Cervical Swede score screening by colposcope and the Gynocular
| ISRCTN | ISRCTN53264564 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN53264564 |
| Secondary identifying numbers | N/A |
- Submission date
- 13/09/2013
- Registration date
- 20/01/2014
- Last edited
- 03/07/2015
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Urological and Genital Diseases
Plain English summary of protocol
Background and study aims
A colposcope is a microscope which is adapted for vaginal examination and helps doctors to detect abnormal areas on the cervix that might harbour the early stages of cervical cancer. This study aims to find out if a battery-driven handheld colposcope, the Gynocular, is equally good at detecting cervical lesions as a stationary colposcope.
Who can participate?
Women referred for colposcopy at the Colposcopy Clinic of Bangabandhu Sheikh Mujib Medical University (BSMMU).
What does the study involve?
Participants were randomly allocated to one of two groups: the participants in Group 1 were screened using the Gynocular and the participants in Group 2 were screened using the stationary device. Participants then swapped over - those allocated to Group 1 were examined with the stationary colposcope and Group 2 were examined using the Gynocular. All women found to have cervical lesions were offered treatment at BSMMU.
What are the possible benefits and risks of participating?
Participating in the study involved no side effects. There were no risks of participating. If a women chose not to participate, she had a standard method of examination.
Where is the study run from?
The study ran from the Department of Colposcopy, BSMMU, Dhaka, Bangladesh.
When is the study starting and how long is it expected to run for?
The study started in June 2012 and ended in September 2013.
Who is funding the study?
The study was funded by Gynius AB (Sweden) and H&M Conscious Foundation (Sweden).
Who is the main contact?
Prof Ashrafun Nessa
ashra58@yahoo.co.uk
Contact information
Scientific
Department of Obstetrics and Gynecology
Bangabandhu Sheikh Mujib Medical University Hospital (BSMMU)
Shabag
Dhaka
1000
Bangladesh
Study information
| Study design | Crossover randomized clinical trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised cross over trial |
| Study setting(s) | Hospital |
| Study type | Screening |
| Participant information sheet | Not available in web format, please use the contact details below to request a patient information sheet |
| Scientific title | The Bangladesh Swede score Gynocular clinical trial |
| Study objectives | Cervical Swede score as an alternative cervical screening approach in low-resource settings by using a pocket-sized battery-driven colposcope, the Gynocular. |
| Ethics approval(s) | The study was approved by the local ethics committees in Bangladesh and in Sweden: 1. The Institutional Review Board of BSMMU (Dnr BSMMU/2012/3176) 2. Stockholm Regional Ethical Review Board (Dnr 2012/545-31/1) |
| Health condition(s) or problem(s) studied | Cervical screening Colposcopy Swede score |
| Intervention | Patients were randomized to two groups: Group 1 were examined with the hand-held colposcope, the Gynocular Group 2 were examined with a stationary colposcope Participants were then crossed over. Those randomized to Group 1 were examined with the stationary colposcope and Group 2 were examined using the Gynocular. Women who had a positive cytology or cervical biopsy with high-grade cervical dysplasia were offered treatment at BSMMU. |
| Intervention type | Device |
| Pharmaceutical study type(s) | |
| Phase | |
| Drug / device / biological / vaccine name(s) | |
| Primary outcome measure | Compare if a hand-held colposcope, the Gynocular, could detect cervical lesions equal to a stationary colposcope |
| Secondary outcome measures | To evaluate the performance of Swede score to detect cervical lesions in VIA-positive women, and detection rates of HPV |
| Overall study start date | 01/06/2012 |
| Completion date | 15/09/2013 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Female |
| Target number of participants | 540 |
| Key inclusion criteria | 1. Women positive for acetic acid (VIA) at opportunistic screening by trained family welfare visitors, senior staff nurses and doctors in the Dhaka region, Bangladesh, referred for colposcopy at the Colposcopy Clinic of Bangabandhu Sheikh Mujib Medical University (BSMMU). A women is considered to be VIA positive when a trained doctor or nurse noticed sharp, distinct, well defined, dense acetowhite areas on the cervix, with or without raised margins, close to the squamocolumnar junction (SCJ) in the transformation zone 6-9, 15. 2. Women signing an informed consent to participate in the study after receiving oral and written information from a social worker 3. Ability to understand written and oral information |
| Key exclusion criteria | 1. Ongoing vaginal bleeding 2. Any previous gynecological examinations for at least one week before 3. Pregnancy |
| Date of first enrolment | 01/06/2012 |
| Date of final enrolment | 15/09/2013 |
Locations
Countries of recruitment
- Bangladesh
Study participating centre
1000
Bangladesh
Sponsor information
Industry
Döbelnsgatan 40
Stockholm
111 40
Sweden
"ROR" |
https://ror.org/04ykj1118 |
|---|
Funders
Funder type
Industry
No information available
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 03/11/2014 | Yes | No |
