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.: PACTR201808146688942 Date of Approval: 08/08/2018
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title Hyoscine in labour
Official scientific title EFFECT OF HYOSCINE -N-BUTYLBROMIDE ON THE DURATION OF FIRST STAGE OF LABOUR IN NULLIPAROUS WOMEN ATTENDING OLABISI ONABANJO UNIVERSITY TEACHING HOSPITAL, SAGAMU: A RANDOMIZED CONTROLLED TRIAL
Brief summary describing the background and objectives of the trial BACKGROUND: Prolonged labour is still a common problem in our environment and its sequelae remain an important cause of maternal and foetal morbidity and mortality. Obstetricians are still exploring ways of shortening the duration of labour so that the incidence of prolonged labour is reduced. Hyoscine -N-Butylbromide, an antimuscarinic agent has been used by some obstetricians to shorten the duration of first stage of labour, but controversies still exist regarding its effectiveness. OBJECTIVE: To assess the effectiveness of Hyoscine-N- Butylbromide on the duration of the first stage of labour in nulliparous women.
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Pregnancy and Childbirth
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Prevention
Anticipated trial start date 01/01/2018
Actual trial start date 01/02/2018
Anticipated date of last follow up 07/08/2018
Actual Last follow-up date 31/08/2018
Anticipated target sample size (number of participants) 126
Actual target sample size (number of participants) 126
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 Simple randomization using a randomization table created by a computer software program Sealed opaque envelopes Masking/blinding used Care giver/Provider,Participants
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group Randomised controlled trial 20mg single dose 2ml of 20mg Hyoscine butylbromide (an antispasmodic agent) 63
Control Group Aqua 2ml of aqua single dose 2mls of aqua 63 Placebo
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
Nulliparity • Singleton foetus at a gestational age between 37- 42 weeks • Cephalic presentation • Spontaneous active phase of labour with cervical dilatation 4cm • Booked Patients History of allergy to Buscopan • Previous uterine scar • Malpresentation • Twin gestation • Prior prolonged rupture of membrane • Antepartum haemorrhage • Contracted pelvis • Pre-eclampsia and other hypertensive diseases in labour • Other medical conditions. Adolescent: 13 Year-18 Year,Adult: 19 Year-44 Year,Middle Aged: 45 Year(s)-64 Year(s) 16 Year(s) 65 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 30/01/2017 Olabisi Onabanjo Uiversity Teaching Hospital Health Research Ethics Committee
Ethics Committee Address
Street address City Postal code Country
Hospital Road sagamu 23401 Nigeria
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome To Determine the duration of first stage (active phase) of labour among parturients administered with Hyoscine-N- Butylbromide (Injection Buscopan) and compare with suitably matched controls administered with placebo. 1 hour after enrolment and end of first stage of labour
Secondary Outcome To compare the foetal outcome of parturients administered with Hyoscine-N- Butylbromide (Injection Buscopan) and suitably matched controls administered with placebo. 1 hour after enrollment and at delivery
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Olabisi Onabanjo University Teaching Hospital Hospital Road Sagamu 23401 Nigeria
FUNDING SOURCES
Name of source Street address City Postal code Country
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Akiseku Adeniyi Hospital Road Sagamu Nigeria Individual
COLLABORATORS
Name Street address City Postal code Country
Prof suleOdu Hospital Road Sagamu Nigeria
Dr Jagun E Hospital road sagamu Nigeria
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Adeniyi Akiseku niyikepler@yahoo.com 2348036103799 Hospital Road
City Postal code Country Position/Affiliation
sagamu Nigeria Senior Registrar
Role Name Email Phone Street address
Public Enquiries Adeniyi Akiseku niyikepler@yahoo.com 2348036103799 Hospital Road
City Postal code Country Position/Affiliation
sagamu Nigeria Senior registrar
Role Name Email Phone Street address
Scientific Enquiries Edward Jagun jocorban@yahoo.com 2348025328996 hospital road
City Postal code Country Position/Affiliation
sagamu Nigeria Senior lecturer and consultant
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Undecided
URL Results Available Results Summary Result Posting Date First Journal Publication Date
No
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