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Completed

NCT Number: NCT02482662

Diagnosis Test for Gestational Diabetes Mellitus

Gestational diabetes mellitus (GDM) is an asymptomatic disease. Diagnosis is based on a oral glucose tolerance test (OGTT) requiring pregnant women to absorb 75g of glucose while fasting since midnight and to stay sober for another two hours. These OGTTs are poorly tolerated by pregnant women. As many OGTT are false positive according to self-monitoring blood glucose (SMBG), the investigators need now to determine the percentage of OGTT results that are false negative.

The comparison of the two tests (OGTT and SMBG) in the same patient with normal results of OGTT will determine the exact percentage of false negative OGTT results.

The opinion of women will also be taken into account. In the everyday clinic, many report that they prefer SMBG to OGTT because they do not have to be fasting, to drink non palatable drink and to attend a 2-hour visit in their schedule. However, no opinion study has yet been performed, the investigators will investigate formally what women think using a questionnaire.

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Key information

Conditions

Gestational Diabetes Mellitus Diabetes Mellitus Diabetes, Gestational Disease Endocrine System Diseases Female Urogenital Diseases and Pregnancy Complications Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Pregnancy Complications Urogenital Diseases

Age range

18 year and older

Sex eligibility

Female

Study type

Observational

Primary location

Centre de recherche clinique du CHUS

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

  • positive GDM screening test (glycemia post-50g of glucose ≥ 7.2 mmol/L),
  • between 24 and 28 weeks of gestation from the last menstruation,
  • single pregnancy,
  • able to read and understand French.

Exclusion criteria

  • known type 1 or type 2 diabetes,
  • disease or treatment interfering with the metabolism of glucose,
  • deficiency may hinder the understanding of the study.

Treatment and study plan

Diagnosis

Procedure

Oral glucose tolerance test and self-monitoring blood glucose

Primary outcomes

  1. proportion of OGTTs falsely negative

    Time frame: Will be evaluated when participants finished SMBG i.e. 7 days after the OGTT

Secondary outcomes

  1. preference of participants regarding the two tests (OGTT vs. SMBG)

    Time frame: Will be evaluated when participants finished SMBG i.e. 7 days after the OGTT

    Evaluated by questionnaire

Sponsors and collaborators

Lead sponsor

Université de Sherbrooke

Other

Registry information

Official study title

Assessment of the Diagnosis Test for Gestational Diabetes Mellitus

Important dates

Study start
2014
Primary completion
2015
Study completion
2017
First posted
Jun 26, 2015
Registry last updated
May 3, 2018

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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