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.: PACTR201302000466116 Date of Approval: 27/11/2012
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title OPMIS
Official scientific title Open Randomized Cluster Clinical Trial of Community Distribution of Oral Misoprostol for Prevention of Post Partum Haemorrhage In Uganda
Brief summary describing the background and objectives of the trial More studies have been recommended by WHO to provide evidence of the acceptability and safety of community distribution of the drug for prevention and control of PPH. This study was designed to generate country-specific evidence of acceptability, feasibility, and level of access of Misoprostol to show the most appropriate form of community distribution of Misoprostol before changing policy and public sector programs. To explore perceptions and Community based distribution of Misoprostol.
Type of trial RCT
Acronym (If the trial has an acronym then please provide) OPMIS
Disease(s) or condition(s) being studied POST PARTUM HAEMORRHAGE,Pregnancy and Childbirth
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Prevention
Anticipated trial start date 01/08/2011
Actual trial start date 05/09/2011
Anticipated date of last follow up 29/02/2012
Actual Last follow-up date 30/04/2012
Anticipated target sample size (number of participants) 4500
Actual target sample size (number of participants) 4375
Recruitment status Completed
Publication URL
Secondary Ids Issuing authority/Trial register
HS 1029 UGANDA NATIONAL COUNCIL FOR SCIENCE AND TECHNOLOGY
#REC REF 2010-112 MAKERERE UNIVERSITY FACULTY OF MEDICINE RESEARCH AND ETHICS COMMITTEE
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 BY CLUSTERS AND THESE WERE PARISHES N/A Open-label(Masking Not Used)
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group USING VILLAGE HEALTH TEAMS AND ALONG CLEAN DELIVERY KITS N/A ALL DURATION OF STUDY 3175 Active-Treatment of Control Group
Control Group Health facility distribution of Misoprostol 600 micrograms of Misoprostol orally after delivery of the baby Statim dose (once only) The health facility distribution of Misoprostol to pregnant mothers at 28 or more weeks of gestation 1200 Active-Treatment of Control Group
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
At the individual level, the study included pregnant women at 28 weeks (7months) or more of gestation determined from LNMP or clinical examination, had to be residents of Mubende or Mityana districts, above 18 years of age and anticipating uncomplicated vaginal delivery. Only women who gave informed written consent were included in the study. At the cluster level, the study included parishes projected to have at least 100 births within the study period. The study excluded pregnant women with diagnosed multiple pregnancy, chronic medical conditions and reported hypersensitivity to prostaglandins or inability to give informed consent (e.g. mental health illness), as assessed by the recruiting research assistant 18 Year(s) 52 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 29/06/2011 UGANDA NATIONAL COUNCIL FOR SCIENCE AND TECHNOLOGY
Ethics Committee Address
Street address City Postal code Country
Plot 6, Kimera Road, Ntinda KAMPALA P.O.Box 6884 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 19/10/2010 MAKERERE UNIVERSITY FACULTY OF MEDICINE RESEARCH AND ETHICS COMMITTEE
Ethics Committee Address
Street address City Postal code Country
OLD MULAGO HILL KAMPALA +256 Uganda
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome The proportion (Percentages) of women receiving misoprostol who correctly self-administered the tablets after delivery in the three arms. AT DELIVERY
Secondary Outcome Acceptability of community distribution of misoprostol AT THE BEGINNING, MIDWAY AND END OF STUDY
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
MUBENDE DISTRICT N/A KAMPALA +256
MITYANA DISTRICT N/A KAMPALA AS CAPITAL CITY OF UGANDA +256 Uganda
FUNDING SOURCES
Name of source Street address City Postal code Country
PACE PLOT 2 IBIS VALE KAMPALA +256 Uganda
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor PACE PLOT 2 IBIS VALE KAMPALA +256 Uganda Commercial Sector/Industry
COLLABORATORS
Name Street address City Postal code Country
MITYANA N/A N/A N/A Uganda
MUBENDE DISTRICT N/A KAMPALA +256 Uganda
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator JOSAPHAT BYAMUGISHA jbyamugisha@gmail.com +256772580330 Old Mulago Hill
City Postal code Country Position/Affiliation
KAMPALA +256 Uganda HEAD OF DEPT
Role Name Email Phone Street address
Public Enquiries WILSON MUBIRU mubiruwh@yahoo.co.uk +256 772670556 N/A
City Postal code Country Position/Affiliation
KAMPALA +256 DIRECTOR OF HEALTH SERVICES MUBENDE DISTRICT
Role Name Email Phone Street address
Public Enquiries FRANCIS KIGONGO Kigongo.francis@yahoo.com +256 772434792 N/A
City Postal code Country Position/Affiliation
KAMPALA +256 Uganda DIRECTOR OF HEALTH SERVICES MITYANA DISTRICT
Role Name Email Phone Street address
Scientific Enquiries JOHN LULE lulej@yahoo.co.uk +256772425104 Old Mulago Hill
City Postal code Country Position/Affiliation
KAMPALA +256 Uganda In charge of research protocol
Role Name Email Phone Street address
Scientific Enquiries OTHMAN KAKAIRE kakaireothman@hotmail.com +256 772514616 Old Mulago Hill
City Postal code Country Position/Affiliation
KAMPALA +256 Uganda Co-Investigator
Role Name Email Phone Street address
Scientific Enquiries OTHMAN KAKAIRE kakaireothman@hotmail.com +256 772514616 Old Mulago Hill
City Postal code Country Position/Affiliation
KAMPALA +256 Uganda Co-Investigator
REPORTING
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Result URL Hyperlinks Link To Protocol
Result URL Hyperlinks
Changes to trial information