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.: PACTR202208851795894 Date of Approval: 01/08/2022
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title Efficacy of Intravenous Acetaminophen as Labour Analgesic Effect on Pregnancy outcomes, and Level of Acceptability in O.L.A Hospital Ibadan.
Official scientific title Randomised Trial on: Efficacy of Intravenous Acetaminophen as Labour Analgesic, Effect on Pregnancy outcomes and Level of Acceptability in O.L.A Hospital, Ibadan.
Brief summary describing the background and objectives of the trial Background: Due to the undesirable maternal and neonatal side effects of opioid analgesics and less ready availability and affordability of epidural analgesia in resource poor settings such as Nigeria, the search has been on for a safe, efficacious, cheap and readily available labour analgesia. Objectives: To determine the efficacy, safety and acceptability of 900mg of intravenous acetaminophen as an intrapartum analgesic.
Type of trial RCT
Acronym (If the trial has an acronym then please provide) RCT
Disease(s) or condition(s) being studied Pregnancy and Childbirth
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Relieve of labour pain.
Anticipated trial start date 01/08/2021
Actual trial start date 01/08/2021
Anticipated date of last follow up 31/12/2021
Actual Last follow-up date 25/02/2022
Anticipated target sample size (number of participants) 162
Actual target sample size (number of participants) 162
Recruitment status Completed
Publication URL http://www/pactr.org/Login
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,Outcome Assessors,Participants
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group Intravenous acetaminophen diluted to 20 ml with normal saline 900mg given once. 15 minutes 900mg of intravenous acetaminophen diluted to 20ml with normal saline was given slowly over 15 minutes. 81
Control Group Normal saline 20ml 15 minutes 20ml of intravenous Normal saline was given slowly over 15 minutes. 81 Placebo
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
Low-risk parturients Established labour with cervical dilatation of at least 4cm and not more than 6cm Singleton viable fetus Cephalic presentation Spontaneous onset of labour at term; Medical disorders in pregnancy Scarred uterus Patient on induction of labour Physically challenged patient Psychiatric disorders in pregnancy Malpresentation Antepartum haemorrhage Intrapartum bleeding Oligohydramnios Polyhydramnios Prelabour rupture ofmembranes Intrauterine infection History of allergy to acetaminophen Any obstetric indication for caesarean delivery. (o.) Unbooked parturients. Adult: 19 Year-44 Year 20 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 21/02/2020 Our Lady of Apostles Catholic Hospital Ethics Committee
Ethics Committee Address
Street address City Postal code Country
O.L.A Hospital, Oluyoro, Oke-Ofa Ibadan 200212 Nigeria
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Efficacy of 900mg intravenous acetaminophen based on labour pain scores measured using the numeric rating scale. 0 minute, 15 minutes, 30 minutes, 1 hour, 2 hours, 3 hours, 4 hours, 5 hours, 6 hours.
Secondary Outcome Maternal side effects 0 minutes, 15 minutes, 30 minutes, 1 hour, 2 hours, 3 hours, 4 hours, 5 hours, 6 hours
Secondary Outcome Neonatal outcomes 5 hours, 6 hours, 7 hours, 8 hours, 9 hours, 10 hours
Secondary Outcome Level of acceptability 24 hours
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Our Lady of Apostles Catholic Hospital O.L.A Hospital, Oluyoro, Oke Ofa Ibadan 200212 Nigeria
FUNDING SOURCES
Name of source Street address City Postal code Country
Mobolaji Philip Oyeyiola No. 1 Oladosu Street, Felele, Challenge Ibadan. 200252 Nigeria
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Mobolaji Philip Oyeyiola Amazing House, Oladosu street, Felele, Challenge Ibadan. 200254 Nigeria Individual
COLLABORATORS
Name Street address City Postal code Country
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Mobolaji Oyeyiola mobolaji.oyeyiola@yahoo.com +2348036415199 No. 1 Oladosu street, Felele, Challenge
City Postal code Country Position/Affiliation
Ibadan 200254 Nigeria Resident Doctor
Role Name Email Phone Street address
Public Enquiries Ayo Arowojolu ayo_arowojolu@yahoo.com +2348033979478 Arowojolu street
City Postal code Country Position/Affiliation
Ibadan 200252 Nigeria Supervisor
Role Name Email Phone Street address
Scientific Enquiries Olayinka Ogunbode jamchose@yahoo.co.uk +2348036415199 UCH, Queen Elizabeth Road, Oritamefa
City Postal code Country Position/Affiliation
Ibadan 200211 Nigeria Supervisor
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes Individual de-identified participant data collected during the trial will be shared. Individual participant data that underlie the reports in this article after de-identification such as text, tables, figures and appendices will also be shared. Analytic Code,Clinical Study Report,Informed Consent Form,Statistical Analysis Plan,Study Protocol The data will be made available starting within 3 months and ending up to 5 years following article publication. Anyone who wishes to access the data.
URL Results Available Results Summary Result Posting Date First Journal Publication Date
https://www.pactr.org/Login 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