Effect of adding the second dose of sertaconazole 300mg vaginal ovule for treating pregnant women with acute vaginal candidiasis who were treated with a 300mg sertaconazole vaginal ovule: a randomized controlled trial
Phase 3
- Conditions
- -Pregnant women diagnosed with vaginal candidiasis-No immunocompromised conditionsertaconazole, second dose, pregnant
- Registration Number
- TCTR20220121004
- Lead Sponsor
- Pacific Health Care (Thailand)
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- nknown
- Sex
- Female
- Target Recruitment
- 110
Inclusion Criteria
1.Age 18 and more years
2.Pregnancy GA 20-34 weeks
3.Diagnosis with vaginal candidiasis by microscope
Exclusion Criteria
1.Abnormal uterine bleeding or abnormal vaginal discharge
2.Having at least 4 times in preceding year
3.Contraindication for imidazole such as liver disease, allergy
4.Cannot understand Thai
5.Being treated with imidazole in preceding month
6.Diabetes mellitus being on insulin
7.Immunocompromised condition
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Microscopic cure 2 weeks following treatment Examination under microscope
- Secondary Outcome Measures
Name Time Method Duration of symptom improvement 2weeks Questionnaire,Side effects and satisfaction 2weeks questionnaire