Ignite Creation Date:
2025-12-24 @ 3:04 PM
Ignite Modification Date:
2026-03-02 @ 4:11 AM
Study NCT ID:
NCT02035059
Status:
COMPLETED
Last Update Posted:
2019-04-26
First Post:
2014-01-12
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Predictability of Gestational Diabetes Mellitus in First and Second Trimester
Sponsor:
University Hospital, Basel, Switzerland
Organization:
Study Overview
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
Status:
COMPLETED
Status Verified Date:
2019-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
GDMPredict
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.
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 Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: