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.: PACTR202007753364675 Date of Approval: 08/07/2020
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title Effects of Speculum Lubrication on Cervical Smears for Cervical Cancer Screening in Nnewi: A Randomized Controlled Study
Official scientific title Effects of Speculum Lubrication on Cervical Smears for Cervical Cancer Screening in Nnewi: A Randomized Controlled Study
Brief summary describing the background and objectives of the trial Background: Carcinoma of the cervix is the most prevalent gynaecological malignancy in this environment, associated with significant morbidity and mortality. Papanicolaou test is a well-recognised and efficient screening modality but the uptake of Pap smear in our environment remains poor. Fear of pain from speculum insertion during vaginal examination has been noted as a factor that may reduce the compliance of women to cervical cancer screening and repeat testing. Speculum lubrication may help to reduce these pain and discomfort, but there are fears of its interference with cytological results. Aim and Objectives: To determine and compare adequacy of cervical cytology smears and mean pain scores of women undergoing cervical screening with or without speculum lubrication. Research Methodology: This proposed work will be a randomized controlled study among women having cervical cancer screening at the gynaecological clinic of Nnamdi Azikiwe University Teaching Hospital, Nnewi. Sixty-six patients would be randomly assigned to the ‘Gel group’ and another 66 patients to the ‘No Gel’ group. Samples will be collected from each participant for Pap smear with lubricated vaginal speculum for the ‘Gel group’ and non-lubricated vaginal speculum for the ‘No Gel group’. Pain scores will be assessed with the numeric rating scale for pain. The primary outcome measures will be the mean numeric rating scale pain scores and proportion of women with inadequate cervical cytology smears.
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Cancer,Obstetrics and Gynecology,Pregnancy and Childbirth,Urological and Genital Diseases
Sub-Disease(s) or condition(s) being studied Fertility-female
Purpose of the trial Early detection /Screening
Anticipated trial start date 11/07/2020
Actual trial start date 21/08/2020
Anticipated date of last follow up 31/12/2020
Actual Last follow-up date 31/12/2020
Anticipated target sample size (number of participants) 132
Actual target sample size (number of participants) 132
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
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group Speculum Lubricated with Water Soluble Gel Once 10 minutes During vaginal examination, the speculum to be used will be lubricated with water soluble gel to ease insertion . 66
Control Group Speculum Without Lubrication Once 10 Minutes During vaginal examination, the speculum to be used will not be lubricated. 66 Historical
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
The participants will include pre and post-menopausal women who require Pap smear. The following women would be excluded from the work virgins, pregnant women, women having their menstrual period, women with any overt cervical pathology, women with vulvar pathologies or those on hormone replacement therapy. Women with vaginitis, those undergoing vulvectomy or vaginectomy and women who had fertility-sparing surgery will not be recruited. Adult: 19 Year-44 Year,Aged: 65+ Year(s),Middle Aged: 45 Year(s)-64 Year(s) 25 Year(s) 79 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 24/09/2019 NNAMDI AZIKIWE UNIVERSITY TEACHING HOSPITAL ETHICAL COMMITTEE
Ethics Committee Address
Street address City Postal code Country
NNEWI ANAMBRA 5025 Nigeria
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome The mean NRS pain scores. 10 minutes
