Clinical trial NCT04451915: Early Gestational Diabetes Mellitus
Official title: Late Versus Early Management of Gestational Diabetes Mellitus: a Non Inferiority Randomized Multicenter Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Gestational Diabetes
Keywords: Early gestational diabetes
pregnancy
fasting plasma glucose
diagnosis
prognosis
Lead sponsor: University Hospital, Lille
Sponsor class: OTHER
First posted: 2020-06-30
Enrollment: 2010
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: In 2010, the International Association of the Diabetes and Pregnancy Study Groups (IADPSG) panel published consensus-based recommendations on the diagnosis and classification of hyperglycemia in pregnancy. Cognizant that milder degrees of hyperglycemia would also be detected by early pregnancy testing, the IADPSG recommended that fasting plasma glucose (FPG) in the range of 5.1-6.9 mmol/l should be considered diagnostic of early Gestational Diabetes Mellitus (GDM) even if the level of proof for this recommendation is very low regarding to prognosis. This threshold was extrapolated from the FPG value used between 24 and 28 weeks.

In France, a FPG is proposed at the first prenatal visit for women with risk factors of GDM. Early GDM is diagnosed if FPG is ≥ 5.1 mmol/l, leading to an intensive metabolic management. Data have shown that GDM prevalence increased rapidly from 5.9% in 2009 to 9.3% in 2014. 26.9% of women with hyperglycemia during their pregnancy but without known diabetes are treated before 22 weeks' gestation (WG). More recent data from Italy and China, where IADPSG diagnosis criteria were applied, have strongly challenged this recommendation, and showed that early FPG ≥ 5.1mmo/L is poorly predictive of later GDM. No prior studies have demonstrated benefits to early screening and management. In 2016, the IADPSG members have suggested that the use of the FPG threshold ≥5.1 mmol/l for the identification of GDM in early pregnancy is not justified by current evidence


Eligibility criteria: Inclusion Criteria:

* Pregnant woman
* Singleton pregnancy
* Early GDM defined by a fasting plasma glucose between 5.1 mmol/l and 6.1 mmol/ with at least one risk factor (age ≥35 years and/or BMI ≥ 25 kg/m2 and/or familial history of diabetes and/or personal history of GDM and/or personal history of macrosomia).
* First prenatal visit prior 20 weeks of gestation at the time of randomization.
* Signed informed consent

Exclusion Criteria:

Diabetic follow-up started at time of inclusion

* Pre-existing diabetes in pregnancy
* Renal impairment
* Hepatic insufficiency
* History of bariatric surgery
* Long time corticosteroids treatment
* Insufficient understanding
* Language difficulties
* Lack of social Insurance
* Person in emergency situation
* Person under the protection of justice (tutelage/ curatorship)
* Persons deprived of their liberty

Primary outcomes:
measure: The occurrence of materno-fetal complications
timeFrame: at delivery
Secondary outcomes:
measure: Correlation between composite endpoint (defined in the outcome 1) and the 5 risk factors of GDM
timeFrame: at delivery
measure: Need for insulin during pregnancy
timeFrame: at each 10 days until delivery
measure: Metabolic data: Fasting plasma glucose
timeFrame: at inclusion (because <20 weeks') and an average at 24 28 weeks of gestation
measure: Metabolic data: HbA1c
timeFrame: at inclusion (because <20 weeks') and an average at 24 28 weeks of gestation
measure: Oral Glucose Tolerance Test (OGTT)
timeFrame: an average at 24 28 weeks of gestation
measure: Percent of GDM women in the late GDM management group according to the IADPSG criteria.
timeFrame: an average at 24 28 weeks of gestation
measure: Number of complications in each subgroup of the late GDM management group
timeFrame: at delivery
Other outcomes:
Locations:
city: Arras
country: France
facility: CH ARRAS
city: Clermont-Ferrand
country: France
facility: Hopital Estaing - Chu63 - Clermont Ferrand
city: Lille
country: France
facility: Hop Claude Huriez Chu Lille
city: Lille
country: France
facility: Hopital Saint Vincent - Saint Antoine - Lille
city: Nîmes
country: France
facility: Chu Nimes Caremeau - Nimes 9
city: Pessac
country: France
facility: Hopital Haut-Leveque - Chu - Pessac
city: Pontoise
country: France
facility: Ch Rene Dubos - Pontoise
city: Saint-Pierre
country: France
facility: Chu Site Sud (Saint Pierre) - St Pierre
city: Strasbourg
country: France
facility: Csapa / Hus / Hopital Civil - Strasbourg
city: Toulouse
country: France
facility: Hopital de Rangueil Chu Toulouse
Study officials:
affiliation: University Hospital, Lille
name: Anne VAMBERGUE
role: STUDY_DIRECTOR
References: