Cervical Swede score screening by colposcope and the Gynocular
- Conditions
- Cervical screeningColposcopySwede scoreUrological and Genital Diseases
- Registration Number
- ISRCTN53264564
- Lead Sponsor
- Gynius AB (Sweden)
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Female
- Target Recruitment
- 540
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
1. Ongoing vaginal bleeding
2. Any previous gynecological examinations for at least one week before
3. Pregnancy
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Compare if a hand-held colposcope, the Gynocular, could detect cervical lesions equal to a stationary colposcope
- Secondary Outcome Measures
Name Time Method To evaluate the performance of Swede score to detect cervical lesions in VIA-positive women, and detection rates of HPV