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Cervical Swede score screening by colposcope and the Gynocular

The Bangladesh Swede score Gynocular clinical trial

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN53264564
Enrollment
540
Registered
2014-01-20
Start date
2012-06-01
Completion date
Unknown
Last updated
2016-10-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cervical screening Colposcopy Swede score Urological and Genital Diseases

Interventions

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. Tho

Sponsors

Gynius AB (Sweden)
Lead Sponsor

Eligibility

Sex/Gender
Female

Inclusion 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

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

Design outcomes

Primary

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

Secondary

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

Countries

Bangladesh

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Mar 7, 2026