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Recruiting NCT03313024

Berlin-Brandenburg Pregnancy Cohort

— Observational Preeclampsia Pregnancy Complications Diabetes Mellitus in Pregnancy

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
This is an observational study: the protocol does not assign a study treatment.
Who it may be relevant to
Registry conditions: Preeclampsia, Pregnancy Complications, Diabetes Mellitus in Pregnancy. Basic parameters: 18 years — 45 years · Female.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Germany
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

Characterization of Immune Cell-trophoblast-interaction in Pregnancy Disorders

Overview

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.

Primary outcome measures

  • 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]

Eligibility 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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Observational model
Cohort

Study locations

Germany · 1 center
  • Experimental and Clinical Research Center (ECRC) — Berlin

Identifiers

NCT: NCT03313024 · BBPC

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