IUD Insertion Pain
Conditions
Brief summary
To investigate whether vaginal dinoprostone administered before the levonorgestrel-releasing intrauterine system(IUs) insertion reduces IUD insertion pain and difficulty in insertion in adolescents and young women.
Detailed description
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.
Interventions
DRUGDinoprostone
1 vaginal tablet of dinoprostone (3mg) (prostin® E2, Pharmacia & Upjohn, Puurs, Belgium) self-inserted by the patient 12 hours before IUD insertion.
DRUGplacebo
one tablet of placebo self-inserted by the patient 12 hours before 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
Age
18 Years to 22 Years
Healthy volunteers
No
Inclusion criteria
* nulliparous adolescent and young women requesting levonorgestrel-releasing intrauterine device
Exclusion criteria
* pregnancy and contraindication or allergy to dinoprostone or contraindication to IUD insertion, chronic pelvic pain,pelvic inflammatory disease,analgesic intake 24 hours prior to IUD insertion.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The difference in pain scores during intrauterine device insertion | 10 minutes | The difference in pain scores during intrauterine device insertion using visual analog scale from 0 to 10 |
Countries
Egypt
Outcome results
None listed