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.: PACTR202308835750161 Date of Approval: 10/08/2023
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title Efficacy of paracetamol in the relief of pain in advanced labour in low resource settings: a randomized double-blind placebo-controlled study.
Official scientific title Efficacy of paracetamol in the relief of pain in advanced labour in low resource settings: a randomized double-blind placebo-controlled study.
Brief summary describing the background and objectives of the trial BACKGROUND: The labour process is associated with pain and may be the most painful experience many women will encounter in their lifetime. Out of all the methods available for pain relief in labour, parenteral opioids are the most popular in developing countries. However, its use is associated with some maternal and neonatal side effects. Paracetamol is a non-opioid analgesic with a lesser incidence of side effects that has been tried in labour pain management. OBJECTIVES: To compare the efficacy of intravenous paracetamol with placebo in the management of labour pains in the advanced first stage 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
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Treatment: Drugs
Anticipated trial start date 20/12/2022
Actual trial start date 02/01/2023
Anticipated date of last follow up 22/06/2023
Actual Last follow-up date 30/06/2023
Anticipated target sample size (number of participants) 140
Actual target sample size (number of participants) 137
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,Outcome Assessors,Participants
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group Paracetamol 900 mg 2 hours 900 mg was given intravenously over minutes as a single dose in advanced first stage of labour. 70
Control Group Water for injections 6 ml 6 ml of water for injections was given intravenously over 3 minutes as a single dose 6 ml of water for injections was given intravenously over 3 minutes in advanced first stage of labour 70 Placebo
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
Parturients, Aged 18–35 years, Spontaneous onset of labour at term (37–41 weeks + 6 days gestation), Cervical dilatation of 6-7 cm A single live fetus in cephalic presentation Consent to participate in the study Multiple pregnancy Previous uterine scar Cervical dilation ≤ 5 and ≥ 8cm at admission Chronic or pregnancy-induced medical conditions Presence of any contraindication to vaginal delivery Fetal distress Congenital malformations Intrauterine growth restriction Intrauterine fetal death Allergy to paracetamol Breech Presentation Use of any other kind of analgesia before recruitment to the study Non-consenting patient Adult: 19 Year-44 Year 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 11/04/2022 Ekiti State University Teaching Hospital Ado Ekiti Research and Ethics Committee
Ethics Committee Address
Street address City Postal code Country
University Road, Ado Ekiti Ado Ekiti 360101 Nigeria
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome The primary outcome was the efficacy of the drug to provide adequate analgesia by the change in the visual analog scale pain intensity score after administration of the drug. 2 hours
Secondary Outcome The secondary outcome was the incidence of side effects and neonatal APGAR scores at one and five minutes of birth 2 hours
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Ekiti State University Teaching Hospital University Road Ado Ekiti 360101 Nigeria
FUNDING SOURCES
Name of source Street address City Postal code Country
Self sponsored Ekiti State Teaching Hopsital Ado Ekiti 360101 Nigeria
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Olufunke Oso Ekiti State Teaching Hospital Ado Ekiti 360101 Nigeria Individual
COLLABORATORS
Name Street address City Postal code Country
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Olufunke Oso temmykowe@gmail.com +2348032073298 University Road
City Postal code Country Position/Affiliation
Ado Ekiti 360101 Nigeria Senior Registrar at Ekiti State Teaching Hospital Ado Ekiti
Role Name Email Phone Street address
Public Enquiries Olusola Aduloju olusola.aduloju@eksu.edu.ng +2348033900908 University Road
City Postal code Country Position/Affiliation
Ado Ekiti 360101 Nigeria Consultant at the Ekiti State Teaching Hospital Ado Ekiti
Role Name Email Phone Street address
Scientific Enquiries Temitope Okunola bezaleelokunola@yahoo.com +2348032549873 University Road
City Postal code Country Position/Affiliation
Ado Ekiti 360101 Nigeria Consultant at the Ekiti State Teaching Hospital Ado Ekiti
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes Individual participant data that underlie the results reported in this article, after deidentification (text, tables, figures, and appendices) Informed Consent Form 2 years 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