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| ID | Type | Description | Link |
|---|---|---|---|
| 2013-A00277-38 | Other Identifier | ANSM |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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 |
| |
| 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 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Post-partum oral glucose tolerance test | Biological | All patients will have an oral glucose tolerance test at 4 to 12 weeks after the end of pregnancy. Study representatives will contact patients by phone to remind them of the necessity of this test, and its importance for their health. |
| Measure | Description | Time Frame |
|---|---|---|
| Presence/absence of abnormal glucose metabolism | Includes type 2 diabetes, glucose intolerance and impaired fasting glucose | 4 to12 weeks post-partum |
| Measure | Description | Time Frame |
|---|---|---|
| Presence/absence of type 2 diabetes | 4 to 12 weeks post partum | |
| Presence/absence of glucose intolerance | 4 to 12 weeks post-partum | |
| Presence/absence of impaired fasting glucose |
| Measure | Description | Time Frame |
|---|---|---|
| Age | baseline (day 0) | |
| Body mass index | baseline (day 0) | |
| Number of pregnancies |
Inclusion Criteria:
Exclusion Criteria:
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The study population is composed of pregnant women consulting before 24 weeks of amenorrhea and who have at least one of the following risk factors: age > 35 years; body mass index > 25; a family history of type 2 diabetes; a history of gestational diabetes or macrosomia.
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| Name | Affiliation | Role |
|---|---|---|
| Valéria Cosma, MD | Centre Hospitalier Universitaire de Nīmes | Study Director |
| Anne-Marie Guedj, MD | Centre Hospitalier Universitaire de Nīmes | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CH d'Arles - Hôpital Joseph Imbert | Arles | 13637 | France | |||
| CHU de Montpellier - Hôpital Arnaud de Villeneuve |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 34001938 | Result | Cosma V, Imbernon J, Zagdoun L, Boulot P, Renard E, Brunet C, Mares P, Rodier M, Kabani S, Demattei C, Guedj AM. A prospective cohort study of postpartum glucose metabolic disorders in early versus standard diagnosed gestational diabetes mellitus. Sci Rep. 2021 May 17;11(1):10430. doi: 10.1038/s41598-021-89679-2. |
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|
American definition: defined as between 1 and 1.26 g/l |
| 4 to12 weeks post-partum |
| Presence/absence of impaired fasting glucose | European definition: defined as between 1.1 and 1.26 g/l | 4 to12 weeks post-partum |
| Patient requiring insulin: yes/no | 4 to12 weeks post-partum |
| Presence/absence of complications | This includes a yes/no response for each of the following: caesarean section, hypertension, preeclampsia, urinary tract infection, macrosomia, dystocia, neonatal transfer, respiratory distress, threat of premature birth. | 4 to12 weeks post-partum |
| Baby's weight at birth (kg) | 4 to 12 weeks post-partum |
| Weeks of amenorrhea (duration of pregnancy in weeks/ gestational age) | 4 to 12 weeks post-partum |
| Patient was older than 35 years of age at beginning of pregnancy? yes/no | baseline (day 0) |
| Body mass index > 25 at beginning of pregnancy? yes/no | baseline (day 0) |
| First degree family history of type 2 diabetes? yes/no | baseline (day 0) |
| History of gestational diabetes? yes/no | baseline (day 0) |
| History of macrosomia? yes/no | baseline (day 0) |
| Fasting glucose (g/l) | before 24 weeks of amenorrhea |
| Oral glucose tolerance test results if necessary | 24 to 28 weeks of amenorrhea |
| baseline (day 0) |
| Montpellier |
| 34295 |
| France |
| CHU de Montpellier - Hôpital Lapeyronie | Montpellier | 34295 | France |
| CHU de Nîmes - Hôpital Universitaire Carémeau | Nîmes | 30029 | France |
| ID | Term |
|---|---|
| D016640 | Diabetes, Gestational |
| D003924 | Diabetes Mellitus, Type 2 |
| D018149 | Glucose Intolerance |
| ID | Term |
|---|---|
| D011248 | Pregnancy Complications |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
| D006943 | Hyperglycemia |
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