Comparative Safety and Efficacy of Vaginal Misoprostol Versus Lidocaine-prilocaine Cream in Levonorgestrel IUD Insertion
Study Details
Study Description
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
Condition or Disease | Intervention/Treatment | Phase |
---|---|---|
|
Phase 3 |
Study Design
Arms and Interventions
Arm | Intervention/Treatment |
---|---|
Experimental: 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 |
Drug: vaginal misoprostol
vaginal misoprostol 200 mcg will be given 3 hours before LNG-IUD insertion plus inert placebo cream vaginally at the time of LNG-IUD insertion
|
Active Comparator: lidocaine prilocaine 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 |
Drug: Lidocaine-Prilocaine Topical cream
Lidocaine-Prilocaine cream will be applied on the cervix at the time of LNG-IUD insertion plus vaginal placebo tablet 3 hours before LNG-IUD insertion
|
Placebo Comparator: 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 |
Drug: placebo
inert placebo cream will be applied on the cervix at the time of LNG-IUD insertion plus vaginal placebo tablet 3 hours before LNG-IUD insertion
|
Outcome Measures
Primary Outcome Measures
- 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
- duration of insertion [5 minutes]
duration of LNG-IUD insertion from speculum in to speculum out
Eligibility Criteria
Criteria
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
Contacts and Locations
Locations
Site | City | State | Country | Postal Code | |
---|---|---|---|---|---|
1 | Ahmedsamy | Giza | Egypt | 12511 |
Sponsors and Collaborators
- Cairo University
Investigators
- Study Director: ahmed taher, MD, Cairo University
- Principal Investigator: sherif dahab, MD, Cairo University
- Principal Investigator: tarek el husseiny, Cairo University
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- misoprostol vs LP cream