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.: PACTR201811685061976 Date of Approval: 14/11/2018
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title IV HYOSICINE BUTYL BROMIDE WITH VAGINAL MISOPROSTOL FOR CERVICAL RIPENING
Official scientific title EFFICACY AND SAFETY OF COMBINING IV HYOSICINE BUTYL BROMIDE WITH VAGINAL MISOPROSTOL VERSUS VAGINAL MISOPROSTOL ALONE FOR CERVICAL RIPENING: A RANDOMISED CLINICAL TRIAL
Brief summary describing the background and objectives of the trial The purpose of this study is to compare the efficacy and safety of combining intravenous Hyoscine Butyl Bromide with vaginal misoprostol with vaginal misoprostol alone in the reduction of the duration to cervical ripening in Ibadan, Oyo State, Nigeria.
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Obstetrics and Gynecology
Sub-Disease(s) or condition(s) being studied CERVICAL RIPENING
Purpose of the trial Addition of intravenous hyoscine for cervical ripening
Anticipated trial start date 30/09/2019
Actual trial start date 02/10/2019
Anticipated date of last follow up 01/08/2019
Actual Last follow-up date
Anticipated target sample size (number of participants) 92
Actual target sample size (number of participants) 92
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
Factorial: participants randomly allocated to either no, one, some or all interventions simultaneously Randomised Simple randomization using a randomization table created by a computer software program Allocation was determined by the holder of the sequence who is situated off site Masking/blinding used Care giver/Provider
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group IV hyoscine 40mg IV hyoscine 2 doses Intervention was addition of IV hyoscine to the process of cervical ripening 46
Control Group PLACEBO 2mls of water for injection X maximum of 2 doses over at 12hrs 2mls of the intervention either the hyoscine or water for injection drug will be given at the commencement of cervical ripening with misoprostol and the 2nd dose will be given if needed 6hrs later 46 Placebo
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
-Women booked for IOL -Singleton pregnancies -Co-morbid medical illness -Multiple pregnancies -Allergies to hyoscine Adolescent: 13 Year-18 Year,Adult: 19 Year-44 Year,Middle Aged: 45 Year(s)-64 Year(s) 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 01/11/2018 Institute for Advanced Medical Research and Training College of Medicine University of Ibadan Nigeria
Ethics Committee Address
Street address City Postal code Country
Elizabeth Road Ibadan Oyo State Ibadan 200284 Nigeria
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome The duration to achieve a favorable bishop score Time interval between the first dose of IV hyoscine and first dose of vaginal misoprostol and a favorable bishop score
Secondary Outcome Rates of caesarian and vaginal delivery, APGAR score at birth, maternal urinary output and side effects like nausea, dry mouth, maternal or fetal tachycardia. Urinary output hrly after commencing cervical ripening, APGAR score at birth
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
University College Hospital Ibadan Oyo State Nigeria Elizabeth Road Ibadan Oyo State Ibadan 200284 Nigeria
FUNDING SOURCES
Name of source Street address City Postal code Country
Ayeni Ayokunle University College Hospital Ibadan IBADAN 20000 Nigeria
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor DR. AYOKUNLE O. AYENI IBADAN Nigeria Hospital
COLLABORATORS
Name Street address City Postal code Country
Dr T.A.O Oluwasola and Dr C.O Aimakhu IBADAN Nigeria
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator AYOKUNLE AYENI, informdprince@yahoo.com 08068066450
City Postal code Country Position/Affiliation
IBADAN Nigeria
Role Name Email Phone Street address
Public Enquiries Sesan Oluwasola sesanoluwasola@yahoo.com 08033384064
City Postal code Country Position/Affiliation
IBADAN Nigeria Consultant Obs and Gyne
Role Name Email Phone Street address
Scientific Enquiries Sesan Oluwasola sesanoluwasola@yahoo.com 08033384064
City Postal code Country Position/Affiliation
IBADAN Nigeria Consultant Obs and Gyne
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