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.: PACTR202203544008183 Date of Approval: 25/03/2022
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title Effect of diclofenac as a prophylactic analgesic during hysterosalpingography in Bayelsa State, South-South Nigeria: a randomized controlled trial
Official scientific title Effect of diclofenac as a prophylactic analgesic during hysterosalpingography in Bayelsa State, South-South Nigeria: a randomized controlled trial
Brief summary describing the background and objectives of the trial Hysterosalpingography is the primary investigative modality of choice for the evaluation of the uterine cavity, fallopian tubes, and adjacent peritoneal cavity. It is easy, has minimal complications, affordable, readily available, reliable, and does not require anesthesia. This investigative modality has a sensitivity, specificity, positive predictive value, and negative predictive value of 88%, 87%, 71%, and 94%, respectively. Despite these advantages, its major shortcoming is pain. The objective of this randomised controlled trial was to compare the effectiveness of diclofenac and placebo in pain reduction when undergoing hysterosalpingography in Bayelsa State, South-South Nigeria. This randomised controlled trial will be conducted at the radiology departments and infertility clinics of the Federal Medical Centre, Yenagoa and Niger Delta University Teaching Hospital, Okolobiri, both in Bayelsa State, Nigeria. Three hundred and eighty infertile women undergoing hysterosalpingography will be enrolled in the study. They will be assigned into two groups by computer-generated randomisation. Women in Group I will have intramuscular diclofenac 75 mg (3 ml), while the women in Group II will have placebo with 3 ml of water for injection. Following adequate counseling, written informed consent will be obtained from all the women. The allocating team and the team performing the hysterosalpingography will be different, to help prevent selection bias. Infertile women referred for hysterosalpingography, and women that gave consent and completely filled the consent/questionnaire form will be included in the study. Exclusion criteria included abnormal uterine/vaginal bleeding before the procedure, on-going menstruation, pregnancy, discharge on inspection of the cervix, cervical stenosis/cervical pathology, evidence of pelvic inflammatory disease, previous history of contrast hypersensitivity, history of allergy to diclofenac, and all patients that declined consent.
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 Fertility-female
Purpose of the trial Diagnosis / Prognosis
Anticipated trial start date 01/04/2021
Actual trial start date 01/06/2021
Anticipated date of last follow up 31/03/2022
Actual Last follow-up date
Anticipated target sample size (number of participants) 380
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,Outcome Assessors,Participants
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group Group I 75 mg of intramuscular diclofenac 30 minutes before hysterosalpingography Stat/single dose Hysterosalpingography for the women will be performed within the proliferative phase of the menstrual cycle (7th – 10th day). Intramuscular diclofenac 75 mg (3 ml) will be given to the women in Group I. The procedure is started 30 minutes after administering intramuscular diclofenac. 190
Control Group Group II 3 ml of intramuscular water for injection - Placebo Stat/single dose Hysterosalpingography for the women will be performed within the proliferative phase of the menstrual cycle (7th – 10th day). Intramuscular placebo (3 ml of water for injection) will be given to the women in Group II. The procedure is started 30 minutes after administering intramuscular placebo. 190 Placebo
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
Infertile women referred for hysterosalpingography, and women that gave consent and completely filled the consent/questionnaire form will be included in the study Exclusion criteria included abnormal uterine/vaginal bleeding before the procedure, on-going menstruation, pregnancy, discharge on inspection of the cervix, cervical stenosis/cervical pathology, evidence of pelvic inflammatory disease, previous history of contrast hypersensitivity, history of allergy to diclofenac, and all patients that declined consent or incompletely filled the consent form and questionnaire. Adult: 19 Year-44 Year 15 Year(s) 49 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 29/03/2021 Research Ethics Committee Federal Medical Centre Yenagoa
Ethics Committee Address
Street address City Postal code Country
1, Hospital Road, Ovom, Yenagoa, Bayelsa State, Nigeria Yenagoa 560001 Nigeria
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome The primary outcomes include pain scores during and immediately after the procedure. During and immediately after the procedure
Secondary Outcome The secondary outcomes include differences in pain scores, and presence of any adverse effect in any of the groups. During and after the procedure.
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Federal Medical Centre Yenagoa 1, Hospital Road, Ovom, Yenagoa, Bayelsa State, Nigeria Yenagoa 560001 Nigeria
Niger Delta University Teaching Hospital Okolobiri Hospital Road, Okolobiri, Bayelsa State, Nigeria Yenagoa 560001 Nigeria
FUNDING SOURCES
Name of source Street address City Postal code Country
Dr. Peter Chibuzor Oriji Federal Medical Centre Yenagoa. 1, Hospital Road, Ovom, Yenagoa, Bayelsa State, Nigeria. Yenagoa 560001 Nigeria
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Dr. Peter Chibuzor Oriji Federal Medical Centre. 1, Hospital Road, Ovom, Yenagoa, Bayelsa State, Nigeria Yenagoa 560001 Nigeria Individual
COLLABORATORS
Name Street address City Postal code Country
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Peter Chibuzor Oriji chibuzor54@gmail.com +2348030677372 Federal Medical Centre. 1, Hospital Road, Ovom, Yenagoa, Bayelsa State, Nigeria
City Postal code Country Position/Affiliation
Yenagoa 560001 Nigeria Consultant Obstetrician and Gynaecologist Federal Medical Centre Yenagoa
Role Name Email Phone Street address
Public Enquiries Enefia Kelvin Kiridi kiridienefia@gmail.com +2348037249828 Niger Delta University Teaching Hospital, Hospital Road, Okolobiri, Bayelsa State, Nigeria
City Postal code Country Position/Affiliation
Yenagoa 560001 Nigeria Consultant Radiologist Niger Delta University Teaching Hospital Okolobiri
Role Name Email Phone Street address
Scientific Enquiries Peter Chibuzor Oriji chibuzor54@gmail.com +2348030677372 Federal Medical Centre. 1, Hospital Road, Ovom, Yenagoa, Bayelsa State, Nigeria
City Postal code Country Position/Affiliation
Yenagoa 560001 Nigeria Consultant Obstetrician and Gynaecologist Federal Medical Centre Yenagoa
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes The participants' data will be available in the results after data analysis. The study protocol and participants' data that underlie the results reported in this article (text, table, figures and appendices), after de-identification will be available. Data will be available immediately after publication. No end date. Data will be available to anyone who wishes to access it, for any purpose, and indefinitely. Analytic Code,Clinical Study Report,Informed Consent Form,Statistical Analysis Plan,Study Protocol Data will be available immediately after the publication of the paper. Data will be available to anyone who wishes to access it, for any purpose, and indefinitely. There will be no restrictions.
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