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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: www.pactr.org

Trial no.: PACTR201302000466116 Date registered: 2012/11/27
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
Purpose of the trial Prevention
Anticipated trial start date 2011-08-01
Actual trial start date 2011-09-05
Anticipated date of last follow up 2012-02-29
Actual date of last follow up 2012-04-30
Anticipated target sample size (number of participants) 4500   
Actual target sample size (number of participants) 4375   
Recruitment status Closed to recruitment: follow up complete
Secondary Ids Issuing authority/Trial register Links to Secondary ID
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
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

ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Min age Max 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 Years 52 Years 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 2010/10/19 MAKERERE UNIVERSITY FACULTY OF MEDICINE RESEARCH AND ETHICS COMMITTEE
Ethics Committee Address
Street address City Postal code Country
OLD MULAGO HILL KAMPALA +256 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 2011/06/29 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

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
MITYANA DISTRICT N/A KAMPALA AS CAPITAL CITY OF UGANDA +256 Uganda
MUBENDE DISTRICT N/A KAMPALA +256

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 Company

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 Fax
Principal Investigator Dr JOSAPHAT BYAMUGISHA jbyamugisha@gmail.com +256772580330 n/a
Street address City Postal code Country Position / Affiliation
Old Mulago Hill KAMPALA +256 Uganda HEAD OF DEPT
Role Name Email Phone Fax
Scientific Enquiries Prof JOHN LULE lulej@yahoo.co.uk +256772425104 n/a
Street address City Postal code Country Position / Affiliation
Old Mulago Hill KAMPALA +256 Uganda In charge of research protocol
Role Name Email Phone Fax
Public Enquiries Dr WILSON MUBIRU mubiruwh@yahoo.co.uk +256 772670556 N/A
Street address City Postal code Country Position / Affiliation
N/A KAMPALA +256 DIRECTOR OF HEALTH SERVICES MUBENDE DISTRICT
Role Name Email Phone Fax
Public Enquiries Dr FRANCIS KIGONGO Kigongo.francis@yahoo.com +256 772434792 N/A
Street address City Postal code Country Position / Affiliation
N/A KAMPALA +256 Uganda DIRECTOR OF HEALTH SERVICES MITYANA DISTRICT
Role Name Email Phone Fax
Scientific Enquiries Dr OTHMAN KAKAIRE kakaireothman@hotmail.com +256 772514616 N/A
Street address City Postal code Country Position / Affiliation
Old Mulago Hill KAMPALA +256 Uganda Co-Investigator
Role Name Email Phone Fax
Scientific Enquiries Dr OTHMAN KAKAIRE kakaireothman@hotmail.com +256 772514616 N/A
Street address City Postal code Country Position / Affiliation
Old Mulago Hill KAMPALA +256 Uganda Co-Investigator