Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
2010 participants
INTERVENTIONAL
2020-11-30
2023-12-31
Brief Summary
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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
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
OTHER
NONE
Study Groups
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Early management GDM group
defined as no intervention until GDM screening at 24-28 weeks' gestation. If there is a diagnosis of GDM at 24-28 according to the IADPSG criteria), intensive metabolic treatment until delivery
early management strategy
early management of GDM defined as intensive metabolic treatment. Intensive treatment involved the following multidisciplinary approach: lifestyle defined by diet and exercise intervention according to the French guidelines
Late management GDM group
early management of GDM defined as intensive metabolic treatment (diet, physical activity self-blood glucose monitoring according and/or insulin therapy according to the French guidelines). This intensive treatment will begin after the randomization until delivery.
late management strategy
late management strategy of GDM defined as no intervention until GDM screening at 24-28 weeks. Between 24-28 weeks gestation, a 75-g OGTT will be done
Interventions
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late management strategy
late management strategy of GDM defined as no intervention until GDM screening at 24-28 weeks. Between 24-28 weeks gestation, a 75-g OGTT will be done
early management strategy
early management of GDM defined as intensive metabolic treatment. Intensive treatment involved the following multidisciplinary approach: lifestyle defined by diet and exercise intervention according to the French guidelines
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
FEMALE
No
Sponsors
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University Hospital, Lille
OTHER
Responsible Party
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Principal Investigators
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Anne VAMBERGUE
Role: STUDY_DIRECTOR
University Hospital, Lille
Locations
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CH ARRAS
Arras, , France
Hopital Estaing - Chu63 - Clermont Ferrand
Clermont-Ferrand, , France
Hop Claude Huriez Chu Lille
Lille, , France
Hopital Saint Vincent - Saint Antoine - Lille
Lille, , France
Chu Nimes Caremeau - Nimes 9
Nîmes, , France
Hopital Haut-Leveque - Chu - Pessac
Pessac, , France
Ch Rene Dubos - Pontoise
Pontoise, , France
Chu Site Sud (Saint Pierre) - St Pierre
Saint-Pierre, , France
Csapa / Hus / Hopital Civil - Strasbourg
Strasbourg, , France
Hopital de Rangueil Chu Toulouse
Toulouse, , France
Countries
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Central Contacts
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Facility Contacts
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Role: primary
Other Identifiers
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2018-A00794-51
Identifier Type: OTHER
Identifier Source: secondary_id
PHRC-17-008
Identifier Type: OTHER
Identifier Source: secondary_id
2017_76
Identifier Type: -
Identifier Source: org_study_id
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