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.: PACTR201710002662398 Date of Approval: 03/10/2017
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title Sildenafil Citrate versus Nifedipine in Women with Recurrent Miscarriages: A Pilot Study
Official scientific title Sildenafil Citrate versus Nifedipine in Women with Recurrent Miscarriages: A Pilot Study
Brief summary describing the background and objectives of the trial To evaluate the effect of sildenafil citrate versus nifedipine on improving the uterine arterial blood flow and endometrial thickness in patients suffering from recurrent unexplained miscarriage.
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Obstetrics and Gynecology,Pregnancy and Childbirth,recurrent abortion
Sub-Disease(s) or condition(s) being studied Fertility-female
Purpose of the trial Treatment: Drugs
Anticipated trial start date 02/10/2016
Actual trial start date 03/10/2017
Anticipated date of last follow up 03/11/2017
Actual Last follow-up date 03/11/2017
Anticipated target sample size (number of participants) 60
Actual target sample size (number of participants) 60
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
Factorial: participants randomly allocated to either no, one, some or all interventions simultaneously Randomised The trial allocation sequence of enrolled women for both groups developed via using a random number table in a statistical textbook. Sequentially numbered sealed opaque envelops was used to hide the generated allocation sequence. Randomization codes were placed in sequentially numbered, opaque, sealed envelopes to be opened at time of enrollment by an investigator who prepared the study drug and had no further involvement with the patient's care. Masking/blinding used Outcome Assessors,Participants
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group Nifedipine 10 mg every 12 hours from the third day of the cycle till the 25th day. women received 10 mg nifedipine orally every 12 hours from the third day of the cycle till the 25th day. 20 Placebo
Experimental Group sildenafil 25 mg orally even 6 hours from the third day of the cycle till the 25th day. women received sildenafil citrate 25 mg orally every 6 hours from the third day of the cycle till the 25th day. 20 Placebo
Control Group control nothing 20
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
Unexplained recurrent miscarriages of three times or more fathered by the same husband (proved by laboratory documents). Having no living children. range (18 ¿ 35) years. 4. Having had regular menstrual cycles in the three months preceding enrollment. 5. Using neither hormonal contraception nor an intrauterine device. Women having anatomical uterine abnormalities such as septate uterus, 3rd degree RVF or pathological uterine abnormalities such as myoma or endometrioma on transvaginal ultrasonography. 2. Systemic diseases that may affect hemodynamic indices. 3. A history of oophorectomy or tubal ligation. 4. The presence of side effects or contraindications to both nifedipine and sildenafil citrate. 5. The occurrence of pregnancy during the first study cycle. 18 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 05/09/2016 Menoufia university Hospital local ethical committee
Ethics Committee Address
Street address City Postal code Country
Yassin Abd Elghafar Street shibin elkom 30225 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome uterine artery blood flow changes and endometrial thickness following the intake of medications. performed 2 times, before and after intervention on monthly basis by the same operator
Secondary Outcome medication side effects. During intake of medication
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
faculty of medicine, Menoufia University Yassin Abd Elghafar Street shibin elkom menoufia. Egypt 30225 Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
Menoufia university hospital Yassin Abd Elghafar Street shibin elkom menoufia. Egypt 30225 Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Menoufia university hospital Yassin Abd Elghafar Street shibin elkom menoufia. Egypt 30225 Egypt University
COLLABORATORS
Name Street address City Postal code Country
Nabih I Elkhouly Yassin Abd Elghafar Street shibin elkom menoufia. Egypt Egypt
Tarek Elsayed Yassin Abd Elghafar Street shibin elkom menoufia. Egypt Egypt
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Nabih Elkhouly nabih.elkhouly@yahoo.com 01060868443 Shibin elkom.egypt
City Postal code Country Position/Affiliation
shibin elkom Egypt obstetrics and gynecology department, faculty of medicine, Menoufia University. Egypt
Role Name Email Phone Street address
Public Enquiries Nabih Elkhouly nabih.elkhouly@yahoo.com 01060868443 Yassin Abd Elghafar Street
City Postal code Country Position/Affiliation
shibin elkom menoufia Egypt obstetrics and gynecology department, faculty of medicine Menoufia university
Role Name Email Phone Street address
Scientific Enquiries Nabih Elkhouly nabih.elkhouly@yahoo.com 01060868443 Yassin Abd Elghafar Street
City Postal code Country Position/Affiliation
shibin elkom menoufia Egypt obstetrics and gynecology department, faculty of medicine Menoufia university
REPORTING
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