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Clinical Trial Details — Status: Withdrawn

Administrative data

NCT number NCT00180219
Other study ID # IKPD-S-01-04
Secondary ID
Status Withdrawn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Status Withdrawn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
Est. primary completion date
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


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, 

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