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.: PACTR201407000825227 Date of Approval: 13/05/2014
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title DOUBLE BLIND RANDOMISED CONTROLLED TRIAL COMPARING MISOPROSTOL AND OXYTOCIN IN MANAGEMENT OF THIRD STAGE OF LABOUR IN A NIGERIAN HOSPITAL
Official scientific title DOUBLE BLIND RANDOMISED CONTROLLED TRIAL COMPARING MISOPROSTOL AND OXYTOCIN IN MANAGEMENT OF THIRD STAGE OF LABOUR IN A NIGERIAN HOSPITAL
Brief summary describing the background and objectives of the trial Obstetric haemorrhage causes 127,000 deaths annually worldwide, and is the world¿s leading cause of maternal mortality. Nearly all of these deaths are due to postpartum haemorrhages (PPH) and are preventable. The contribution of PPH to maternal death is disproportionately higher in developing countries, particularly in rural settings with limited infrastructure and availability of skilled delivery attendants and uterotonic agents for management of PPH. To prevent PPH, evidence strongly supports the use of active management of third stage of labour (AMTSL) with a skilled birth attendant. The evaluation of individual components of the active management of the third stage of labour has focused on the uterotonic medications such as ergometrine, oxytocin, syntometrine and misoprostol. The use of ergometrine is discouraged because of its side effects namely increase in blood pressure, nausea and vomiting, while oxytocin and misoprostol are effective for management of third stage of labour with acceptable side effects. The major drawbacks to oxytocin usage are that it is administered parenterally and requires cool storage. However, in developing countries there is inadequate manpower to administer parenteral drugs and poor electricity power supply, while misoprostol is a tablet that can be administered orally, sublingually, vaginally and rectally: and is stable at ambient temperature. WHO regards oxytocin as the gold standard for prevention of post-partum haemorrhage and misoprostol as an alternative in low-resource settings. The specific objectives are to compare the postpartum blood loss and occurrence of postpartum haemorrhage between the group that used oral misoprostol and those that used intramuscular oxytocin for active management of third stage of labour, to compare the need for extra oxytocics and the side effects of oral misoprosol and intramuscular oxytocin for active management of the third stage of labour.
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied PPH
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Prevention
Anticipated trial start date 01/01/2013
Actual trial start date 07/01/2013
Anticipated date of last follow up 11/06/2013
Actual Last follow-up date 28/06/2013
Anticipated target sample size (number of participants) 0
Actual target sample size (number of participants) 200
Recruitment status Completed
Publication URL
Secondary Ids Issuing authority/Trial register
NHREC/02/05/2010 Nigerian health research and ethical committee
ERC 1129 1/06/2012 Ethics and research committee (ERC) UITH, Ilorin, Nigeria
NAFDAC/ RA/CT/TM/Vol3. Protocol No 1232. National Agency for Food and Drug Administration and Control
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 Simple randomisation using a randomisation table created by a computer software program Sealed opaque envelopes Masking/blinding used
Parallel: different groups receive different interventions at same time during study Randomised Simple randomisation using a randomisation table created by a computer software program Sealed opaque envelopes Masking/blinding used Care giver/Provider,Outcome Assessors,Participants
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group Oral Misoprostol 600microgram once Once Oral misoprostol was given to the participant within one minute of delivery 100
Control Group intramuscular oxytocin 10i.u once once intramuscular oxytocin was given to participants within one minute of delivery 100
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
singleton pregnancy term pregnancy spontaneous active phase labour spontaneous vaginal delivery grandmultiparity multiple pregnancies uterine fibroid co-existing with pregnancy polyhydramnios preeclampsia/eclampsia, hypertension cardiac disease asthma placenta praevia abruption placenta previous postpartum haemorrhage patients who had oxytocin and/or misoprostol in labour other than in the third stage of labour patients being planned for instrumental vaginal delivery patients with prolonged rupture of membrane patients with anaemia (Hb < 10g/dl) 15 Year(s) 42 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 12/06/2012 University of Ilorin Teaching Hospital(UITH) Ethical Research Committeettee
Ethics Committee Address
Street address City Postal code Country
Old jebba road oke-ose, Ilorin Ilorin PMB 1459, Ilorin, Nigeria
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 Ethics and research commitee, University of Ilorin Teaching Hospitals, Ilorin
Ethics Committee Address
Street address City Postal code Country
Old jebba road Ilorin 1459 Nigeria
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Postpartum blood loss With one hour of delivery
Primary Outcome Postpartum blood loss With one hour of delivery
Secondary Outcome change in maternal haemoglobin concentration At admission in active phase labour 24hour after delivery
Secondary Outcome Duration of third stage of labour Delivery of baby Delivery of placenta
Secondary Outcome Use of additional uterotonics Blood loss in excess of 500ml Vomiting Flabby uterus
Secondary Outcome Side effects such as shivering, vomiting, diarrhoea, pyexia(>38degree celsius)0 As it occurs
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
University of Ilorin Teaching Hospital, Ilorin, Kwara state, Nigeria Old Jebba road Ilorin 1459 Nigeria
FUNDING SOURCES
Name of source Street address City Postal code Country
University of Ilorin Teaching Hospital Old Jebba road Ilorin 1459 Nigeria
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Dr. Musa Abdulkarim Omoyine Hospital road, Federal medical centre lokoja Nigeria Hospital
Primary Sponsor University of Ilorin Teaching Hospital Old Jebba road Ilorin 1459 Nigeria Hospital
COLLABORATORS
Name Street address City Postal code Country
Zolon Healthcare Limited 37, Osolo Way, Isolo, Oshodi Isolo, Lagos, Nigeria. Lagos Nigeria
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Abdulkarim Omoyine doctormusaak2004@yahoo.com +2348062872400 Hospital road, federal medical centre, lokoja
City Postal code Country Position/Affiliation
lokoja Nigeria Consultant
Role Name Email Phone Street address
Public Enquiries Abdulkarim Omoyine doctormusaak2004@yahoo.com +2348062872400 Hospital road
City Postal code Country Position/Affiliation
Lokoja 1001 Nigeria Consultant
Role Name Email Phone Street address
Scientific Enquiries Munirdeen Aderemi munirijaiya@yahoo.com +2348033801565; +2348057068400 Old jebba road
City Postal code Country Position/Affiliation
Ilorin 1459 Nigeria Consultant
REPORTING
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