PregnancyGDMPredictNCT02035059
Predictability of Gestational Diabetes Mellitus in First and Second Trimester
An observational study of Pregnancy and Gestational Diabetes Mellitus, run by University Hospital, Basel, Switzerland at 1 site in Switzerland.
Trial 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 more about this study
- Who is it for?
- Ages 18 to 45 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Pregnancy, Gestational Diabetes Mellitus
- Type of treatment
- Pill or oral medicine
- How many people
- 820 participants
- Where
- 1 siteSwitzerland
- Study dates
- 1 May 2014to 31 Dec 2018
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- Women only
- Healthy volunteers accepted
- Adult
Study population: Pregnant Women
Who may be able to join
- Healthy singleton pregnancies
- Women at least 18 years old and not under guardianship
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Switzerland1 site
Women's Hospital, University Basel
Basel, Canton of Basel-City, 4031
About this study
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
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.
- Conditions
- Pregnancy, Gestational Diabetes Mellitus
- Keywords
- Oral Glucose Tolerance Test, Fibronectin, Adiponectin, Copeptin, Cortisol
- Medical subject headings
- Diabetes, Gestational, Diabetes Insipidus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Women with/without gestational diabetes | Women with/without gestational diabetes diagnosed by clinically routine 75 g oral glucose tolerance testing |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 24-28 weeks of gestation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jan 2014 (estimated)
- Study start1 May 2014
- Primary completion31 Dec 2018
- Study completion31 Dec 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for PregnancyStudies of the same condition, open and under way.
- More trials run by University Hospital, Basel, SwitzerlandThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 820 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Basel, Switzerland
- Sponsor type
- University, hospital or other
- Collaborators
- University Hospital, Zürich, Cantonal Hospital of Aarau, Switzerland, Vienna General Hospital, Paracelsus Medical University, University Hospital Freiburg
- Responsible party
- Sponsor
- Investigators
- Evelyn Huhn, MD, Study director, Women's Hospital, University BaselIrene Hösli, MD, Principal investigator, Women's Hospital, University Basel
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02035059
- Sponsor's protocol ID
- EKBB195/13
- Acronym
- GDMPredict
- Status last verified
- Apr 2019
- First submitted
- 12 Jan 2014
- Last updated
- 26 Apr 2019
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 40817933Huhn 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.
PubMed 37720695Huhn 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
Study at a glance
From the registry record, last updated by the sponsor on 26 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02035059
- Acronym / sponsor ID
- GDMPredict / EKBB195/13
- Conditions
- Pregnancy, Gestational Diabetes Mellitus
- Keywords
- Oral Glucose Tolerance Test, Fibronectin, Adiponectin, Copeptin, Cortisol
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 820 participants (actual)
- Lead sponsor
- University Hospital, Basel, SwitzerlandUniversity, hospital or other
- Collaborators
- University Hospital, Zürich, Cantonal Hospital of Aarau, Switzerland, Vienna General Hospital, Paracelsus Medical University, University Hospital Freiburg
- Study start
- 1 May 2014 (actual)
- Primary completion
- 31 Dec 2018 (actual)
- Study completion
- 31 Dec 2018 (actual)
- First posted
- 14 Jan 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Women with/without gestational diabetes | – | –Women with/without gestational diabetes diagnosed by clinically routine 75 g oral glucose tolerance testing |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Pregnant Women
Key inclusion criteria (2 listed)
- Healthy singleton pregnancies
- Women at least 18 years old and not under guardianship
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Apr 2019.
- Derived from this study: PubMed 40817933Huhn 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.
- Derived from this study: PubMed 37720695Huhn 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.
- Derived from this study: PubMed 27733413Huhn 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.
Related trials for Pregnancy
Recruiting
Methylation Profiling in Self-Samples for Identification of (Epi)Genetic Biomarkers for Gynecological Cancers
Gynaecological Cancers, Ovarian Cancer
RecruitingPhase 1/2
Study of INBRX-106 and INBRX-106 in Combination With Pembrolizumab (Keytruda®) in Subjects With Locally Advanced or Metastatic Solid Tumors (Hexavalent OX40 Agonist)
Solid Tumor, Non-Small Cell Lung Cancer
RecruitingObservational study
Population Pharmacokinetics of Temocillin in Acute Enterobacterial Pyelonephritis in Children
Pyelonephritis
Active, not recruitingPhase 3
A Study of Belzutifan (MK-6482) in Combination With Lenvatinib Versus Cabozantinib for Treatment of Renal Cell Carcinoma (MK-6482-011)
Carcinoma, Renal Cell
Recruiting
Safety and Performance of UCon Patch Electrode
Urinary Incontinence, Urinary Incontinence, Urge
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Evelyn Huhn, MD study director
Women's Hospital, University Basel
Irene Hösli, MD principal investigator
Women's Hospital, University Basel
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pregnancy and Gestational Diabetes Mellitus, run by University Hospital, Basel, Switzerland at 1 site in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Apr 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Development of Gestational Diabetes in second/third trimester (time frame: 24-28 weeks of gestation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02035059, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Apr 2019.