NCT04463940

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jun 2020

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 8, 2020

Completed
22 days until next milestone

Study Start

First participant enrolled

June 30, 2020

Completed
9 days until next milestone

First Posted

Study publicly available on registry

July 9, 2020

Completed
3.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2023

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2024

Completed
Last Updated

July 25, 2022

Status Verified

July 1, 2022

Enrollment Period

3.1 years

First QC Date

June 8, 2020

Last Update Submit

July 20, 2022

Conditions

Pre-EclampsiaHyperuricemia

Keywords

Xanthine oxidaseUric acid

Outcome Measures

Primary Outcomes (1)

  • Uric Acid

    mg/dL

    through study completion, an average of 1 year

Study Arms (3)

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

No interventionOTHER

No intervention

Maternal bloodUmbilical cord arterial bloodUmbilical cord venus blood

Eligibility Criteria

Age20 Years - 55 Years
Sexfemale
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

  • preeclampsia and none-preeclampsia diagnosed pregnant women.

You may not qualify if:

  • Known or reported kidney disease.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Barzilai Medical Center

Ashkelon, 78306, Israel

RECRUITING

MeSH Terms

Conditions

Pre-EclampsiaHyperuricemia

Condition Hierarchy (Ancestors)

Hypertension, Pregnancy-InducedPregnancy ComplicationsFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Simon Shenhav, Dr

    Barzilai University Medical Center

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Yaniv Ovadia, Dr

CONTACT

+ 972 (0) 8 6745220yanivo@bmc.gov.il

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Dr Simon Shenhav, head of High Risk Pregnancy Unit

Study Record Dates

First Submitted

June 8, 2020

First Posted

July 9, 2020

Study Start

June 30, 2020

Primary Completion

August 1, 2023

Study Completion

August 1, 2024

Last Updated

July 25, 2022

Record last verified: 2022-07

Locations

IL(1)