Comparative Safety and Efficacy of Vaginal Dinoprostone Versus Lidocaine-prilocaine Cream in Copper IUD Insertion
Phase 3
- Conditions
- Contraception
- Interventions
- Registration Number
- NCT04340778
- Lead Sponsor
- Cairo University
- Brief Summary
the aim of the present study is to Compare Safety and Efficacy of Vaginal dinoprostone Versus Lidocaine-prilocaine Cream in copper IUD Insertion in nulliparous women: a randomized controlled trial
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- Female
- Target Recruitment
- 210
Inclusion Criteria
- nulliparous women requesting copper IUD insertion
Exclusion Criteria
- multiparous women, active vaginal or cervical infections and contraindications to IUD Insertion.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description vaginal dinoprostone vaginal dinoprostone vaginal dinoprostone 3 mg will be given 3 hours before copper IUD insertion plus inert placebo cream will be applied on the cervix at the time of IUD insertion. lidocaine prilocaine cream Lidocaine-prilocaine Cream Lidocaine-prilocaine Cream will be applied on the cervix at the time of copper IUD insertion plus vaginal placebo tablet 3 hours before IUD insertion placebo placebo inert placebo Cream will be applied on the cervix at the time of copper IUD insertion plus vaginal placebo tablet 3 hours before IUD insertion
- Primary Outcome Measures
Name Time Method pain during IUD insertion: visual analog scale 5 minutes pain during copper IUD insertion evaluated by 10 cm visual analog scale where 0 denotes no pain and 10 cm denotes the worst pain imaginable
- Secondary Outcome Measures
Name Time Method duration of insertion 5 minutes duration of insertion from speculum in to speculum out