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

October 27, 2011 updated by: Dorte Nymark Brask, Zealand University Hospital

"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".

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Anticipated)

2000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Denmark
    • Region Sjælland
      • Roskilde, Region Sjælland, Denmark, 4000
        • Gynækologisk-Obstetrisk Afdeling, Sygehus Nord

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 50 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Female

Sampling Method

Probability Sample

Study Population

Pregnant women attending nuchal transcluency examination at Gynækologisk-Obstetrisk dept. Roskilde University Hospital

Description

Inclusion Criteria:

  • Pregnant danish speeking women

Exclusion Criteria:

  • Conditions/diseases involving chronical inflammation, or immunological activity

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
1
Pregnant women are included when they attend nuchal transcluency examination and will during their pregnancy be examined 4 times with ultrasound
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Zealand University Hospital

Collaborators

University of Copenhagen
Region Zealand

Investigators

  • Study Director: Estrid Høgdall, PhD leader, Dept of Pathology Herlev Hospital, Denmark
  • Study Director: Julia S. Johansen, Dr med prof, Dept. of oncology and medicine, Herlev Hospital, Denmark

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2009

Primary Completion (Anticipated)

November 1, 2011

Study Completion (Anticipated)

September 1, 2012

Study Registration Dates

First Submitted

February 3, 2009

First Submitted That Met QC Criteria

February 3, 2009

First Posted (Estimate)

February 4, 2009

Study Record Updates

Last Update Posted (Estimate)

October 28, 2011

Last Update Submitted That Met QC Criteria

October 27, 2011

Last Verified

October 1, 2011

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SJ-55

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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