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Completed

NCT Number: NCT01869608

Postpartum Screening of Type 2 Diabetes

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.

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Key information

Conditions

Type 2 Diabetes Diabetes Mellitus Diabetes Mellitus, Type 2 Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

18 year–45 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Clinical Research Center Étienne-Le Bel of the Sherbrooke University Hospital

Sherbrooke, Quebec, J1H 5N4, Canada

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.).

Treatment and study plan

oral glucose tolerance test 2 days post-partum

Procedure

Screening for type 2 diabetes after gestational diabetes mellitus.

Primary outcomes

  1. Diagnosis of abnormal glucose tolerance

    Time frame: 12 weeks postpartum

    Oral glucose tolerance test

Secondary outcomes

  1. Patient's satisfaction

    Time frame: 12 weeks post-partum

    Satisfaction questionnaire

Sponsors and collaborators

Lead sponsor

Université de Sherbrooke

Other

Collaborators

  • The Lawson Foundation

Registry information

Official study title

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

Acronym: Tot ou tard

Important dates

Study start
2014
Primary completion
2014
Study completion
2018
First posted
Jun 5, 2013
Registry last updated
May 1, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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