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

NCT00836524 | Unknown

• 1 other identifier: SJ-55
• Study Type: observational
• Target: 2,000
• Locations: 1 country
• Sites: 1

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.

Conditions

Intrauterine Growth Restriction; Preeclampsia

Keywords

IUGR; Preeclampsia; ultrasound; YKL-40

Study Arms (1)

1

Pregnant women are included when they attend nuchal transcluency examination and will during their pregnancy be examined 4 times with ultrasound

Procedure: ultrasound

Interventions

ultrasound PROCEDURE

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

1

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• Sampling Method: Probability Sample

Study Population

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

You may qualify if:

• Pregnant danish speeking women

You may not qualify if:

• Conditions/diseases involving chronical inflammation, or immunological activity

Sponsors & Collaborators

• Zealand University Hospital: lead
• Region Zealand: collaborator
• University of Copenhagen: collaborator

Study Sites (1)

Gynækologisk-Obstetrisk Afdeling, Sygehus Nord

Roskilde, Region Sjælland, 4000, Denmark

Location

Related Publications (1)

• Gybel-Brask D, Hogdall 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.

  PMID: 24861484 DERIVED

Biospecimen

Retention: SAMPLES WITH DNA

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

MeSH Terms

Conditions

Fetal Growth Retardation; Pre-Eclampsia

Interventions

High-Energy Shock Waves

Condition Hierarchy (Ancestors)

Fetal Diseases; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Growth Disorders; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Hypertension, Pregnancy-Induced

Intervention Hierarchy (Ancestors)

Ultrasonic Waves; Sound; Radiation, Nonionizing; Radiation; Physical Phenomena

Study Officials

• 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

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, phd student

Study Record Dates

• First Submitted: February 3, 2009
• First Posted: February 4, 2009
• Study Start: January 1, 2009
• Primary Completion: November 1, 2011
• Study Completion: September 1, 2012
• Last Updated: October 28, 2011

Record last verified: 2011-10

Locations

DK (1)