Abnormal Post-partum Glucose Metabolism After Gestational Diabetes Diagnosed Before or After 24 Weeks of Gestation

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

Patrocinadores

Patrocinador principal: Centre Hospitalier Universitaire de Nīmes

Fuente Centre Hospitalier Universitaire de Nīmes
Resumen breve

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.

Descripción detallada

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.

Estado general Completed
Fecha de inicio March 27, 2014
Fecha de Terminación August 16, 2017
Fecha de finalización primaria August 16, 2017
Tipo de estudio Observational
Resultado primario
Medida Periodo de tiempo
Presence/absence of abnormal glucose metabolism 4 to12 weeks post-partum
Resultado secundario
Medida Periodo de tiempo
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 4 to12 weeks post-partum
Presence/absence of impaired fasting glucose 4 to12 weeks post-partum
Patient requiring insulin: yes/no 4 to12 weeks post-partum
Presence/absence of complications 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
Inscripción 500
Condición
Intervención

Tipo de intervención: Biological

Nombre de intervención: Post-partum oral glucose tolerance test

Descripción: 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.

Elegibilidad

Método de muestreo: Non-Probability Sample

Criterios:

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.

Género: Female

Edad mínima: 18 Years

Edad máxima: N/A

Voluntarios Saludables: No

Oficial general
Ubicación
Instalaciones:
CH d'Arles - Hôpital Joseph Imbert | Arles Cedex, 13637, France
CHU de Montpellier - Hôpital Arnaud de Villeneuve | Montpellier Cedex 5, 34295, France
CHU de Montpellier - Hôpital Lapeyronie | Montpellier, 34295, France
CHU de Nîmes - Hôpital Universitaire Carémeau | Nîmes Cedex 9, 30029, France
Ubicacion Paises

France

Fecha de verificación

January 2018

Fiesta responsable

Tipo: Sponsor

Palabras clave
Tiene acceso ampliado No
Condición Examinar
Grupo de brazo

Etiqueta: GD diagnosis before 24 weeks

Descripción: 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

Etiqueta: GD diagnosed at 24 to 28 weeks

Descripción: 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

Acrónimo DG Post-Partum
Información de diseño del estudio

Modelo de observación: Cohort

Perspectiva de tiempo: Prospective

Fuente: ClinicalTrials.gov