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Trial registered on ANZCTR


Registration number
ACTRN12613001085763
Ethics application status
Approved
Date submitted
24/09/2013
Date registered
27/09/2013
Date last updated
27/09/2013
Type of registration
Retrospectively registered

Titles & IDs
Public title
nitric oxide donors drugs for treatment of recurrent abortion due to primary antiphospholipid syndrome
Scientific title
Prospective, randomized, controlled pilot study of aspirin plus nitric oxide donors treatment of recurrent abortion due to primary antiphospholipid syndrome
Secondary ID [1] 283292 0
nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
recurrent abortion 290175 0
primary antiphospholipid syndrome 290176 0
Condition category
Condition code
Reproductive Health and Childbirth 290561 290561 0 0
Abortion
Inflammatory and Immune System 290579 290579 0 0
Autoimmune diseases

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Prospective, randomized, controlled pilot study of aspirin plus nitric oxide donors treatment of recurrent abortion due to primary antiphospholipid syndrome

Two groups of pregnant with history of recurrent abortion due to primary antiphospholipid syndrome. The control group was treated with acetyl salicylic acid 81 mg oral tablets (low dose aspirin) alone once daily and the study group was treated with low dose aspirin 81 mg oral tablets plus 20 mg isosorbid mononitrate tablets applied vaginally once daily. Treatment in both groups started once pregnancy was confirmed by B-hGC and ultrasound examination and continued till the end of pregnancy. All patients were firmly instructed to adhere to treatment through regular antenatal care followup and drug tablet return
Intervention code [1] 288016 0
Treatment: Drugs
Comparator / control treatment
Active control received 81 mg acetyl salicylic acid orally once daily starting from confirmation of pregnancy at 5-6 weeks gestation till the end of pregnancy
Control group
Active

Outcomes
Primary outcome [1] 290587 0
The full term live birth rate
Timepoint [1] 290587 0
Labor at 37- 41 weeks gestation
Primary outcome [2] 290598 0
Abortion rate
Timepoint [2] 290598 0
Abortion: Spontaneous termination of pregnancy before 28 weeks gestation
Primary outcome [3] 290611 0
premature birth rate
Timepoint [3] 290611 0
Premature labor: Spontaneous termination of pregnancy after 28 weeks and before 37 weeks
Secondary outcome [1] 304848 0
Uterine artery blood flow assessed by the pulsation and resistant indices at 24 weeks gestation
Timepoint [1] 304848 0
At 24 weeks gestation

Eligibility
Key inclusion criteria
pregnant with recurrent abortion due to primary antiphospholipid syndrone
Minimum age
20 Years
Maximum age
32 Years
Sex
Females
Can healthy volunteers participate?
No
Key exclusion criteria
recurrent abortion due to anatomical, endocrine and other systemic diseases

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



Intervention assignment
Parallel
Other design features
Phase
Type of endpoint/s
Efficacy
Statistical methods / analysis
Statistical Package of Social Science (SPSS) version 16.
Result was represented by the mean and the standard deviation. Student t test was used to compare between two independent groups, the paired t test was used to compare the results in the same group before and after intervention and the Z test to compare between two proportions. P value of = 0.05 was considered significant.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
24/09/2013
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
34
Accrual to date
Final
Recruitment outside Australia
Country [1] 5441 0
Egypt
State/province [1] 5441 0
Kalyoupia; Benha

Funding & Sponsors
Funding source category [1] 288031 0
Hospital
Name [1] 288031 0
Benha university hospital
Country [1] 288031 0
Egypt
Primary sponsor type
Hospital
Name
Benha university hospital
Address
Farid Nada street, Benha, Kalyoupia, Egypt
Country
Egypt
Secondary sponsor category [1] 286748 0
None
Name [1] 286748 0
Address [1] 286748 0
Country [1] 286748 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 289965 0
Ethics Committee of the Department of OB/GYN, Benha university hospital
Ethics committee address [1] 289965 0
Farid Nada street, Benha, Kalyoupia
Ethics committee country [1] 289965 0
Egypt
Date submitted for ethics approval [1] 289965 0
Approval date [1] 289965 0
01/01/2011
Ethics approval number [1] 289965 0

Summary
Brief summary
Antiphospholipid syndrome (an autoimmune disease) is important cause for recurrent abortion (Three or more spontaneous successive abortion). Low dose aspirin and low molecular weight heparin are used for treatment on the assumption that the disease leads to placental thrombosis and fetal demise but results of treatment are unsatisfactory. Recently, abnormal endogenous nitric oxide synthesis was alleged to play a role.This study was performed to know if treatment with nitric oxide donors (drugs the release nitric oxide in the body) will improve pregnancy outcome and the full term live birth rate





Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 43246 0
Prof Mohamed Abdelrazik
Address 43246 0
Department of OB/GYN, Benha university hospital, Farid Nada street, Benha , Kalyoupia
Country 43246 0
Egypt
Phone 43246 0
+20 013 01223860001
Fax 43246 0
Email 43246 0
[email protected]
Contact person for public queries
Name 43247 0
Prof Mohamed Abdelrazik
Address 43247 0
Department of OB/GYN, Benha university hospital, Farid Nada street, Benha , Kalyoupia
Country 43247 0
Egypt
Phone 43247 0
+20 013 01223860001
Fax 43247 0
Email 43247 0
[email protected]
Contact person for scientific queries
Name 43248 0
Prof Mohamed Abdelrazik
Address 43248 0
Department of OB/GYN, Benha university hospital, Farid Nada street, Benha , Kalyoupia
Country 43248 0
Egypt
Phone 43248 0
+20 013 01223860001
Fax 43248 0
Email 43248 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.