CClinicalTrials.gg
Status unknownNCT00836524Updated Oct 28, 2011

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

An observational study in Intrauterine Growth Restriction and Preeclampsia, sponsored by Zealand University Hospital. Status unknown at 1 site in Denmark. Open to female participants aged 18 Years to 50 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2011-10-28.

Sponsored by Zealand University Hospital · Observational

The sponsor has not verified this record recently (last verified Oct 2011), so the status shown — last known as Active, not recruiting — may be out of date.
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
2,000
Ages
18 Years to 50 Years
Sex
Female
01

Study 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.

02

Conditions studied

  • Intrauterine Growth Restriction
  • Preeclampsia

Keywords

  • IUGR
  • Preeclampsia
  • ultrasound
  • YKL-40
03

In context

Pre-Eclampsia

882 studies on the registry are indexed under Pre-Eclampsia; 237 are open to participants now.

This study's planned enrollment of 2,000 is above the median of 163 across 380 observational studies indexed under Pre-Eclampsia.

Browse Pre-Eclampsia studies →

Lead sponsor

Zealand University Hospital is the lead sponsor of 234 studies on the registry; 51 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 50 Years
Sexes eligible
Female
Accepts healthy volunteers
Yes
Sampling method
Probability sample

Study population

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

Inclusion criteria

  • Pregnant danish speeking women

Exclusion criteria

Exclusion Criteria:

  • Conditions/diseases involving chronical inflammation, or immunological activity
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
2,000 participants (estimated)
Biospecimen retention
Samples with dna

Groups and cohorts

  • 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

  • Procedureultrasound

    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

06

Study locations

1 site
  • Gynækologisk-Obstetrisk Afdeling, Sygehus Nord
    Roskilde, Region Sjælland 4000, Denmark
07

References and documents

Publications

  • 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. PubMed 24861484 ↗
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Oct 28, 2011, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT00836524
Lead sponsor
Zealand University Hospital
Collaborators
Region Zealand, University of Copenhagen
Responsible party
Dorte Nymark Brask (MD, phd student, Zealand University Hospital) — Principal investigator
First posted
Feb 4, 2009
Start date
Jan 2009
Primary completion
Nov 2011 (estimated)
Completion
Sep 2012 (estimated)
Last update
Oct 28, 2011

Study contacts

Estrid Høgdall, PhD leader
study director · Dept of Pathology Herlev Hospital, Denmark
Julia S. Johansen, Dr med prof
study director · Dept. of oncology and medicine, Herlev Hospital, Denmark

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Oct 2011. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion