Trial Review

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial registered on ANZCTR


Registration number
ACTRN12611000444987
Ethics application status
Approved
Date submitted
14/04/2011
Date registered
2/05/2011
Date last updated
2/05/2011
Type of registration
Retrospectively registered

Titles & IDs
Public title
the effect of antioxidant vitamins on blood coagulation during pregnancy in women at risk of preeclampsia
Scientific title
The possible effect of gestational antioxidant on coagulopathy associated preeclampsia in women at risk of preeclampsia
Secondary ID [1] 260052 0
nil
Universal Trial Number (UTN)
The Universal Trial Number (UTN) is U1111-1120-4057
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
preeclampsia coagulopathy 265715 0
Condition category
Condition code
Reproductive Health and Childbirth 265857 265857 0 0
Other reproductive health and childbirth disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
This study was a prospective randomized controlled blinded trial. Participating women were randomly assigned to receive either antioxidants cocktail (group I) containing 1000 mg vitamin C, 400 IU vitamin E, 100 micro g Selenium and 1500 IU vitamin A; or identical placebos (group II) in form of oral capsules. This supplementation was given daily from enrolment to delivery and was continued even after pre-eclampsia or hypertension was diagnosed. Participating women were seen once a month for clinical evaluation according to the standardized antenatal care protocol. The definition of pre-eclampsia was in accordance with the American College of Obstetricians. In the last visit in the first and second trimester, and immediately before delivery blood samples were drawn for laboratory investigations.
Intervention code [1] 264428 0
Prevention
Comparator / control treatment
placebo oral microcellulose capsules
Control group
Placebo

Outcomes
Primary outcome [1] 266617 0
preeclampsia : any case diagnosed as preeclampsia by hypertension, lower limb oedema,proteinuria
Timepoint [1] 266617 0
2nd and 3rd trimesters of pregnancy till the delivery
Secondary outcome [1] 276100 0
coagulopathy indicated by d-dimer
Timepoint [1] 276100 0
every trimester( 3 month )

Eligibility
Key inclusion criteria
Only pregnant women with high risk for pre-eclampsia were considered. The inclusion criteria were gestational age between 6-10 weeks with one or more of the following risk factors: pre-eclampsia in the pregnancy preceding the current one, eclampsia in any previous pregnancy, essential hypertension requiring medication, diagnosis of HELLP syndrome (hemolysis, elevated liver enzymes, and low platelet count), and chronic renal disease pre-pregnancy or during pregnancy
Minimum age
24 Years
Maximum age
35 Years
Sex
Females
Can healthy volunteers participate?
No
Key exclusion criteria
. Exclusion criteria included maternal liver disease, diabetes mellitus and possible materno-fetal fetus Rh incompatibility.

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Allocation is not concealed
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using computerised sequence generation
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
no
Phase
Phase 1 / Phase 2
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
30/06/2006
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
251
Accrual to date
Final
Recruitment outside Australia
Country [1] 3391 0
Egypt
State/province [1] 3391 0
sohag

Funding & Sponsors
Funding source category [1] 264946 0
University
Name [1] 264946 0
sohag university hospital , Egypt
Country [1] 264946 0
Egypt
Primary sponsor type
Individual
Name
magdy ameen elkady
Address
obestetric and gynecology department , sohag university hospital, naser city, university street, sohag, Egypt
Country
Egypt
Secondary sponsor category [1] 264043 0
Individual
Name [1] 264043 0
hasnaa ahmed abo_elwafa
Address [1] 264043 0
clinical pathology department , sohag university hospital, naser city, university street, sohag,Egypt
Country [1] 264043 0
Egypt
Other collaborator category [1] 251970 0
Individual
Name [1] 251970 0
nagwa sief ahmed
Address [1] 251970 0
biochemistry department ,sohag university faculty of medicine, university street, naser city, sohag, Egypt
Country [1] 251970 0
Egypt

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 266902 0
sohag university ethical committee
Ethics committee address [1] 266902 0
obestetric department, faculty of medicine, sohag university hospital, ethical committe, sohag university, naser city, university street, sohag, Egypt
Ethics committee country [1] 266902 0
Egypt
Date submitted for ethics approval [1] 266902 0
20/06/2006
Approval date [1] 266902 0
23/06/2006
Ethics approval number [1] 266902 0
22/15

Summary
Brief summary
Abstract
Background: Oxidative stress is blamed in the pathogenesis of pre-eclampsia. However, it is less clear what effect gestational antioxidants would have on pre-eclampsia associated coagulopathy, aim of the study: to investigate the effect of antioxidants supplementation on coagulopathy during pre-eclampsia, patients and Methods: The study was performed as a randomized, controlled, blinded trial; 251 high risk pregnant women were randomized to receive either antioxidants (1000mg vitamin C, 400IU vitamin E, 100 micro g Selenium and 1500IU vitamin A) or placebo. Primary maternal outcome was pre-eclampsia or one of its complications. . In each trimester, detailed blood chemistry lipogram, and coagulation profile were done. Antioxidants blood levels (vitamins A, C, and E) were measured immediately before delivery.
Results: Incidence of pre-eclampsia did not differ between the two groups. However, a significant reduction in disease severity was noticed. Antioxidants reduced the levels of D-dimer, von Willibrand factor, and fibrinogen significantly. Platelets activity showed a significant reduction in the supplemented group. Antioxidants were significantly higher in blood of the supplemented group. Conclusion: Supplementing high risk women with antioxidants during pregnancy may help to counteract the oxidative stress and control coagulopathy. However, it does not prevent the disease. Keywords: coagulopathy, antioxidants, pre-eclampsia, vitamins
Trial website
no
Trial related presentations / publications
nil
Public notes

Contacts
Principal investigator
Name 32498 0
Address 32498 0
Country 32498 0
Phone 32498 0
Fax 32498 0
Email 32498 0
Contact person for public queries
Name 15745 0
Hasnaa Ahmed Abo-Elwafa
Address 15745 0
clinical pathology department, sohag university hospital, faculty of medicine, sohag university, naser city, university street, sohag, Egypt
Country 15745 0
Egypt
Phone 15745 0
+2 093 4604494 mobile +20 0162090475
Fax 15745 0
no
Email 15745 0
[email protected]
Contact person for scientific queries
Name 6673 0
magdy ameen elkady
Address 6673 0
obestetric and gynecology department. sohag university hospital, faculty of medicine, sohag university, naser city, university street, sohag. Egypt
Country 6673 0
Egypt
Phone 6673 0
+20934604449
Fax 6673 0
no
Email 6673 0
[email protected]

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.