Comparative Safety and Efficacy of Vaginal Misoprostol Versus Lidocaine-prilocaine Cream in Levonorgestrel IUD Insertion
Phase 3
Completed
- Conditions
- Contraception
- Interventions
- Registration Number
- NCT04339348
- Lead Sponsor
- Cairo University
- Brief Summary
the aim of the present study is to compare the safety and Efficacy of vaginal misoprostol versus Lidocaine-prilocaine cream in reducing pain during levonorgestrel IUD Insertion in women delivered only by cesarean deliveries
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 210
Inclusion Criteria
- women who delivered only by previous cesarean delivery and requesting LNG-IUD insertion
Exclusion Criteria
- women who delivered vaginally, active vaginal or cervical infections and contraindications to IUD insertion or study drugs
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description lidocaine prilocaine cream Lidocaine-Prilocaine Topical cream Lidocaine-prilocaine anesthetic cream will be placed on the cervix at the time of IUD insertion plus vaginal placebo will be given 3 hours before LNG-IUD insertion placebo placebo inert vaginal placebo cream will be placed on the cervix at the time of IUD insertion plus vaginal placebo tablet will be given 3 hours before LNG-IUD insertion vaginal misoprostol vaginal misoprostol vaginal misoprostol 200 mcg will be given 3 hours before LNG-IUD insertion plus vaginal inert placebo cream at the time of IUD insertion
- Primary Outcome Measures
Name Time Method pain during LNG-IUD insertion 5 minutes pain during LNG-IUD insertion evaluated by 10 cm visual analog scale where 0 denotes no pain and 10 denotes the worst imaginable pain
- Secondary Outcome Measures
Name Time Method duration of insertion 5 minutes duration of LNG-IUD insertion from speculum in to speculum out
Trial Locations
- Locations (1)
Ahmedsamy
🇪🇬Giza, Egypt