Please note that the copy function is not enabled for this field.
If you wish to
modify
existing outcomes, please copy and paste the current outcome text into the Update field.
LOGIN
CREATE ACCOUNT
LOGIN
CREATE ACCOUNT
MY TRIALS
REGISTER TRIAL
FAQs
HINTS AND TIPS
DEFINITIONS
Trial Review
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
Download to PDF
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
Query!
Scientific title
Investigation Into The Efficacy And Safety Of Sildenafil Versus Natural Progesterone For prevention Of Preterm Labour
A randomized controlled study
Query!
Secondary ID [1]
251647
0
None
Query!
Universal Trial Number (UTN)
Query!
Trial acronym
Query!
Linked study record
Query!
Health condition
Health condition(s) or problem(s) studied:
prevention Of Preterm Labour
256494
0
Query!
preterm labour
258676
0
Query!
Condition category
Condition code
Reproductive Health and Childbirth
256663
256663
0
0
Query!
Other reproductive health and childbirth disorders
Query!
Reproductive Health and Childbirth
257250
257250
0
0
Query!
Antenatal care
Query!
Intervention/exposure
Study type
Interventional
Query!
Description of intervention(s) / exposure
sildenafil 100 mg vaginally every 12 hours , for 10 weeks prior to scheduled labour
Query!
Intervention code [1]
255778
0
Treatment: Drugs
Query!
Comparator / control treatment
progesterone 100 mg tablet vaginally every 12 hours , for 10 weeks prior to scheduled labour
Query!
Control group
Active
Query!
Outcomes
Primary outcome [1]
257558
0
preterm birth less than 37 weeks gestation ( assessed clinically ).
Query!
Assessment method [1]
257558
0
Query!
Timepoint [1]
257558
0
6 months
Query!
Secondary outcome [1]
262804
0
neonatal outcome ( neonatal death , RDS, intraventricular hemorrhage), assessed clinically & by cranial ultrasound.
Query!
Assessment method [1]
262804
0
Query!
Timepoint [1]
262804
0
6 months
Query!
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
Query!
Assessment method [2]
263988
0
Query!
Timepoint [2]
263988
0
6 months
Query!
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).
Query!
Minimum age
18
Years
Query!
Query!
Maximum age
40
Years
Query!
Query!
Sex
Females
Query!
Can healthy volunteers participate?
Yes
Query!
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.
Query!
Study design
Purpose of the study
Prevention
Query!
Allocation to intervention
Randomised controlled trial
Query!
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
closed sealed envelope techniqe
Query!
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
random numebr table
Query!
Masking / blinding
Blinded (masking used)
Query!
Who is / are masked / blinded?
Query!
Query!
Query!
Query!
Intervention assignment
Parallel
Query!
Other design features
Query!
Phase
Phase 4
Query!
Type of endpoint/s
Safety/efficacy
Query!
Statistical methods / analysis
Query!
Recruitment
Recruitment status
Recruiting
Query!
Date of first participant enrolment
Anticipated
1/06/2010
Query!
Actual
Query!
Date of last participant enrolment
Anticipated
Query!
Actual
Query!
Date of last data collection
Anticipated
Query!
Actual
Query!
Sample size
Target
60
Query!
Accrual to date
Query!
Final
Query!
Recruitment outside Australia
Country [1]
2389
0
Egypt
Query!
State/province [1]
2389
0
Cairo
Query!
Funding & Sponsors
Funding source category [1]
256761
0
Self funded/Unfunded
Query!
Name [1]
256761
0
waleed elkhayat
Query!
Address [1]
256761
0
5 Qura Ibn Shourik , Giza , Egypt , 12211
Query!
Country [1]
256761
0
Egypt
Query!
Primary sponsor type
Individual
Query!
Name
waleed elkhayat
Query!
Address
5 Qura Ibn Shourik , Giza , Egypt , 12211
Query!
Country
Egypt
Query!
Secondary sponsor category [1]
256043
0
None
Query!
Name [1]
256043
0
Query!
Address [1]
256043
0
Query!
Country [1]
256043
0
Query!
Ethics approval
Ethics application status
Approved
Query!
Ethics committee name [1]
258787
0
Cairo University hospital research ethics committee (REC)
Query!
Ethics committee address [1]
258787
0
cairo University , faculty of medicine , Egypt
kasr Elini street , 11451
Query!
Ethics committee country [1]
258787
0
Egypt
Query!
Date submitted for ethics approval [1]
258787
0
01/03/2010
Query!
Approval date [1]
258787
0
27/03/2010
Query!
Ethics approval number [1]
258787
0
17/2010
Query!
Summary
Brief summary
to use sildenafil to prevent preterm labour with high effeicacy & most safe , as it is an excellent muscle relaxant.
Query!
Trial website
Query!
Trial related presentations / publications
Query!
Public notes
Query!
Contacts
Principal investigator
Name
30675
0
Query!
Address
30675
0
Query!
Country
30675
0
Query!
Phone
30675
0
Query!
Fax
30675
0
Query!
Email
30675
0
Query!
Contact person for public queries
Name
13922
0
waleed mamdouh elkhayat
Query!
Address
13922
0
5 Qura Ibn shourik street off Mourad street ,Giza , Egypt
post code : 12211.
country : Egypt.
Query!
Country
13922
0
Egypt
Query!
Phone
13922
0
+20 0105135542
Query!
Fax
13922
0
Query!
Email
13922
0
[email protected]
Query!
Contact person for scientific queries
Name
4850
0
waleed mamdouh elkhayat
Query!
Address
4850
0
5 qura ibn shourik street , giza , 12211
Query!
Country
4850
0
Egypt
Query!
Phone
4850
0
+20 0105135542
Query!
Fax
4850
0
Query!
Email
4850
0
[email protected]
Query!
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.
Download to PDF