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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified October 2011 by University Hospital Roskilde.
Recruitment status was  Active, not recruiting
Sponsor:
Collaborators:
Region Zealand
University of Copenhagen
Information provided by (Responsible Party):
Dorte Nymark Brask, University Hospital Roskilde
ClinicalTrials.gov Identifier:
NCT00836524
First received: February 3, 2009
Last updated: October 27, 2011
Last verified: October 2011
  Purpose

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.


Condition Intervention
Intrauterine Growth Restriction
Preeclampsia
Procedure: ultrasound

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
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".

Resource links provided by NLM:


Further study details as provided by University Hospital Roskilde:

Biospecimen Retention:   Samples With DNA

Bloodsamples will be collected as well as placenta tissue for histology.


Estimated Enrollment: 2000
Study Start Date: January 2009
Estimated Study Completion Date: September 2012
Estimated Primary Completion Date: November 2011 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years to 50 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population

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

Criteria

Inclusion Criteria:

  • Pregnant danish speeking women

Exclusion Criteria:

  • Conditions/diseases involving chronical inflammation, or immunological activity
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00836524

Locations
Denmark
Gynækologisk-Obstetrisk Afdeling, Sygehus Nord
Roskilde, Region Sjælland, Denmark, 4000
Sponsors and Collaborators
University Hospital Roskilde
Region Zealand
University of Copenhagen
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
  More Information

No publications provided

Responsible Party: Dorte Nymark Brask, MD, phd student, University Hospital Roskilde
ClinicalTrials.gov Identifier: NCT00836524     History of Changes
Other Study ID Numbers: SJ-55
Study First Received: February 3, 2009
Last Updated: October 27, 2011
Health Authority: Denmark: The Regional Committee on Biomedical Research Ethics
Denmark: Danish Dataprotection Agency

Keywords provided by University Hospital Roskilde:
IUGR
Preeclampsia
ultrasound
YKL-40

Additional relevant MeSH terms:
Fetal Growth Retardation
Pre-Eclampsia
Fetal Diseases
Pregnancy Complications
Growth Disorders
Pathologic Processes
Hypertension, Pregnancy-Induced

ClinicalTrials.gov processed this record on August 01, 2014