Condition category
Urological and Genital Diseases
Date applied
13/09/2013
Date assigned
20/01/2014
Last edited
03/07/2015
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

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

Trial website

Contact information

Type

Scientific

Primary contact

Prof Ashrafun Nessa

ORCID ID

Contact details

Department of Obstetrics and Gynecology
Bangabandhu Sheikh Mujib Medical University Hospital (BSMMU)
Shabag
Dhaka
1000
Bangladesh

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N/A

Study information

Scientific title

The Bangladesh Swede score Gynocular clinical trial

Acronym

Study hypothesis

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

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)

Study design

Crossover randomized clinical trial

Primary study design

Interventional

Secondary study design

Randomised cross over trial

Trial setting

Hospitals

Trial type

Screening

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

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

Phase

Drug names

Primary outcome measures

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 trial start date

01/06/2012

Overall trial end date

15/09/2013

Reason abandoned

Eligibility

Participant 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

Participant type

Patient

Age group

Adult

Gender

Female

Target number of participants

540

Participant exclusion criteria

1. Ongoing vaginal bleeding
2. Any previous gynecological examinations for at least one week before
3. Pregnancy

Recruitment start date

01/06/2012

Recruitment end date

15/09/2013

Locations

Countries of recruitment

Bangladesh

Trial participating centre

Bangabandhu Sheikh Mujib Medical University Hospital (BSMMU)
Dhaka
1000
Bangladesh

Sponsor information

Organisation

Gynius AB (Sweden)

Sponsor details

Döbelnsgatan 40
Stockholm
111 40
Sweden

Sponsor type

Industry

Website

Funders

Funder type

Industry

Funder name

Gynius AB (Sweden)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

H&M Conscious Foundation (Sweden)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

2014 results in: http://www.ncbi.nlm.nih.gov/pubmed/25366674

Publication citations

Additional files

Editorial Notes