Telomere LengthNCT01384136
The Telomere System in Cord Blood and in the Placenta in High Risk Pregnancies
An observational study of Telomere Length and Mechanisms of Telomter Homeostasis, run by Meir Medical Center at 1 site in Israel.
Trial summary
The telomere system stabilizes the chromosomes. Telomeres are shortened during senescence, in cases of genetic instability and secondary to stress. The investigators aim is to study the telomere system in cord blood and in the placenta immediately after the delivery in pregnancies defined as high risk pregnancies… Read more about this study
- Who is it for?
- Ages 18 to 45 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Telomere Length, Mechanisms of Telomter Homeostasis, High Risk Pregnancies
- How many people
- 100 participants
- Where
- 1 siteIsrael
- Study dates
- Jun 2011to Jun 2015
- 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 18 to 45 years
- Women only
- Healthy volunteers accepted
- Adult
Study population: High risk pregnancies, third trimester, after the delivery/
Who may be able to join
- Third trimester post delivery
- Intrauterine growth restriction
- Preeclampsia
- Diabetes
- Control - low risk normal pregnancies
Who cannot join
- Patients who do not want to participate
- Known HIV or Hepatitis
Trial locations and contacts
1 site in 1 country.
About this study
The telomere system stabilizes the chromosomes. Telomeres are shortened during senescence, in cases of genetic instability and secondary to stress.
The investigators aim is to study the telomere system in cord blood and in the placenta immediately after the delivery in pregnancies defined as high risk pregnancies following sterss events such as placental insufficiency, preeclampsia, diabetes.
The investigators intend to compare the telomere system in maternal blood to cord blood and to placental biopsies and to study the influence of different stressogenes on this system.
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 |
|---|---|---|
| High risk pregnancy | Not described | |
| |Control - Normal low risk pregnancies | Not described |
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jun 2011 (estimated)
- Study startJun 2011
- Primary completionJun 2015 (estimated)
- Study completionJun 2015 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Telomere LengthStudies of the same condition, open and under way.
- 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
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Meir Medical Center
- Sponsor type
- University, hospital or other
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01384136
- Sponsor's protocol ID
- 036-2011 MMC
- Status last verified
- Jun 2011
- First submitted
- 27 Jun 2011
- Last updated
- 28 Jun 2011
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 28 Jun 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Telomere System in Cord Blood and in the Placenta in High Risk Pregnancies
- ClinicalTrials.gov ID
- NCT01384136
- Acronym / sponsor ID
- 036-2011 MMC
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Meir Medical CenterUniversity, hospital or other
- Study start
- Jun 2011
- Primary completion
- Jun 2015 (estimated)
- Study completion
- Jun 2015 (estimated)
- First posted
- 28 Jun 2011 (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.
The telomere system stabilizes the chromosomes. Telomeres are shortened during senescence, in cases of genetic instability and secondary to stress.
The investigators aim is to study the telomere system in cord blood and in the placenta immediately after the delivery in pregnancies defined as high risk pregnancies following sterss events such as placental insufficiency, preeclampsia, diabetes.
The investigators intend to compare the telomere system in maternal blood to cord blood and to placental biopsies and to study the influence of different stressogenes on this system.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| High risk pregnancy | – | – |
| |Control - Normal low risk pregnancies | – | – |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- High risk pregnancies, third trimester, after the delivery/
Key inclusion criteria (5 listed)
- Third trimester post delivery
- Intrauterine growth restriction
- Preeclampsia
- Diabetes
- Control - low risk normal pregnancies
Key exclusion criteria (2 listed)
- Patients who do not want to participate
- Known HIV or Hepatitis
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
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jun 2011.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 Telomere Length and Mechanisms of Telomter Homeostasis, run by Meir Medical Center at 1 site in Israel.
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 5 inclusion and 2 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: status not confirmed, as of the sponsor's last update on 28 Jun 2011. 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 Israel. 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?
Results are not available in the source record.
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 28 Jun 2011.