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

NCT ID: NCT00836524

Last Updated: 2011-10-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

2000 participants

Study Classification

OBSERVATIONAL

Study Start Date

2009-01-31

Study Completion Date

2012-09-30

Brief Summary

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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.

Detailed Description

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Conditions

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Intrauterine Growth Restriction Preeclampsia

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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1

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

ultrasound

Intervention Type 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

Interventions

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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

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* Pregnant danish speeking women

Exclusion Criteria

* Conditions/diseases involving chronical inflammation, or immunological activity
Minimum Eligible Age

18 Years

Maximum Eligible Age

50 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Region Zealand

OTHER

Sponsor Role collaborator

University of Copenhagen

OTHER

Sponsor Role collaborator

Zealand University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Dorte Nymark Brask

MD, phd student

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Estrid Høgdall, PhD leader

Role: STUDY_DIRECTOR

Dept of Pathology Herlev Hospital, Denmark

Julia S. Johansen, Dr med prof

Role: STUDY_DIRECTOR

Dept. of oncology and medicine, Herlev Hospital, Denmark

Locations

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Gynækologisk-Obstetrisk Afdeling, Sygehus Nord

Roskilde, Region Sjælland, Denmark

Site Status

Countries

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Denmark

References

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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.

Reference Type DERIVED
PMID: 24861484 (View on PubMed)

Other Identifiers

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SJ-55

Identifier Type: -

Identifier Source: org_study_id