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Completed

NCT Number: NCT02035059

Predictability of Gestational Diabetes Mellitus in First and Second Trimester

The objective of the study is, if an early oral glucose tolerance test combined with maternal history, condition and multiple biomarker analysis can be used to detect gestational diabetes mellitus in the first trimester (12-14 weeks of gestation).

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Key information

Conditions

Pregnancy Diabetes Insipidus Diabetes Mellitus Diabetes, Gestational Endocrine System Diseases Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Gestational Diabetes Mellitus Glucose Metabolism Disorders Kidney Diseases Male Urogenital Diseases Metabolic Diseases Nutritional and Metabolic Diseases Pituitary Diseases Pregnancy Complications Urogenital Diseases Urologic Diseases

Age range

18 year–45 year

Sex eligibility

Female

Study type

Observational

Primary location

Women's Hospital, University Basel

Basel, Canton of Basel-City, 4031, Switzerland

About this study

It is the investigators' aim to prospectively examine an extended form of the current 1st trimester screening test for the detection of foetal aneuploidy, in order to ascertain whether this can also be used for the detection of patients at-risk for gestational diabetes mellitus. For this purpose the investigators will include a combination of new markers in a multiplex bio-array manner in conjunction with an early oral glucose tolerance test. A nested case-control proteomic analysis will be performed in a retrospective manner at the completion of this study in order to develop more specific biomarker panels.

The primary outcome will be development of gestational diabetes mellitus in the second or third trimester.

The secondary endpoints are the delivery outcome, neonatal morbidity, neonatal mortality, maternal morbidity and costs.

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Healthy singleton pregnancies
  • Women at least 18 years old and not under guardianship

Exclusion criteria

  • Maternal diseases like hypertension, diabetes mellitus and chronic disease, known infection like hepatitis or human immunodeficiency virus
  • Maternal history of hypertensive diseases in previous pregnancy and now under prophylactic acetylsalicylate treatment
  • Foetal genetic, chromosomal or intervention-requiring morphologic abnormalities

Treatment and study plan

Primary outcomes

  1. Development of Gestational Diabetes in second/third trimester

    Time frame: 24-28 weeks of gestation

    Development of gestational diabetes in 24-28 weeks of gestation by pathological values in oral glucose tolerance test 75g

Sponsors and collaborators

Lead sponsor

University Hospital, Basel, Switzerland

Other

Collaborators

  • Cantonal Hospital of Aarau, Switzerland
  • Paracelsus Medical University
  • University Hospital Freiburg
  • University Hospital, Zürich
  • Vienna General Hospital

Registry information

Official study title

Predictability of Gestational Diabetes Mellitus in First and Second Trimester, Using Novel Biomarkers, and the Development of New Biomarkers by Quantitative Proteomic Analysis

Acronym: GDMPredict

Important dates

Study start
2014
Primary completion
2018
Study completion
2018
First posted
Jan 14, 2014
Registry last updated
Apr 26, 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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