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.: PACTR201602001468135 Date of Approval: 13/02/2016
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title Intravenous Ferrous Sucrose Versus Oral Ferrous Sulphate in Treatment of Postpartum Iron Difficiency Anaemia: A Randomized Controlled Clinical Trial
Official scientific title Intravenous Ferrous Sucrose Versus Oral Ferrous Sulphate in Treatment of Postpartum Iron Difficiency Anaemia: A Randomized Controlled Clinical Trial
Brief summary describing the background and objectives of the trial To evaluate effectiveness and safety of intravenous Ferrous Sucrose and oral Ferrous Sulphate in Treatment of Postpartum Iron Difficiency anaemia
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied ,Obstetrics and Gynecology
Sub-Disease(s) or condition(s) being studied Fertility-female
Purpose of the trial Treatment: Drugs
Anticipated trial start date 13/02/2016
Actual trial start date 23/03/2016
Anticipated date of last follow up 23/03/2016
Actual Last follow-up date 23/03/2016
Anticipated target sample size (number of participants) 100
Actual target sample size (number of participants) 100
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 computer randomization tables sealed envelope Open-label(Masking Not Used)
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group intravenous Iron Sucrose 300-600 mg on three doses on alternate days 3 doses intravenous Iron Sucrose 50 Active-Treatment of Control Group
Control Group oral Ferrous Sulphate 150 mg twice daily for 6 weeks 6 weeks oral Ferrous sulphate 50 Active-Treatment of Control Group
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
Postpartum Iron Difficiency Anaemia with haemoglobin <9g/dL and serum ferritin <15microgram/l Iron intolerance-asthma-seizures-renal disease-hepatic disease 18 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 02/02/2016 hospital local ethical commoittee
Ethics Committee Address
Street address City Postal code Country
yassin abd elghafar shibin elkom 32465 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome haemoglobi-ferritin-mean corpuscular haemoglobin concentration -haematocrit-red blood indices Days 0,5,14,40 after start of treatment
Secondary Outcome adverse effects of oral and intravenous Iron 5-14-40 days of treatment
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
department of obstetrics and gynecology.faculty of medicinemenoufia university yassin abd elghafar street shibin elkom 32465 Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
menoufia university yassin abd elghafar street shibin elkom 32465 Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor menoufia university yassin abd elghafar street shibin elkom 32465 Egypt University
COLLABORATORS
Name Street address City Postal code Country
nabih elkhouly yassin abd elghafar street shibin elkom 32465 Egypt
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator nabih elkhouly nabih.elkhouly@yahoo.com 01060868443 yassin abd elghafar
City Postal code Country Position/Affiliation
shibin elkom 32465 Egypt lecturer of obstetrics and gynecology.faculty of medicine.menoufia university
Role Name Email Phone Street address
Public Enquiries nabih elkhouly nabih.elkhouly@yahoo.com 01060868443 yassin abd elghafar
City Postal code Country Position/Affiliation
shibin elkom 32645 Egypt lecturer of 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
City Postal code Country Position/Affiliation
shibin elkom 32645 Egypt lecturer of obstetrics and gynecology department.Faculty of medicine.menoufia university
REPORTING
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