The Role of Cytokines in Apparently Normal Pregnancies | NCT01098214

Studies
The Role of Cytokines in Apparently Normal Pregnancies

NCT01098214

Sponsor

NYU Langone Health

Status

Withdrawn

Last Update Posted

May 21, 2019Actual

Enrollment

0Actual

Phase

Not provided

Conditions

Pregnancy

Interventions

Not provided

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

May 2019

Overall Recruitment Status or Expanded Access Status

Withdrawn

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Decided not to pursue study at this time. Resources not available

Expanded Access Info

Start Date

Apr 2010

Primary Completion Date

Nov 2011Actual

Completion Date

Nov 2011Actual

First Submitted Date

Apr 1, 2010

First Submission Date that Met QC Criteria

Apr 1, 2010

First Posted Date

Apr 2, 2010Estimated

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

May 17, 2019

Last Update Posted Date

May 21, 2019Actual

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

To provide rigorous, detailed normative data for diagnostics and comparative studies, to determine relationships between cytokine levels (and other biomarkers) and clinical data, and gain further insight into the pro-/anti-inflammatory cytokine profile of normal midtrimester amniotic fluid.

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

Not provided

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

Retention

Enrollment

0Actual

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Age over 18
Pregnancies between 15-25 weeks gestation.
Able to provide informed consent.
No apparent major sonographic abnormality.

Exclusion Criteria:

Any major fetal anomaly

Accepts Healthy Volunteers

Yes

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Women undergoing amniocentesis with an apparently normal pregnancy

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Nazeeh Hanna, M.D.	Winthrop University Hospital	Principal Investigator

Locations

Not provided