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.: PACTR201707002436264 Date of Approval: 16/07/2017
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title THE IMPACT OF BLISTER PACKAGING IRON AND FOLATE ON ADHRENCE TO MEDICATION AND HEMOGLOBIN LEVELS AMONG PREGNANT WOMEN AT MULAGO HOSPITAL ANTENATAL CLIN
Official scientific title THE IMPACT OF BLISTER PACKAGING IRON AND FOLATE ON ADHRENCE TO MEDICATION AND HEMOGLOBIN LEVELS AMONG PREGNANT WOMEN AT MULAGO HOSPITAL ANTENATAL CLINIC: A RANDOMISED CONTROLLED TRIAL
Brief summary describing the background and objectives of the trial No trials have been done to assess the impact of changes in packaging of Iron-Folic Acid (IFA) on adherence to treatment in Uganda. To determine the effect of blister-Packaging IFA on compliance and haemoglobin levels of women attending Mulago Hospital Antenatal clinic Specific objectives: 1) To compare the effect of blister pre-packaging to loose IFA pills on compliance to iron intake 2) To determine the improvement/ change in Hb concentration following pre-packaged IFA supplementation. 3) To assess the acceptability and ease of use of the of the IFA in blister packaging by the health service providers and mothers in the antenatal clinic. 4) To assess the acceptability of the pre-packaging of IFA by the pregnant women.
Type of trial RCT
Acronym (If the trial has an acronym then please provide) The IFAd Trial
Disease(s) or condition(s) being studied ANAEMIA IRON AND FOLIC ACID,Circulatory System,Nutritional, Metabolic, Endocrine
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Prevention
Anticipated trial start date 01/12/2015
Actual trial start date 01/04/2016
Anticipated date of last follow up 31/12/2016
Actual Last follow-up date 16/01/2017
Anticipated target sample size (number of participants) 950
Actual target sample size (number of participants) 950
Recruitment status Completed
Publication URL NOT YET
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 Using a blocked randomisation sampling technique, computer random numbers were generated by a statistician in blocks of 6. The statistician produced allocation list of the study arms Sealed opaque envelopes Open-label(Masking Not Used)
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Control Group LOOSE PACKS OF IFA 30 PILLS 30 DAYS BLISTER PACKING OF IFA 475 Dose Comparison
Experimental Group BLISTER PACKAGED IFA 30 PILLS 30 DAYS BLISTER PACKAGING. Does it affect adherence 475
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
a) Consenting pregnant women attending Mulago antenatal clinic at 28 weeks or less with no signs of anaemia with Congestive Cardiac Failure. b) Consenting prescribing and dispensing Health Workers in the antenatal clinic. Pregnant women with complications like signs Of anaemia in congestive cardiac failure, sickle cell anemia 15 Year(s) 49 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 28/08/2015 MULAGO RESEARCH AND ETHICS COMMITTEE
Ethics Committee Address
Street address City Postal code Country
MULAGO HILL KAMPALA 7051 Uganda
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 10/11/2015 Uganda National Council for Science and Technology-UNCST
Ethics Committee Address
Street address City Postal code Country
Plot 6 Kimera Road, Ntinda Kampala +256 Uganda
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome ADHERENCE TO THE IFA SUPPLEMENTATION 4 WEEKS 8 WEEKS
Secondary Outcome Change in haemoglobin concentration between the arms 4TH WEEK 8TH WEEK
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
MULAGO HOSPITAL MULAGO HILL, KAMPALA, UGANDA KAMPALA 7051 Uganda
FUNDING SOURCES
Name of source Street address City Postal code Country
SPRING Martyr's Way, Minister's Village, Ntinda, Kampala KAMPALA Plot 36/37A Uganda
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor JOSAPHAT BYAMUGISHA MULAGO HILL, KAMPALA, UGANDA KAMPALA 7051 Uganda Hospital
COLLABORATORS
Name Street address City Postal code Country
MAKERERE UNIVERSITY COLLEGE OF HEALTH SCIENCES MULAGO HILL, KAMPALA, UGANDA KAMPALA 7062 Uganda
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator JOSAPHAT BYAMUGISHA jbyamugisha@gmail.com +256772580330 MULAGO HILL
City Postal code Country Position/Affiliation
KAMPALA 7072 Uganda PRINCIPAL INVESTIGATOR
Role Name Email Phone Street address
Public Enquiries IMELDA NAMAGEMBE imeldanamagembe@gmail.com +256772404902 MULAGO HILL
City Postal code Country Position/Affiliation
KAMPALA 7051 Uganda GYNAECOLOGIST AT MULAGO HOSPITAL
Role Name Email Phone Street address
Scientific Enquiries SAM ONONGE sam1ononge@gmail.com +256772486301 MULAGO HILL
City Postal code Country Position/Affiliation
KAMPALA 7062 Uganda GYNAECOLOGIST/EPIDEMIOLOGIST AT MAKERERE 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
Result Upload 1: Result Upload 2: Result Upload 3: Result Upload 4: Result Upload 5:
Result URL Hyperlinks Link To Protocol
Result URL Hyperlinks
Changes to trial information
Section Name Field Name Date Reason Old Value Updated Value
Trial Information Trial phase 05/07/2018 PACTR UPDATE Not Applicable
Section Name Field Name Date Reason Old Value Updated Value
Study Design Intervention assignment 17/07/2017 Had been missed out One group receives loose IFA ie Iron and Folic Acid Another group receives Blister packaged IFA Parallel: different groups receive different interventions at same time during study
Section Name Field Name Date Reason Old Value Updated Value
Intervention InterventionTypeID 17/07/2017 Had been mis labelled as intervention Control group Control group
Section Name Field Name Date Reason Old Value Updated Value
Trial Information Disease(s) 05/07/2018 PACTR UPDATE Other Circulatory System, Nutritional, Metabolic, Endocrine, Other