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.: PACTR201705002278236 Date of Approval: 08/05/2017
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title Sildenafil citrate for the treatment of asymmetrical intrauterine growth restriction: A randomized controlled trial
Official scientific title Sildenafil citrate for the treatment of asymmetrical intrauterine growth restriction: A randomized controlled trial
Brief summary describing the background and objectives of the trial This study aims to assess the efficacy of adding sildenafil citrate to low dose aspirin in improving intra-uterine fetal growth and Doppler indices in pregnant women with asymmetrical IUGR and search for the earliest marker of improvement in fetal circulation.
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Intrauterine growth restriction,Pregnancy and Childbirth
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Treatment: Drugs
Anticipated trial start date 02/05/2017
Actual trial start date 08/05/2017
Anticipated date of last follow up 01/05/2017
Actual Last follow-up date 01/05/2017
Anticipated target sample size (number of participants) 80
Actual target sample size (number of participants) 80
Recruitment status Recruiting
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 Eighty opaque envelopes were numbered serially where in each envelope the corresponding letter which denotes the allocated group they are put according to computer generated randomization table then all envelopes were closed and put in one box. When the first patient had arrived the first envelope was opened and the patient was allocated according to the letter inside Sealed opaque envelopes Masking/blinding used Outcome Assessors,Participants
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group Sildenafil citrate 25mg/8hr. till termination of pregnancy In addition to low dose aspirin 81mg/day 40
Control Group Low dose aspirin 81mg/day till termination of pregnancy In addition to placepo/ 8hr. 40 Active-Treatment of Control Group
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
1.Pregnant Women diagnosed as IUGR. 2.Patients aged between 20¿40 years old. 3.Consenting to participate. 1.Severe preeclampsia with a diastolic blood pressure ¿ 110 mmHg on two occasions or systolic blood pressure ¿ 160 mmHg on two occasions and that, together with significant proteinuria (at least 1g/litre). 2.Fetus with reversed UA end diastolic flow. 3.Fetus diagnosed to have any congenital anomalies. 4.Diabetes mellitus with pregnancy. 5.Any contraindication for conservative management of IUGR as non-reassuring non-stress test (NST). 6.Patients with contraindication for the drugs given as gastric or duodenal ulcer, bleeding tendency and severe hypotension. 7.Smokers. 20 Year(s) 40 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 02/04/2017 Ain shams university, Faculty of Medicine, Research Ethics Committee
Ethics Committee Address
Street address City Postal code Country
Ahmed Lotfy El Sayed St.. Abbassia Cairo 11566 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Gain in fetal AC. Every week
Secondary Outcome Number of days between intervention and termination for fetal indication. No time point
Secondary Outcome Doppler changes in UA, UV and MCA and whether venous circulation or arterial circulation blood flow will be reversed first. ¿Every 2 weeks ¿If abnormal Doppler studies with normal NST 2 to 3 times per week
Secondary Outcome Maternal blood pressure changes. Daily
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Obstetric Outpatient Clinics of Ain shams University Maternity Hospital. Ahmed Lotfi El Sayed St., Abbassia Cairo 11566 Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
Ain Shams University Ahmed Lotfy El Sayed St.. Abbassia Cairo 11566 Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Ain Shams university Ahmed Lotfy El Sayed St., Abbassia Cairo 11566 Egypt University
COLLABORATORS
Name Street address City Postal code Country
Mohammed Abdallah Mohammed Elnabawy 23, Dr Al Nabawi Al Mohandes St., Seventh district, Nasr city Cairo 11765 Egypt
Ahmed Sherif Abdel Hamid Ahmed Lotfy El Sayed St., Abbassia Cairo 11566 Egypt
Haitham Torky As-Salam International Hospital, Corniche El Nile, Corniche El Maadi, El Maadi Cairo 11728 Egypt
Essam Eldien Mohamed Ammar Ahmed Lotfy El Sayed St., Abbassia Cairo 11566 Egypt
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Ahmed Abdel Hamid dr.m.elnabawy@hotmail.com +20224821485 Ahmed Lotfy El Sayed, Abbassia
City Postal code Country Position/Affiliation
Cairo 11566 Egypt Lecturer of Obstetrics and Gynecology
Role Name Email Phone Street address
Principal Investigator Mohammed Elnabawy dr.m.elnabawy@hotmail.com +20223514083 23, Al Nabawi Al Mohandes St., Nasr city
City Postal code Country Position/Affiliation
Cairo 11765 Egypt Resident of obstetrics and gynecology
Role Name Email Phone Street address
Scientific Enquiries Haitham Torky haithamtorky@yahoo.com +21985 As-Salam international hospital, Corniche El Maadi, El Maadi
City Postal code Country Position/Affiliation
Cairo 11728 Egypt Lecturer of Obstetrics and Gynecology
REPORTING
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Result URL Hyperlinks Link To Protocol
Result URL Hyperlinks
Changes to trial information