Is Serum YKL-40 Capable of Predicting Intrauterine Growth Restriction (IUGR) and Preeclampsia?
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| First Received Date ICMJE | February 3, 2009 | ||||||||
| Last Updated Date | October 27, 2011 | ||||||||
| Start Date ICMJE | January 2009 | ||||||||
| Estimated Primary Completion Date | November 2011 (final data collection date for primary outcome measure) | ||||||||
| Current Primary Outcome Measures ICMJE | Not Provided | ||||||||
| Original Primary Outcome Measures ICMJE | Not Provided | ||||||||
| Change History | Complete list of historical versions of study NCT00836524 on ClinicalTrials.gov Archive Site | ||||||||
| Current Secondary Outcome Measures ICMJE | Not Provided | ||||||||
| Original Secondary Outcome Measures ICMJE | Not Provided | ||||||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||||||
| Descriptive Information | |||||||||
| Brief Title ICMJE | Is Serum YKL-40 Capable of Predicting Intrauterine Growth Restriction (IUGR) and Preeclampsia? | ||||||||
| Official Title ICMJE | "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". | ||||||||
| 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. |
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| Detailed Description | Not Provided | ||||||||
| Study Type ICMJE | Observational | ||||||||
| Study Design ICMJE | Observational Model: Cohort Time Perspective: Prospective |
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| Target Follow-Up Duration | Not Provided | ||||||||
| Biospecimen | Retention: Samples With DNA Description: Bloodsamples will be collected as well as placenta tissue for histology. |
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| Sampling Method | Probability Sample | ||||||||
| Study Population | Pregnant women attending nuchal transcluency examination at Gynækologisk-Obstetrisk dept. Roskilde University Hospital |
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| Condition ICMJE |
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| Intervention ICMJE | 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 |
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| Study Group/Cohort (s) | 1
Pregnant women are included when they attend nuchal transcluency examination and will during their pregnancy be examined 4 times with ultrasound
Intervention: Procedure: ultrasound |
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| Publications * | Not Provided | ||||||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||||||
| Recruitment Status ICMJE | Active, not recruiting | ||||||||
| Estimated Enrollment ICMJE | 2000 | ||||||||
| Estimated Completion Date | September 2012 | ||||||||
| Estimated Primary Completion Date | November 2011 (final data collection date for primary outcome measure) | ||||||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Female | ||||||||
| Ages | 18 Years to 50 Years | ||||||||
| Accepts Healthy Volunteers | Yes | ||||||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||||||
| Location Countries ICMJE | Denmark | ||||||||
| Administrative Information | |||||||||
| NCT Number ICMJE | NCT00836524 | ||||||||
| Other Study ID Numbers ICMJE | SJ-55 | ||||||||
| Has Data Monitoring Committee | No | ||||||||
| Responsible Party | Dorte Nymark Brask, University Hospital Roskilde | ||||||||
| Study Sponsor ICMJE | University Hospital Roskilde | ||||||||
| Collaborators ICMJE |
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| Investigators ICMJE |
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| Information Provided By | University Hospital Roskilde | ||||||||
| Verification Date | October 2011 | ||||||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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