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NCT02691364 Clinical Trial

Different Regulation of Immune Cells in Patients With Preeclampsia

Pregnancy Clinical Trial

Clinical Trial Details — Status: Not yet recruiting

Administrative data
NCT number NCT02691364
Other study ID # 2015/612
Secondary ID
Status Not yet recruiting
Phase N/A
First received February 22, 2016
Last updated February 24, 2016
Start date April 2016
Est. completion date June 2017

Study information
Verified date February 2016
Source University Medical Center Groningen
Contact n/a
Is FDA regulated No
Health authority Netherlands: Medical Ethics Review Committee (METC)
Study type Observational

Clinical Trial Summary

Adaptation of the maternal immune system to accommodate the semi-allogeneic fetus is necessary for pregnancy success. Dysregulation of this immune adaptation is implicated in reproductive disorders as infertility, recurrent miscarriage, fetal growth restriction, and preeclampsia. The mechanisms being responsible for fetal tolerance are not known. Several T cell subsets have been implicated in fetal tolerance. The effects of preeclampsia on memory cells are not known. The main objective of this study is to analyze the effect of preeclampsia on levels of immune cells.

Recruitment information / eligibility
Status Not yet recruiting
Enrollment 30
Est. completion date June 2017
Est. primary completion date May 2017
Accepts healthy volunteers No
Gender Female
Age group 18 Years to 40 Years
Eligibility Inclusion Criteria:

- healthy

- written informed consent

- 18-40 years

Exclusion Criteria:

- smoking

- immune related disorders (other than preeclampsia)

- fever / illness within the last month

- infertility

- body mass index <18 or >30

Study Design

Observational Model: Case Control, Time Perspective: Prospective

Related Conditions & MeSH terms

Intervention

Procedure:
• Blood withdrawal

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
University Medical Center Groningen

Outcome
Type Measure Description Time frame Safety issue
Primary Cell levels 1 year No
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