Trial Review

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The ANZCTR now automatically displays published trial results and simplifies the addition of trial documents such as unpublished protocols and statistical analysis plans.

These enhancements will offer a more comprehensive view of trials, regardless of whether their results are positive, negative, or inconclusive.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
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
cairo University , faculty of medicine , Egypt
kasr Elini street , 11451
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
to use sildenafil to prevent preterm labour with high effeicacy & most safe , as it is an excellent muscle relaxant.
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.