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.: PACTR202203856122115 Date of Approval: 15/03/2022
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title Effect of paracetamol as a prophylactic analgesic in infertile women undergoing hysterosalpingography in Bayelsa State, South-South Nigeria: a randomised control trial
Official scientific title Effect of paracetamol as a prophylactic analgesic in infertile women undergoing hysterosalpingography in Bayelsa State, South-South Nigeria: a randomised control trial
Brief summary describing the background and objectives of the trial Background: 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. Many women experience mild to severe pain during and after hysterosalpingography, and this is one of the reasons some women decline to undergo this investigative modality Paracetamol is an analgesic and an antipyretic. Its action is close to that of non-steroidal anti-inflammatory drugs, and it is frequently preferred due to its superior tolerance. There is paucity of published data on the use of paracetamol as prophylaxis for the control of pain during hysterosalpingography Objective: To compare the effectiveness of paracetamol and placebo in pain reduction during hysterosalpingography in Bayelsa State, South-South Nigeria. Materials and Methods: This randomised control 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, over a one-year period. Three hundred and eighty infertile women undergoing hysterosalpingography were assigned into two groups. Women in Group I received paracervical block, while the women in Group II received placebo. Data were analysed using Statistical Product and Service Solutions for windows® version 25.
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 01/02/2021
Actual trial start date 01/04/2021
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 Paracetamol group Intramuscular Paracetamol 600 mg (4 ml) Stat dose Three hundred and eighty infertile women undergoing hysterosalpingography were enrolled in the study. They were assigned into two groups by computer‑generated randomisation. Women in Group I will have intramuscular paracetamol 600 mg (4 ml), Following adequate counselling, written informed consent was obtained from all the women. The allocating team and the team performing the hysterosalpingography were different, to help prevent selection bias. Pain scores will be calculated at the end of the procedure, and compared with those of the placebo group. 190
Control Group Placebo group Intramuscular 4 ml of water for injection Stat dose Three hundred and eighty infertile women undergoing hysterosalpingography were enrolled in the study. They were assigned into two groups by computer‑generated randomisation. Women in Group II will have intramuscular water for injection (4 ml). Following adequate counselling, written informed consent was obtained from all the women. The allocating team and the team performing the hysterosalpingography were different, to help prevent selection bias. Pain scores will be calculated at the end of the procedure, and compared with those of the placebo group. 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 were 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 paracetamol, and all patients that declined consent or incompletely filled the consent form and questionnaire. Adult: 19 Year-44 Year 18 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 01/02/2021 Research Ethics Committee
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 included procedure pain scores of the different steps. During the investigative modality
Secondary Outcome The secondary outcomes included difference in pain scores, and presence of any adverse effect in any group. At the end of the investigative modality.
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Federal Medical Centre Yenagoa and Niger Delta University Teaching Hospital Bayelsa State Nigeria 1, Hospital Road, Ovom, Yenagoa, Bayelsa State, Nigeria Yenagoa 560001 Nigeria
FUNDING SOURCES
Name of source Street address City Postal code Country
Dr. Peter Chibuzor Oriji Department of Obstetrics and Gynaecology, Federal Medical Centre, Yenagoa 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, Yenagoa, 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, Yenagoa
City Postal code Country Position/Affiliation
Yenagoa 560001 Nigeria Consultant Obstetrician and Gynaecologist
Role Name Email Phone Street address
Public Enquiries Dr. Kelvin Enefia Kiridi kiridienefia@gmail.com +2348037249828 Niger Delta University Teaching Hospital Okolobiri
City Postal code Country Position/Affiliation
Yenagoa 560001 Nigeria Consultant Radiologist
Role Name Email Phone Street address
Scientific Enquiries Peter Chibuzor Oriji chibuzor54@gmail.com +2348030677372 Federal Medical Centre, Yenagoa
City Postal code Country Position/Affiliation
Yenagoa 560001 Nigeria Consultant Obstetrician and Gynaecologist
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.
URL Results Available Results Summary Result Posting Date First Journal Publication Date
Research is not published yet. No URL yet. 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