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

This study is currently recruiting participants. (see Contacts and Locations)
Verified November 2014 by Centre Hospitalier Universitaire de Nīmes
Sponsor:
Information provided by (Responsible Party):
Centre Hospitalier Universitaire de Nīmes
ClinicalTrials.gov Identifier:
NCT01839448
First received: April 22, 2013
Last updated: November 4, 2014
Last verified: November 2014

April 22, 2013
November 4, 2014
March 2014
January 2017   (final data collection date for primary outcome measure)
Presence/absence of abnormal glucose metabolism [ Time Frame: 4 to12 weeks post-partum ] [ Designated as safety issue: No ]
Includes type 2 diabetes, glucose intolerance and impaired fasting glucose
Same as current
Complete list of historical versions of study NCT01839448 on ClinicalTrials.gov Archive Site
  • Presence/absence of type 2 diabetes [ Time Frame: 4 to 12 weeks post partum ] [ Designated as safety issue: No ]
  • Presence/absence of glucose intolerance [ Time Frame: 4 to 12 weeks post-partum ] [ Designated as safety issue: No ]
  • Presence/absence of impaired fasting glucose [ Time Frame: 4 to12 weeks post-partum ] [ Designated as safety issue: No ]
    American definition: defined as between 1 and 1.26 g/l
  • Presence/absence of impaired fasting glucose [ Time Frame: 4 to12 weeks post-partum ] [ Designated as safety issue: No ]
    European definition: defined as between 1.1 and 1.26 g/l
  • Patient requiring insulin: yes/no [ Time Frame: 4 to12 weeks post-partum ] [ Designated as safety issue: No ]
  • Presence/absence of complications [ Time Frame: 4 to12 weeks post-partum ] [ Designated as safety issue: No ]
    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.
  • Baby's weight at birth (kg) [ Time Frame: 4 to 12 weeks post-partum ] [ Designated as safety issue: No ]
  • Weeks of amenorrhea (duration of pregnancy in weeks/ gestational age) [ Time Frame: 4 to 12 weeks post-partum ] [ Designated as safety issue: No ]
  • Patient was older than 35 years of age at beginning of pregnancy? yes/no [ Time Frame: baseline (day 0) ] [ Designated as safety issue: No ]
  • Body mass index > 25 at beginning of pregnancy? yes/no [ Time Frame: baseline (day 0) ] [ Designated as safety issue: No ]
  • First degree family history of type 2 diabetes? yes/no [ Time Frame: baseline (day 0) ] [ Designated as safety issue: No ]
  • History of gestational diabetes? yes/no [ Time Frame: baseline (day 0) ] [ Designated as safety issue: No ]
  • History of macrosomia? yes/no [ Time Frame: baseline (day 0) ] [ Designated as safety issue: No ]
  • Fasting glucose (g/l) [ Time Frame: before 24 weeks of amenorrhea ] [ Designated as safety issue: No ]
  • Oral glucose tolerance test results if necessary [ Time Frame: 24 to 28 weeks of amenorrhea ] [ Designated as safety issue: No ]
Same as current
  • Age [ Time Frame: baseline (day 0) ] [ Designated as safety issue: No ]
  • Body mass index [ Time Frame: baseline (day 0) ] [ Designated as safety issue: No ]
  • Number of pregnancies [ Time Frame: baseline (day 0) ] [ Designated as safety issue: No ]
Same as current
 
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

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.

Observational
Observational Model: Cohort
Time Perspective: Prospective
Not Provided
Not Provided
Non-Probability Sample

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.

  • Gestational Diabetes
  • Type 2 Diabetes
  • Glucose Intolerance
Biological: Post-partum oral glucose tolerance test
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.
  • 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: Biological: 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: Biological: Post-partum oral glucose tolerance test
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
500
January 2017
January 2017   (final data collection date for primary outcome measure)

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
  • 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.
Female
18 Years and older
No
Contact: Anne-Marie Guedj, MD +33.(0)4.66.68.33.21 anne.marie.guedj@chu-nimes.fr
Contact: Carey M Suehs, PhD +33.(0)4.66.68.67.88 carey.suehs@chu-nimes.fr
France
 
NCT01839448
AOI/2012/VC-01, 2013-A00277-38
No
Centre Hospitalier Universitaire de Nīmes
Centre Hospitalier Universitaire de Nīmes
Not Provided
Study Director: Valéria Cosma, MD Centre Hospitalier Universitaire de Nîmes
Principal Investigator: Anne-Marie Guedj, MD Centre Hospitalier Universitaire de Nîmes
Centre Hospitalier Universitaire de Nīmes
November 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP