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Predictability of Gestational Diabetes Mellitus in First and Second Trimester (GDMPredict)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02035059
Recruitment Status : Completed
First Posted : January 14, 2014
Last Update Posted : April 26, 2019
Sponsor:
Collaborators:
University Hospital, Zürich
Cantonal Hospital of Aarau, Switzerland
Vienna General Hospital
Paracelsus Medical University
University Hospital Freiburg
Information provided by (Responsible Party):
University Hospital, Basel, Switzerland

Tracking Information
First Submitted Date January 12, 2014
First Posted Date January 14, 2014
Last Update Posted Date April 26, 2019
Actual Study Start Date May 1, 2014
Actual Primary Completion Date December 31, 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: January 13, 2014)
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
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Predictability of Gestational Diabetes Mellitus in First and Second Trimester
Official Title Predictability of Gestational Diabetes Mellitus in First and Second Trimester, Using Novel Biomarkers, and the Development of New Biomarkers by Quantitative Proteomic Analysis
Brief Summary 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).
Detailed Description

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.

Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Retention:   Samples Without DNA
Description:
Blood Saliva
Sampling Method Non-Probability Sample
Study Population Pregnant Women
Condition
  • Pregnancy
  • Gestational Diabetes Mellitus
Intervention Not Provided
Study Groups/Cohorts Women with/without gestational diabetes
Women with/without gestational diabetes diagnosed by clinically routine 75 g oral glucose tolerance testing
Publications * Huhn EA, Fischer T, Göbl CS, Todesco Bernasconi M, Kreft M, Kunze M, Schoetzau A, Dölzlmüller E, Eppel W, Husslein P, Ochsenbein-Koelble N, Zimmermann R, Bäz E, Prömpeler H, Bruder E, Hahn S, Hoesli I. Screening of gestational diabetes mellitus in early pregnancy by oral glucose tolerance test and glycosylated fibronectin: study protocol for an international, prospective, multicentre cohort trial. BMJ Open. 2016 Oct 12;6(10):e012115. doi: 10.1136/bmjopen-2016-012115.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: July 26, 2018)
820
Original Estimated Enrollment
 (submitted: January 13, 2014)
550
Actual Study Completion Date December 31, 2018
Actual Primary Completion Date December 31, 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria

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
Sex/Gender
Sexes Eligible for Study: Female
Ages 18 Years to 45 Years   (Adult)
Accepts Healthy Volunteers Yes
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Switzerland
Removed Location Countries  
 
Administrative Information
NCT Number NCT02035059
Other Study ID Numbers EKBB195/13
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Current Responsible Party University Hospital, Basel, Switzerland
Original Responsible Party Basel Women's University Hospital
Current Study Sponsor University Hospital, Basel, Switzerland
Original Study Sponsor Basel Women's University Hospital
Collaborators
  • University Hospital, Zürich
  • Cantonal Hospital of Aarau, Switzerland
  • Vienna General Hospital
  • Paracelsus Medical University
  • University Hospital Freiburg
Investigators
Study Director: Evelyn Huhn, MD Women's Hospital, University Basel
Principal Investigator: Irene Hösli, MD Women's Hospital, University Basel
PRS Account University Hospital, Basel, Switzerland
Verification Date April 2019