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.: PACTR202203895560162 Date of Approval: 28/03/2022
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title Comparison of different pain relief methods in infertile women undergoing hysterosalpingography in Bayelsa State, South-South Nigeria: a randomised controlled trial
Official scientific title Comparison of different pain relief methods in infertile women undergoing hysterosalpingography in Bayelsa State, South-South Nigeria: a randomised controlled trial
Brief summary describing the background and objectives of the trial Infertility is defined as the failure of a couple to conceive ≥12 months of regular unprotected intercourse. It affects 6.6% and 26.4% of reproductive-aged women. Tubal abnormalities account for 30–40% of cases of infertility. Hysterosalpingography is considered the initial diagnostic tool for assessment of tubal patency. Additionally, it can be useful in the diagnosis of intrauterine pathology. This randomised controlled trial is being 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. Women in Group I will receive intramuscular diclofenac 75 mg (3 ml) and paracervical block with 3 ml of water for injection. Women in Group II will receive intramuscular diclofenac 75 mg (3 ml) and paracervical block with 2% lignocaine. Women in Group III will receive intramuscular diclofenac 75 mg (3 ml) and intrauterine instillation of 2% lignocaine. Women in Group IV will receive intramuscular diclofenac 75 mg (3 ml) and 5% lignocaine cream applied on the cervix. 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 lignocaine, 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 03/02/2020
Actual trial start date 01/04/2020
Anticipated date of last follow up 31/03/2022
Actual Last follow-up date
Anticipated target sample size (number of participants) 1040
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
Control Group Group I Intramuscular diclofenac 75 mg (3 ml) Paracervical block with 10 ml of water for injection Stat/single dose The sample size was calculated to be 190 per group, making a total of 760 participants in the study. Seven hundred and sixty infertile women undergoing hysterosalpingography will be enrolled in the study. They were assigned into four groups by computer-generated randomisation. Women in Group I will receive intramuscular diclofenac 75 mg (3 ml) and paracervical block with 10 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 are different, to help prevent selection bias. 260 Active-Treatment of Control Group
Experimental Group Group II Intramuscular diclofenac 75 mg (3 ml) Paracervical block with 2% lignocaine (10 ml). Stat/single dose The sample size was calculated to be 190 per group, making a total of 760 participants in the study. Seven hundred and sixty infertile women undergoing hysterosalpingography will be enrolled in the study. They were assigned into four groups by computer-generated randomisation. Women in Group II receive intramuscular diclofenac 75 mg (3 ml) and paracervical block with 2% lignocaine. Following adequate counseling, written informed consent will be obtained from all the women. The allocating team and the team performing the hysterosalpingography are different, to help prevent selection bias. 260
Experimental Group Group III Intramuscular diclofenac 75 mg (3 ml). Intrauterine instillation of 2% lignocaine. Stat/single dose The sample size was calculated to be 190 per group, making a total of 760 participants in the study. Seven hundred and sixty infertile women undergoing hysterosalpingography will be enrolled in the study. They were assigned into four groups by computer-generated randomisation. Women in Group III receive intramuscular diclofenac 75 mg (3 ml) and intrauterine instillation of 2% lignocaine. Following adequate counseling, written informed consent will be obtained from all the women. The allocating team and the team performing the hysterosalpingography are different, to help prevent selection bias. 260
Experimental Group Group IV Intramuscular diclofenac 75 mg (3 ml). 5% lignocaine cream applied on the cervix. Stat/single dose The sample size was calculated to be 190 per group, making a total of 760 participants in the study. Seven hundred and sixty infertile women undergoing hysterosalpingography will be enrolled in the study. They were assigned into four groups by computer-generated randomisation. Women in Group IV receive intramuscular diclofenac 75 mg (3 ml) and 5% lignocaine cream applied on the cervix. Following adequate counseling, written informed consent will be obtained from all the women. The allocating team and the team performing the hysterosalpingography are different, to help prevent selection bias. 260
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 lignocaine, and all patients that declined consent or incompletely filled the consent form and questionnaire. Adolescent: 13 Year-18 Year,Adult: 19 Year-44 Year,Middle Aged: 45 Year(s)-64 Year(s) 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 07/01/2020 Research Ethics Committee Federal Medical Centre Yenagoa
Ethics Committee Address
Street address City Postal code Country
Federal Medical Centre. 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 included pain scores during and immediately after the procedure. During and immediately after the procedure
Secondary Outcome The secondary outcomes included differences in pain scores and the presence of any adverse effect in any group. 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
Silhouette Radiodiagnostic Consultants Mbiama-Yenagoa Road, Yenagoa, Bayelsa State, Nigeria. Yenagoa 560001 Nigeria
Diete Koki Memorial Hospital Hospital Road, Opolo, Yenagoa, Bayelsa State, Nigeria. Yenagoa 560001 Nigeria
FUNDING SOURCES
Name of source Street address City Postal code Country
Dr. Peter Chibuzor Oriji Federal Medical Centre. 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 Okolobiri 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 publication. No end date. Data will be available to anyone who wishes to access it, for any purpose, and indefinitely. No distinctions
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