Postpartum Screening of Type 2 Diabetes (Tot ou tard)

Can we Screen Type 2 Diabetes on the 2nd Day After Delivery in Women Who Had Gestational Diabetes Mellitus?

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.

Study Overview

• Status: Completed
• Conditions: Type 2 Diabetes
• Intervention / Treatment: Procedure: oral glucose tolerance test 2 days post-partum

• Study Type: Interventional
• Enrollment (Actual): 121
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Canada
  • Quebec
    • Sherbrooke, Quebec, Canada, J1H 5N4
      • Clinical Research Center Étienne-Le Bel of the Sherbrooke University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 45 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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.).

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Diagnosis of abnormal glucose tolerance	Oral glucose tolerance test	12 weeks postpartum

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Patient's satisfaction	Satisfaction questionnaire	12 weeks post-partum

Collaborators and Investigators

• Sponsor: Université de Sherbrooke
• Collaborators: The Lawson Foundation
• Investigators: Principal Investigator: Jean-Luc Ardilouze, MD, PhD, Clinical Research Center Étienne-Le Bel of the Sherbrooke University Hospital

Study record dates

Study Major Dates

• Study Start (Actual): April 1, 2014
• Primary Completion (Actual): December 1, 2014
• Study Completion (Actual): December 31, 2018

Study Registration Dates

• First Submitted: May 15, 2013
• First Submitted That Met QC Criteria: May 31, 2013
• First Posted (Estimate): June 5, 2013

Study Record Updates

• Last Update Posted (Actual): May 1, 2019
• Last Update Submitted That Met QC Criteria: April 29, 2019
• Last Verified: April 1, 2019

More Information

Terms related to this study

• Keywords: type 2 diabetes; postpartum screening
• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Diabetes Mellitus; Diabetes Mellitus, Type 2
• Other Study ID Numbers: 13-005