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.: PACTR202103490512646 Date of Approval: 02/03/2021
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title Efficacy of Intramuscular Diclofenac for Pain Relief in Women Undergoing Hysterosalpingography in Ahmadu Bello University Teaching Hospital, Zaria: A Randomized Controlled Study
Official scientific title Efficacy of Intramuscular Diclofenac for Pain Relief in Women Undergoing Hysterosalpingography in Ahmadu Bello University Teaching Hospital, Zaria: A Randomized Controlled Study
Brief summary describing the background and objectives of the trial • BACKGROUND: Female infertility is a common gynecological problem and a major contributor to this, in woman of reproductive age group is tubal blockage. Hysterosalpingography (HSG) is often the first line investigation for the evaluation of tubal patency. It is simple, reliable and affordable for testing tubal patency. However, it is mostly associated with considerable pain and discomfort to the women. The use of analgesia for HSG is not a routine or standard practice in Ahmadu Bello University Teaching Hospital (ABUTH), Zaria. • OBJECTIVE: The main objective of the study is to assess the effectiveness of intramuscular Diclofenac for pain relief in women undergoing HSG for the evaluation of tubal factor infertility. • STUDY DESIGN: The study is a randomized controlled study. • SETTING: The gynaecology clinic & radiology department of Ahmadu Bello University Teaching Hospital (ABUTH), ZARIA. • PARTICIPANTS: Patients indicated for HSG investigation. • INTERVENTIONS: Patients will be randomized to receive either i.m (75mg/3mls) Diclofenac or placebo (3mls of 0.9% Nacl solution) 30 minutes before HSG procedure. • RESULTS: Findings from the study will be analyzed and conclusions will be drawn.
Type of trial RCT
Acronym (If the trial has an acronym then please provide) PARUH
Disease(s) or condition(s) being studied Obstetrics and Gynecology
Sub-Disease(s) or condition(s) being studied Fertility-female
Purpose of the trial Prevention
Anticipated trial start date 01/06/2020
Actual trial start date 01/06/2020
Anticipated date of last follow up 31/12/2020
Actual Last follow-up date 31/12/2020
Anticipated target sample size (number of participants) 72
Actual target sample size (number of participants) 72
Recruitment status Completed
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
Factorial: participants randomly allocated to either no, one, some or all interventions simultaneously Randomised Simple randomization using a randomization table created by a computer software program Sealed opaque envelopes Masking/blinding used Outcome Assessors,Participants
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group Intramuscular Diclofenac 75mg 3ominutes before procedure The trained nurse will then withdraw the test drugs either i.m Diclofenac or Nacl solution in 3mls syringe. Following withdrawal of its content, the ampoules will be discarded in a sharp box. The test drug will be administered into the upper quadrant of the gluteal muscle after sterilization with spirit swab 30 minutes before HSG procedure. 36
Control Group Placebo 3mls of 3.9% Nacl solution 30 minutes before procedure 3mls of 3.9% Nacl solution administered 30 minutes before HSG 36 Placebo
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
i. Women of reproductive age. ii. All consenting women presenting at the gynecologic clinic indicated for HSG for the evaluation of tubal factor infertility. i.Acute pelvic infection ii.Genital tuberculosis ii.Allergy to contrast iv.Allergy to NSAIDs v.Unexplained vaginal discharge vi.Unexplained vaginal bleeding vii.Chronic pelvic pain vii.Recent or chronic use of NSAIDs Adolescent: 13 Year-18 Year,Adult: 19 Year-44 Year,Middle Aged: 45 Year(s)-64 Year(s) 15 Year(s) 45 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 Health Research Ethics Committee Ahmadu Bello University Teaching Hospital
Ethics Committee Address
Street address City Postal code Country
Shika Zaria Zaria 810211 Nigeria
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome difference in mean pain scores during cervical instrumentation and contrast instillation 1: cervical instrumentation 2: contrast instillation 3. 5 mins post hsg 4. 30 mins post hsg
Secondary Outcome 1. Difference in mean pain scores at 5 and 30 minutes post Hsg 2. Number of patient needing a additional analgesics after hsg 3. To determine side effects of Diclofenac 1: cervical instrumentation 2: contrast instillation 3. 5 mins post hsg 4. 30 mins post hsg
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Ahmadu Bello University Teaching Hospital Shika Zaria Zaria 810211 Nigeria
FUNDING SOURCES
Name of source Street address City Postal code Country
Hassan Kabir Dauda C/o Department of Obstetrics and Gynaecology, ABUTH Zaria 810211 Nigeria
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Dr Hassan Kabir Dauda Block-K Shika Transit Camp Zaria 810211 Nigeria Individual
COLLABORATORS
Name Street address City Postal code Country
Prof Adesiyun Department of Obstetrics and Gynaecology, Ahmadu Bello University Teaching Hospital Zaria 810211 Nigeria
Dr Igashi J.B Department of Radiology Ahmadu Bello University Teaching Hospital Zaria 810211 Nigeria
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Hassan Kabir Dauda hassankdauda@yahoo.com +2347033299296 Department of Obstetrics and Gynaecology, Ahmadu Bello University Teaching Hospital
City Postal code Country Position/Affiliation
Zaria PMB 06 Nigeria Senior Registrar
Role Name Email Phone Street address
Scientific Enquiries Adesiyun A.G biyi.adesiyun@yahoo.com +2348037861630 Shika Zaria
City Postal code Country Position/Affiliation
Zaria PMB 06 Nigeria Consultant
Role Name Email Phone Street address
Public Enquiries Gabriel Dogbanya angelgabe3j@gmail.com +2348030790966 Shika
City Postal code Country Position/Affiliation
Zaria PMB 06 Nigeria Consultant
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes All IPD that underlie result in a publication Analytic Code,Clinical Study Report,Informed Consent Form,Statistical Analysis Plan,Study Protocol Within a year of conclusion of the study All registered researchers interested in the study area
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