Pre-EclampsiaNCT04463940
Xanthine Oxidase and Uric Acid Origin in Preeclamptic Women
An observational study of Pre-Eclampsia and Hyperuricemia, run by Barzilai Medical Center at 1 site in Israel.
Trial summary
Findings regarding the presence of xanthine oxidase and uric acid in different blood locations is important in preeclamptic women. We aim to detecting Xanthine oxidase and uric acid levels in both umbilical cord artery and vein as well as maternal blood (3 "locations") in pregnant women with and without diagnosis of… Read more about this study
- Who is it for?
- Ages 20 to 55 years, women only
- Conditions the study is for
- Pre-Eclampsia, Hyperuricemia
- How many people
- 100 participants
- Where
- 1 siteIsrael
- Study dates
- 30 Jun 2020to Aug 2024
- 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 55 years
- Women only
- Adult
Study population: Pregnant women with and without diagnosis of Pre-Eclampsia and serum Uric Acid greater than 6 mg/dL
Who may be able to join
- preeclampsia and none-preeclampsia diagnosed pregnant women.
Who cannot join
- Known or reported kidney disease.
Trial locations and contacts
1 site in 1 country.
Israel1 site, 1 recruiting
- Recruiting
Barzilai Medical Center
Ashkelon, 78306
Simon Shenhav, 972-86745937
About this study
Official title: The Origin of Xanthine Oxidase and Its Metabolite, Uric Acid, in Preeclamptic Pregnant Women - A Pilot Study
Findings regarding the presence of xanthine oxidase and uric acid in different blood locations is important in preeclamptic women. We aim to detecting Xanthine oxidase and uric acid levels in both umbilical cord artery and vein as well as maternal blood (3 "locations") in pregnant women with and without diagnosis of preeclampsia. The study population will be divided into groups matching the three "locations" in order to describe and compare outcome levels.
Read the detailed description
Significance - findings regarding the presence of xanthine oxidase and uric acid in different blood locations may provide a scientific basis for understanding the source of them in preeclamptic women. Aim - detecting Xanthine oxidase and uric acid levels in both umbilical cord artery and vein as well as maternal blood (3 "locations"). Methods - samples will be collected from pregnant women with and without diagnosis of preeclampsia with blood uric acid > 6 mg/dL. Than the study population will be divided into groups matching the three "locations". The investigators will describe and compare outcome levels (including Xanthine oxidase, uric acid).
- Conditions
- Pre-Eclampsia, Hyperuricemia
- Being tested
- No intervention
- Keywords
- Xanthine oxidase, Uric acid
- Medical subject headings
- Pre-Eclampsia, Hyperuricemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No interventionOther
No intervention
| Study group | Role | What they receive |
|---|---|---|
| Umbilical cord arterial blood | participant's umbilical cord arterial blood will be obtained Receives: Other: No intervention | |
| Umbilical cord venus blood | participant's umbilical cord Venus blood will be obtained Receives: Other: No intervention | |
| Maternal blood | participant's blood will be obtained Receives: Other: No intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Uric Acid
mg/dL
Measured: through study completion, an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jul 2020
- Study start30 Jun 2020
- Primary completionAug 2023 (estimated)
- Study completionAug 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pre-EclampsiaStudies 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
- Prospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Barzilai Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Simon Shanhav, Barzilai Medical Center
- Investigators
- Simon Shenhav, Dr, Principal investigator, Barzilai University Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04463940
- Sponsor's protocol ID
- 0024-19-BRZ
- Status last verified
- Jul 2022
- First submitted
- 8 Jun 2020
- Last updated
- 25 Jul 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 25 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Origin of Xanthine Oxidase and Its Metabolite, Uric Acid, in Preeclamptic Pregnant Women - A Pilot Study
- ClinicalTrials.gov ID
- NCT04463940
- Acronym / sponsor ID
- 0024-19-BRZ
- Conditions
- Pre-Eclampsia, Hyperuricemia
- Keywords
- Xanthine oxidase, Uric acid
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Barzilai Medical CenterUniversity, hospital or other
- Study start
- 30 Jun 2020 (actual)
- Primary completion
- Aug 2023 (estimated)
- Study completion
- Aug 2024 (estimated)
- First posted
- 9 Jul 2020 (actual)
- 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.
Findings regarding the presence of xanthine oxidase and uric acid in different blood locations is important in preeclamptic women. We aim to detecting Xanthine oxidase and uric acid levels in both umbilical cord artery and vein as well as maternal blood (3 "locations") in pregnant women with and without diagnosis of preeclampsia. The study population will be divided into groups matching the three "locations" in order to describe and compare outcome levels.
Detailed description
Significance - findings regarding the presence of xanthine oxidase and uric acid in different blood locations may provide a scientific basis for understanding the source of them in preeclamptic women. Aim - detecting Xanthine oxidase and uric acid levels in both umbilical cord artery and vein as well as maternal blood (3 "locations"). Methods - samples will be collected from pregnant women with and without diagnosis of preeclampsia with blood uric acid > 6 mg/dL. Than the study population will be divided into groups matching the three "locations". The investigators will describe and compare outcome levels (including Xanthine oxidase, uric acid).
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Umbilical cord arterial blood | – | Other: No interventionparticipant's umbilical cord arterial blood will be obtained |
| Umbilical cord venus blood | – | Other: No interventionparticipant's umbilical cord Venus blood will be obtained |
| Maternal blood | – | Other: No interventionparticipant's blood will be obtained |
Who may qualify
- Ages
- 20 to 55 years
- Sex
- Female only
- Age groups
- Adult
- Study population
- Pregnant women with and without diagnosis of Pre-Eclampsia and serum Uric Acid greater than 6 mg/dL
Key inclusion criteria (1 listed)
- preeclampsia and none-preeclampsia diagnosed pregnant women.
Key exclusion criteria (1 listed)
- Known or reported kidney disease.
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 |
|---|---|---|
| No interventionNo intervention | Other | Maternal blood, Umbilical cord arterial blood, Umbilical cord venus blood |
Primary outcome
Uric Acid
Time frame: through study completion, an average of 1 year
mg/dL
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jul 2022.
- Individual participant dataSharing planned: Undecided
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Estimated Risk of Preeclampsia in the First Trimester and Its Association With Subclinical Atherosclerosis and Cardiovascular Risk in Women With Type 1 Diabetes
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Severe Preeclampsia
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.
Simon Shenhav, Dr principal investigator
Barzilai University Medical Center
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 Pre-Eclampsia and Hyperuricemia, run by Barzilai 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 25 Jul 2022. 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 Yaniv Ovadia, Dr (+ 972 (0) 8 6745220, yanivo@bmc.gov.il), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Uric Acid (time frame: through study completion, an average of 1 year). 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 25 Jul 2022.