Cervical Swede score screening by colposcope and the Gynocular

• Register: ISRCTN
• Last refreshed on: 17 October 2016
• Main ID: ISRCTN53264564
• Date of registration: 20/01/2014
• Prospective Registration: No
• Primary sponsor: Gynius AB (Sweden)
• Public title: Cervical Swede score screening by colposcope and the Gynocular
• Scientific title: The Bangladesh Swede score Gynocular clinical trial
• Date of first enrolment: 01/06/2012
• Target sample size: 540
• Recruitment status: Completed
• URL: http://isrctn.com/ISRCTN53264564
• Study type: Interventional
• Study design: Crossover randomized clinical trial (Screening)

Countries of recruitment

Bangladesh

Contacts

• Name: Ashrafun Nessa

Key inclusion & exclusion criteria

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

Age minimum:
Age maximum:
Gender: Female

Health Condition(s) or Problem(s) studied

Cervical screening Colposcopy Swede score
Urological and Genital Diseases

Intervention(s)

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.

Primary Outcome(s)

Compare if a hand-held colposcope, the Gynocular, could detect cervical lesions equal to a stationary colposcope

Secondary Outcome(s)

To evaluate the performance of Swede score to detect cervical lesions in VIA-positive women, and detection rates of HPV

Secondary ID(s)

N/A

Source(s) of Monetary Support

Gynius AB (Sweden), H&M Conscious Foundation (Sweden)