Postpartum Screening of Type 2 Diabetes

Type 2 Diabetes Clinical Trial

— Tot ou tard  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01869608
• Other study ID #: 13-005
• Status: Completed
• Phase: N/A
• Start date: April 2014
• Est. completion date: December 31, 2018

Study information

• Verified date: April 2019
• Source: Université de Sherbrooke
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 121
• Est. completion date: December 31, 2018
• Est. primary completion date: December 2014
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 45 Years

Eligibility

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.).

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2
• Type 2 Diabetes

Intervention

Procedure:
• oral glucose tolerance test 2 days post-partum
Screening for type 2 diabetes after gestational diabetes mellitus.

Locations

Country	Name	City	State
Canada	Clinical Research Center Étienne-Le Bel of the Sherbrooke University Hospital	Sherbrooke	Quebec

Sponsors (2)

Lead Sponsor	Collaborator
Université de Sherbrooke	The Lawson Foundation

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Diagnosis of abnormal glucose tolerance	Oral glucose tolerance test	12 weeks postpartum
Secondary	Patient's satisfaction	Satisfaction questionnaire	12 weeks post-partum