Is Serum YKL-40 Capable of Predicting Intrauterine Growth Restriction (IUGR) and Preeclampsia?
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Purpose
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 | Intervention |
|---|---|
|
Intrauterine Growth Restriction Preeclampsia |
Procedure: ultrasound |
| Study Type: | Observational |
| Study Design: | 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". |
Bloodsamples will be collected as well as placenta tissue for histology.
| Estimated Enrollment: | 2000 |
| Study Start Date: | January 2009 |
| Estimated Study Completion Date: | September 2012 |
| Estimated Primary Completion Date: | November 2011 (Final data collection date for primary outcome measure) |
| Groups/Cohorts | Assigned Interventions |
|---|---|
|
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
|
Eligibility| Ages Eligible for Study: | 18 Years to 50 Years |
| Genders Eligible for Study: | Female |
| Accepts Healthy Volunteers: | Yes |
| Sampling Method: | Probability Sample |
Pregnant women attending nuchal transcluency examination at Gynækologisk-Obstetrisk dept. Roskilde University Hospital
Inclusion Criteria:
- Pregnant danish speeking women
Exclusion Criteria:
- Conditions/diseases involving chronical inflammation, or immunological activity
Contacts and Locations| Denmark | |
| Gynækologisk-Obstetrisk Afdeling, Sygehus Nord | |
| Roskilde, Region Sjælland, Denmark, 4000 | |
| 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 |
More Information
No publications provided
| Responsible Party: | Dorte Nymark Brask, MD, phd student, University Hospital Roskilde |
| ClinicalTrials.gov Identifier: | NCT00836524 History of Changes |
| Other Study ID Numbers: | SJ-55 |
| Study First Received: | February 3, 2009 |
| Last Updated: | October 27, 2011 |
| Health Authority: | Denmark: The Regional Committee on Biomedical Research Ethics Denmark: Danish Dataprotection Agency |
Keywords provided by University Hospital Roskilde:
|
IUGR Preeclampsia ultrasound YKL-40 |
Additional relevant MeSH terms:
|
Fetal Growth Retardation Pre-Eclampsia Fetal Diseases Pregnancy Complications |
Growth Disorders Pathologic Processes Hypertension, Pregnancy-Induced |
ClinicalTrials.gov processed this record on June 18, 2013