Study Stopped
difficult to enroll subjects
the Implications of Pathogenesis of Pre-Eclampsia
The Impact of Interleukin-10 in the Invasion Capacity and Immunoregulation During Pregnancy: the Implications of Pathogenesis of Pre-Eclampsia.
1 other identifier
observational
N/A
1 country
1
Brief Summary
Preeclampsia is a severe complication of human pregnancy. It occurs in 4-5% of all pregnancies and remains a leading cause of maternal and neonatal mortality and morbidity. The pathophysiology of this syndrome is not fully understood. Two theories are proposed to explain the development of preeclampsia: defective trophoblast invasion in the first trimester, and poor maternal immunoregulation against the fetus. Pro-inflammatory cytokines are induced in the second mechanism, with a subsequent generalized endothelial dysfunction in the mother. Interleukin-10 (IL-10) plays a major role in this pathway. According to recent literature, debates still exist on the role of IL-10 in the pathogenesis of preeclampsia. IL-10 may increase immunoregulation (seemingly against the development of preeclampsia), but also prohibit the extravillous trophoblast invasion on the other hand (seemingly towards the development of preeclampsia). According to recent authoritative journals, the expression of IL-10 pre-eclamptic placenta is increased; but some other influential journals have the totally contrary results. We believe this diverse exhibition may be due to overlook the paracrine effect of decidual cells (representative of maternal environment), and in vitro cultured condition does not parallel to physiological condition. Our experiment has first obtained the qualification of Ethical Committee of our hospital and the permission of the examined patients. We first collect the serum sample of preeclampsia patient and analyze the IL-10 level by ELISA kit, and compared with normal control. Then we isolate trophoblast from pre-eclamptic women and normal control. These trophoblasts are further treated with (1) co-cultured with decidual cell line (2) Lipofectamine transfection with IL-10 (overexpression of IL-10) (3) signal interference ribonucleotide (siRNA) of IL-10 (knockdown IL-10 function). Each groups (including trophoblast alone from patients or normal control) were subjected to the analysis of IL-10 mRNA amount by RT-PCR. Further experiments for these treated trophoblast are transwell migration assay and invasion assay, matrix metalloproteinase assay to determine the change of invasive capacity; and Fas ligand expression to determine the change of immunoregulation. Our effort is not only to determine the role of IL-10 in the pathogenesis of preeclampsia, but also the development of siRNA IL-10 may give a light in the treatment of preeclampsia.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
Started Jan 2004
Longer than P75 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2004
CompletedFirst Submitted
Initial submission to the registry
September 9, 2005
CompletedFirst Posted
Study publicly available on registry
September 12, 2005
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2009
CompletedFebruary 3, 2009
January 1, 2009
September 9, 2005
February 2, 2009
Conditions
Eligibility Criteria
pregnacnt women
You may qualify if:
- Preeclampsia
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Shih Jin-Chung
Taipei, 10016, Taiwan
Biospecimen
placenta biopsy
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Yang Pan-Chyr
National Taiwan University Hospital Research Ethics Committee
Study Design
- Study Type
- observational
- Observational Model
- CASE CONTROL
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
September 9, 2005
First Posted
September 12, 2005
Study Start
January 1, 2004
Study Completion
January 1, 2009
Last Updated
February 3, 2009
Record last verified: 2009-01