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.: PACTR201802002759357 Date of Approval: 13/11/2017
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title Vitamin C versus placebo in prevention of preeclampsia in high risk patients: a randomized controlled trial
Official scientific title Vitamin C versus placebo in prevention of preeclampsia in high risk patients: a randomized controlled tria
Brief summary describing the background and objectives of the trial Two groups of patients with high-risk of preeclampsia one was given vitamin C and the other placebo starting from 12 weeks then were followed until delivery. Maternal and neonatal data were collected.
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied preeclampsia,Pregnancy and Childbirth
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Prevention
Anticipated trial start date 15/11/2017
Actual trial start date 15/11/2017
Anticipated date of last follow up 30/06/2018
Actual Last follow-up date 30/06/2018
Anticipated target sample size (number of participants) 940
Actual target sample size (number of participants) 940
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 randomization using a randomized table created by a computer software program sealed opaque envelope Masking/blinding used Care giver/Provider,Participants
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group vitamin C group 1000 mg daily from 12 weeks until delivery vitamin C effervescent 1000 mg oral daily 470
Control Group placebo group methyle cellulose 1000 mg from 12 weeks until delivery placebo effervescent 470
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
pregnant patients with: Essential hypertension Renal disease past or family history of preeclampsia Any other risk factors for preeclampsia except diabetes mellitus Hypersensitvity to treatment Diabetes mellitus 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 13/11/2017 Air-Force specialized hospital
Ethics Committee Address
Street address City Postal code Country
Elteseen (ninety) street Cairo not available Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome development of preeclampsia from 20 weeks gestational age until delivery
Secondary Outcome Fetal outcome Fetal birth weight, fetal complications as admission to neonatal intensive care unit, iatrogenic preterm delivery
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Air-Force Specialized hospital Elteseen (ninety street) Cairo not available Egypt
October 6th University Hospital central axis Giza not available Egypt
Al-Azhar University hospital Downtown Cairo not available Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
Al-Azhar university Hospital Downtown Cairo not available Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Air-Force specialized hospital Elteseen (ninety street) Cairo not available Egypt Hospital
Primary Sponsor Al-Azhar university Hospital Downtown Cairo not available Egypt University
COLLABORATORS
Name Street address City Postal code Country
October 6th University central axis Giza not available Egypt
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Haitham Torky haithamtorky@yahoo.com +201001230161 Central axis
City Postal code Country Position/Affiliation
6th October city-Cairo Not available Egypt October 6th University
Role Name Email Phone Street address
Public Enquiries Haitham Torky Haithamtorky@yahoo.com +201001230161 Central axis
City Postal code Country Position/Affiliation
6th October city-Cairo Not available Egypt October 6th University
Role Name Email Phone Street address
Scientific Enquiries Haitham Torky Haithamtorky@yahoo.com +201001230161 Central axis
City Postal code Country Position/Affiliation
6th October city-Cairo Not available Egypt October 6th University
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
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Result URL Hyperlinks Link To Protocol
Result URL Hyperlinks
Changes to trial information