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.: PACTR202407919661367 Date of Approval: 24/07/2024
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title Evaluation of effectiveness of Rectal Diaclofenac and Paracetamol suppositories in relieving labour pain among women in Calabar
Official scientific title Evaluation of effectiveness of Rectal Diaclofenac and Paracetamol suppositories in relieving labour pain among women in Calabar
Brief summary describing the background and objectives of the trial The aim of the study is to find ways to helping our women to have better childbirth experience. Labour pain is among the most frightening event that women of reproductive age are faced with. Many methods of labour analgesia are either costly or associated with maternal and total sedation. Neuraxial block is not readily available in low income countries. It is the matter of equity and human right for women to be given effective and readily available analgesia in labour. This is a double blinded randomised trial comparing two drugs. Each participant is to be given either 1000mg of Paracetamol or 100mg Diclofenac rectal suppository in active phase of labour. The potency of each drug shall be assessed by asking each participant to rate the pain intensity perceived using a scale of 1 to 10 using a visual analog scale at certain intervals. The two drugs when administered through the rectum/anal canal are not known to cause adverse effects on the mother or the unborn baby. The study has been approved by the Health Research Ethics Committee of Cross River State Ministry of Health ad the University of Calabar Teaching Hospital.
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Anaesthesia,Pregnancy and Childbirth
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Relieve of labour pain
Anticipated trial start date 01/07/2024
Actual trial start date 16/07/2024
Anticipated date of last follow up 29/11/2024
Actual Last follow-up date 16/12/2024
Anticipated target sample size (number of participants) 300
Actual target sample size (number of participants) 260
Recruitment status Recruiting
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 Labour Rectal Analgesia Study 100mg Diclofenac Rectal Suppository administered once in active phase of labour (stat dose) The estimated trial period is 3 months based on the estimated sample size. Each participant is to be given 100mg Diclofenac rectal suppository in active phase of labour. The potency of the drug shall be assessed by asking each participant to rate the pain intensity perceived in a scale of 1 to 10 using a visual analog scale at certain intervals. The intervals are 30 minutes, 1 hour, 2 hours, 6 hours and 24 hours. The baseline pain scores shall be assessed before drug administration (intervention). The mean pain scores shall computed across groups. 65
Control Group Labour Rectal Analgesia Study 1000mg Paracetamol Rectal Suppository administered once in active phase of labour (stat dose) The estimated trial period is 3 months based on the estimated sample size. Each participant is to be given 1000mg Paracetamol rectal suppository in active phase of labour. The potency of the drug shall be assessed by asking each participant to rate the pain intensity perceived in a scale of 1 to 10 using a visual analog scale at certain intervals. The intervals are 30 minutes, 1 hour, 2 hours, 6 hours and 24 hours. The baseline pain scores shall be assessed before drug administration (intervention). The mean pain scores shall computed across groups. 65 Active-Treatment of Control Group
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
All pregnant women from 37 weeks’ gestational age and above with singleton pregnancy and fetus in cephalic presentation that are admitted into the labour ward for vaginal delivery or induction of labour shall be included in the study. The pregnant women with the following conditions would be excluded from the study. These include women with multiple gestation, abnormal foetal lie such as transverse or oblique lie, uterine masses such as fibroids, antepartum haemorrhage, fetal congenital anomaly, polyhydramnios, and oligohydramnios. Others are preterm labour, pre-labour rupture of membranes, and pregnant women who are unsure of their LMP or no dating ultrasound scan done before 13 weeks’ gestational age. Also, pregnant women that present in advanced first stage of labour or second stage of labour shall be excluded from the study. Adult: 19 Year-44 Year 19 Year(s) 44 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 26/10/2023 Health Research Ethics Committee. Ministry of Health Calabar
Ethics Committee Address
Street address City Postal code Country
Michael Ani Secretariat, Diamond Hill Rd, Naval Base, Calabar Calabar 540281 Nigeria
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome The primary outcome will be to compare the differences in the mean pain scores across the groups and maternal satisfaction ratings after intervention. The baseline pain score before drug administration shall be assessed within 10 minutes before the drug is administered. After drug administration, the pain score shall be assessed in the following intervals, 30 minutes, 1 hour, 2 hours, 6 hours and 24 hours. Baseline, 30 minutes, 1 hour, 2 hours, 6 hours and 24 hours after drug administration.
Secondary Outcome The secondary outcome will be to compare the differences in maternal and perinatal outcomes such as duration of labour, caesarean delivery, genital tear, febrile illness, time of initiation of breastfeeding and self care. Also symptoms like vomiting or urinary problem. The perinatal outcome include apgar scores, febrile illness, admission to neonatal intensive care unit. At delivery and 24 hours after delivery
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
University of Calabar Teaching Hospital Unical Hotel Road, Etta Agbor Calabar 540271 Nigeria
FUNDING SOURCES
Name of source Street address City Postal code Country
Personal Source Department of Obstetrics and Gynaecology, University of Calabar Calabar 540271 Nigeria
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Nil Nil Nil Nil Nigeria No sponsor
COLLABORATORS
Name Street address City Postal code Country
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Ubong Akpan ubongabasiakpan@gmail.com +2348039099041 Department of Obstetrics and Gynaecology, University of Calabar
City Postal code Country Position/Affiliation
Calabar 540271 Nigeria Associate Professor
Role Name Email Phone Street address
Public Enquiries Gabriel Adim kebyayi@gmail.com +2347037291111 Women and Children Hospital
City Postal code Country Position/Affiliation
Calabar 540211 Nigeria Hospital Administrator
Role Name Email Phone Street address
Scientific Enquiries Saturday Etuk imaetuks345@yahoo.com +2348033172687 Department of Obstetrics and Gynaecology, University of Calabar
City Postal code Country Position/Affiliation
Calabar 540271 Nigeria Professor of Obstetrics and Gynaecology
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes CONSENT FORM Consent to participate in a research on a comparative efficacy of paracetamol and diclofenac suppository on the relieve of labour pain. Each participant shall be entitled to access to her own personal data if requested through hard copy or electronic format. The protocol of the research and the study methodology shall also be freely shared to each participant. The final outcome of the research findings shall also be freely shared to individual participants. The benefits of the intervention shall also be freely shared with the participants. The results of this research is expected to be available in three (3) months time. The information shall be made available to each participant through the participant's address in either hard copy or electronic format. The data sharing shall follow the recommended pattern of the International Committee of Medical Journal Editors data statement recommendation for Clinical Trials. Confidentiality of each participant is ensured and participation is voluntary. Informed Consent Form 3 months One on One contact with the hospital per health worker
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