Pan African Clinical Trials Registry
South African Medical Research Council, South African Cochrane Centre
PO Box 19070, Tygerberg, 7505, South Africa
Telephone: +27 21 938 0506 / +27 21 938 0834 Fax: +27 21 938 0836
Email: pactradmin@mrc.ac.za Website: pactr.samrc.ac.za
Trial no.: PACTR201501000895269 Date of Approval: 29/09/2014
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title sildenafil citrate effect on IUGR
Official scientific title sildenafil citrate effect on placental blood flow
Brief summary describing the background and objectives of the trial sildenafil citrate effect on placental blood flow & Doppler indices in Intrauterine fetal growth restriction
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied IUGR,Pregnancy and Childbirth
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Treatment: Drugs
Anticipated trial start date 01/12/2013
Actual trial start date 01/01/2014
Anticipated date of last follow up 02/01/2014
Actual Last follow-up date 02/01/2014
Anticipated target sample size (number of participants) 40
Actual target sample size (number of participants) 40
Recruitment status Completed
Publication URL
Secondary Ids Issuing authority/Trial register
STUDY DESIGN
Intervention assignment Allocation to intervention If randomised, describe how the allocation sequence was generated Describe how the allocation sequence/code was concealed from the person allocating the participants to the intervention arms Masking If masking / blinding was used
Parallel: different groups receive different interventions at same time during study Randomised Simple randomisation using a randomisation table from a statistics book Allocation was determined by the holder of the sequence who is situated off site Masking/blinding used Participants
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group sildenafil citrate 25-50 mg 2 hours tablets 22
Control Group placebo 25-50 mg 2 hours tablets 22 Placebo
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
pregnant in IUGR over 28 weeks gestation any age any parity any medical disorder congenital anomalies chromosomal anomalies 19 Year(s) 35 Year(s) Female
ETHICS APPROVAL
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
Yes 01/08/2014 menoufia university
Ethics Committee Address
Street address City Postal code Country
yassen abdel ghaffar st sheben el kom 32511 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome improve placental blood flow after 2hours
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
menoufia university yassen abdel ghaffar st sheben el kom 32511 Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
pfizer information centre Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor faculty of medicine menoufia university yassen abdel ghaffar st sheben el kom 32511 Egypt University
COLLABORATORS
Name Street address City Postal code Country
dr/ mohammed adel 15 waheeb doos st el mehatta square cairo Egypt
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator mohammed maher mohamaher2010@yahoo.com 00201065465354 12 maxeem st
City Postal code Country Position/Affiliation
sheben el kom 32511 Egypt prof menoufia university
Role Name Email Phone Street address
Public Enquiries said saleh dr.said27@yahoo.com 00201005245483 22 el bahr st
City Postal code Country Position/Affiliation
sheben el kom 32511 Egypt lecturer menoufia university
Role Name Email Phone Street address
Scientific Enquiries ahmed samir ahmeddoc2003@yahoo.co.uk 00201065465354 9 el sabahy st quesna
City Postal code Country Position/Affiliation
menoufia 24350 Egypt physician
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
URL Results Available Results Summary Result Posting Date First Journal Publication Date
Result Upload 1: Result Upload 2: Result Upload 3: Result Upload 4: Result Upload 5:
Result URL Hyperlinks Link To Protocol
Result URL Hyperlinks
Changes to trial information