Xanthine Oxidase and Uric Acid Origin in Preeclamptic Women | NCT04463940

Studies
Xanthine Oxidase and Uric Acid Origin in Preeclamptic Women

NCT04463940

Sponsor

Barzilai Medical Center

Status

Unknown status

Last Update Posted

Jul 25, 2022Actual

Enrollment

100Estimated

Phase

Not provided

Conditions

Pre-Eclampsia
Hyperuricemia

Interventions

No intervention

Countries

Israel

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jul 2022

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jun 30, 2020Actual

Primary Completion Date

Aug 2023Estimated

Completion Date

Aug 2024Estimated

First Submitted Date

Jun 8, 2020

First Submission Date that Met QC Criteria

Jul 8, 2020

First Posted Date

Jul 9, 2020Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jul 20, 2022

Last Update Posted Date

Jul 25, 2022Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Simon Shanhav, Dr Simon Shenhav, head of High Risk Pregnancy Unit, Barzilai Medical CenterPrincipal Investigator

Lead Sponsor

Barzilai Medical CenterOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief 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 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).

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

100Estimated

Arms/Interventions Module

Arm Groups

Label	Description	Intervention Names
Umbilical cord arterial blood	participant's umbilical cord arterial blood will be obtained	Other: No intervention
Umbilical cord venus blood	participant's umbilical cord Venus blood will be obtained	Other: No intervention
Maternal blood	participant's blood will be obtained	Other: No intervention

Interventions

Name	Type	Description	Arm Group Labels	Other Names
No intervention	Other	No intervention	Maternal blood Umbilical cord arterial blood Umbilical cord venus blood

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Uric Acid	mg/dL	through study completion, an average of 1 year

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

preeclampsia and none-preeclampsia diagnosed pregnant women.

Exclusion Criteria:

Known or reported kidney disease.

Accepts Healthy Volunteers

Not provided

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

20 Years

Maximum Age

55 Years

Standard Ages

Adult

Study Population

Pregnant women with and without diagnosis of Pre-Eclampsia and serum Uric Acid greater than 6 mg/dL

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Yaniv Ovadia, Dr	Contact	+ 972 (0) 8 6745220		yanivo@bmc.gov.il

Overall Officials

Name	Affiliation	Role
Simon Shenhav, Dr	Barzilai University Medical Center	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Barzilai Medical Center	Recruiting	Ashkelon		78306	Israel

IPD Sharing Statement Module

Plan to Share IPD

Undecided

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D011225	Pre-Eclampsia
D033461	Hyperuricemia

Ancestor Terms

ID	Term
D046110	Hypertension, Pregnancy-Induced
D011248	Pregnancy Complications
D005261	Female Urogenital Diseases and Pregnancy Complications
D000091642	Urogenital Diseases

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Browse Branches

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