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.: PACTR202407499773220 Date of Approval: 16/07/2024
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title Rectal versus oral diclofenac for relief of perineal pain after episiotomy repair in Enugu, Nigeria: A randomized controlled trial.
Official scientific title Rectal versus oral diclofenac for relief of perineal pain after episiotomy repair in Enugu, Nigeria: A randomized controlled trial.
Brief summary describing the background and objectives of the trial Background: Perineal pain is the commonest immediate complication following episiotomy repair after vaginal childbirth. In the presence of pain, various treatments are used in clinical practice ranging from local anaesthetics, to oral analgesics, therapeutic ultrasound and non- pharmacological application of heat, ice packs and bath. Objective: To compare the effectiveness of diclofenac in two different routes (rectal and oral) on reduction of pain following episiotomy repair. Method: This will be a prospective randomized controlled trial that will be carried out among parturients that will have spontaneous vaginal delivery, episiotomy and its repair in the labour wards of three tertiary hospitals in Enugu - (Mother of Christ Specialist Hospital, Ogui, Enugu; Enugu State University Teaching Hospital, Parklane and University of Nigeria Teaching Hospital, Ituku-ozalla, Enugu). Women who will present in labour for vaginal delivery from 37 weeks of gestation upwards will be recruited into the study after obtaining their informed consent. Eligible women will be randomly allocated following delivery to either Group A or B. Group A will consist of oral diclofenac and suppository placebo while group B will consist of an oral placebo tablet and suppository diclofenac. Drugs will be administered immediately after suturing of episiotomy and then every 12 hours up to 48 hours. The study will last a period of six months, between December 2023 and May 2024. A total of 204 parturients will be randomized to either group A or group B. A ten-point visual analogue scale (VAS) for pain will be used to assess the degree of pain the parturient has over one, twelve, twenty-four, thirty-six and forty-eight hours after the episiotomy repair. The time of commencement of activities like sitting, walking and initiation of breastfeeding will also be assessed in both groups.
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 02/09/2024
Actual trial start date 02/09/2024
Anticipated date of last follow up 31/03/2025
Actual Last follow-up date
Anticipated target sample size (number of participants) 276
Actual target sample size (number of participants)
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
Control Group Oral diclofenac and suppository placebo group 100mg oral diclofenac will be received by the parturients 12 hourly 48 hours 100mg oral diclofenac will be received by the parturients who had episiotomy wound repair 12 hourly for 48 hours.This group will also receive rectal placebo 12 hourly for 48 hours. 138 Active-Treatment of Control Group
Experimental Group Oral placebo tablet and suppository diclofenac 100mg of rectal diclofenac 12 hourly 48 hours This group will receive oral placebo and 100mg of rectal diclofenac 12 hourly for 48 hours. 138
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
1. Informed consent 2. Uncomplicated singleton pregnancy 3. Cephalic presentation 4. Gestational age at 37-41 weeks 5. Absence of contraindication to vaginal delivery 1. History of sensitivity to NSAIDs 2. Intact perineum 3. Asthma 4. Gastric or duodenal ulcer 5. Pre-eclampsia/eclampsia 6. Co-existing comorbidities 7. Postpartum haemorrhage 8. Patients with diarrhea disease 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 09/05/2024 University of Nigeria Teaching Hospital Research Ethics Committee
Ethics Committee Address
Street address City Postal code Country
Ituku-Ozalla Enugu 40001 Nigeria
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome The mean post-episiotomy wound repair pain score after commencement of diclofenac administration to the participants. 12 hourly intervals for 48 hours.
Secondary Outcome Commencement of activities like sitting ,walking, urinating, initiation of breast-feeding,side- effects of the drugs based routes of administration, maternal satisfaction. 12 hourly intervals for 48 hours.
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
University of Nigeria Teaching Hospital Ituku-Ozalla Enugu 40001 Nigeria
ESUT Teaching Hospital Park Lane Enugu 400001 Nigeria
Mother of Christ Hospital Ogbete Nigeria 400102 Nigeria
FUNDING SOURCES
Name of source Street address City Postal code Country
The authors Ituku-Ozalla Enugu 40001 Nigeria
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Edegware Ifeoma Shirley Ituku-Ozalla Enugu 40001 Nigeria Individual
Secondary Sponsor Prof. Leonard Ogbonna Ajah Ituku-Ozalla Enugu 40001 Nigeria Individual
COLLABORATORS
Name Street address City Postal code Country
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Ifeoma Edegware brifyede27@gmail.com +2348032504990 Ituku-Ozalla
City Postal code Country Position/Affiliation
Enugu 40001 Nigeria Senior registrar
Role Name Email Phone Street address
Scientific Enquiries Leonard Ajah leonard.ajah@unn.edu.ng +2348033920789 Ituku-Ozalla
City Postal code Country Position/Affiliation
Enugu 40001 Nigeria Professor
Role Name Email Phone Street address
Public Enquiries Theophilus Nwankwo theophilus.nwankwo@unn.edu.ng +2348037511519 Ituku-Ozalla
City Postal code Country Position/Affiliation
Enugu 40001 Nigeria Professor
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes Plan to Share IPD: Yes Data obtained through this study may be provided to qualified researchers with academic interest in obstetrics and Gynaecology. Data or samples shared will be coded with the personal identification excluded. Approval of the request and execution of all applicable agreements (i.e. a material transfer agreement) are prerequisites to the sharing of data with the requesting party. Clinical Study Report,Informed Consent Form,Statistical Analysis Plan,Study Protocol Data requests can be submitted starting 6 months after article publication and the data will be made accessible for up to 2 years. Extension can be considered on a case-by-case basis. Access to trial IPD can be requested by qualified researchers engaging in independent scientific research, and will be provided following review and approval of a study protocol,Statistical Analysis Plan ,informed consent form and clinical study report. For more information or to submit a request, please contact pactradmin@mrc.ac.za.
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