IUD Insertion Complication
Conditions
Brief summary
To compare the effect of vaginal dinoprostone versus vaginal misoprostol administered before the copper intrauterine device(IUD) insertion in reducing IUD inertion pain and the difficulty in inserting the IUD in nulliparous 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) inserted by the study nurse 3hours before IUD insertion.
DRUGMisoprostol
1 vaginal tablet of misoprostol (200mcg) (Misotac®; Sigma Pharma, SAE, Egypt) inserted by the study nurse 3 hours before IUD insertion.
DRUGplacebo
one tablet of placebo inserted by the study nurse 3 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 No maximum
Healthy volunteers
No
Inclusion criteria
* nulliparous women requesting copper IUD insertion
Exclusion criteria
* pregnancy, Parous women, contraindications or allergy to dinoprostone or misoprostol,contraindication to IUD insertion, untreated active cervicitis or vaginitis, undiagnosed abnormal uterine bleeding
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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| the difference in pain scores during tenaculum application | 10 minutes | The difference in pain scores during tenaculum application using a visual analog scale from 0 to 10 |
| the difference in pain scores during sound insertion | 10 minutes | The difference in pain scores during sound insertion using a visual analog scale from 0 to 10 |
| the ease of IUD insertion | 10 minutes | the ease of IUD insertion using ease of insertion score from 0 to 10 cm (0 = very easy insertion, 10 cm = terribly difficult insertion) |
| women's satisfaction level | 10 minutes | women's satisfaction level using satisfaction score from 0 to 10 cm where 0 denotes no satisfaction and 10 denotes maximum satisfaction |
Countries
Egypt
Outcome results
None listed