Clinical trial NCT02035059: 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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Pregnancy
Gestational Diabetes Mellitus
Keywords: Oral Glucose Tolerance Test
Fibronectin
Adiponectin
Copeptin
Cortisol
Lead sponsor: University Hospital, Basel, Switzerland
Sponsor class: OTHER
Collaborators: name: University Hospital, Zürich
name: Cantonal Hospital of Aarau, Switzerland
name: Vienna General Hospital
name: Paracelsus Medical University
name: University Hospital Freiburg
First posted: 2014-01-14
Enrollment: 820
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Pregnant Women

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.

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

Primary outcomes:
measure: Development of Gestational Diabetes in second/third trimester
timeFrame: 24-28 weeks of gestation
Secondary outcomes:
Other outcomes:
Locations:
city: Basel
country: Switzerland
facility: Women's Hospital, University Basel
state: Basel-Stadt
Study officials:
affiliation: Women's Hospital, University Basel
name: Evelyn Huhn, MD
role: STUDY_DIRECTOR
affiliation: Women's Hospital, University Basel
name: Irene Hösli, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.