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| Name | Class |
|---|---|
| Société Francophone du Diabète | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Pregnant women | Experimental | 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). |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Pregnant women | Diagnostic Test | 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. |
| 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 |
| 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. |
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Inclusion criteria:
Exclusion criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| FOUSSARD NINON, Dr | Contact | 5.57.65.60.78 | +33 | ninon.foussard@u-bordeaux.fr |
| RIGALLEAU VINCENT, Pr | Contact | 5.57.65.60.78 | +33 | vincent.rigalleau@chu-bordeaux.fr |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hopital Pellegrin | Recruiting | Bordeaux | 33000 | France |
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| ID | Term |
|---|---|
| D005320 | Fetal Macrosomia |
| D016640 | Diabetes, Gestational |
| ID | Term |
|---|---|
| D011248 | Pregnancy Complications |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D005315 | Fetal Diseases |
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| 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 |
| D011254 | Pregnancy in Diabetics |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D048909 | Diabetes Complications |
| D003920 | Diabetes Mellitus |
| D004700 | Endocrine System Diseases |
| D001724 | Birth Weight |
| D001835 | Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |