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

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ClinicalTrials.gov Identifier: NCT00836524
Recruitment Status : Unknown
Verified October 2011 by Dorte Nymark Brask, Zealand University Hospital.
Recruitment status was:  Active, not recruiting
First Posted : February 4, 2009
Last Update Posted : October 28, 2011
Sponsor:
Collaborators:
Region Zealand
University of Copenhagen
Information provided by (Responsible Party):
Dorte Nymark Brask, Zealand University Hospital

Brief 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.


Condition or disease Intervention/treatment
Intrauterine Growth Restriction Preeclampsia Procedure: ultrasound

Study Type : Observational
Estimated Enrollment : 2000 participants
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".
Study Start Date : January 2009
Estimated Primary Completion Date : November 2011
Estimated Study Completion Date : September 2012

Resource links provided by the National Library of Medicine


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




Biospecimen Retention:   Samples With DNA
Bloodsamples will be collected as well as placenta tissue for histology.


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Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00836524


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

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Dorte Nymark Brask, MD, phd student, Zealand University Hospital
ClinicalTrials.gov Identifier: NCT00836524     History of Changes
Other Study ID Numbers: SJ-55
First Posted: February 4, 2009    Key Record Dates
Last Update Posted: October 28, 2011
Last Verified: October 2011

Keywords provided by Dorte Nymark Brask, Zealand University Hospital:
IUGR
Preeclampsia
ultrasound
YKL-40

Additional relevant MeSH terms:
Pre-Eclampsia
Fetal Growth Retardation
Hypertension, Pregnancy-Induced
Pregnancy Complications
Fetal Diseases
Growth Disorders
Pathologic Processes
CHI3L1 protein, human
Growth Substances
Physiological Effects of Drugs