The Telomere System in Cord Blood and in the Placenta in... | NCT01384136

Studies
The Telomere System in Cord Blood and in the Placenta in High Risk Pregnancies

NCT01384136

Sponsor

Meir Medical Center

Status

Unknown status

Last Update Posted

Jun 28, 2011Estimated

Enrollment

100Estimated

Phase

Not provided

Conditions

Telomere Length
Mechanisms of Telomter Homeostasis
High Risk Pregnancies

Interventions

Not provided

Countries

Israel

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

Jun 2011

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Active, not recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jun 2011

Primary Completion Date

Jun 2015Estimated

Completion Date

Jun 2015Estimated

First Submitted Date

Jun 27, 2011

First Submission Date that Met QC Criteria

Jun 27, 2011

First Posted Date

Jun 28, 2011Estimated

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

Jun 27, 2011

Last Update Posted Date

Jun 28, 2011Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

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

The telomere system stabilizes the chromosomes. Telomeres are shortened during senescence, in cases of genetic instability and secondary to stress.

The investigators aim is to study the telomere system in cord blood and in the placenta immediately after the delivery in pregnancies defined as high risk pregnancies following sterss events such as placental insufficiency, preeclampsia, diabetes.

The investigators intend to compare the telomere system in maternal blood to cord blood and to placental biopsies and to study the influence of different stressogenes on this system.

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

No data available

No data is available for this block.

Enrollment

100Estimated

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Third trimester post delivery
Intrauterine growth restriction
Preeclampsia
Diabetes
Control - low risk normal pregnancies

Exclusion Criteria:

Patients who do not want to participate
Known HIV or Hepatitis

Accepts Healthy Volunteers

Yes

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

45 Years

Standard Ages

Adult

Study Population

High risk pregnancies, third trimester, after the delivery/

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Meir Medical Center		Kfar Saba			Israel

Label	Type	Description	Intervention Names
High risk pregnancy
\|Control - Normal low risk pregnancies