Pregnancy Trimester, FirstNCT00180219
Clinical Trial to Assess the Influence of Gestational Stage and Maternal Age on Arterial Stiffness of the Mother
An observational study of Pregnancy Trimester, First and Pregnancy Trimester, Second, run by Technische Universität Dresden at 1 site in Germany.
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. Read more about this study
- Who is it for?
- Ages 20 to 42 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Pregnancy Trimester, First, Pregnancy Trimester, Second, Pregnancy Trimester, Third
- How many people
- 0 participants
- Where
- 1 siteGermany
- Study dates
- Jan 2006to Jun 2006
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 42 years
- Women only
- Healthy volunteers accepted
- Adult
Study population: three age groups
Who may be able to join
- 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
Who cannot join
- Non pregnant women
- Men
- No informed consent
- Age not included in inclusion criteria
- Major concomitant disease
Trial locations and contacts
1 site in 1 country.
Germany1 site
Medizinische Fakultät der Technischen Universität Dresden
Dresden, 01307
About this study
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)
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.
Read the 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.
- Keywords
- G08.520.769.550.408, G08.520.769.550.490, G08.520.769.550.520
- Medical subject headings
- Neoplasm Metastasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 1 | 20 to 22 years | |
| 2 | 30 to 32 years | |
| 3 | 40 to 42 years |
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Sep 2005 (estimated)
- Study startJan 2006
- Study completionJun 2006
Why it stopped: recruitment failure
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pregnancy Trimester, FirstStudies of the same condition, open and under way.
- More trials run by Technische Universität DresdenThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Technische Universität Dresden
- Sponsor type
- University, hospital or other
- Investigators
- Joachim Siegert, MD, DPharm, Phd, Principal investigator, Technische Universität Dresden
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00180219
- Sponsor's protocol ID
- IKPD-S-01-04
- Status last verified
- Aug 2016
- First submitted
- 14 Sep 2005
- Last updated
- 25 Aug 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Aug 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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)
- ClinicalTrials.gov ID
- NCT00180219
- Acronym / sponsor ID
- IKPD-S-01-04
- Keywords
- G08.520.769.550.408, G08.520.769.550.490, G08.520.769.550.520
- Study type
- Observational
- Recruitment status
- WithdrawnReason stopped: recruitment failure
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Technische Universität DresdenUniversity, hospital or other
- Study start
- Jan 2006
- Study completion
- Jun 2006 (actual)
- First posted
- 16 Sep 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 1 | – | –20 to 22 years |
| 2 | – | –30 to 32 years |
| 3 | – | –40 to 42 years |
Who may qualify
- Ages
- 20 to 42 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- three age groups
Key inclusion criteria (6 listed)
- Pregnant women without major concomitant disease
- Willing and able to provide informed consent
- Age (three age groups):
Key exclusion criteria (5 listed)
- Non pregnant women
- Men
- No informed consent
- Age not included in inclusion criteria
- Major concomitant disease
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Not reported in the source record.
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Aug 2016.
Related trials for Pregnancy Trimester, First
RecruitingObservational study
Molecular Study of the Maternal-fetal Interface in Preeclampsia.
Preeclampsia
RecruitingObservational study
Estimated Risk of Preeclampsia in the First Trimester and Its Association With Subclinical Atherosclerosis and Cardiovascular Risk in Women With Type 1 Diabetes
Type 1 Diabetes, Preeclampsia
Active, not recruitingObservational study
Validation of the MaiRa Preeclampsia Test for Screening Early/Late Preeclampsia in First and Second Trimesters
Preeclampsia (PE)
RecruitingObservational study
Comparison of Operative Hysteroscopy and Vacuum Aspiration for Terminating First-trimester Pregnancy With Intrauterine Adhesions
Pregnancy Complicated With Intrauterine Adhesion
Not yet recruitingObservational study
Predictors of Successful Office Operative Hysteroscopy Using a Mini-Resectoscope
Retained Products of Conception, Hysteroscopy
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Joachim Siegert, MD, DPharm, Phd principal investigator
Technische Universität Dresden
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pregnancy Trimester, First and Pregnancy Trimester, Second, run by Technische Universität Dresden at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 25 Aug 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Aug 2016.