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Postpartum Screening of Type 2 Diabetes (Tot ou tard)

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ClinicalTrials.gov Identifier: NCT01869608
Recruitment Status : Active, not recruiting
First Posted : June 5, 2013
Last Update Posted : May 3, 2018
Sponsor:
Collaborator:
The Lawson Foundation
Information provided by (Responsible Party):
Jean-Luc Ardilouze, Université de Sherbrooke

Brief Summary:

Gestational diabetes mellitus (GDM) complicates 5 to 30 % of pregnancies. GDM is defined as hyperglycemia with onset or first recognition during pregnancy. Because it is a forerunner of type 2 diabetes mellitus (T2DM), professional associations recommend T2DM postpartum screening (T2DM-pPS) at 6 weeks/6 months post delivery, using a 75g oral glucose tolerance test (OGTT).

However, less than a quarter of these women are screened. This recommendation has failed for multiple reasons; the most important being that busy new mothers must deal with the major inconveniences of returning to a sampling center for a 2h testing session, bringing baby along or paying for a sitter, transportation, parking… A mother-friendly solution is direly needed.

The investigators hypothesize that, in these women, results of an OGTT performed after delivery on the last day of their hospital stay (OGTT-1) will predict results of the recommended OGTT (OGTT-2) at 6 weeks/6 months postpartum.

The main aim of our project is to determine the optimal cut-off value for the 2h glucose result during OGTT-1 in order to predict abnormal glucose tolerance status at OGTT-2 (the gold standard), in the same woman.


Condition or disease Intervention/treatment Phase
Type 2 Diabetes Procedure: oral glucose tolerance test 2 days post-partum Not Applicable

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 145 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Can we Screen Type 2 Diabetes on the 2nd Day After Delivery in Women Who Had Gestational Diabetes Mellitus?
Study Start Date : April 2014
Actual Primary Completion Date : December 2014
Estimated Study Completion Date : December 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Postpartum Care

Arm Intervention/treatment
Experimental: postpartum screening
Oral glucose tolerance test 2 days post-partum
Procedure: oral glucose tolerance test 2 days post-partum
Screening for type 2 diabetes after gestational diabetes mellitus.




Primary Outcome Measures :
  1. Diagnosis of abnormal glucose tolerance [ Time Frame: 12 weeks postpartum ]
    Oral glucose tolerance test


Secondary Outcome Measures :
  1. Patient's satisfaction [ Time Frame: 12 weeks post-partum ]
    Satisfaction questionnaire



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Women aged between 18 and 45 years;
  • Having a positive diagnosis of gestational diabetes mellitus (IADPSG criteria);
  • Treated with diet or insulin;
  • Have given birth to a child at term; gestational age > 37 weeks;
  • Have been followed during her pregnancy by a physician who delivers in CHUS;
  • Have signed the consent form.

Exclusion Criteria:

  • History of glucose intolerance or diabetes before the pregnancy;
  • Have presented another obstetrical pathology during the pregnancy;

    • Severe gestational high blood pressure with proteinuria;
    • Delayed intrauterine development syndrome;
    • Pregnancy with more than a foetus;
    • Drug addiction;
    • Had complications during the delivery such as:
  • Moderate to severe postpartum bleeding;
  • Surgery in postpartum (curettage, hysterectomy, etc.).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01869608


Locations
Canada, Quebec
Clinical Research Center Étienne-Le Bel of the Sherbrooke University Hospital
Sherbrooke, Quebec, Canada, J1H 5N4
Sponsors and Collaborators
Université de Sherbrooke
The Lawson Foundation
Investigators
Principal Investigator: Jean-Luc Ardilouze, MD, PhD Clinical Research Center Étienne-Le Bel of the Sherbrooke University Hospital

Responsible Party: Jean-Luc Ardilouze, Full professor, endocrinologist, researcher, Université de Sherbrooke
ClinicalTrials.gov Identifier: NCT01869608     History of Changes
Other Study ID Numbers: 13-005
First Posted: June 5, 2013    Key Record Dates
Last Update Posted: May 3, 2018
Last Verified: May 2018

Keywords provided by Jean-Luc Ardilouze, Université de Sherbrooke:
postpartum screening
type 2 diabetes

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases