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Trial registered on ANZCTR


Registration number
ACTRN12613001354774
Ethics application status
Approved
Date submitted
4/12/2013
Date registered
11/12/2013
Date last updated
11/12/2013
Type of registration
Retrospectively registered

Titles & IDs
Public title
Do nitric oxide donor drugs decrease the incidence of pre-eclampsia in high risk teenagers pregnant for the first time?
Scientific title
Does prophylactic treatment with nitric oxide donor drugs decrease the incidence and severity of pre-eclampsia in high risk teenage primigravidas with uterine artery diastolic notch at 20-24 weeks gestation?
Secondary ID [1] 283685 0
nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
pre-eclampsia 290650 0
Condition category
Condition code
Cardiovascular 291028 291028 0 0
Hypertension
Reproductive Health and Childbirth 291071 291071 0 0
Fetal medicine and complications of pregnancy

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Teenagers primigravidas with uterine artery diastolic notch at 20-24 weeks gestation were randomized to a control group received iron supplementation and a study group received iron supplementation plus 20 mg isosorbid mononitrate tablets once daily applied vaginally until delivery. Both groups were followed by routine antenatal care until delivery. Adherence to treatment was monitored by drug tablet return.
Intervention code [1] 288399 0
Prevention
Comparator / control treatment
Active control group received iron supplementation in the form of 50 mg elemental iron capsule once daily starting from 20-24 weeks gestation until delivery. Adherence to treatment was monitored by drug tablet return and estimation of hemoglobin concentration every 2-4 weeks
Control group
Active

Outcomes
Primary outcome [1] 291016 0
Incidence of pre-eclampsia in the study and control groups. Pre-eclampsia was diagnosed when the MAP was > 90 with 1+ or 2+ albuminuria on dipstick
Timepoint [1] 291016 0
delivery
Primary outcome [2] 291032 0
Severity of pre-eclampsia in the study and control groups , Mild PE was diagnosed when the MAP was > 90 with 1+ or 2+ albuminuria on dipstick and severe PE when the MAP was > 110 mmHg with 3+ or 4+ albuminuria.
Timepoint [2] 291032 0
delivery
Secondary outcome [1] 305848 0
validity of uterine artery diastolic notch at 20-24 weeks gestation for prediction of pre-eclampsia
Timepoint [1] 305848 0
delivery

Eligibility
Key inclusion criteria
teenagers primigravidas with normal pregnancy who showed uterine artery diastolic notch at 20-24 weeks gestation.
Minimum age
16 Years
Maximum age
20 Years
Gender
Females
Can healthy volunteers participate?
No
Key exclusion criteria
patients treated with vasodilators

Study design
Purpose of the study
Prevention
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] 5662 0
Egypt
State/province [1] 5662 0

Funding & Sponsors
Funding source category [1] 288373 0
Hospital
Name [1] 288373 0
Benha university hospital
Address [1] 288373 0
Farid Nada street, Benha, Kalyopia

NB: No post code
Country [1] 288373 0
Egypt
Funding source category [2] 288374 0
University
Name [2] 288374 0
Benha university
Address [2] 288374 0
Farid Nada street, Benha , Kalyopia

NB: No post code
Country [2] 288374 0
Egypt
Primary sponsor type
Hospital
Name
Benha university hospital
Address
Farid Nada street, Benha , Kalyopia

NB: No post code
Country
Egypt
Secondary sponsor category [1] 287077 0
None
Name [1] 287077 0
none
Address [1] 287077 0
Country [1] 287077 0

Ethics approval
Ethics application status
Approved

Summary
Brief summary
Teenagers primigravidas with uterine artery diastolic notch at 20-24 weeks gestation are considered at high risk for pre-eclampsia and were randomized to a control group received iron supplementation and a study group received iron supplementation plus 20 mg isosorbid mononitrate tablet vaginally once daily with the aim of decreasing the incidence and severity of pre-eclampsia. Both groups received treatment until delivery and were followed by antenatal care.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 44694 0
Prof Mohamed Abdelrazik
Address 44694 0
Department of Obstetrics and Gynecology, Benha university hospital, Farid Nada street, Benha, kalyopia, Egypt

Country 44694 0
Egypt
Phone 44694 0
+20 013 01223860001
Fax 44694 0
Email 44694 0
Prof.mohamedabdelrazik@hotmail.com
Contact person for public queries
Name 44695 0
Prof Mohamed Abdelrazik
Address 44695 0
Department of Obstetrics and Gynecology, Benha university hospital, Farid Nada street, Benha, kalyopia, Egypt
Country 44695 0
Egypt
Phone 44695 0
+20 013 01223860001
Fax 44695 0
Email 44695 0
Prof.mohamedabdelrazik@hotmail.com
Contact person for scientific queries
Name 44696 0
Prof Mohamed Abdelrazik
Address 44696 0
Department of Obstetrics and Gynecology, Benha university hospital, Farid Nada street, Benha, kalyopia, Egypt
Country 44696 0
Egypt
Phone 44696 0
+20 013 01223860001
Fax 44696 0
Email 44696 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