Different Regulation of Immune Cells in Patients With Preeclampsia

• Sponsor: University Medical Center Groningen (Other)
• Overall Status: Unknown status
• CT.gov ID: NCT02691364
• Collaborator: (none)
• Enrollment: 30
• Duration (Months): 14

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Preeclampsia; Pregnancy	Procedure: Blood withdrawal

Study Design

• Study Type: Observational
• Anticipated Enrollment: 30 participants
• Observational Model: Case-Control
• Time Perspective: Prospective
• Study Start Date: Apr 1, 2016
• Anticipated Primary Completion Date: May 1, 2017
• Anticipated Study Completion Date: Jun 1, 2017

Arms and Interventions

Arm	Intervention/Treatment
Healthy Healthy women	Procedure: Blood withdrawal
Preeclamptic Pregnant women with preeclampsia	Procedure: Blood withdrawal

Outcome Measures

Primary Outcome Measures

1. Cell levels [1 year]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 40 Years
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

• University Medical Center Groningen

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Jelmer Prins, MD PhD, University Medical Center Groningen
• ClinicalTrials.gov Identifier: NCT02691364
• Other Study ID Numbers: 2015/612
• First Posted: Feb 25, 2016
• Last Update Posted: Feb 25, 2016
• Last Verified: Feb 1, 2016

• Additional relevant MeSH terms: Pre-Eclampsia

Study Results

No Results Posted as of Feb 25, 2016