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History of Changes for Study: NCT02035059
Predictability of Gestational Diabetes Mellitus in First and Second Trimester (GDMPredict)
Latest version (submitted April 25, 2019) on ClinicalTrials.gov
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Study Record Versions
Version A B Submitted Date Changes
1 January 13, 2014 None (earliest Version on record)
2 October 7, 2015 Recruitment Status, Study Status, Sponsor/Collaborators, Study Identification and Contacts/Locations
3 April 11, 2016 Study Status
4 October 11, 2016 Study Status
5 October 24, 2016 Study Status
6 October 24, 2017 Study Status
7 February 2, 2018 Study Status
8 July 26, 2018 Study Status, Study Design and Sponsor/Collaborators
9 April 25, 2019 Recruitment Status, Study Status, Contacts/Locations and Study Design
Comparison Format:

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Study NCT02035059
Submitted Date:  January 13, 2014 (v1)

Open or close this module Study Identification
Unique Protocol ID: EKBB195/13
Brief Title: Predictability of Gestational Diabetes Mellitus in First and Second Trimester (GDMPredict)
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
Secondary IDs:
Open or close this module Study Status
Record Verification: January 2014
Overall Status: Not yet recruiting
Study Start: February 2014
Primary Completion: December 2016 [Anticipated]
Study Completion: April 2017 [Anticipated]
First Submitted: January 12, 2014
First Submitted that
Met QC Criteria:
January 13, 2014
First Posted: January 14, 2014 [Estimate]
Last Update Submitted that
Met QC Criteria:
January 13, 2014
Last Update Posted: January 14, 2014 [Estimate]
Open or close this module Sponsor/Collaborators
Sponsor: Basel Women's University Hospital
Responsible Party: Sponsor
Collaborators:
Open or close this module Oversight
U.S. FDA-regulated Drug:
U.S. FDA-regulated Device:
Data Monitoring: Yes
Open or close this module Study Description
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.

Open or close this module Conditions
Conditions: Pregnancy
Gestational Diabetes Mellitus
Keywords: Oral Glucose Tolerance Test
Fibronectin
Adiponectin
Copeptin
Cortisol
Open or close this module Study Design
Study Type: Observational
Observational Study Model: Cohort
Time Perspective: Prospective
Biospecimen Retention: Samples Without DNA
Biospecimen Description: Blood Saliva
Enrollment: 550 [Anticipated]
Number of Groups/Cohorts 1
Open or close this module Groups and Interventions
Groups/Cohorts Interventions
Women with/without gestational diabetes
Women with/without gestational diabetes diagnosed by clinically routine 75 g oral glucose tolerance testing
Open or close this module Outcome Measures
Primary Outcome Measures:
1. 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
Open or close this module Eligibility
Study Population: Pregnant Women
Sampling Method: Non-Probability Sample
Minimum Age: 18 Years
Maximum Age: 45 Years
Sex: Female
Gender Based:
Accepts Healthy Volunteers: Yes
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
Open or close this module Contacts/Locations
Central Contact Person: Evelyn Huhn, MD
Telephone: +41615565144
Email: evelyn.huhn@usb.ch
Study Officials: Evelyn Huhn, MD
Study Director
Women's Hospital, University Basel
Irene Hösli, MD
Principal Investigator
Women's Hospital, University Basel
Locations: Switzerland, Basel-Stadt
Women's Hospital, University Basel
Basel, Basel-Stadt, Switzerland, 4031
Contact:Contact: Evelyn Huhn, MD +41615565144 evelyn.huhn@usb.ch
Contact:Principal Investigator: Irene Hösli, MD
Contact:Principal Investigator: Huhn Evelyn, MD
Open or close this module IPDSharing
Plan to Share IPD:
Open or close this module References
Links:
Available IPD/Information:

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