From Cytotrophoblast to Syncytiotrophoblast | NCT02368821

Studies
From Cytotrophoblast to Syncytiotrophoblast

NCT02368821

Sponsor

Meir Medical Center

Status

Unknown status

Last Update Posted

Feb 24, 2015Estimated

Enrollment

300Estimated

Phase

Not provided

Conditions

Syncytiotrophoblast

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

Jan 2015

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

Mar 2015

Primary Completion Date

Jan 2017Estimated

Completion Date

Not provided

First Submitted Date

Jan 15, 2015

First Submission Date that Met QC Criteria

Feb 15, 2015

First Posted Date

Feb 23, 2015Estimated

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 22, 2015

Last Update Posted Date

Feb 24, 2015Estimated

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

A deeper understanding of the syncytiotrophoblast development processes and its properties may allow a better understanding of the placenta pathological process for the development of treatment models for the relevant pregnancy complications.The aim of this study is to compare telomere length, aggregate formation, and senescence markers in placentas from complicated pregnancy with placentas from normal pregnancy.

Detailed Description

Protocol summary No. 2 for research 0202-14 of date: 22/11/2014. Rationale for the research A deeper understanding of the syncytiotrophoblast development processes and its properties may allow a better understanding of the placenta pathological process for the development of treatment models for the relevant pregnancy complications.

The aim of this study is to compare telomere length, aggregate formation, and senescence markers in the syncytiotrophoblast of placentas from complicated pregnancy with placentas from normal pregnancy.

Telomere lenght and aggregate formation will be assessed by the fluorescent intensity of telomere FISH.

Senescence will be assessed by immunohistochemistry for the markers - SAHF, cyclin dependent kinase inhibitors p16/p21, HLAX, ERVWE1, SA-B-gal.

The study groups

A retrospective arm - paraffin blocks which were collected over the years from placentas from complicated pregnancy ( intrauterine growth restriction, preeclampsia , placenta accrete) will be compared to blocks of placentas from normal pregnancies.
The prospective arm - placental from complicated pregnancy ( intrauterine growth restriction, preeclampsia , placenta accrete) . Will be compared to placentas of normal pregnancies.
A laboratory model based on human placenta cell cultures

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

300Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
normal pregnancy		placental from normal pregnancy
complacted pregnancy		placental from complicated pregnancy ( intrauterine growth restriction, preeclampsia , placenta accrete

Interventions

Not provided

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Length of telomere and senescence markers amount in the placentas.		2 years

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

placentas from normal and complicated pregnancy

Exclusion Criteria:

women consent

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

placentas from normal and complicated pregnancy

Sampling Method

Non-Probability Sample

Condition Browse Module

MeSH Terms

ID	Term
D005317	Fetal Growth Retardation
D011225	Pre-Eclampsia

Ancestor Terms

ID	Term
D005315	Fetal Diseases
D011248	Pregnancy Complications
D005261	Female Urogenital Diseases and Pregnancy Complications
D000091642	Urogenital Diseases

Browse Leaves

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Browse Branches

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