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NCT Number: NCT01839448

Abnormal Post-partum Glucose Metabolism After 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.

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Key information

Conditions

Gestational Diabetes Diabetes Mellitus Diabetes Mellitus, Type 2 Diabetes, Gestational Endocrine System Diseases Female Urogenital Diseases and Pregnancy Complications Glucose Intolerance Glucose Metabolism Disorders Hyperglycemia Metabolic Diseases Nutritional and Metabolic Diseases Pregnancy Complications Type 2 Diabetes Urogenital Diseases

Age range

18 year and older

Sex eligibility

Female

Study type

Observational

Primary location

CH d'Arles - Hôpital Joseph Imbert, Arles, France

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Primary outcomes

  1. 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

  1. Presence/absence of type 2 diabetes

    Time frame: 4 to 12 weeks post partum

  2. Presence/absence of glucose intolerance

    Time frame: 4 to 12 weeks post-partum

  3. Presence/absence of impaired fasting glucose

    Time frame: 4 to12 weeks post-partum

    American definition: defined as between 1 and 1.26 g/l

  4. Presence/absence of impaired fasting glucose

    Time frame: 4 to12 weeks post-partum

    European definition: defined as between 1.1 and 1.26 g/l

  5. Patient requiring insulin: yes/no

    Time frame: 4 to12 weeks post-partum

  6. Presence/absence of complications

    Time frame: 4 to12 weeks post-partum

    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.

  7. Baby's weight at birth (kg)

    Time frame: 4 to 12 weeks post-partum

  8. Weeks of amenorrhea (duration of pregnancy in weeks/ gestational age)

    Time frame: 4 to 12 weeks post-partum

  9. Patient was older than 35 years of age at beginning of pregnancy? yes/no

    Time frame: baseline (day 0)

  10. Body mass index > 25 at beginning of pregnancy? yes/no

    Time frame: baseline (day 0)

  11. First degree family history of type 2 diabetes? yes/no

    Time frame: baseline (day 0)

  12. History of gestational diabetes? yes/no

    Time frame: baseline (day 0)

  13. History of macrosomia? yes/no

    Time frame: baseline (day 0)

  14. Fasting glucose (g/l)

    Time frame: before 24 weeks of amenorrhea

  15. Oral glucose tolerance test results if necessary

    Time frame: 24 to 28 weeks of amenorrhea

Other outcomes

  1. Age

    Time frame: baseline (day 0)

  2. Body mass index

    Time frame: baseline (day 0)

  3. Number of pregnancies

    Time frame: baseline (day 0)

Sponsors and collaborators

Lead sponsor

Centre Hospitalier Universitaire de Nīmes

Other

Registry information

Official study title

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

Acronym: DG Post-Partum

Important dates

Study start
2014
Primary completion
2016
Study completion
2016
First posted
Apr 24, 2013
Registry last updated
Nov 19, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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