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.: PACTR201303000459148 Date of Approval: 19/11/2012
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title Prevention of excessive vaginal bleeding after vaginal using misoprostol
Official scientific title Prevention of Post Partum Haemorrhage: Role of self administered misoprostol
Brief summary describing the background and objectives of the trial Post Partum Haemorrhage(PPH) remains a leading cause of maternal deaths in Africa. Effective tools(oxytocics) for prevention of PPH are available, however not practical for use in low-income countries with many home births. Uganda DHS 2011 showed that 33% of the women deliver occur at home. WHO does not recommend community distribution of misoprostol for PPH prevention.the aim is to assess the effectiveness and safety of self administered misoprostol in prevention of PPH after home births.
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
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 17/12/2012
Actual trial start date 14/02/2013
Anticipated date of last follow up 31/05/2013
Actual Last follow-up date
Anticipated target sample size (number of participants) 2400
Actual target sample size (number of participants)
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
Crossover: all participants receive all interventions in different sequence during study Randomised step wedge cluster RCT Next cluster was determined by statistician at Makerere College of Health Sciences. Open-label(Masking Not Used)
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group Miso Arm 600mcg stat once sublingual 600mcg of misoprostol taken immediately after delivery of baby but before delivery of the placenta 1200 Historical
Control Group control (no drugs offered) N/A N/A This group of participants will not receive misoprostol, 1200
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
Attending antenatal during study period Pregnancy 28 weeks of amenorrhae and more Willing to be visited at home on the third day after baby by research assistant. Able and willing to give informed consent Resident within the study district Previous caesarian section Planned caesarian section delivery Blood pressure more than 140 mm of Hg systolic and 90 mm of Hg diastolic recorded twice at interval 1 hour Hemoglobin level less than 8 gms% Multiple pregnancy Known history of bronchial asthma Prior enrollment in this study during previous pregnancy High risk conditions including: diabetes, cardiac ailments, seizures, placenta praevia or anticipated breech delivery. Absence of fetal heart sounds History of known drug allergies Episodes of ante partum bleeding during the current pregnancy 14 Year(s) 50 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 13/04/2012 Uganda National Council for Science and Technology
Ethics Committee Address
Street address City Postal code Country
Plot 6 Kimera Road Kampala Uganda
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome more than 500ml of blood loss after vaginal births One hour after baby's births
Primary Outcome pre-delivery Hemoglobin change measured between 3rd and 5th days post delivery.
Secondary Outcome Transfer to health facility or higher health facility within 30 days after delivery.
Secondary Outcome Blood transfusion Within 30 days after delivery
Secondary Outcome Fluid replacement within 24 hours after delivery of the baby
Secondary Outcome Surgical Treatment of PPH Third day after delivery
Secondary Outcome maternal Death 42 days after baby is delivered
Secondary Outcome Fever Within 4 hours after delivery
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Sekyiyunga Health centre III Mpigi District Kampala Uganda
Buwama Health Centre III Mpigi district Kampala Uganda
Kampigirisa Health Centre III Mpigi District Kampala Uganda
Mpigi Health centre Mpigi District Kampala Uganda
Butoolo Health centre III Mpigi District Kampala Uganda
Muduma Health Centre III Mpigi Distric Kampala Uganda
FUNDING SOURCES
Name of source Street address City Postal code Country
Welcome Trust (THRiVE) Makerere University Kampala Uganda
Makerere University Box 7072 Kampala
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Makerere University Mulago Hill Kampala Uganda University
COLLABORATORS
Name Street address City Postal code Country
London School of Hygiene and Tropical Medicine Keppel Street London United Kingdom
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Sam Ononge ononge2006@yahoo.com 256772486301 Makerere University College of Health Sciences, Mulago Hill
City Postal code Country Position/Affiliation
Kampala Uganda
Role Name Email Phone Street address
Public Enquiries sam Ononge ononge2006@yahoo.com 256772486301 Mulago Hil hill
City Postal code Country Position/Affiliation
kampala Uganda
Role Name Email Phone Street address
Scientific Enquiries Florence Mirembe flomir2002@yahoo.com 256772467655 Makerere University College of Health Sciences, Mulago Hill
City Postal code Country Position/Affiliation
Kampala Uganda Supervisor
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