Contraception
Conditions
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
Interventions
DRUGvaginal 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
DRUGLidocaine-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
DRUGplacebo
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
Sponsors
Cairo University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
FEMALE
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| duration of insertion | 5 minutes | duration of LNG-IUD insertion from speculum in to speculum out |
Countries
Egypt
Outcome results
None listed