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NCT00836524 Clinical Trial

Is Serum YKL-40 Capable of Predicting Intrauterine Growth Restriction (IUGR) and Preeclampsia?

Preeclampsia Clinical Trial

Official title:
"Kan IUGR og præeclampsi Forudsiges ud Fra YKL-40 målt i Serum?" "Metoder Til at Vurdere om Den Gravide Har Risiko for at Udvikle Svangerskabsforgiftning og/Eller væksthæmning Hos Fosteret".

Clinical Trial Details — Status: Active, not recruiting

Administrative data
NCT number NCT00836524
Other study ID # SJ-55
Secondary ID
Status Active, not recruiting
Phase N/A
First received February 3, 2009
Last updated October 27, 2011
Start date January 2009
Est. completion date September 2012

Study information
Verified date October 2011
Source University Hospital Roskilde
Contact n/a
Is FDA regulated No
Health authority Denmark: The Regional Committee on Biomedical Research EthicsDenmark: Danish Dataprotection Agency
Study type Observational

Clinical Trial Summary

Objective: To investigate the role of maternal serum YKL-40 and uterine artery doppler, at gestational age 12, 20, 25 and 32 weeks, and the relation to preeclampsia and intrauterine growth restriction. The serum marker YKL-40 is related to conditions involving inflammation, infection, tissue remodeling, fibrosis and cancer. IUGR and preeclampsia are known to be related to inflammation and tissue remodeling.

Methods: women attending screening for downs syndrome is scanned with uterine artery doppler and delivered blood samples at GA 12, 20, 25 and 32 respectively. When pregnancy outcome is registered by medical records blood samples are retrieved and analyzed for serum YKL-40. Serum YKL-40 are correlated to the presence of bilateral notching, preeclampsia and different degrees of intrauterine growth restriction.

Recruitment information / eligibility
Status Active, not recruiting
Enrollment 2000
Est. completion date September 2012
Est. primary completion date November 2011
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Female
Age group 18 Years to 50 Years
Eligibility Inclusion Criteria:

- Pregnant danish speeking women

Exclusion Criteria:

- Conditions/diseases involving chronical inflammation, or immunological activity

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

Intervention

Procedure:
• ultrasound
4 ultrasound examinations during pregnancy and every time a blood sample is colletted. blood sample from the mother and the umbilical cord is collected as well

Locations
Country Name City State
Denmark Gynækologisk-Obstetrisk Afdeling, Sygehus Nord Roskilde Region Sjælland

Sponsors (3)
Lead Sponsor Collaborator
University Hospital Roskilde Region Zealand, University of Copenhagen

Country where clinical trial is conducted

Denmark, 

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