Xanthine Oxidase and Uric Acid Origin in Preeclamptic Women

• Sponsor: Barzilai Medical Center (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT04463940
• Collaborator: (none)
• Enrollment: 100
• Location: 1
• Anticipated Duration (Months): 49.1
• Patients Per Site Per Month: 2

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Pre-Eclampsia; Hyperuricemia	Other: No intervention

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

• Study Type: Observational
• Anticipated Enrollment: 100 participants
• Observational Model: Case-Control
• Time Perspective: Prospective
• Official Title: The Origin of Xanthine Oxidase and Its Metabolite, Uric Acid, in Preeclamptic Pregnant Women - A Pilot Study
• Actual Study Start Date: Jun 30, 2020
• Anticipated Primary Completion Date: Aug 1, 2023
• Anticipated Study Completion Date: Aug 1, 2024

Arms and Interventions

Arm	Intervention/Treatment
Umbilical cord arterial blood participant's umbilical cord arterial blood will be obtained	Other: No intervention; No intervention
Umbilical cord venus blood participant's umbilical cord Venus blood will be obtained	Other: No intervention; No intervention
Maternal blood participant's blood will be obtained	Other: No intervention; No intervention

Outcome Measures

Primary Outcome Measures

1. Uric Acid [through study completion, an average of 1 year]

   mg/dL

Eligibility Criteria

Criteria

• Ages Eligible for Study: 20 Years to 55 Years
• Sexes Eligible for Study: Female

Inclusion Criteria:

• preeclampsia and none-preeclampsia diagnosed pregnant women.

Exclusion Criteria:

• Known or reported kidney disease.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Barzilai Medical Center	Ashkelon		Israel	78306

Sponsors and Collaborators

• Barzilai Medical Center

Investigators

• Principal Investigator: Simon Shenhav, Dr, Barzilai University Medical Center

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Simon Shanhav, Dr Simon Shenhav, head of High Risk Pregnancy Unit, Barzilai Medical Center
• ClinicalTrials.gov Identifier: NCT04463940
• Other Study ID Numbers: 0024-19-BRZ
• First Posted: Jul 9, 2020
• Last Update Posted: Jul 25, 2022
• Last Verified: Jul 1, 2022

• Individual Participant Data (IPD) Sharing Statement: Undecided
• Plan to Share IPD: Undecided
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Simon Shanhav, Dr Simon Shenhav, head of High Risk Pregnancy Unit, Barzilai Medical Center: Xanthine oxidase; Uric acid
• Additional relevant MeSH terms: Eclampsia; Pre-Eclampsia; Hyperuricemia

Study Results

No Results Posted as of Jul 25, 2022