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

Pregnancy Trimester, Second Clinical Trial

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)

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT00180219
• Other study ID #: IKPD-S-01-04
• Status: Withdrawn
• Phase: Phase 1
• First received: September 14, 2005
• Last updated: August 24, 2016
• Start date: January 2006
• Est. completion date: June 2006

Study information

• Verified date: August 2016
• Source: Technische Universität Dresden
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Federal Institute for Drugs and Medical Devices
• Study type: Observational

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: June 2006
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 20 Years to 42 Years

Eligibility

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

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Pregnancy Trimester, First
• Pregnancy Trimester, Second
• Pregnancy Trimester, Third

Locations

Country	Name	City	State
Germany	Medizinische Fakultät der Technischen Universität Dresden	Dresden

Sponsors (1)

Lead Sponsor	Collaborator
Technische Universität Dresden

Country where clinical trial is conducted

Germany,