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the Implications of Pathogenesis of Pre-Eclampsia

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00154934
Recruitment Status : Terminated (difficult to enroll subjects)
First Posted : September 12, 2005
Last Update Posted : February 3, 2009
Information provided by:
National Taiwan University Hospital

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.

Condition or disease

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Study Type : Observational
Actual Enrollment : 0 participants
Observational Model: Case-Control
Time Perspective: Prospective
Official Title: The Impact of Interleukin-10 in the Invasion Capacity and Immunoregulation During Pregnancy: the Implications of Pathogenesis of Pre-Eclampsia.
Study Start Date : January 2004
Actual Study Completion Date : January 2009

Resource links provided by the National Library of Medicine

Biospecimen Retention:   Samples Without DNA
placenta biopsy

Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 40 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
pregnacnt women

Inclusion Criteria:

  • Preeclampsia

Exclusion Criteria:

  • no

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00154934

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Shih Jin-Chung
Taipei, Taiwan, 10016
Sponsors and Collaborators
National Taiwan University Hospital
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Study Chair: Yang Pan-Chyr National Taiwan University Hospital Research Ethics Committee
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Responsible Party: National Taiwan University Hospital Identifier: NCT00154934    
Other Study ID Numbers: 9361700215
First Posted: September 12, 2005    Key Record Dates
Last Update Posted: February 3, 2009
Last Verified: January 2009
Additional relevant MeSH terms:
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Hypertension, Pregnancy-Induced
Pregnancy Complications