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Berlin-Brandenburg Pregnancy Cohort (BBPC)

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ClinicalTrials.gov Identifier: NCT03313024
Recruitment Status : Recruiting
First Posted : October 18, 2017
Last Update Posted : August 14, 2018
Sponsor:
Information provided by (Responsible Party):
Florian Herse, Charite University, Berlin, Germany

Brief 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.

Condition or disease
Preeclampsia Pregnancy Complications Diabetes Mellitus in Pregnancy

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Study Type : Observational
Estimated Enrollment : 1580 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Characterization of Immune Cell-trophoblast-interaction in Pregnancy Disorders
Actual Study Start Date : September 26, 2017
Estimated Primary Completion Date : October 2027
Estimated Study Completion Date : October 2027

Resource links provided by the National Library of Medicine





Primary Outcome Measures :
  1. 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 ]


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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population
Pregnant women between 18 and 45 years of age without infections, severe or chronic diseases
Criteria

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

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 ClinicalTrials.gov identifier (NCT number): NCT03313024


Contacts
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Contact: Florian Herse, PhD +49 30 450 540 434 florian.herse@charite.de

Locations
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Germany
Experimental and Clinical Research Center (ECRC) Recruiting
Berlin, Germany, 13125
Contact: Florian Herse, PhD    +49 30 450 540 434    florian.herse@charite.de   
Principal Investigator: Florian Herse, PhD         
Sponsors and Collaborators
Charite University, Berlin, Germany

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Responsible Party: Florian Herse, PhD, Charite University, Berlin, Germany
ClinicalTrials.gov Identifier: NCT03313024     History of Changes
Other Study ID Numbers: BBPC
First Posted: October 18, 2017    Key Record Dates
Last Update Posted: August 14, 2018
Last Verified: August 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Diabetes Mellitus
Pre-Eclampsia
Pregnancy Complications
Pregnancy in Diabetics
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Hypertension, Pregnancy-Induced