Contraception
Conditions
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
Interventions
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 will be applied on the cervix at the time of IUD insertion plus vaginal placebo tablet will be given 3 hours prior to IUD insertion
DRUGplacebo
inert placebo Cream will be applied on the cervix at the time of IUD insertion plus vaginal placebo tablet will be given 3 hours prior to 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
* nulliparous women requesting copper IUD insertion
Exclusion criteria
* multiparous women, active vaginal or cervical infections and contraindications to IUD Insertion.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| duration of insertion | 5 minutes | duration of insertion from speculum in to speculum out |
Contacts
Primary ContactAHMED SAMY
Outcome results
None listed