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.: PACTR201505001107182 Date of Approval: 16/04/2015
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title 200µg versus 400µg sublingual misoprostol in prevention of postpartum haemorrhage
Official scientific title COMPARATIVE EFFECTIVENESS OF 200µG VERSUS 400µG OF SUBLINGUAL MISOPROSTOL FOR THE PREVENTION OF PRIMARY POSTPARTUM HAEMORRHAGE: A RANDOMISED CONTROLLED TRIAL
Brief summary describing the background and objectives of the trial Postpartum haemorrhage (PPH) has remained the leading cause of maternal mortality in our environment. Several uterotonics have been employed in the active management of third stage of labour (AMTSL). Oxytocin, though preferred, has been negatively affected by problems of storage since it is unstable in high temperature and requires cold chain storage while misoprostol, a prostaglandin E1 analogue, has been suggested as an alternative to oxytocin since it could act as an effective uterotonic agent. However, misoprostol has been associated with several side effects which are dose-dependent. Earlier reports have suggested that for prevention of PPH, 200µg may be of similar effectiveness when compared with 400µg or 600µg of misoprostol but with reduced incidence of side effects. We set out to compare the effectiveness of 200µg versus 400µg misoprostol given sublingually for PPH prevention in the third stage of labor as well as the incidence of side effects using both doses.
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied POSTPARTUM HAEMORRHAGE,Pregnancy and Childbirth
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Prevention
Anticipated trial start date 21/04/2011
Actual trial start date 10/01/2011
Anticipated date of last follow up 02/07/2011
Actual Last follow-up date 10/02/2012
Anticipated target sample size (number of participants) 0
Actual target sample size (number of participants) 124
Recruitment status Completed
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 Randomisation was done using the ¿blocked randomization method¿ in which an independent statistician generated sets of four random numbers per box ¿ each box containing four separate random allocations in opaque, sealed envelopes. Equal numbers of subjects were assigned to each treatment arm The medication was contained in sealed opaque envelopes and was administered by an independent person who was neither involved in allocation concealment nor in measurement of blood loss Masking/blinding used
Parallel: different groups receive different interventions at same time during study Randomised Randomisation was done using the ¿blocked randomization method¿ in which an independent statistician generated sets of four random numbers per box ¿ each box containing four separate random allocations in opaque, sealed envelopes. Equal numbers of subjects were assigned to each treatment arm The medication was contained in sealed opaque envelopes and was administered by an independent person who was neither involved in allocation concealment nor in measurement of blood loss Masking/blinding used Outcome Assessors
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group sublingual misoprostol 200ug once all participants in this group received 200ug sublingual misoprostol alongside the standard treatment for active management of the third stage of labour 62
Control Group sublingual misoprostol 400ug once all participants in this group received 400ug sublingual misoprostol alongside the standard treatment for active management of the third stage of labour 62 Dose Comparison
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
Women at term with singleton pregnancy in active phase labour, or women undergoing induction of labour and with anticipated spontaneous vaginal delivery contraindications for use of misoprostol such as asthma paturients undergoing caesarean section presence of coagulation disorders pre-eclampsia and other hypertensive diseases in pregnancy anaemia conditions requiring prophylactic oxytocin infusion after delivery such as grandmultiparity, multiple pregnancy, polyhydramnios and coexisiting uterine fibroids previous history of postpartum haemorrhage history of anteparturm haemorrhage Refusal or withdrawal of consent 18 Year(s) 45 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 21/04/2011 UI/UCH Ethics Committee
Ethics Committee Address
Street address City Postal code Country
Institute for Advanced Medical Research and Trainning, College of Medicine, University of Ibadan. Ibadan PMB 5016 Nigeria
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome amount of postpartum blood loss at delivery of the baby and up till one hour after delivery
Primary Outcome presence of notable side effects of misoprostol within one hour of delivery of the baby and up till 24 hours after delivery
Primary Outcome occurence of postpartum haemorrhage within one hour of delivery of the baby and up till 24 hours after delivery
Secondary Outcome change in packed cell volume 24 hours after delivery of the baby
Secondary Outcome need for blood transfusion up till 24 hours after delivery
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Labour Ward Complex University College Hospital Ibadan PMB 5016 Nigeria
FUNDING SOURCES
Name of source Street address City Postal code Country
Dr I.A Ugwu and other authors Department of Obstettrics and Gynaecology, University College Hospital, Ibadan PMB 5016 Nigeria
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Dr I.A Ugwu Department of Obstettrics and Gynaecology, University College Hospital, Ibadan 200281 Nigeria Hospital
Primary Sponsor Dr Timothy A. Oluwasola Department of Obstetrics and Gynaecology, University College Hospital, Ibadan 200281 Nigeria Hospital
Secondary Sponsor Dr O.O Enabor Department of Obstettrics and Gynaecology, University College Hospital, Ibadan 200281 Nigeria Hospital
Secondary Sponsor Anayochukwu-Ugwu N.N Department of Haematology, University College Hospital, Ibadan 200281 Nigeria Hospital
Secondary Sponsor Dr A.B Adeyemi Department of Obstetrics and Gynaecology, University College Hospital, Ibadan 200281 Nigeria Hospital
Secondary Sponsor Prof O.O Olayemi Department of Obstetrics and Gynaecology, University College Hospital, Ibadan 200281 Nigeria Hospital
COLLABORATORS
Name Street address City Postal code Country
Anayochukwu-Ugwu N.N Department of Haematology, University College Hospital, Ibadan 200281 Nigeria
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Innocent Ugwu anayochukwui@yahoo.com +2348028160976 Deaprtment of Obstetrics & Gynaecology, University College Hospital
City Postal code Country Position/Affiliation
Ibadan 200281 Nigeria Obstetrician/Gynaecologist
Role Name Email Phone Street address
Public Enquiries Timothy Oluwasola sesanoluwasola@yahoo.com +2348033384064 Deaprtment of Obstetrics & Gynaecology, University College Hospital
City Postal code Country Position/Affiliation
Ibadan 200281 Nigeria Lecturer / Consultant Obstetrician & Gynaecologist
Role Name Email Phone Street address
Scientific Enquiries Timothy Oluwasola sesanoluwasola@yahoo.com +2348033384064 Deaprtment of Obstetrics & Gynaecology, University College Hospital
City Postal code Country Position/Affiliation
Ibadan 200281 Nigeria Lecturer / Consultant Obstetrician & Gynaecologist
REPORTING
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URL Results Available Results Summary Result Posting Date First Journal Publication Date
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Result URL Hyperlinks Link To Protocol
Result URL Hyperlinks
Changes to trial information