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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ANZCTR |
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Last refreshed on:
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13 January 2020 |
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Main ID: |
ACTRN12614000808640 |
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Date of registration:
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30/07/2014 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Can treatment of unexplained recurrent abortion patients with nitric oxide donors decrease the incidence of abortion?
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Scientific title:
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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 |
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Date of first enrolment:
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01/01/2013 |
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Target sample size:
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60 |
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Recruitment status: |
Completed |
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URL:
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https://anzctr.org.au/ACTRN12614000808640.aspx |
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Study type:
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Interventional |
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Study design:
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Purpose: Treatment; Allocation: Randomised controlled trial;
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Phase:
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Countries of recruitment
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Egypt
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Contacts
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Name:
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Prof Mohamed Abdelrazik
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Address:
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Department of Obstetrics and Gynecology, Benha Faculty of Medicine, Benha, Farid Nada street
Egypt |
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Telephone:
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+20 02 26070837 or +20 013 3225385 |
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Email:
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Prof.mohamedabdelrazik@hotmail.com |
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Affiliation:
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Name:
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Prof Mohamed Abdelrazik
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Address:
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Department of Obstetrics and Gynecology, Benha Faculty of Medicine, Benha, Farid Nada street
Egypt |
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Telephone:
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+20 02 26070837 or +20 013 3225385 |
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Email:
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Prof.mohamedabdelrazik@hotmail.com |
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Affiliation:
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Key inclusion & exclusion criteria
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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
Exclusion criteria: Patients treated with vasodilators
Age minimum:
20 Years
Age maximum:
30 Years
Gender:
Females
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Health Condition(s) or Problem(s) studied
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Reproductive Health and Childbirth - Fertility including in vitro fertilisation
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Unexplained recurrent abortion;
Unexplained recurrent abortion
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Intervention(s)
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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
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Primary Outcome(s)
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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 [20 weeks gestation]
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Incidence of abortion in both groups[20 weeks gestation]
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Secondary Outcome(s)
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Nil[Nil]
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Source(s) of Monetary Support
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Benha university hospital
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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