Clinical trial NCT01869608: Postpartum Screening of Type 2 Diabetes
Official title: Can we Screen Type 2 Diabetes on the 2nd Day After Delivery in Women Who Had Gestational Diabetes Mellitus?
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Type 2 Diabetes
Keywords: postpartum screening
type 2 diabetes
Lead sponsor: Université de Sherbrooke
Sponsor class: OTHER
Collaborators: name: The Lawson Foundation
First posted: 2013-06-05
Enrollment: 121
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

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.


Eligibility 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.).

Primary outcomes:
measure: Diagnosis of abnormal glucose tolerance
timeFrame: 12 weeks postpartum
Secondary outcomes:
measure: Patient's satisfaction
timeFrame: 12 weeks post-partum
Other outcomes:
Locations:
city: Sherbrooke
country: Canada
facility: Clinical Research Center Étienne-Le Bel of the Sherbrooke University Hospital
state: Quebec
Study officials:
affiliation: Clinical Research Center Étienne-Le Bel of the Sherbrooke University Hospital
name: Jean-Luc Ardilouze, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: