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Trial registered on ANZCTR


Registration number
ACTRN12614000586617
Ethics application status
Approved
Date submitted
18/05/2014
Date registered
2/06/2014
Date last updated
2/06/2014
Type of registration
Retrospectively registered

Titles & IDs
Public title
Can nitric oxide donors treatment improve pregnancy outcome in patients with antiphospholipid syndrome?
Scientific title
Prospective, randomized, controlled trial comparing low dose aspirin plus low molecular weight heparin and low dose aspirin plus nitric oxide donors as regards pregnancy outcome in patients with history of obstetric morbidity due to antiphospholipid syndrome.
Secondary ID [1] 284622 0
Nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Antiphospholipid syndrome 291935 0
recurrent abortion 292006 0
premature labor 292007 0
Condition category
Condition code
Reproductive Health and Childbirth 292287 292287 0 0
Abortion
Inflammatory and Immune System 292288 292288 0 0
Autoimmune diseases

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Prospective, randomized controlled trial. Two groups of pregnant women each 17 cases with a history of recurrent abortion or premature labor due to antiphospholipid syndrome were randomized to a control group treated once daily with oral low dose aspirin 81 mg plus subcutaneous low molecular weight heparin 40 mg, and a study group treated once daily with low dose aspirin 81 mg plus isosorbid mononitrate 20 mg tablet applied vaginally. Treatment started once pregnancy was confirmed by B-hCG and ultrasound examination and continued until the end of pregnancy. Adherence to the treatment was confirmed by the aspirin tablet and low molecular weight heparin vial return
Intervention code [1] 289407 0
Treatment: Drugs
Comparator / control treatment
Control group received the traditional treatment of oral low dose aspirin 81 mg plus subcutaneous low molecular weight heparin 40 mg
Control group
Active

Outcomes
Primary outcome [1] 292193 0
Incidence of full term live birth
Timepoint [1] 292193 0
End of pregnancy at 37-40 weeks gestation
Primary outcome [2] 292194 0
Compliance of patients to treatment in both groups was assessed by drug tablet return and satisfaction with treatment in both groups was assessed using structured interviews
Timepoint [2] 292194 0
End of pregnancy
Primary outcome [3] 292208 0
Incidence of abortion
Timepoint [3] 292208 0
termination of pregnancy before 20 weeks gestation
Secondary outcome [1] 308312 0
Doppler ultrasound measurement of uterine artery resistance and pulsation indices at 24 weeks after treatment compared to before treatment
Timepoint [1] 308312 0
At 24 weeks gestation

Eligibility
Key inclusion criteria
Patients with recurrent abortion or premature labor with preclampsia due to antiphospholipid syndrome
Minimum age
20 Years
Maximum age
30 Years
Gender
Females
Can healthy volunteers participate?
No
Key exclusion criteria
Recurrent abortion or premature labor due to causes other than antiphospholipid syndrome as uterine anomalies, cervical incompetence and chronic 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
Who is / are masked / blinded?



Intervention assignment
Other design features
Phase
Type of endpoint(s)
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment outside Australia
Country [1] 6060 0
Egypt
State/province [1] 6060 0
Kalyoupia, Benha

Funding & Sponsors
Funding source category [1] 289250 0
University
Name [1] 289250 0
Benha university
Address [1] 289250 0
Benha, Kalyoupia, Farid Nada street
Country [1] 289250 0
Egypt
Primary sponsor type
Hospital
Name
Benha university hospital
Address
Benha, Kalyoupia, Farid Nada street
Country
Egypt
Secondary sponsor category [1] 287964 0
University
Name [1] 287964 0
Benha university hospital
Address [1] 287964 0
Kalyoupia, Benha, Farid Nada street
Country [1] 287964 0
Egypt

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 291017 0
Department of Obstetrics and Gynecology
Ethics committee address [1] 291017 0
Benha university hospital, Farid Nada street, Benha, Kalyoupia
Ethics committee country [1] 291017 0
Egypt
Date submitted for ethics approval [1] 291017 0
01/01/2009
Approval date [1] 291017 0
01/01/2009
Ethics approval number [1] 291017 0

Summary
Brief summary
Adverse pregnancy outcome as recurrent abortion, premature labor and severe preeclampsia due to antiphospholipid syndrome is attributed to placental thrombosis; So, the traditional treatment is oral low dose aspirin plus subcutaneous low molecular weight heparin. Results in most studies are unsatisfactory because other pathologies do exist. Impaired synthesis of endogenous nitric oxide has been recently put forward. In this study we compare the traditional treatment with low dose aspirin plus the nitric oxide donors isosorbid mononitrate applied vaginally with the aim of improving pregnancy outcome especially the live birth rate
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 48514 0
Prof Mohamed Abdelrazik
Address 48514 0
Department of Obstetrics and Gynecology, Benha university hospital, Farid Nada street, Benha , Kalyoupia
Country 48514 0
Egypt
Phone 48514 0
+20 02 26070837 or +2 013 3225385
Fax 48514 0
Email 48514 0
Prof.mohamedabdelrazik@hotmail.com
Contact person for public queries
Name 48515 0
Prof Mohamed Abdelrazik
Address 48515 0
Department of Obstetrics and Gynecology, Benha university hospital, Farid Nada street, Benha , Kalyoupia
Country 48515 0
Egypt
Phone 48515 0
+20 02 26070837 or +2 013 3225385
Fax 48515 0
Email 48515 0
Prof.mohamedabdelrazik@hotmail.com
Contact person for scientific queries
Name 48516 0
Prof Mohamed Abdelrazik
Address 48516 0
Department of Obstetrics and Gynecology, Benha university hospital, Farid Nada street, Benha , Kalyoupia
Country 48516 0
Egypt
Phone 48516 0
+20 02 26070837 or +2 013 3225385
Fax 48516 0
Email 48516 0
Prof.mohamedabdelrazik@hotmail.com

No information has been provided regarding IPD availability
Summary results
Have study results been published in a peer-reviewed journal?
Other publications
Have study results been made publicly available in another format?
Results – basic reporting
Results – plain English summary