Comparison between two ablative techniques for treatment of symptomatic cervical ectopy
Phase 4
- Conditions
- Health Condition 1: N86- Erosion and ectropion of cervix uteri
- Registration Number
- CTRI/2020/03/024208
- Lead Sponsor
- niversity College of Medical Sciences and Guru Teg Bahadur Hospital
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Yet Recruiting
- Sex
- Not specified
- Target Recruitment
- 0
Inclusion Criteria
Women of reproductive age group (18-49 years) having symptoms of persistent vaginal discharge, backache, intermenstrual bleeding, postcoital bleeding and showing cervical ectopy on per-speculum examination.
Exclusion Criteria
- Cervical intraepithelial neoplasia (CIN)
- Acute cervicitis
- Nulliparity
- Pregnancy
- Pelvic inflammatory disease (PID)
- Women on hormonal contraception
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 1. Efficacy <br/ ><br>a) Post-procedure, remission of symptoms at 8 and 12 weeks in following groups:- <br/ ><br>i) 0-25% <br/ ><br>ii) 25-50% <br/ ><br>iii) 50-75% <br/ ><br>iv) 75-100% <br/ ><br>b) Recurrence of symptoms at 12 weeks <br/ ><br>c) Cure rate (healing of lesion on per speculum examination) <br/ ><br>Partial cure and complete cure at 8 and 12 weeksTimepoint: 8 and 12 weeks
- Secondary Outcome Measures
Name Time Method 1) Feasibility <br/ ><br>- Number of cases where procedure could not be done <br/ ><br>- Difficulties encountered <br/ ><br>2) Acceptability and Safety <br/ ><br>- Pain and discomfort during or after the procedure <br/ ><br>- Bleeding during or after the procedure <br/ ><br>- Any reaction such as fainting, dizziness, nausea during the procedureTimepoint: During the procedure