Comparative Safety and Efficacy of Vaginal Dinoprostone Versus Lidocaine-prilocaine Cream in Copper IUD Insertion in Nulliparous Women: a Randomized Controlled Trial
Overview
- Phase
- Phase 3
- Intervention
- vaginal dinoprostone
- Conditions
- Contraception
- Sponsor
- Cairo University
- Enrollment
- 210
- Primary Endpoint
- pain during IUD insertion: visual analog scale
- Last Updated
- 6 years ago
Overview
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
Investigators
Ahmed Samy aly ashour
assistant professor obstetrics and gynecology
Cairo University
Eligibility Criteria
Inclusion Criteria
- •nulliparous women requesting copper IUD insertion
Exclusion Criteria
- •multiparous women, active vaginal or cervical infections and contraindications to IUD Insertion.
Arms & Interventions
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.
Intervention: vaginal dinoprostone
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
Intervention: Lidocaine-prilocaine Cream
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
Intervention: placebo
Outcomes
Primary Outcomes
pain during IUD insertion: visual analog scale
Time Frame: 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 Outcomes
- duration of insertion(5 minutes)