Predictability of Gestational Diabetes Mellitus in First and Second Trimester

NCT ID: NCT02035059

Last Updated: 2019-04-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

820 participants

Study Classification

OBSERVATIONAL

Study Start Date

2014-05-01

Study Completion Date

2018-12-31

Brief Summary

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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

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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.

Conditions

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Pregnancy Gestational Diabetes Mellitus

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Women with/without gestational diabetes

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

No interventions assigned to this group

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

45 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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University Hospital, Zürich

OTHER

Sponsor Role collaborator

Cantonal Hospital of Aarau, Switzerland

OTHER

Sponsor Role collaborator

Vienna General Hospital

OTHER

Sponsor Role collaborator

Paracelsus Medical University

OTHER

Sponsor Role collaborator

University Hospital Freiburg

OTHER

Sponsor Role collaborator

University Hospital, Basel, Switzerland

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Evelyn Huhn, MD

Role: STUDY_DIRECTOR

Women's Hospital, University Basel

Irene Hösli, MD

Role: PRINCIPAL_INVESTIGATOR

Women's Hospital, University Basel

Locations

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Women's Hospital, University Basel

Basel, Canton of Basel-City, Switzerland

Site Status

Countries

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Switzerland

References

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Huhn EA, Kotzaeridi G, Fischer T, Todesco Bernasconi M, Richter AS, Kunze M, Dolzlmuller E, Jaksch-Bogensperger H, Weidinger L, Eppel D, Ochsenbein-Koelble N, Baz E, Winzeler B, Tura A, Stach H, Schafer G, van Breda SV, Vokalova L, Hoesli I, Gobl CS. The utility of early gestational OGTT and biomarkers for the development of gestational diabetes mellitus: an international prospective multicentre cohort study. Diabetologia. 2025 Aug 16. doi: 10.1007/s00125-025-06517-0. Online ahead of print.

Reference Type DERIVED
PMID: 40817933 (View on PubMed)

Huhn EA, Gobl CS, Fischer T, Todesco Bernasconi M, Kreft M, Kunze M, Vogt DR, Dolzlmuller E, Jaksch-Bogensperger H, Heldstab S, Eppel W, Husslein P, Ochsenbein Kolble N, Richter A, Baz E, Winzeler B, Hoesli I. Sensitivity, specificity, and diagnostic accuracy of WHO 2013 criteria for diagnosis of gestational diabetes mellitus in low risk early pregnancies: international, prospective, multicentre cohort study. BMJ Med. 2023 Sep 13;2(1):e000330. doi: 10.1136/bmjmed-2022-000330. eCollection 2023.

Reference Type DERIVED
PMID: 37720695 (View on PubMed)

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.

Reference Type DERIVED
PMID: 27733413 (View on PubMed)

Other Identifiers

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EKBB195/13

Identifier Type: -

Identifier Source: org_study_id

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