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.: PACTR202112821475292 Date of Approval: 22/12/2021
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title AGADAGA Trial
Official scientific title A COMPARISON OF THE DURATION OF CERVICAL RIPENING WITH USE OF VAGINAL MISOPROSTOL PLUS HYOSCINE-N-BUTYLBROMIDE (HBB) TO VAGINAL MISOPROSTOL ALONE: A DOUBLE-BLIND RANDOMISED CONTROLLED TRIAL
Brief summary describing the background and objectives of the trial Vaginal misoprostol is widely used for cervical ripening but has been associated with significant maternal and fetal complications irrespective of the dose and there are maternal concerns regarding multiple vaginal examinations. Hyoscine-N-Butylbromide (HBB) has been shown to be beneficial in reducing the duration of first stage of labour; but with very limited information on its role in cervical ripening. The aim of the trial is to compare the duration of cervical ripening with the use of vaginal Misoprostol plus HBB with vaginal Misoprostol alone, among antenatal women in Federal Medical Centre Asaba.
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 Treatment: Drugs
Anticipated trial start date 15/12/2021
Actual trial start date 15/12/2021
Anticipated date of last follow up 08/06/2022
Actual Last follow-up date 20/10/2022
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
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,Outcome Assessors,Participants
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Control Group Placebo 1ml of water for injection every 6 hours to a maximum of 4 doses every 6 hours to a maximum of 4 doses 1ml of the intervention, either the hyoscine or water for injection, will be administered at the commencement of the cervical ripening with vaginal misoprostol and repeated every 6 hours if needed. 63 Placebo
Experimental Group IM Hyoscine 20mg IM Hyoscine every 6 hours to a maximum of 4 doses Addition of 20mg IM Hyoscine to the process of cervical ripening 63
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
All consenting participants Singleton pregnancy Cephalic presentation Intact fetal membrane Gestational age greater or equal to 37 weeks Absence of spontaneous uterine contraction Bishop score less than or equal to 5 Reactive non stress test Participant's refusal Multiple pregnancy Abnormal fetal presentation Ruptured fetal membrane Gestational age less than 37 weeks Presence of spontaneous uterine contraction Fetal congenital abnormality Intrauterine fetal death Previous uterine surgery Grandmultiparity Contraindication to vaginal delivery Abnormal non stress test Bishop score greater or equal to 6 Any known allergy to misoprostol and/or 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 26/08/2021 Research and ethics committee of federal medical centre Asaba
Ethics Committee Address
Street address City Postal code Country
Nnebisi road, Asaba, Delta state Asaba 320213 Nigeria
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome The cervical ripening time Time interval between the onset of cervical ripening and a favourable Bishop score
Secondary Outcome Induction-delivery interval, oxytocin requirement, rate of vaginal and operative deliveries, Apgar scores at 1 and 5 minutes, admission into the neonatal unit, complications of cervical ripening and side effects hyoscine and/or misoprostol Hourly vital signs check and Apgar score at birth
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Federal medical centre Nnebisi road Asaba 320213 Nigeria
FUNDING SOURCES
Name of source Street address City Postal code Country
D. Agadaga Ifeakachukwu Destiny 10 Usonia Asaba 320233 Nigeria
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Dr. Agadaga Ifeakachukwu Destiny 10 Usonia Asaba 320233 Nigeria Individual
COLLABORATORS
Name Street address City Postal code Country
Prof. Peter Ndidi Ebeigbe Ugbowo road Benin Nigeria
Dr. Oyefara Babatunde Okpanam road Asaba Nigeria
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Ifeakachukwu Agadaga agadest@gmail.com +2348068844035 10 Usonia
City Postal code Country Position/Affiliation
Asaba 230233 Nigeria Senior Registrar
Role Name Email Phone Street address
Public Enquiries Ifeakachukwu Agadaga agadest@gmail.com +2348068844035 10 Usonia
City Postal code Country Position/Affiliation
Asaba 230233 Nigeria Senior Registrar
Role Name Email Phone Street address
Scientific Enquiries Peter Ebeigbe peternebeigbe@gmail.com +2348035649146 off Ugbowo road
City Postal code Country Position/Affiliation
Benin Nigeria Professor of Obstetrics and Gynaecology and Consultant Obstetrician and Gynaecologist
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes All of the individual participant data collected during the trial, after deidentification. Informed Consent Form,Statistical Analysis Plan,Study Protocol September 2022 to December 2022 Open
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