Fetal Growth RetardationNCT01177020
The Role of Pro-angiogenic Immune Cells in Human Pregnancies
An observational study of Fetal Growth Retardation and Preeclampsia, run by Hillel Yaffe Medical Center at 1 site in Israel.
Trial summary
Identification of the presence of proangiogenic immune cells in normal human placentas may enable predication of some pregnancy disorders. Read more about this study
- Who is it for?
- Any age, women onlyHealthy volunteers can take part
- Conditions the study is for
- Fetal Growth Retardation, Preeclampsia
- What is being tested?
- Biological specimen
- How many people
- 300 participants
- Where
- 1 siteIsrael
- Study dates
- Aug 2010to Dec 2011
- 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 Any age
- Women only
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: Placentas after delivery or abortion
Who may be able to join
- Placentas that have been delivered in the Medical Center
Who cannot join
- None
Trial locations and contacts
1 site in 1 country.
Israel1 site, 1 recruiting
- Recruiting
Hillel Yaffe Medical Center
Hadera, 38100
Elad Meidan, MD
About this study
Identification of the presence of proangiogenic immune cells in normal human placentas may enable predication of some pregnancy disorders.
- Conditions
- Fetal Growth Retardation, Preeclampsia
- Being tested
- Biological specimen
- Medical subject headings
- Fetal Growth Retardation, Pre-Eclampsia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Biological specimenOther
Biological specimen taken from placenta
| Study group | Role | What they receive |
|---|---|---|
| Placentas after delivery or abortion | Not described Receives: Other: Biological specimen |
What is being measured
The primary outcome is the main question the study is designed to answer.
To find the angiogenic potential of proangiogenic immune cells derived from human placentas.
Measured: Two years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Aug 2010 (estimated)
- Study startAug 2010
- Primary completionAug 2011 (estimated)
- Study completionDec 2011 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Fetal Growth RetardationStudies 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
- Retrospective
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hillel Yaffe Medical Center
- Sponsor type
- Other government
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01177020
- Sponsor's protocol ID
- HYMC1069A
- Status last verified
- Aug 2010
- First submitted
- 12 May 2010
- Last updated
- 6 Aug 2010
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Aug 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Role of Pro-angiogenic Immune Cells in Human Pregnancies
- ClinicalTrials.gov ID
- NCT01177020
- Acronym / sponsor ID
- HYMC1069A
- Conditions
- Fetal Growth Retardation, Preeclampsia
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Hillel Yaffe Medical CenterOther government
- Study start
- Aug 2010
- Primary completion
- Aug 2011 (estimated)
- Study completion
- Dec 2011 (estimated)
- First posted
- 6 Aug 2010 (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.
Identification of the presence of proangiogenic immune cells in normal human placentas may enable predication of some pregnancy disorders.
Study design
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Placentas after delivery or abortion | – | Other: Biological specimen |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Placentas after delivery or abortion
Key inclusion criteria (1 listed)
- Placentas that have been delivered in the Medical Center
Key exclusion criteria (1 listed)
- None
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Biological specimenBiological specimen taken from placenta | Other | Placentas after delivery or abortion |
Primary outcome
To find the angiogenic potential of proangiogenic immune cells derived from human placentas.
Time frame: Two years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Aug 2010.
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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.
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 Fetal Growth Retardation and Preeclampsia, run by Hillel Yaffe 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 1 inclusion and 1 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 6 Aug 2010. 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?
Contact Elad Mei-Dan, MD (972-4-6304248, eladmei@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To find the angiogenic potential of proangiogenic immune cells derived from human placentas. (time frame: Two years). It is what the study was designed to measure, not a finding.
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 6 Aug 2010.