Different Regulation of Immune Cells in Patients With Pre... | NCT02691364

Studies
Different Regulation of Immune Cells in Patients With Preeclampsia

NCT02691364

Sponsor

University Medical Center Groningen

Status

Unknown status

Last Update Posted

Feb 25, 2016Estimated

Enrollment

30Estimated

Phase

Not provided

Conditions

Preeclampsia
Pregnancy

Interventions

Blood withdrawal

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Feb 2016

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Not yet recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Apr 2016

Primary Completion Date

May 2017Estimated

Completion Date

Jun 2017Estimated

First Submitted Date

Feb 22, 2016

First Submission Date that Met QC Criteria

Feb 24, 2016

First Posted Date

Feb 25, 2016Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Feb 24, 2016

Last Update Posted Date

Feb 25, 2016Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

Jelmer Prins, MD PhD, University Medical Center GroningenPrincipal Investigator

Lead Sponsor

University Medical Center GroningenOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

Adaptation of the maternal immune system to accommodate the semi-allogeneic fetus is necessary for pregnancy success. Dysregulation of this immune adaptation is implicated in reproductive disorders as infertility, recurrent miscarriage, fetal growth restriction, and preeclampsia. The mechanisms being responsible for fetal tolerance are not known. Several T cell subsets have been implicated in fetal tolerance. The effects of preeclampsia on memory cells are not known. The main objective of this study is to analyze the effect of preeclampsia on levels of immune cells.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

Retention

Enrollment

30Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Healthy		Healthy women	Procedure: Blood withdrawal
Preeclamptic		Pregnant women with preeclampsia	Procedure: Blood withdrawal

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Blood withdrawal	Procedure		Healthy Preeclamptic

Measure	Description	Time Frame
Cell levels		1 year

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

healthy
written informed consent
18-40 years

Exclusion Criteria:

smoking
immune related disorders (other than preeclampsia)
fever / illness within the last month
infertility
body mass index <18 or >30

Accepts Healthy Volunteers

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

40 Years

Standard Ages

Adult

Study Population

Pregnant women with and without preeclampsia

Sampling Method

Probability Sample

Condition Browse Module

MeSH Terms

ID	Term
D011225	Pre-Eclampsia

Ancestor Terms

ID	Term
D046110	Hypertension, Pregnancy-Induced
D011248	Pregnancy Complications
D005261	Female Urogenital Diseases and Pregnancy Complications
D000091642	Urogenital Diseases

Browse Leaves

Not provided

Browse Branches

Not provided