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.: PACTR201403000779211 Date of Approval: 04/03/2014
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title Effect of Hyoscine butylbromide on the rate of cervical dilatation in labour.
Official scientific title Effect of hyoscine butylbromide on the rate of cervical dilatation in active phase of labour: a randomized control trial
Brief summary describing the background and objectives of the trial The quest for drugs to shorten labour, make it as natural as possible, reduce pain and offer a favourable outcome for the mother and baby is on the increase.Hyoscine butylbromide is known for its antispasmodic action and has been in use for over five decades, reports about its effectiveness in the labour process are however conflicting. The objective of this study is to determine the effect of hyoscine butyl bromide on the duration and safety of labour.
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Pregnancy and Childbirth,The labour process and progress
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Treatment: Drugs
Anticipated trial start date 10/02/2014
Actual trial start date 08/03/2014
Anticipated date of last follow up 31/05/2014
Actual Last follow-up date 23/12/2014
Anticipated target sample size (number of participants) 160
Actual target sample size (number of participants)
Recruitment status Recruiting
Publication URL
Secondary Ids Issuing authority/Trial register
NHREC/27/02/2009a Ethical Committee- OAUTHC. Ile-Ife.
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 Permuted block randomisation, Block size is 10 Sealed opaque envelopes Masking/blinding used
Parallel: different groups receive different interventions at same time during study Randomised Permuted block randomisation, Block size is 10 Sealed opaque envelopes Masking/blinding used
Parallel: different groups receive different interventions at same time during study Randomised Permuted block randomisation, Block size is 10 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 Hyoscine butyl bromide 20mg intravenously, given at once. Given once only 20mg of Hyoscine butyl bromide,as 2ml injection drawn into a 2ml syringe and put in a sealed brown envelope. 80
Control Group Normal Saline 2ml intravenously Once when cervical dilation reaches 4cm 80 Placebo
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
Parturients aged 18-35 years Singleton pregnancies Term pregnancies( between 37 completed weeks and 41 weeks) Active phase of labour. Post-term or preterm pregnancies Abnormal fetal lie or presentation Complicated pregnancies Previous uterine scar Pre-labour rupture of membrane Glaucoma Myasthena gravis Obstructive uropathy Paralytic pileus Allergy to Hyoscine or excipients 18 Year(s) 35 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 03/12/2012 Ethics and Research Committee (ERC) OAUTHC.
Ethics Committee Address
Street address City Postal code Country
Ilesa road Ile-Ife 234 Nigeria
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome duration of first stage of labour From attainment of 4cm cervical dilatation to full cervical dilatation.
Secondary Outcome duration of second stage of labour From attainment of full cervical dilatation to the delivery of the baby.
Secondary Outcome duration of third stage of labour From delivery of the baby to the delivery of the placenta
Secondary Outcome occurence of primary postpartum haemorrhage From delivery of baby to 2 hours post partum
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Department of Obstetrics and Gynaecology. Obafemi Awolowo University Teaching Hospitals Complex - OAUTHC. Ilesa road Ile-Ife 234 Nigeria
FUNDING SOURCES
Name of source Street address City Postal code Country
John Imaralu Ilesa road Ile-Ife 234 Nigeria
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor John Imaralu Ilesa road Ile-Ife 234 Nigeria Hospital
Primary Sponsor The postgraduate training committee OAUTHC. Ilesa road Ile-Ife Nigeria University
Primary Sponsor National postgraduate medical college of Nigeria Km 26, Lagos- Badagry expressway,Ijanikin Lagos Nigeria University
COLLABORATORS
Name Street address City Postal code Country
John Imaralu Ilesa road Ile-Ife 234 Nigeria
Dr O.M. Loto. Department of Obstetrics and Gynaecology. Wesley Guild. Hospital. Bolorunduro road Ilesa 234 Nigeria
Dr O.O.Badejoko : Department of Obstetrics and Gynecology. Wesley Guild Hospital. Bolorunduro road Ilesa 234 Nigeria
Prof O Kuti Department of Obstetrics and Gynaecology. OAUTHC, Ilsa Rd Ile-Ife Nigeria
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator John Imaralu imaralujohn@yahoo.co.uk 08067957419 Ilesa Road
City Postal code Country Position/Affiliation
Ile-Ife 234 Nigeria FWACS
Role Name Email Phone Street address
Public Enquiries Olusegun Badejoko oobmed@yahoo.com 08034919210 Bolorunduro road
City Postal code Country Position/Affiliation
Ilesa 234 Nigeria FMCOG,FWACS. Consultant Obstetrician and Gynaecologist
Role Name Email Phone Street address
Scientific Enquiries JO Imarulu Imaralujohn@yahoo.co.uk 2348067857419 Department of Obstetrics and Gynecology. OAUTHC. ILEA road
City Postal code Country Position/Affiliation
Ile-Ife Nigeria
REPORTING
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Result URL Hyperlinks
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