Contraception
Conditions
Brief summary
the aim of this study is to compare the safety and Efficacy of Lidocaine Spray Versus Vaginal dinoprostone in relieving pain during levonorgestrel IUD Insertion in nulliparous women
Interventions
DRUGlidocaine spray
four puffs (50 ml, 10 mg/puff) of lidocaine spray before tenaculum placement plus vaginal placebo 3 hours before IUD insertion
vaginal dinoprostone 3 mg will be given 3 hours before IUD insertion plus four puffs of saline spray before tenaculum placement
DRUGplacebo
vaginal placebo will be given 3 hours before IUD insertion plus four puffs of saline spray before tenaculum placement
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 levonorgestrel IUD insertion
Exclusion criteria
* multiparous women, allergy or contraindication to study drugs or contraindications to LNG-IUD insertion
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| pain during IUD insertion | 2 minutes | pain during IUD insertion assessed by 10 cm visual analog scale where 0 denotes no pain and 10 denotes the worst pain imaginable |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| insertion duration | 5 minutes | duration of LNG-IUD insertion from speculum in to speculum out |
Contacts
Primary ContactAHMED SAMY
Outcome results
None listed