Contraception
Conditions
Brief summary
Long-acting reversible contraception methods are highly effective methods for reduction of the unplanned pregnancy rate worldwide. The intrauterine device is a single procedure that provides reliable, effective and long term contraception for many women. However, the insertion procedure can be associated with a troublesome degree of pain that prevent some women from choosing its use. Different interventions have been described to decrease pain perception during intrauterine device insertion with no agreement on an effective one. Pre-insertion oral ibuprofen, diclofenac, nitroprusside, local anesthetics as lidocaine and prostaglandins has been reported with variable degrees of success .
Interventions
DRUGlidocaine gel
syringe filled with 5 ml gel to be self-administered vaginal 10 minutes prior to insertion
DRUGplacebo gel
syringe filled with 5 ml gel to be self-administered vaginal 10 minutes prior to insertion
Sponsors
Assiut University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 49 Years
Healthy volunteers
No
Inclusion criteria
* Non-pregnant women * Women that did not receive any analgesics or misoprostol in the 24 hours prior to insertion * Women who delivered only by caesarean section
Exclusion criteria
* Women with any uterine abnormalities as congenital anomalies, endometrial lesions, adenomyosis, fibroids * Those with a Category 3 or 4 conditions for intrauterine device insertion according to the WHO Medical Eligibility Criteria for contraceptive use * Allergy to lidocaine. * Women refuse to participate in the study
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The difference in pain scores during intrauterine device insertion | 10 minutes | using visual analog scale from 0 to 10 |
Countries
Egypt
Outcome results
None listed