Contraception
Conditions
Keywords
Long Acting Reversible Contraception, Intrauterine Device (IUD), Intrauterine Device (IUD) Insertion, Family Planning, International Family Planning
Brief summary
This is a randomized controlled trial that compares traditional IUD insertion with that of a no uterine sound, no bimanual pelvic exam approach. The investigators hypothesis is that IUD placement is safe and effective without pre-procedural assessment of uterine size, direction, or depth.
Interventions
PROCEDURESimplified IUD Insertion
IUD Insertion with no bimanual pelvic exam or uterine sounding.
Sponsors
Stanford University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Women 18 years and older presenting to contraceptive clinic in Gaborone, Botswana for IUD insertion and have ability to give informed consent.
Exclusion criteria
* Known contradictions to copper IUD, inability to comply with study protocol
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Correct IUD Placement Immediately Post-Insertion | Immediately post-insertion | Percent of correct IUD placements between control (traditional IUD insertion) and experimental (simplified IUD insertion) groups at time of insertion as visualized by transvaginal ultrasound. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Correct IUD Placements 4-6 Weeks Post-Insertion | 4-6 weeks post-insertion | Percent of correct IUD placements between control (traditional IUD insertion) and experimental (simplified IUD insertion) groups at 4-6 weeks after insertion as visualized by transvaginal ultrasound. |
| Patient Satisfaction with IUD Insertion | Immediately Post-Insertion | Visual Analogue Scale (VAS) |
| Patient Pain Scores (VAS) | Immediately Post-Insertion | Visual Analogue Scale (VAS) |
Outcome results
None listed