Early Gestational Diabetes Mellitus

NCT04451915 | Recruiting

• 3 other identifiers: 2017_762018-A00794-51PHRC-17-008
• Study Type: interventional
• Target: 2,010
• Locations: 1 country
• Sites: 10

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

Conditions

Gestational Diabetes

Keywords

Early gestational diabetes; pregnancy; fasting plasma glucose; diagnosis; prognosis

Outcome Measures

Primary Outcomes (1)

• The occurrence of materno-fetal complications

  Composite endpoint defined by Large for Gestational Age (LGA) (defined by birth weight ≥90th percentile, adjusted for gestational age, sex, maternal BMI, parity, ethnicity) and/or neonatal hypoglycemia and/or shoulder dystocia and/or birth traumatisms

  at delivery

Secondary Outcomes (12)

• Correlation between composite endpoint (defined in the outcome 1) and the 5 risk factors of GDM

  at delivery

• Need for insulin during pregnancy

  at each 10 days until delivery

• Metabolic data: Fasting plasma glucose

  at inclusion (because <20 weeks') and an average at 24 28 weeks of gestation

• Metabolic data: HbA1c

  at inclusion (because <20 weeks') and an average at 24 28 weeks of gestation

• Oral Glucose Tolerance Test (OGTT)

  an average at 24 28 weeks of gestation

Study Arms (2)

Early management GDM group

EXPERIMENTAL

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

Other: early management strategy

Late management GDM group

EXPERIMENTAL

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.

Other: late management strategy

Interventions

late management strategy OTHER

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

Late management GDM group

early management strategy OTHER

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

Early management GDM group

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: Pregnant women with at least one GDM risk factor and a fasting plasma glucose between 5.1 mmol/l and 6.1 mmol/l prior 20 weeks' gestation.
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University Hospital, Lille: lead

Study Sites (10)

CH ARRAS

Arras, France

RECRUITING

Hopital Estaing - Chu63 - Clermont Ferrand

Clermont-Ferrand, France

RECRUITING

Hop Claude Huriez Chu Lille

Lille, 59037, France

RECRUITING

Hopital Saint Vincent - Saint Antoine - Lille

Lille, 59037, France

RECRUITING

Chu Nimes Caremeau - Nimes 9

Nîmes, France

RECRUITING

Hopital Haut-Leveque - Chu - Pessac

Pessac, 33604, France

RECRUITING

Ch Rene Dubos - Pontoise

Pontoise, France

RECRUITING

Chu Site Sud (Saint Pierre) - St Pierre

Saint-Pierre, France

RECRUITING

Csapa / Hus / Hopital Civil - Strasbourg

Strasbourg, 67091, France

RECRUITING

Hopital de Rangueil Chu Toulouse

Toulouse, 31300, France

RECRUITING

MeSH Terms

Conditions

Diabetes, Gestational; Disease

Condition Hierarchy (Ancestors)

Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Anne VAMBERGUE

  University Hospital, Lille

  STUDY DIRECTOR

Central Study Contacts

Anne VAMBERGUE, MD,PhD

CONTACT

0320445962; anne.vambergue@chru-lille.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 22, 2020
• First Posted: June 30, 2020
• Study Start: November 30, 2020
• Primary Completion (Estimated): February 15, 2027
• Study Completion (Estimated): June 30, 2027
• Last Updated: June 2, 2026

Record last verified: 2026-05

Locations

FR (10)