Primary Outcome The proportion of women with inadequate cervical cytology smears. 2 weeks
Secondary Outcome The pattern of Pap smear results. 2 weeks
Secondary Outcome The proportion of women willing to come for repeat testing. 10 minutes
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
NNAMDI AZIKIWE UNIVERSITY TEACHING HOSPITAL NNEWI ANAMBRA Nigeria
FUNDING SOURCES
Name of source Street address City Postal code Country
Dr ILIKA CHITO PACHELLA Department of Obstetrics and Gynaecology, Nnamdi Azikiwe Univeristy Teaching Hospital Nnewi Nigeria
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor ILIKA CHITO PACHELLA DEPARTMENT OF OBSTETRICS AND GYNAECOLOGY NNAMDI AZIKIWE UNIVERSITY TEACHING HOSPITAL, NNEWI ANAMBRA Nigeria Individual
COLLABORATORS
Name Street address City Postal code Country
Prof. Joseph Ikechebelu DEPARTMENT OF OBSTETRICS AND GYNAECOLOGY, NNAMDI AZIKIWE UNIVERSITY TEACHING HOSPITAL, NNEWI Nigeria
Dr George Uchenna Eleje DEPARTMENT OF OBSTETRICS AND GYNAECOLOGY, NNAMDI AZIKIWE UNIVERSITY TEACHING HOSPITAL NNEWI Nigeria
Dr Chiemeka Michael Emeka DEPARTMENT OF OBSTETRICS AND GYNAECOLOGY, NNAMDI AZIKIWE UNIVERSITY TEACHING HOSPITAL NNEWI Nigeria
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator CHITO ILIKA pacla15@yahoo.com +2348032017499 DEPARTMENT OF OBSTETRICS AND GYNAECOLOGY NNAMDI AZIKIWE UNIVERSITY TEACHING HOSPITAL,
City Postal code Country Position/Affiliation
NNEWI Nigeria SENIOR REGISTRAR
Role Name Email Phone Street address
Public Enquiries Joseph Ikechebelu jikechebelu@yahoo.com +2348034044189 DEPARTMENT OF OBSTETRICS AND GYNAECOLOGY NNAMDI AZIKIWE UNIVERSITY TEACHING HOSPITAL
City Postal code Country Position/Affiliation
NNEWI Nigeria Professor
Role Name Email Phone Street address
Scientific Enquiries GEORGE ELEJE georgel21@yahoo.com +2348068117444 DEPARTMENT OF OBSTETRICS AND GYNAECOLOGY NNAMDI AZIKIWE UNIVERSITY TEACHING HOSPITAL
City Postal code Country Position/Affiliation
NNEWI Nigeria SENIOR LECTURER
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes RESEARCH PROFORMA EFFECTS OF SPECULUM LUBRICATION ON CERVICAL SMEARS FOR CERVICAL CANCER SCREENING IN NNEWI: A RANDOMIZED CONTROLLED STUDY Please do fill the parameters below. Tick [X] where appropriate. Code No………Folder Number………………Date of Enrolment…………… PARTICIPANT INFORMATION SECTION A. ELIGIBILITY CHECK LIST: A subject is not eligible if the answer to any of these is YES 1. Menstruating YES [ ] NO [ ] 2. Pregnant YES [ ] NO[ ] 3. Cervical cancer patient YES [ ] NO [ ] 4. Vulvar lesion or malignancy YES [ ] NO[ ] 5. History of cervical or vulvar surgeries YES [ ] NO[ ] 6. Hormone therapy YES [ ] NO[ ] 7. Vaginitis YES [ ] NO[ ] B. BIODATA 1. AGE AS AT LAST BIRTHDAY(YEARS)………25-30 [ ] 31-40 [ ] 41-50 [ ] >50 [ ] 2. PARITY: P0 [ ] P1 [ ] P2 [ ] P3 [ ] P4 [ ] P5 [ ] P>5 [ ] 3. MARITAL STATUS: SINGLE [ ] MARRIED [ ] DIVORCED/SEPARATED [ ] WIDOWED [ ] 4. EDUCATIONAL STATUS: NO EDUCATION [ ] PRIMARY [ ] SECONDARY [ ] TERTIARY [ ] 5. RELIGION: CHRISTIANITY [ ] ISLAM [ ] TRADITIONAL [ ] 6. OCCUPATION……………………………………… 7. ETHNICITY: IGBO [ ] HAUSA [ ] YORUBA [ ] OTHERS Specify…… C. SMEAR SAMPLE STATUS SATISFACTORY [ ] UNSATISFACTORY [ ] UNSATISFACTORY( SPECIFY REASON)……………… D. PAP SMEAR RESULT: HSIL [ ] LSIL [ ] ASCUS [ ] ASC-H[ ] BCC [ ] NORMAL LIMIT[ ] INFECTION/CERVICITIS [ ] E. NUMERIC RATING SCALE- what number best describes your pain during the procedure 0 [ ] 1[ ]2 [ ] 3 [ ]4[ ]5 [ ] 6 [ ]7 [ ] 8 [ ] 9[ ]10 [ ] (where 0 is No pain and 10 worst possible pain) F. SATISFIED WITH PAP SMEAR PROCEDURE: YES [ ] NO [ ] G. ARE YOU WILLING TO COME FOR REPEAT TESTING IN THE FUTURE: YES [ ] NO [ ] Informed Consent Form 1 Year On request
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
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