NCT02035059

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).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
820

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started May 2014

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 12, 2014

Completed
2 days until next milestone

First Posted

Study publicly available on registry

January 14, 2014

Completed
4 months until next milestone

Study Start

First participant enrolled

May 1, 2014

Completed
4.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2018

Completed
Last Updated

April 26, 2019

Status Verified

April 1, 2019

Enrollment Period

4.7 years

First QC Date

January 12, 2014

Last Update Submit

April 25, 2019

Conditions

PregnancyGestational Diabetes Mellitus

Keywords

Oral Glucose Tolerance TestFibronectinAdiponectinCopeptinCortisol

Outcome Measures

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

    24-28 weeks of gestation

Study Arms (1)

Women with/without gestational diabetes

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

Eligibility Criteria

Age18 Years - 45 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
Study Population

Pregnant Women

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Women's Hospital, University Basel

Basel, Canton of Basel-City, 4031, Switzerland

Location

Related Publications (3)

  • 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 Nov;68(11):2511-2522. doi: 10.1007/s00125-025-06517-0. Epub 2025 Aug 16.

    PMID: 40817933DERIVED

  • 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.

    PMID: 37720695DERIVED

  • 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.

    PMID: 27733413DERIVED

Biospecimen

Retention: SAMPLES WITHOUT DNA

Blood Saliva

MeSH Terms

Conditions

Diabetes, GestationalDiabetes Insipidus

Condition Hierarchy (Ancestors)

Pregnancy ComplicationsFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesDiabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesKidney DiseasesUrologic DiseasesFemale Urogenital DiseasesMale Urogenital DiseasesPituitary Diseases

Study Officials

  • Evelyn Huhn, MD

    Women's Hospital, University Basel

    STUDY DIRECTOR

  • Irene Hösli, MD

    Women's Hospital, University Basel

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 12, 2014

First Posted

January 14, 2014

Study Start

May 1, 2014

Primary Completion

December 31, 2018

Study Completion

December 31, 2018

Last Updated

April 26, 2019

Record last verified: 2019-04

Locations

CH(1)