ClinicalTrials.Veeva

Menu

Predictability of Gestational Diabetes Mellitus in First and Second Trimester (GDMPredict)

University Hospital Basel logo

University Hospital Basel

Status

Completed

Conditions

Gestational Diabetes Mellitus
Pregnancy

Study type

Observational

Funder types

Other

Identifiers

NCT02035059
EKBB195/13

Details and patient eligibility

About

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).

Full 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.

Enrollment

820 patients

Sex

Female

Ages

18 to 45 years old

Volunteers

Accepts Healthy Volunteers

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

Trial design

820 participants in 1 patient group

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

Trial contacts and locations

1

Loading...

Data sourced from clinicaltrials.gov

Clinical trials

Find clinical trialsTrials by location
© Copyright 2024 Veeva Systems