Clinical Trial to Assess the Influence of Gestational Stage and Maternal Age on Arterial Stiffness of the Mother

This study has been suspended.

Sponsored by:	Dresden University of Technology
Information provided by:	Dresden University of Technology
ClinicalTrials.gov Identifier:	NCT00180219

Purpose

This is a single-centre, open, parallel-group study with three age groups; no study medication or intervention will be provided. This is a longitudinal follow-up of physiological parameters.

Condition	Phase
Pregnancy Trimester, First Pregnancy Trimester, Second Pregnancy Trimester, Third	Phase I

U.S. FDA Resources

Study Type:	Observational
Study Design:	Prospective
Official Title:	An Open Clinical Trial to Assess the Influence of Gestational Stage and Maternal Age on Arterial Stiffness of the Mother (Hormonal and Age Related Changes of the Aortal Elasticity)

Further study details as provided by Dresden University of Technology:

Estimated Enrollment:	60
Study Start Date:	January 2006
Estimated Study Completion Date:	June 2006

Detailed Description:

The subjects will be investigated as outpatients. For each subject, 4 individual dates with a duration of approximately 30 minutes each are scheduled - at the end of the first trimenon, at the end of the second trimenon, 4 weeks prior to the calculated date of birth, and 6 weeks after the effective date of birth.

Eligibility

Ages Eligible for Study:	20 Years to 42 Years
Genders Eligible for Study:	Female
Accepts Healthy Volunteers:	Yes

Criteria

Inclusion Criteria:

Pregnant women without major concomitant disease
Willing and able to provide informed consent
Age (three age groups):
- 20 to 22 years
- 30 to 32 years
- 40 to 42 years

Exclusion Criteria:

Non pregnant women
Men
No informed consent
Age not included in inclusion criteria
Major concomitant disease

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00180219

Locations

Germany
Medizinische Fakultät der Technischen Universität Dresden
Dresden, Germany, 01307

Sponsors and Collaborators

Dresden University of Technology

Investigators

Principal Investigator:

Joachim Siegert, MD, DPharm, Phd

Technische Universität Dresden

More Information

Study ID Numbers:	IKPD-S-01-04
Study First Received:	September 14, 2005
Last Updated:	May 6, 2008
ClinicalTrials.gov Identifier:	NCT00180219
Health Authority:	Germany: Federal Institute for Drugs and Medical Devices

Keywords provided by Dresden University of Technology:

G08.520.769.550.408
G08.520.769.550.490
G08.520.769.550.520

ClinicalTrials.gov processed this record on January 16, 2009