Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12614000808640
Ethics application status
Approved
Date submitted
8/07/2014
Date registered
30/07/2014
Date last updated
30/07/2014
Type of registration
Retrospectively registered

Titles & IDs
Public title
Can treatment of unexplained recurrent abortion patients with nitric oxide donors decrease the incidence of abortion?
Scientific title
Comparative study between folic acid control group and folic acid plus isosorbid mononitrate as a nitric oxide donors study group treatment of unexplained recurrent abortion patients as regards incidence of abortion
Secondary ID [1] 284936 0
Nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Unexplained recurrent abortion 292417 0
Condition category
Condition code
Reproductive Health and Childbirth 292732 292732 0 0
Fertility including in vitro fertilisation

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
A control of 30 patients with unexplained recurrent abortion treated with folic acid 0.5 mg once daily orally starting before pregnancy until 20 weeks gestation and a study group of 30 patients treated with folic acid 0.5 mg once daily orally plus isosorbid mononitrate 20 mg dailly applied vaginally
Intervention code [1] 289764 0
Treatment: Drugs
Comparator / control treatment
Control group treated with folic acid 0.5 mg orally from before pregnancy to 20 weeks gestation
Control group
Active

Outcomes
Primary outcome [1] 292582 0
Incidence of abortion in both groups
Timepoint [1] 292582 0
20 weeks gestation
Primary outcome [2] 292583 0
Uterine artery resistance and pulsation indices before treatment and at 20 weeks gestation after treatment measured by trans-vaginal and trans-abdominal pulsed color Doppler ultrasound
Timepoint [2] 292583 0
20 weeks gestation
Secondary outcome [1] 309261 0
Nil
Timepoint [1] 309261 0
Nil

Eligibility
Key inclusion criteria
Patients with unexplained recurrent abortion with normal uterine cavity, normal glucose tolerance, normal levels of antiphospholipid antibodies, normal thyroid functions and normal karyotyping
Minimum age
20 Years
Maximum age
30 Years
Sex
Females
Can healthy volunteers participate?
No
Key exclusion criteria
Patients treated with vasodilators

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
1/01/2013
Actual
1/01/2013
Date of last participant enrolment
Anticipated
1/12/2013
Actual
1/12/2013
Date of last data collection
Anticipated
Actual
Sample size
Target
60
Accrual to date
Final
Recruitment outside Australia
Country [1] 6201 0
Egypt
State/province [1] 6201 0

Funding & Sponsors
Funding source category [1] 289564 0
Hospital
Name [1] 289564 0
Benha university hospital
Country [1] 289564 0
Egypt
Primary sponsor type
Hospital
Name
Benha university hospital
Address
Kalyoupia , Benha, Farid Nada street
Country
Egypt
Secondary sponsor category [1] 288352 0
None
Name [1] 288352 0
Address [1] 288352 0
Country [1] 288352 0

Ethics approval
Ethics application status
Approved

Summary
Brief summary
The study included a control and a study group each 30 cases with history of unexplained recurrent abortion. The control group was treated with folic acid tablet 0.5 mg once daily orally and the study group treated with folic acid plus isosorbid mononitrate 20 mg given vaginally. Treatment was given monthly from day 21-23 of the cycle until menstruation and continued if pregnancy occurred until 20 weeks gestation. Doppler ultrasound was done vaginally before treatment and abdominally at 20 weeks gestation to measure uterine artery resistance and pulsation indices. Patients were treated until 20 weeks gestation to compare uterine artery indices before and after treatment and the incidence of abortion in both groups
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 49770 0
Prof Mohamed Abdelrazik
Address 49770 0
Department of Obstetrics and Gynecology, Benha Faculty of Medicine, Benha, Farid Nada street
Country 49770 0
Egypt
Phone 49770 0
+20 02 26070837 or +20 013 3225385
Fax 49770 0
Email 49770 0
[email protected]
Contact person for public queries
Name 49771 0
Prof Mohamed Abdelrazik
Address 49771 0
Department of Obstetrics and Gynecology, Benha Faculty of Medicine, Benha, Farid Nada street
Country 49771 0
Egypt
Phone 49771 0
+20 02 26070837 or +20 013 3225385
Fax 49771 0
Email 49771 0
[email protected]
Contact person for scientific queries
Name 49772 0
Prof Mohamed Abdelrazik
Address 49772 0
Department of Obstetrics and Gynecology, Benha Faculty of Medicine, Benha, Farid Nada street
Country 49772 0
Egypt
Phone 49772 0
+20 02 26070837 or +20 013 3225385
Fax 49772 0
Email 49772 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.