL (5.06 mmol/L) and/or time 60min ≥ 180 mg/dL (9.9 mmol/L) and/or time 120min ≥153 mg/dL (8.42 mmol/L). | At trimester 1 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Fetal morbidity | Incidence of fetal death in utero | Between the day of delivery and the following day | 
| Obstetrical outcome | Incidence of labor induction, caesarean section, instrumental delivery. | Between the day of delivery and the following day | 
| Maternal morbidity | Documentation of maternal morbidity diagnosis | Between the day of delivery and the following day | 
| Neonatal morbidity 1 | Incidence of macrosomia (by birth weight ≥ 4,000g and Large for Gestational Age if ≥ 90th centiles according to sex and gestational age) | Between the day of delivery and the following day | 
| Neonatal morbidity 2 | Documentation of neonatal morbidity diagnosis | Between the day of delivery and the following day | 
| Neonatal morbidity 3 | Hospitalization in neonatology or neonatal intensive care unit | Between the day of delivery and the following day | 
| Neonatal morbidity 4 | Presence of anoxic-ischemic encephalopath or neonatal seizure | Between the day of delivery and the following day | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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skin autofluorescence, glycated albumin,, HbA1c, glycation biomarkers, macrosomia, gestational diabetes mellitus