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CompletedNCT02035059GDMPredictUpdated Apr 26, 2019

Predictability of Gestational Diabetes Mellitus in First and Second Trimester

An observational study in Pregnancy and Gestational Diabetes Mellitus, sponsored by University Hospital, Basel, Switzerland. Completed at 1 site in Switzerland. Open to female participants aged 18 Years to 45 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2019-04-26.

Sponsored by University Hospital, Basel, Switzerland · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
820
Ages
18 Years to 45 Years
Sex
Female
01

Study 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).

Read the 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.

02

Conditions studied

  • Pregnancy
  • Gestational Diabetes Mellitus

Keywords

  • Oral Glucose Tolerance Test
  • Fibronectin
  • Adiponectin
  • Copeptin
  • Cortisol
03

In context

Diabetes, Gestational

842 studies on the registry are indexed under Diabetes, Gestational; 198 are open to participants now.

This study's enrollment of 820 is above the median of 200 across 269 observational studies indexed under Diabetes, Gestational.

Browse Diabetes, Gestational studies →

Lead sponsor

University Hospital, Basel, Switzerland is the lead sponsor of 968 studies on the registry; 191 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 45 Years
Sexes eligible
Female
Accepts healthy volunteers
Yes
Sampling method
Non-probability sample

Study population

Pregnant Women

Inclusion criteria

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

Exclusion criteria

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
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
820 participants (actual)
Patient registry
No
Biospecimen retention
Samples without dna

Groups and cohorts

  • Women with/without gestational diabetes

    Women with/without gestational diabetes diagnosed by clinically routine 75 g oral glucose tolerance testing

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What researchers measure

Primary outcomes

  1. Development of Gestational Diabetes in second/third trimester

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

    Time frame: 24-28 weeks of gestation

07

Study locations

1 site
  • Women's Hospital, University Basel
    Basel, Basel-Stadt 4031, Switzerland
08

References and documents

Publications

  • Huhn EA, Fischer T, Gobl CS, Todesco Bernasconi M, Kreft M, Kunze M, Schoetzau A, Dolzlmuller E, Eppel W, Husslein P, Ochsenbein-Koelble N, Zimmermann R, Baz E, Prompeler 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. PubMed 27733413 ↗
09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 26, 2019, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT02035059
Lead sponsor
University Hospital, Basel, Switzerland
Collaborators
University Hospital, Zürich, Cantonal Hospital of Aarau, Switzerland, Vienna General Hospital, Paracelsus Medical University, University Hospital Freiburg
Responsible party
Sponsor
First posted
Jan 14, 2014
Start date
May 1, 2014
Primary completion
Dec 31, 2018
Completion
Dec 31, 2018
Last update
Apr 26, 2019

Study contacts

Evelyn Huhn, MD
study director · Women's Hospital, University Basel
Irene Hösli, MD
principal investigator · Women's Hospital, University Basel

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Apr 2019. You cannot join it, but the record below documents what was studied.

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