NCT03313024

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,580

participants targeted

Target at P75+ for all trials

Timeline
14mo left

Started Sep 2017

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress88%
Sep 2017Oct 2027

Study Start

First participant enrolled

September 26, 2017

Completed
17 days until next milestone

First Submitted

Initial submission to the registry

October 13, 2017

Completed
5 days until next milestone

First Posted

Study publicly available on registry

October 18, 2017

Completed
10 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2027

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2027

Last Updated

August 14, 2018

Status Verified

August 1, 2018

Enrollment Period

10 years

First QC Date

October 13, 2017

Last Update Submit

August 13, 2018

Conditions

PreeclampsiaPregnancy ComplicationsDiabetes Mellitus in Pregnancy

Outcome Measures

Primary Outcomes (1)

  • 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

Eligibility Criteria

Age18 Years - 45 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)
Sampling MethodProbability Sample
Study Population

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

You may qualify if:

  • healthy pregnant women after giving informed consent
  • pregnant with diagnosis of preeclampsia, gestational hypertension or gestational diabetes

You may not qualify if:

  • infections
  • alcohol and drug abuse
  • manifest and chronic diseases

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Experimental and Clinical Research Center (ECRC)

Berlin, 13125, Germany

RECRUITING

MeSH Terms

Conditions

Pre-EclampsiaPregnancy ComplicationsDiabetes, Gestational

Condition Hierarchy (Ancestors)

Hypertension, Pregnancy-InducedFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesDiabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Central Study Contacts

Florian Herse, PhD

CONTACT

+49 30 450 540 434florian.herse@charite.de

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
PhD

Study Record Dates

First Submitted

October 13, 2017

First Posted

October 18, 2017

Study Start

September 26, 2017

Primary Completion (Estimated)

October 1, 2027

Study Completion (Estimated)

October 1, 2027

Last Updated

August 14, 2018

Record last verified: 2018-08

Locations

DE(1)