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.: PACTR202308864630455 Date of Approval: 10/08/2023
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title A randomized comparative study on rectal versus oral Diclofenac for perineal pain relief following episiotomy repair in a tertiary hospital
Official scientific title A randomized comparative study on rectal versus oral Diclofenac for perineal pain relief following episiotomy repair in a tertiary hospital
Brief summary describing the background and objectives of the trial Perineal pain following episiotomy repair is a common complaint after vaginal delivery. It usually results from incision site inflammation, tissue oedema and spasms of the perineal muscles. It may be severe, especially in the immediate postpartum period requiring the use of analgesics. Diclofenac is a non-steroidal anti-inflammatory drug commonly used in pain relief as it controls inflammation and inhibits chemical mediators of pain. The aim is to determine the effectiveness rectal versus oral Diclofenac in the management of pain following episiotomy repair.
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 Episiotomy pain
Purpose of the trial Treatment: Drugs
Anticipated trial start date 25/08/2023
Actual trial start date
Anticipated date of last follow up 31/12/2023
Actual Last follow-up date
Anticipated target sample size (number of participants) 132
Actual target sample size (number of participants)
Recruitment status Not yet 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 Allocation was determined by the holder of the sequence who is situated off site Masking/blinding used Outcome Assessors,Participants
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group Oral diclofenac and rectal placebo Oral diclofenac 100mg 12hourly Rectal placebo 100mg 12hourly 48hours Term pregnant women who are potentially eligible will be identified in the antenatal clinic and pre-informed about the study. In labour, women that are eligible will be identified and informed about the study. Written consent will be obtained. A single staged sampling will be employed in recruiting these women and they will be randomized and alloted into experimental group using computer generated random numbers. A box containing 132 sealed envelopes will be kept there. After episiotomy repair, each participant will randomly pick an envelope and the appropriate drug will be administered according to the recruitment number. 66
Control Group Oral placebo and rectal diclofenac Oral placebo 100mg 12hourly Rectal diclofenac 100mg 12hourly 48hours Term pregnant women who are potentially eligible will be identified in the antenatal clinic and pre-informed about the study. In labour, women that are eligible will be identified and informed about the study. Written consent will be obtained. A single staged sampling will be employed in recruiting these women and they will be randomized and alloted into the control group using computer generated random numbers. A box containing 132 sealed envelopes will be kept there. After episiotomy repair, each participant will randomly pick an envelope and the appropriate drug will be administered according to the recruitment number. 66 Active-Treatment of Control Group
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
1. All parturients who will have episiotomy repair following delivery. 2. Live foetuses 3. All booked consenting women whose consent will be revalidated during labou 1.Women with contraindications to NSAIDS e.g. peptic ulcer, liver disease, renal disease, bronchial asthma. 2. Women who will have 3rd or 4th-degree perineal tear 3. Women with severe primary postpartum haemorrhage >1000mls. 4. Any patient that would require specialized post- delivery pain control such as Sickle cell disease patients 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 26/06/2023 RIVERS STATE UNIVERSITY TEACHING HOSPITAL HEALTH RESEARCH ETHICS COMMITTEE
Ethics Committee Address
Street address City Postal code Country
5-7 HARVEY STREET OLD GRA PORT HARCOURT 500241 Nigeria
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome The difference in the mean pain score/ median between the two groups (rectal versus oral) in perineal pain relief following episiotomy repair 6, 12,18, 24, 36, 48 hours
Secondary Outcome The secondary outcome variables include the mean time interval for the need for additional analgesia, frequency of additional (rescue) analgesia requested, the mean time interval between drug administration and voiding of first urine and the proportion of maternal satisfaction for the route of drug administration 6,12,18,24,36,48
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
RIVERS STATE UNIVERSITY TEACHING HOSPITAL 5-7 HARVEY STREET OLD GRA PORT HARCOURT 500241 Nigeria
FUNDING SOURCES
Name of source Street address City Postal code Country
Princeb Tamunobelema Amachree 5-7 HARVEY STREET OLD GRA PORT HARCOURT 500241 Nigeria
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Princeba Tamunobelema Amachree 5-7 HARVEY STREET OLD GRA Port Harcourt 500241 Nigeria Individual
COLLABORATORS
Name Street address City Postal code Country
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Princeba Amachree tbelsamas@gmail.com 2348033389989 5-7 HARVEY STREET OLD GRA
City Postal code Country Position/Affiliation
Port Harcourt 500241 Nigeria Researcher
Role Name Email Phone Street address
Public Enquiries Peter Awoyesuku pawoyesuku@yahoo.com +2348033389988 5-7 HARVEY STREET OLD GRA
City Postal code Country Position/Affiliation
Port Harcourt 500241 Nigeria Public enquiries
Role Name Email Phone Street address
Scientific Enquiries Awopola Jumbo awopola2002@gmail.com +2347064901474 Rivers State University Teaching Hospital
City Postal code Country Position/Affiliation
Port Harcourt 500241 Nigeria Scientific enquiries
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes Yes all of the individual participant data collected during a trial after deidentification. Data will be shared immediately following publication. Data will be shared with anyone who wishes to access the data. It will be available for analysis for any purpose. Data will be available indefinitely on the available link. Informed Consent Form,Statistical Analysis Plan 12 months Access would be granted to researchers on approval of their request
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