Postpartum Screening of Type 2 Diabetes

Not Applicable

Completed

• Conditions: Type 2 Diabetes
• Interventions: Procedure: oral glucose tolerance test 2 days post-partum

• Registration Number: NCT01869608
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2013-05-15
• Study First Submitted QC: 2013-05-31
• Study First Posted: 2013-06-05
• Study Start: 2014-04
• Primary Completion: 2014-12
• Study Completion: 2018-12-31
• Status Verified: 2019-04
• Last Update Submitted: 2019-04-29
• Last Update Posted: 2019-05-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 121

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
postpartum screening	oral glucose tolerance test 2 days post-partum	Oral glucose tolerance test 2 days post-partum

Primary Outcome Measures

Name	Time	Method
Diagnosis of abnormal glucose tolerance	12 weeks postpartum	Oral glucose tolerance test

Secondary Outcome Measures

Name	Time	Method
Patient's satisfaction	12 weeks post-partum	Satisfaction questionnaire

Trial Locations

Locations (1)

Clinical Research Center Étienne-Le Bel of the Sherbrooke University Hospital; 🇨🇦 Sherbrooke, Quebec, Canada