Overview

This trial is active, not recruiting.

Condition type 2 diabetes
Treatment oral glucose tolerance test 2 days post-partum
Sponsor Université de Sherbrooke
Collaborator The Lawson Foundation
Start date April 2014
End date December 2014
Trial size 145 participants
Trial identifier NCT01869608, 13-005

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Endpoint classification efficacy study
Intervention model single group assignment
Masking open label
Primary purpose diagnostic
Arm
(Experimental)
Oral glucose tolerance test 2 days post-partum
oral glucose tolerance test 2 days post-partum
Screening for type 2 diabetes after gestational diabetes mellitus.

Primary Outcomes

Measure
Diagnosis of abnormal glucose tolerance
time frame: 12 weeks postpartum

Secondary Outcomes

Measure
Patient's satisfaction
time frame: 12 weeks post-partum

Eligibility Criteria

Female participants from 18 years up to 45 years old.

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.).

Additional Information

Official title Can we Screen Type 2 Diabetes on the 2nd Day After Delivery in Women Who Had Gestational Diabetes Mellitus?
Principal investigator Jean-Luc Ardilouze, MD, PhD
Trial information was received from ClinicalTrials.gov and was last updated in June 2016.
Information provided to ClinicalTrials.gov by Université de Sherbrooke.