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Trial registered on ANZCTR


Registration number
ACTRN12610001017011
Ethics application status
Approved
Date submitted
6/04/2010
Date registered
22/11/2010
Date last updated
4/04/2011
Type of registration
Retrospectively registered

Titles & IDs
Public title
Investigation Into The Efficacy And Safety Of Sildenafil Versus Natural Progesterone For prevention Of Preterm Labour

A randomized controlled study
Scientific title
Investigation Into The Efficacy And Safety Of Sildenafil Versus Natural Progesterone For prevention Of Preterm Labour

A randomized controlled study
Secondary ID [1] 251647 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
prevention Of Preterm Labour 256494 0
preterm labour 258676 0
Condition category
Condition code
Reproductive Health and Childbirth 256663 256663 0 0
Other reproductive health and childbirth disorders
Reproductive Health and Childbirth 257250 257250 0 0
Antenatal care

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
sildenafil 100 mg vaginally every 12 hours , for 10 weeks prior to scheduled labour
Intervention code [1] 255778 0
Treatment: Drugs
Comparator / control treatment
progesterone 100 mg tablet vaginally every 12 hours , for 10 weeks prior to scheduled labour
Control group
Active

Outcomes
Primary outcome [1] 257558 0
preterm birth less than 37 weeks gestation ( assessed clinically ).
Timepoint [1] 257558 0
6 months
Secondary outcome [1] 262804 0
neonatal outcome ( neonatal death , RDS, intraventricular hemorrhage), assessed clinically & by cranial ultrasound.
Timepoint [1] 262804 0
6 months
Secondary outcome [2] 263988 0
drug side effects( headache, flushing, dyspepsia, nasal congestion and impaired vision, including photophobia and blurred vision. hypotension, myocardial infarction (heart attack), ventricular arrhythmias, stroke).

assessed clinically
Timepoint [2] 263988 0
6 months

Eligibility
Key inclusion criteria
-pregnant woman 18-24 weeks gestation , the gestational age was estimated by the date of the last menstrual period and confirmed by fetal growth measurement with ultrasound.
-Asymptomatic pregnant woman with a history of at least 1 previous preterm labour( between 20 and 36 weeks plus 6 days gestational age).
Minimum age
18 Years
Maximum age
40 Years
Sex
Females
Can healthy volunteers participate?
Yes
Key exclusion criteria
-multiple pregnancy
-premature rupture of membrane
-vaginal bleeding
-diabetes
-history of cardiovascular disease
-herniation of the membrane beyond the external cervical os
-congenital anomalies of the fetus
-any fetal or maternal contraindication to tocolysis(fetal asphyxia, intrauterine growth restriction, pre-ecalmpsia , clinical diagnosis of abruption placentae, placenta previa)
-active liver disease, renal impairment.
- recent stroke or heart attack.

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)
closed sealed envelope techniqe
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
random numebr table
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 4
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
1/06/2010
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
60
Accrual to date
Final
Recruitment outside Australia
Country [1] 2389 0
Egypt
State/province [1] 2389 0
Cairo

Funding & Sponsors
Funding source category [1] 256761 0
Self funded/Unfunded
Name [1] 256761 0
waleed elkhayat
Country [1] 256761 0
Egypt
Primary sponsor type
Individual
Name
waleed elkhayat
Address
5 Qura Ibn Shourik , Giza , Egypt , 12211
Country
Egypt
Secondary sponsor category [1] 256043 0
None
Name [1] 256043 0
Address [1] 256043 0
Country [1] 256043 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 258787 0
Cairo University hospital research ethics committee (REC)
Ethics committee address [1] 258787 0
Ethics committee country [1] 258787 0
Egypt
Date submitted for ethics approval [1] 258787 0
01/03/2010
Approval date [1] 258787 0
27/03/2010
Ethics approval number [1] 258787 0
17/2010

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 30675 0
Address 30675 0
Country 30675 0
Phone 30675 0
Fax 30675 0
Email 30675 0
Contact person for public queries
Name 13922 0
waleed mamdouh elkhayat
Address 13922 0
5 Qura Ibn shourik street off Mourad street ,Giza , Egypt
post code : 12211.
country : Egypt.
Country 13922 0
Egypt
Phone 13922 0
+20 0105135542
Fax 13922 0
Email 13922 0
[email protected]
Contact person for scientific queries
Name 4850 0
waleed mamdouh elkhayat
Address 4850 0
5 qura ibn shourik street , giza , 12211
Country 4850 0
Egypt
Phone 4850 0
+20 0105135542
Fax 4850 0
Email 4850 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.