Preeclampsia/ToxemiaNCT01255202
The Prediction of Preeclampsia/Toxemia in Twin Pregnancy
An observational study of Preeclampsia/Toxemia, run by Assaf-Harofeh Medical Center at 1 site in Israel.
Trial summary
The purpose of this study is to finout whetere uterinae artery flow , PP13 and endogolin levels in the serum and kongo red in the urine can predict preeclamsia toxemia in twin pregnancies. Read more about this study
- Who is it for?
- Ages 18 to 60 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Preeclampsia/Toxemia
- How many people
- 200 participants
- Where
- 1 siteIsrael
- Study dates
- Sep 2009to 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 18 to 60 years
- Women only
- Healthy volunteers accepted
- Adult
Study population: women with twin preganacy undergoing nuchal scan in our department
Who may be able to join
- a women with a vaiable twin pregnany
Who cannot join
- women with thrombophilya
- women terated with anticoagolant
- women with vascular disease
Trial locations and contacts
1 site in 1 country.
Israel1 site, 1 recruiting
- Recruiting
Assaf Harofe Medical Center
Zrifin
Ran Svirsky, MD, 972-8-9779000, rsvirs@gmail.com
Ran Svirsky, MD
About this study
Official title: Prospective Longitudenal Study in the Prediction of Preeclampsia/Toxemia in Twin Pregnancy
The purpose of this study is to finout whetere uterinae artery flow , PP13 and endogolin levels in the serum and kongo red in the urine can predict preeclamsia toxemia in twin pregnancies.
- Conditions
- Preeclampsia/Toxemia
- Keywords
- preeclampsia, toxemia, twin, pregnancy, pp13, prediction, kongo red
- Medical subject headings
- Pre-Eclampsia, Toxemia
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 |
|---|---|---|
| twin preganacies | Not described |
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Dec 2010 (estimated)
- Study startSep 2009
- Primary completionApr 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 Preeclampsia/ToxemiaStudies 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assaf-Harofeh Medical Center
- Sponsor type
- Other government
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01255202
- Sponsor's protocol ID
- 189/09
- Status last verified
- Dec 2010
- First submitted
- 5 Dec 2010
- Last updated
- 7 Dec 2010
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Dec 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Longitudenal Study in the Prediction of Preeclampsia/Toxemia in Twin Pregnancy
- ClinicalTrials.gov ID
- NCT01255202
- Acronym / sponsor ID
- 189/09
- Conditions
- Preeclampsia/Toxemia
- Keywords
- preeclampsia, toxemia, twin, pregnancy, pp13, prediction, kongo red
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Assaf-Harofeh Medical CenterOther government
- Study start
- Sep 2009
- Primary completion
- Apr 2011 (estimated)
- Study completion
- Dec 2011 (estimated)
- First posted
- 7 Dec 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.
The purpose of this study is to finout whetere uterinae artery flow , PP13 and endogolin levels in the serum and kongo red in the urine can predict preeclamsia toxemia in twin pregnancies.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| twin preganacies | – | – |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- women with twin preganacy undergoing nuchal scan in our department
Key inclusion criteria (1 listed)
- a women with a vaiable twin pregnany
Key exclusion criteria (3 listed)
- women with thrombophilya
- women terated with anticoagolant
- women with vascular 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
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Dec 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 Preeclampsia/Toxemia, run by Assaf-Harofeh 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 3 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 7 Dec 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 Ran Svirsky, MD (972-8-9779000, rsvirs@gmail.com), or a site near the patient. 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 7 Dec 2010.