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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, University Hospital Roskilde.
Recruitment status was:  Active, not recruiting
First Posted : February 4, 2009
Last Update Posted : October 28, 2011
Region Zealand
University of Copenhagen
Information provided by (Responsible Party):
Dorte Nymark Brask, University Hospital Roskilde

February 3, 2009
February 4, 2009
October 28, 2011
January 2009
November 2011   (Final data collection date for primary outcome measure)
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Complete list of historical versions of study NCT00836524 on ClinicalTrials.gov Archive Site
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Is Serum YKL-40 Capable of Predicting Intrauterine Growth Restriction (IUGR) and Preeclampsia?
"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.

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Observational Model: Cohort
Time Perspective: Prospective
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Retention:   Samples With DNA
Bloodsamples will be collected as well as placenta tissue for histology.
Probability Sample
Pregnant women attending nuchal transcluency examination at Gynækologisk-Obstetrisk dept. Roskilde University Hospital
  • Intrauterine Growth Restriction
  • Preeclampsia
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
Pregnant women are included when they attend nuchal transcluency examination and will during their pregnancy be examined 4 times with ultrasound
Intervention: Procedure: ultrasound
Gybel-Brask D, Høgdall E, Johansen J, Christensen IJ, Skibsted L. Serum YKL-40 and uterine artery Doppler -- a prospective cohort study, with focus on preeclampsia and small-for-gestational-age. Acta Obstet Gynecol Scand. 2014 Aug;93(8):817-24. doi: 10.1111/aogs.12432. Epub 2014 Jun 20.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
Unknown status
September 2012
November 2011   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • Pregnant danish speeking women

Exclusion Criteria:

  • Conditions/diseases involving chronical inflammation, or immunological activity
Sexes Eligible for Study: Female
18 Years to 50 Years   (Adult)
Contact information is only displayed when the study is recruiting subjects
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Dorte Nymark Brask, University Hospital Roskilde
Zealand University Hospital
  • Region Zealand
  • University of Copenhagen
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
Zealand University Hospital
October 2011