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.: PACTR201803003150307 Date of Registration: 26/02/2018
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title Nifedipine and Nicorandil in treatment of severe pre-eclampsia
Official scientific title Mechanisms of nifedipine, nicorandil and coenzyme q 10 in the treatment of patients with severe preeclampsia
Brief summary describing the background and objectives of the trial Nifedipine is a dihydropyridine calcium channel blocker that is mainly used for the treatment of cardiovascular disorders. Its use in treatment of severe preeclampsia has been widely explored . Nicorandil, a nicotinamide nitrate derivative (2-nicotinamide ethyl nitrate), is a nitric oxide (NO) donor and potassium channel opener that acts as coronary and peripheral vasodilator and reduces both cardiac preload and afterload, thereby it is used for the treatment of angina pectoris. However, according to literature review, its use in treatment of preeclampsia hasn`t yet been studied. Coenzyme Q10 (CoQ10) is an essential component of oxidative phosphorylation in the mitochondria, a potent antioxidant and cell membrane stabilizer. CoQ10 is involved in many diseases such as cancer, cardiovascular and muscle diseases. Many studies have reported that pregnant women with established preeclampsia have significantly lower plasma levels of CoQ10 compared with healthy pregnant and non-pregnant women.
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Pregnancy and Childbirth,Severe pre-eclampsia
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Treatment: Drugs
Anticipated trial start date 26/02/2018
Actual trial start date 26/02/2018
Anticipated date of last follow up 27/02/2019
Actual Last follow-up date
Anticipated target sample size (number of participants) 140
Actual target sample size (number of participants)
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 computer generated numbers Sealed opaque envelopes Masking/blinding used Participants
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Control Group nifedipine tablets 10 mg capsules three times a day till fetal delivery oral capsules 35 Active-Treatment of Control Group
Experimental Group Nicorandil tablets 20 mg tablets twice a day till fetal delivery oral tablets 35
Control Group nifedipine tablets plus coenzyme q10 10 mg cap threetimes a day and 100 mg softgels two times a day till fetal deliver oral capsules and softgels 35 Active-Treatment of Control Group
Experimental Group nicorandil tablets and coenzyme q10 softgels 20mg tablets two times a day and 100mg softgels two times a day till fetal delivery oral tblets and softgels 35
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
1) Greater than 30 weeks of gestation. 2) Uncomplicated severe preeclampsia on the basis of : a- severe hypertension [systolic blood pressure (SBP) ¿160 mmHg and/or diastolic blood pressure (DBP) ¿110 mmHg]. b- clinically significant proteinuria (0.3 g or more of protein in 24-h urine collection). 1) Imminence of eclampsia. 2) Chronic hypertension or other concomitant chronic diseases 20 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 07/08/2017 Faculty of medicine ethical committee
Ethics Committee Address
Street address City Postal code Country
Faculty of medicine street, azarita alexandria 21526 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome control of blood pressure fetal delivery
Primary Outcome changes in doppler ultrasound evaluation of the umbilical artery after 48 hours of treatment
Secondary Outcome changes in Serum endothelial nitric oxide synthase, antioxidant enzyme, superoxide dismutase blood level. ¿ The biomarker of oxidative stress, malondialdehyde (MDA) serum level. ¿ Platelet aggregation after 48 hours of treatment
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Shatby Maternity university hospital Army road Alexandria 21526 Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
University of alexandria Army road Alexandria 21526 Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor University of alexandria army road Alexandria 21526 Egypt University
COLLABORATORS
Name Street address City Postal code Country
Tamer M Abdel Dayem 18 pharanaa street, Azarita Alexandria 21526 Egypt
Gehad Mahmoud khamis 18 pharanaa street, Azarita Alexandria 21526 Egypt
Tarek Abdel-Zaher Karkor 18 pharanaa street, Azarita alexandria 21526 Egypt
Maged Mishel Matta 18 pharanaa street, Azarita Alexandria 21526 Egypt
Eman Ibrahim Anwar 18 pharanaa street, Azarita Alexandria 21526 Egypt
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Tamer M Abdel Dayem tmdaeim@gmail.com 00201226720766 18 pharanaa street, Azarita
City Postal code Country Position/Affiliation
Alexandria 21526 Egypt Department of obsterics and gynecology, University of Alexandria
Role Name Email Phone Street address
Public Enquiries Tamer M Dayem tmdaeim@gmail.com 00201226720766 18 pharanaa street, Azarita
City Postal code Country Position/Affiliation
Alexandria 21526 Egypt Department of Obstetrics and gynecology, university of alexandria
Role Name Email Phone Street address
Scientific Enquiries Tamer M Dayem tmdaeim@gmail.com 00201226720766 18 pharanaa street, Azarita
City Postal code Country Position/Affiliation
Alexandria 21526 Egypt Department of Obstetrics and gynecology, university of alexandria
REPORTING
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