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NCT03313024 Clinical Trial

Berlin-Brandenburg Pregnancy Cohort

Preeclampsia Clinical Trial

— BBPC  

Official title:
Characterization of Immune Cell-trophoblast-interaction in Pregnancy Disorders

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT03313024
Other study ID # BBPC
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date September 26, 2017
Est. completion date October 2027

Study information
Verified date August 2018
Source Charite University, Berlin, Germany
Contact Florian Herse, PhD
Phone +49 30 450 540 434
Email florian.herse@charite.de
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

This study will investigate the interplay of different immune cells and placental cells as well as their potential for the development of pregnancy complications. In particular, the translation of the uteroplacental syndrome into a maternal syndrome, considered in the multifactorial pregnancy disorder preeclampsia, will be investigated. Immune cell subtypes are causally involved in the formation and translation of preeclampsia by inducing an endothelial dysfunction which leads to cardiovascular damage.

Recruitment information / eligibility
Status Recruiting
Enrollment 1580
Est. completion date October 2027
Est. primary completion date October 2027
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Female
Age group 18 Years to 45 Years
Eligibility Inclusion Criteria:

- healthy pregnant women after giving informed consent

- pregnant with diagnosis of preeclampsia, gestational hypertension or gestational diabetes

Exclusion Criteria:

- infections

- alcohol and drug abuse

- manifest and chronic diseases

Study Design

Related Conditions & MeSH terms

Locations
Country Name City State
Germany Experimental and Clinical Research Center (ECRC) Berlin

Sponsors (1)
Lead Sponsor Collaborator
Charite University, Berlin, Germany

Country where clinical trial is conducted

Germany, 

Outcome
Type Measure Description Time frame Safety issue
Primary T cell population content at the time of preeclampsia diagnosis compared to controls and verified by flow cytometry at the time of preeclampsia diagnosis compared to controls at the same time point in pregnancy
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