Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12614000069651
Ethics application status
Approved
Date submitted
1/01/2014
Date registered
21/01/2014
Date last updated
21/01/2014
Type of registration
Retrospectively registered

Titles & IDs
Public title
Can nitric oxide donors increase uterine blood flow to improve endometrial receptivity and pregnancy outcome in patients with unexplained recurrent abortion?
Scientific title
Can the nitric oxide donors Isosorbid Mononitrate increase uterine blood flow to improve endometrial receptivity and pregnancy outcome in patients with unexplained recurrent abortion?"
Secondary ID [1] 283827 0
Nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
unexplained recurrent abortion 290803 0
decrease uterine artery and sub-endometrial blood flow 290804 0
Condition category
Condition code
Reproductive Health and Childbirth 291172 291172 0 0
Abortion

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The study included a control group of 30 women without history of abortion who delivered at least one living child and an abortion group of 30 nulliparous women with history of two or more unexplained recurrent abortion. Trans-vaginal three dimensional pulsed color Doppler ultrasound was done at 21-23 day of the menstrual cycle to measure uterine arteries resistance and pulsation indices and the sub-endometrial vascular, flow and vascular-flow indicies. Isosorbid mononitrate 20 mg tablet was administered once only vaginally in the abortion group after the Doppler ultrasound was completed and after two hours the blood flow indices were measured again
Intervention code [1] 288513 0
Treatment: Drugs
Comparator / control treatment
No treatment
Control group
Active

Outcomes
Primary outcome [1] 291159 0
Doppler ultrasound measurement of uterine artery resistance and pulsation indices
Timepoint [1] 291159 0
Two hours after vaginal administration of 20 mg isosorbid mononitrate
Primary outcome [2] 291232 0
Three dimensions power Doppler ultrasound and the histogram and VOCAL facility for measuring the sub-endometrial vascular, flow and vascular-flow indices
Timepoint [2] 291232 0
Two hours after vaginal administration of 20 mg isosorbid mononitrate
Secondary outcome [1] 306464 0
Nil
Timepoint [1] 306464 0
Nil

Eligibility
Key inclusion criteria
The control group included primipara who had a normal vaginal delivery and no history of abortion. The unexplained recurrent abortion group (URA) group had the following inclusion criteria: 1- Nullipara. 2- History of two or more successive URA. Diagnosis of URA entails1 presence of a normal uterine cavity by hysterography, no luteal phase defect (progesterone level greater than 10 ng / ml), normal thyroid function tests (TSH, T3 and T4), normal levels of lupus anticoagulant measured by the activated partial thromboplastin time (32 - 43 seconds), normal levels of anticardiolipin IgG (less than 20 GPL) and IgM (less than 15 MPL) antibodies measured by ELISA and normal karyotyping (done for 10 cases with more than three successive abortions). Patients treated with vasodilators were also excluded.
Minimum age
22 Years
Maximum age
30 Years
Sex
Females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Exclusion criteria in the control group includes: Women using hormonal or intrauterine device contraception or treated with vasodilators.

Exclusion criteria in the abortion group include: patients treated with vasodilators.

Study design
Purpose of the study
Prevention
Allocation to intervention
Non-randomised 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
1/11/2013
Actual
1/11/2013
Date of last data collection
Anticipated
Actual
Sample size
Target
60
Accrual to date
Final
Recruitment outside Australia
Country [1] 5707 0
Egypt
State/province [1] 5707 0
Kalyoupia; Benha

Funding & Sponsors
Funding source category [1] 288486 0
University
Name [1] 288486 0
Benha University
Country [1] 288486 0
Egypt
Primary sponsor type
University
Name
Benha university hospital
Address
Farid Nada st. Benha; Kalyoupia
Country
Egypt
Secondary sponsor category [1] 287188 0
None
Name [1] 287188 0
Address [1] 287188 0
Country [1] 287188 0

Ethics approval
Ethics application status
Approved

Summary
Brief summary
Decreased uterine blood flow has been claimed a cause of unexplained recurrent abortion. Nitric oxide plays a major role in increasing uterine blood flow during the luteal phase and early pregnancy and impaired nitric oxide synthesis may be a cause of recurrent abortion. The study was done to compare uterine artery and sub-endometrial blood flow indices during the luteal phase in patients with history of unexplained recurrent abortion compared to normal fertile women and to evaluate the effects of nitric oxide donors on blood flow indices in the abortion group.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 45234 0
Prof Mohamed Abdelrazik
Address 45234 0
Department of Obstetrics and Gynecology, Benha University hospital, Farid Nada street, Benha, Kalyoupia
Country 45234 0
Egypt
Phone 45234 0
+20 013 01223860001
Fax 45234 0
Email 45234 0
Prof.mohamedabdelrazik@hotmail.com
Contact person for public queries
Name 45235 0
Prof Mohamed Abdelrazik
Address 45235 0
Department of Obstetrics and Gynecology, Benha University hospital, Farid Nada street, Benha, Kalyoupia
Country 45235 0
Egypt
Phone 45235 0
+20 013 01223860001
Fax 45235 0
Email 45235 0
Prof.mohamedabdelrazik@hotmail.com
Contact person for scientific queries
Name 45236 0
Prof Mohamed Abdelrazik
Address 45236 0
Department of Obstetrics and Gynecology, Benha University hospital, Farid Nada street, Benha, Kalyoupia
Country 45236 0
Egypt
Phone 45236 0
+20 013 01223860001
Fax 45236 0
Email 45236 0
Prof.mohamedabdelrazik@hotmail.com

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No Supporting Document Provided



Results publications and other study-related documents

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