Berlin-Brandenburg Pregnancy Cohort (BBPC)

August 13, 2018 updated by: Florian Herse, Charite University, Berlin, Germany

Characterization of Immune Cell-trophoblast-interaction in Pregnancy Disorders

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.

Study Overview

Status

Recruiting

Conditions

Study Type

Observational

Enrollment (Anticipated)

1580

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Germany
      • Berlin, Germany, 13125
        • Recruiting
        • Experimental and Clinical Research Center (ECRC)
        • Contact:
        • Principal Investigator:
          • Florian Herse, PhD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 45 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Female

Sampling Method

Probability Sample

Study Population

Pregnant women between 18 and 45 years of age without infections, severe or chronic diseases

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
T cell population content at the time of preeclampsia diagnosis compared to controls and verified by flow cytometry
Time Frame: at the time of preeclampsia diagnosis compared to controls at the same time point in pregnancy
at the time of preeclampsia diagnosis compared to controls at the same time point in pregnancy

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Charite University, Berlin, Germany

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 26, 2017

Primary Completion (Anticipated)

October 1, 2027

Study Completion (Anticipated)

October 1, 2027

Study Registration Dates

First Submitted

October 13, 2017

First Submitted That Met QC Criteria

October 13, 2017

First Posted (Actual)

October 18, 2017

Study Record Updates

Last Update Posted (Actual)

August 14, 2018

Last Update Submitted That Met QC Criteria

August 13, 2018

Last Verified

August 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • BBPC

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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