Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12614000023651
Ethics application status
Approved
Date submitted
16/12/2013
Date registered
9/01/2014
Date last updated
9/01/2014
Type of registration
Prospectively registered

Titles & IDs
Public title
genetic alteration in preeclampsia
Scientific title
Impact of genetic polymorphism on the development of preeclampsia and its severity
Secondary ID [1] 283782 0
603/26 faculty of medicine Alexandria university
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
preeclampsia 290758 0
Condition category
Condition code
Reproductive Health and Childbirth 291119 291119 0 0
Fertility including in vitro fertilisation

Intervention/exposure
Study type
Observational
Patient registry
False
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
A prospective case control study
Will include 120 preeclamptic patients will be subdivided into mild and severe groups according to blood pressure and proteinuria .2 ml venous blood samples were taken once from the patient under a septic technique on Vaccutainer Ethylenediaminetetraacetic acid (EDTA) tubes . Deoxyribonucleic acid (DNA) Extraction and Purification using a DNA salting-out technique.Detection of C677T MTHFR gene polymorphis ,G1691A Factor V Lieden , G20210A Prothrombin genes and insertion /deletion(I/D) of ACE polymorphisms were done.
Intervention code [1] 288468 0
Not applicable
Comparator / control treatment
120 age-matched normotensive pregnant females
2 ml venous blood samples were taken under a septic technique on Vaccutainer EDTA tubes . DNA Extraction and Purification using a DNA salting-out technique.Detection of C677T MTHFR gene polymorphis ,G1691A Factor V Lieden , G20210A Prothrombin genes and insertion /deletion(I/D) ofACE polymorphisms were done.
Control group
Uncontrolled

Outcomes
Primary outcome [1] 291104 0
The correlation of the development of preeclampsia and the levels of methylene Tetrahydrofolate reductase (MTHFR), Factor five (FV Lieden), Prothrombin genes’ polymorphisms and angiotensin converting enzyme (ACE) polymorphism measured
Timepoint [1] 291104 0
after analysis of the genetic study of the blood sample
Primary outcome [2] 291105 0
The correlation of the severity of preeclampsia and the levels of methylene Tetrahydrofolate reductase (MTHFR), Factor five (FV Lieden), Prothrombin genes’ polymorphisms and angiotensin converting enzyme (ACE) polymorphism measured
Timepoint [2] 291105 0
after analysis of the genetic study of the blood sample
Secondary outcome [1] 306005 0
none
Timepoint [1] 306005 0
none

Eligibility
Key inclusion criteria
normotensive pregnant female in third trimester
mild preeclampsia in third trimester
severe preeclampsia in third trimester
Minimum age
20 Years
Maximum age
38 Years
Sex
Females
Can healthy volunteers participate?
No
Key exclusion criteria
other hypertensive diseases with pregnancy

Study design
Purpose
Screening
Duration
Cross-sectional
Selection
Case control
Timing
Prospective
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
15/01/2014
Actual
Date of last participant enrolment
Anticipated
17/04/2014
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
240
Accrual to date
Final
Recruitment outside Australia
Country [1] 5682 0
Egypt
State/province [1] 5682 0
alexandria

Funding & Sponsors
Funding source category [1] 288441 0
Self funded/Unfunded
Name [1] 288441 0
Country [1] 288441 0
Egypt
Primary sponsor type
University
Name
alexandria university , faculty of medicine
Address
22 elgeish street , elshatby 21526
Alexandria , egypt
Country
Egypt
Secondary sponsor category [1] 287143 0
None
Name [1] 287143 0
Address [1] 287143 0
Country [1] 287143 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 290316 0
ethical committe , faculty of medicine ,alexandria university
Ethics committee address [1] 290316 0
Champollion Street

El-Khartoum Square

Azarita Medical Campus alexandria egypt
21526
Ethics committee country [1] 290316 0
Egypt
Date submitted for ethics approval [1] 290316 0
Approval date [1] 290316 0
27/11/2013
Ethics approval number [1] 290316 0
IRB 00007555-fwa no : 00015712

Summary
Brief summary
study of the effect of the presence of gene mutation on development of preeclampsia and determination of its severity
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 45034 0
Dr ahmed fawzy galal
Address 45034 0
Elshatby maternity university hospital
port saeed street
alexandria Egypt
21526
Country 45034 0
Egypt
Phone 45034 0
+201222286962
Fax 45034 0
Email 45034 0
galal_af@yahoo.com
Contact person for public queries
Name 45035 0
Dr ahmed fawzy galal
Address 45035 0
Elshatby maternity university hospital
port saeed street
alexandria Egypt
21526
Country 45035 0
Egypt
Phone 45035 0
+201222286962
Fax 45035 0
Email 45035 0
galal_af@yahoo.com
Contact person for scientific queries
Name 45036 0
Dr ahmed fawzy galal
Address 45036 0
Elshatby maternity university hospital
port saeed street
alexandria Egypt
21526
Country 45036 0
Egypt
Phone 45036 0
+201222286962
Fax 45036 0
Email 45036 0
galal_af@yahoo.com

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.