Gestational Diabetes Mellitus in Pregnancy, Macrosomia, Fetal
Conditions
Keywords
skin autofluorescence, glycated albumin,, HbA1c, glycation biomarkers, macrosomia, gestational diabetes mellitus
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.
Interventions
DIAGNOSTIC_TESTPregnant 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.
Sponsors
Société Francophone du Diabète
University Hospital, Bordeaux
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 99 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of GDM diagnosed during pregnancy. | At trimester 1 | 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). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Neonatal morbidity 3 | Between the day of delivery and the following day | Hospitalization in neonatology or neonatal intensive care unit |
| Fetal morbidity | Between the day of delivery and the following day | Incidence of fetal death in utero |
| Obstetrical outcome | Between the day of delivery and the following day | Incidence of labor induction, caesarean section, instrumental delivery. |
| Neonatal morbidity 4 | Between the day of delivery and the following day | Presence of anoxic-ischemic encephalopath or neonatal seizure |
| Neonatal morbidity 1 | Between the day of delivery and the following day | Incidence of macrosomia (by birth weight ≥ 4,000g and Large for Gestational Age if ≥ 90th centiles according to sex and gestational age) |
| Neonatal morbidity 2 | Between the day of delivery and the following day | Documentation of neonatal morbidity diagnosis |
| Maternal morbidity | Between the day of delivery and the following day | Documentation of maternal morbidity diagnosis |
Countries
France
Contacts
Primary ContactFOUSSARD NINON, Dr
Backup ContactRIGALLEAU VINCENT, Pr
Outcome results
None listed