Expression of EPK in Recurrent Miscarriage | NCT02694367

Studies
Expression of EPK in Recurrent Miscarriage

NCT02694367

Sponsor

Assiut University

Status

Completed

Last Update Posted

Feb 29, 2016Estimated

Enrollment

39Actual

Phase

Not provided

Conditions

Recurrent Miscarriage

Interventions

Investigate the MAP kinase signaling pathways through ERK and p-ERK proteins

Countries

Egypt

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

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 2015

Primary Completion Date

Dec 2015Actual

Completion Date

Jan 2016Actual

First Submitted Date

Feb 24, 2016

First Submission Date that Met QC Criteria

Feb 26, 2016

First Posted Date

Feb 29, 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 26, 2016

Last Update Posted Date

Feb 29, 2016Estimated

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 present study is based on hypotheses that some as yet unknown genetic factors may result in recurrent miscarriage (RM). Consequently, the main aim of this study was to gain new information about the underlying genetic causes of RM in the Egyptian population and to investigate the expression of ERK and p-ERK protein in human placenta and their corresponding tissue, to assess the significance of MAPK signal pathway in progression of recurrent miscarriage and PI3K-Akt Pathway.

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

No data available

No data is available for this block.

Enrollment

39Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Recurrent miscarriage group		Women with previous history of RM, defined as two or more consecutive miscarriages	Other: Investigate the MAP kinase signaling pathways through ERK and p-ERK proteins
Control group		Women with no history of RM	Other: Investigate the MAP kinase signaling pathways through ERK and p-ERK proteins

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Investigate the MAP kinase signaling pathways through ERK and p-ERK proteins	Other		Control group Recurrent miscarriage group

Measure	Description	Time Frame
The levels of ERK and AKT in placenta		48 hours

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Gestational age less than 12 weeks.
no uterine abnormalities (examined by ultrasonography or hysterosonogram)
previous history of RM, defined as two or more consecutive miscarriages

Exclusion Criteria:

Gestational age 12 weeks or more.
Endocrine etiology like (thyroid dysfunction, and uncontrolled diabetes mellitus).
Antiphospholipid syndrome, inherited thrombophilias, alloimmune causes.
Uterine anatomic anomalies

Accepts Healthy Volunteers

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

20 Years

Maximum Age

40 Years

Standard Ages

Adult

Study Population

Women fulfilling the eligibility criteria had been tested and complete history and examination was done

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Ahmed Abbas		Assiut	Cairo Governorate	002	Egypt

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D000026	Abortion, Habitual

Ancestor Terms

ID	Term
D000022	Abortion, Spontaneous
D011248	Pregnancy Complications
D005261	Female Urogenital Diseases and Pregnancy Complications
D000091642	Urogenital Diseases

Browse Leaves

Not provided

Browse Branches

Not provided