New Markers of Glycation to Predict Gestational Diabetes Mellitus and Macrosomia.
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-99
SponsorUniversity Hospital, Bordeaux
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
Gestational age at inclusion ≥ 28 weeks of amenorrhea
Multiple pregnancy
Known diabetes prior to pregnancy
History of bariatric surgery
Trial design
Design model
Single group
Treatments tested in this trial
Pregnant women
Diagnostic testGestational 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.
Treatment groups
800 Participants
are divided into 1 treatment groupGroup A: Pregnant womenExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
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).
Time frame
At trimester 1Secondary outcomes
1
Fetal morbidity
Incidence of fetal death in utero
Time frame
Between the day of delivery and the following day2
Obstetrical outcome
Incidence of labor induction, caesarean section, instrumental delivery.
Time frame
Between the day of delivery and the following day3
Maternal morbidity
Documentation of maternal morbidity diagnosis
Time frame
Between the day of delivery and the following day4
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)
Time frame
Between the day of delivery and the following daySponsors and contacts
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University Hospital, Bordeaux
Lead sponsor
Société Francophone du Diabète
Collaborator
Source ClinicalTrials.gov