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.: PACTR202407618349397 Date of Approval: 29/07/2024
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title Effect of Hyoscine-N-Butyl Bromide on Hysterosalpingography-Associated Pain and Tubal Spasm. A Double-Blind Randomized Placebo-Controlled Study
Official scientific title Effect of Hyoscine-N-Butyl Bromide on Hysterosalpingography-Associated Pain and Tubal Spasm. A Double-Blind Randomized Placebo-Controlled Study
Brief summary describing the background and objectives of the trial Background Hysterosalpingography is one of the first initial investigations in evaluating women with infertility. Pain and tubal spasms are common challenges encountered during the procedure, which have the potential to make the procedure unpalatable for the patient and frustrating to the clinician. While some patients are given no medication to prevent pain or spasms, a number of other agents have been tried to ameliorate the pain. However, there appears to be no consensus on the recommended agents to minimize pain and spasm encountered during hysterosalpingography. Hyoscine-n-Butyl Bromide is a well-known antispasmodic commonly used for its relaxant effects on smooth muscles and it is effective in the gastrointestinal and renal systems and even in aiding cervical relaxation during labour and it has the potential to be a single agent that can minimize both pain and spasm. Objective: To investigate the effect of hyoscine-n-butyl bromide (HBB) for alleviating pain and spasm during hysterosalpingography (HSG) during the evaluation of women with infertility.
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 Treatment: Drugs
Anticipated trial start date 11/03/2024
Actual trial start date 10/06/2024
Anticipated date of last follow up 10/06/2024
Actual Last follow-up date
Anticipated target sample size (number of participants) 136
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 Permuted block randomization Allocation was determined by the holder of the sequence who is situated off site Masking/blinding used Care giver/Provider,Participants
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group Hyoscine Butyl Bromide 20mg Hyoscine Butyl Bromide given intramuscularly stat 20mg of Hyoscine-n-Butyl Bromide (2mls) will be given intramuscularly to participants about 10 minutes before hysterosapingography procedure 68
Control Group Placebo 2mls of sterile injection water stat 2mls of sterile injection water will be given intramuscularly about 10 minutes before the procedure of hysterosalpingography 68 Placebo
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
All adult patients (female) ≥ 18 years undergoing hysterosalpingography at the study centre during the study period and do not have any of the exclusion criteria Non-consenting patients. Patients with active pelvic inflammatory disease Patients with a history of any allergy to radiopaque dye Patients with previous cervical surgery. Patients who took any form of analgesic within 6-hours before the procedure. Patients with congenital uterine abnormality or other indications for HSG aside from infertility. Patients with cardiac disease, e.g. cardiac failure, cardiac arrhythmias, hypertensive heart disease Patients with known allergies to hyoscine Adult: 19 Year-44 Year 18 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 09/01/2024 Health Research Ethics Committee National Hospital Abuja
Ethics Committee Address
Street address City Postal code Country
Plot 132 Central District Phase II, Garki, Abuja, Nigeria Abuja 900211 Nigeria
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Pain score 1.Before the procedure 2.After speculum application 3.After the application of the tenaculum and metal cannula 4.At the end of uterine filling with contrast medium: 5.At 30minutes 6. After 24 hours
Primary Outcome Tubal spasm The presence or absence of tubal spasm will be observed on the HSG film
Secondary Outcome Incidence of side effects of hyoscine butyl bromide when used during HSG After the procedure
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
National Hospital Abuja Plot 132 Central Business District Garki Abuja. Abuja 900211 Nigeria
FUNDING SOURCES
Name of source Street address City Postal code Country
Medical Residency Training Fund Federal Government of Nigeria Abuja 900103 Nigeria
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor None None NA Nigeria None
COLLABORATORS
Name Street address City Postal code Country
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator EMMANUEL OLADUNNI doctkayindestiny@gmail.com +2347032624565 Obstetrics Gynaecology Department, National Hospital Abuja
City Postal code Country Position/Affiliation
Abuja 900211 Nigeria Senior Registrar
Role Name Email Phone Street address
Public Enquiries Efena Efetie efenae@yahoo.com +2348033118171 Obstetrics Gynaecology Department, National Hospital Abuja
City Postal code Country Position/Affiliation
Abuja 900211 Nigeria Chief Consultant
Role Name Email Phone Street address
Scientific Enquiries Olubunmi Olatunji bunmiolatunji64@gmail.com +2348055262402 Radiology Department, National Hospital Abuja
City Postal code Country Position/Affiliation
Abuja 900211 Nigeria Chief Consultant
Role Name Email Phone Street address
Scientific Enquiries Rukayya Babandi rmbabandi@yahoo.com +2348032280518 Obstetrics Gynaecology Department, National Hosptal Abuja
City Postal code Country Position/Affiliation
Abuja 900211 Nigeria Consultant
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes Individual participant data will be shared according to ICMJE requirements. This include those that underlie the results reported in the article, after deidentification (text, tables, figures, and appendices) Analytic Code,Clinical Study Report,Informed Consent Form,Statistical Analysis Plan,Study Protocol Beginning 3 months and ending 5 years following article publication Investigators whose proposed use of the data has been approved by an independent review committee (“learned intermediary”) identified for this purpose
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