Frequency of Abnormal Glucose Metabolism (Diabetes, Impaired Glucose Tolerance, Impaired Fasting Glucose) in the Immediate Postpartum Period Following Gestational Diabetes Diagnosed Before or After 24 Weeks of Gestation
Overview
- Phase
- Not Applicable
- Intervention
- Post-partum oral glucose tolerance test
- Conditions
- Gestational Diabetes
- Sponsor
- Centre Hospitalier Universitaire de Nīmes
- Enrollment
- 500
- Locations
- 4
- Primary Endpoint
- Presence/absence of abnormal glucose metabolism
- Status
- Completed
- Last Updated
- 5 months ago
Overview
Brief Summary
The main objective of the study is to estimate and compare the percentage of patients with abnormal glucose metabolism at 4-12 weeks postpartum between two groups: patients diagnosed with gestational diabetes before or after 24 weeks of pregnancy. Abnormal glucose metabolism is defined as type 2 diabetes, glucose intolerance or impaired fasting glucose.
Detailed Description
The secondary objectives of this study are to compare between the two groups: A. the rate of type 2 diabetes only, glucose intolerance only, impaired fasting glucose only, and patients requiring insulin at 4-12 weeks postpartum B. rates of maternal and obstetric complications C. risk factors (age, body mass index, personal history of gestational diabetes or macrosomia, first degree family history of diabetes). D. For fasting glucose done before 24SA, we will calculate the optimal threshold for predicting abnormal glucose metabolism in the immediate postpartum period among women with gestational diabetes.
Investigators
Eligibility Criteria
Inclusion Criteria
- •The patient must have given her informed and signed consent
- •The patient must be insured or beneficiary of a health insurance plan
- •The patient is available for 10 months of follow-up
- •The patient is pregnant and consulting before 24 weeks of amenorrhea AND has at least one of the following risk factors: age \> 35 years; body mass index \> 25; family history of type 2 diabetes; history of gestational diabetes; history of macrosomia.
- •The patient has a fasting blood glucose level \>= 0.92 g/l before 24 weeks of amenorrhea OR a fasting blood glucose level \< 0.92 g/l before 24 weeks of amenorrhea AND an abnormal oral glucose tolerance test (75 g of glucose) between 24 and 28 weeks of amenorrhea (normal values are set at T0 \< 0.92 g/l; T60 \< 1.80 g/l; T120 \< 1.53 g/l).
Exclusion Criteria
- •The patient is participating in another study
- •The patient is in an exclusion period determined by a previous study, with the exception of the following studies: Papillo PMA (RCB 2013-A00538-37), LXRs (RCB 2009-A00968-49), GrossPath (RCB 2014-A01120-47), BAKRI (RCB 2013-A00914-41), OASIS II (RCB 2013-A00773-42), ElastoMAP (RCB 2013-A01148-37), ElastoDéclench (RCB 2014-A00828-39) and UpSideDown (RCB 2014-A01921-46).
- •The patient is under judicial protection, under tutorship or curatorship
- •The patient refuses to sign the consent
- •It is impossible to correctly inform the patient
- •The patient cannot read French
- •The patient has a known history of type 2 diabetes
- •The patient is diagnosed with type 2 diabetes during pregnancy (fasting blood glucose level \> 1.26 g/l)
- •The patient has a contra-indication for a treatment necessary for this study
- •The patient is taking chronic or intermittent oral or inhaled corticosteroids, or a β2 agonist treatment for a previous disease or a disease discovered during pregnancy within one week preceding the fasting glucose or oral glucose tolerance test.
Arms & Interventions
GD diagnosis before 24 weeks
Patients in this group are diagnosed with gestational diabetes (GD) before 24 weeks of amenorrhea by means of a fasting blood glucose test \>= 0.92 g/l. Intervention: Post-partum oral glucose tolerance test
Intervention: Post-partum oral glucose tolerance test
GD diagnosed at 24 to 28 weeks
Patients in this group are diagnosed with gestational diabetes between 24 and 28 weeks of amenorrhea based on a normal fasting blood glucose level before 24 weeks of amenorrhea AND an abnormal oral glucose tolerance test between 24 and 28 weeks of amenorrhea. Intervention: Post-partum oral glucose tolerance test
Intervention: Post-partum oral glucose tolerance test
Outcomes
Primary Outcomes
Presence/absence of abnormal glucose metabolism
Time Frame: 4 to12 weeks post-partum
Includes type 2 diabetes, glucose intolerance and impaired fasting glucose
Secondary Outcomes
- Presence/absence of impaired fasting glucose(4 to12 weeks post-partum)
- Presence/absence of type 2 diabetes(4 to 12 weeks post partum)
- Presence/absence of complications(4 to12 weeks post-partum)
- Weeks of amenorrhea (duration of pregnancy in weeks/ gestational age)(4 to 12 weeks post-partum)
- Body mass index > 25 at beginning of pregnancy? yes/no(baseline (day 0))
- History of macrosomia? yes/no(baseline (day 0))
- Fasting glucose (g/l)(before 24 weeks of amenorrhea)
- Presence/absence of glucose intolerance(4 to 12 weeks post-partum)
- Baby's weight at birth (kg)(4 to 12 weeks post-partum)
- Patient was older than 35 years of age at beginning of pregnancy? yes/no(baseline (day 0))
- First degree family history of type 2 diabetes? yes/no(baseline (day 0))
- Patient requiring insulin: yes/no(4 to12 weeks post-partum)
- History of gestational diabetes? yes/no(baseline (day 0))
- Oral glucose tolerance test results if necessary(24 to 28 weeks of amenorrhea)