Contraception
Conditions
Keywords
intrauterine device, contraception
Brief summary
The IUB (Intrauterine ball) is a copper releasing intrauterine contraceptive device consisting of copper beads on a flexible NiTinol wire. It was designed to reduce the pain and bleeding caused by traditional T-shaped copper IUDs and to reduce expulsions. In an initial pilot of 15 women, there were no complications during the 12 months. This observational pilot study of 50 women will determine that the early expulsion rate is not greater than 10% and that there is patient and physician acceptance, so that we can plan a larger randomized controlled trial for efficacy and safety.
Interventions
DEVICEIUB
intrauterine contraceptive device
Sponsors
Wiebe, Ellen, M.D.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
PREVENTION
Masking
NONE
Intervention model description
intrauterine contraceptive device IUB
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 50 Years
Healthy volunteers
Yes
Inclusion criteria
* requesting non-hormonal intrauterine contraception * able to return for ultrasound in 6-8 weeks
Exclusion criteria
* History of recent pelvic inflammatory disease * Known anemia * Dysfunctional uterine bleeding * Malignancy or suspected malignant disease of female inner or outer genitalia * Known intolerance or allergy to copper and/or copper IUDs * Any other significant disease or condition that could interfere with the subject's ability to complete the protocol * Pregnancy
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Expulsion Rate | at 6-8 weeks | The device being expelled from the uterus as documented by ultrasound or by seeing the actual device outside the uterus |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Complication | 12 months | infection, perforation, pregnancy |
| Acceptability | 12 months | patient-reported acceptability |
Countries
Canada
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| IUB Inserted There is one arm of women who will have IUBs inserted
IUB: intrauterine contraceptive device | 51 |
| Total | 51 |
Baseline characteristics
| Characteristic | IUB Inserted |
|---|---|
| Age, Continuous | 27 years |
| Sex: Female, Male Female | 51 Participants |
| Sex: Female, Male Male | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 15 / 51 |
| serious Total, serious adverse events | 0 / 51 |
Outcome results
Primary
Expulsion Rate
The device being expelled from the uterus as documented by ultrasound or by seeing the actual device outside the uterus
Time frame: at 6-8 weeks
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| IUB Inserted | Expulsion Rate | 9 participants |
Secondary
Acceptability
patient-reported acceptability
Time frame: 12 months
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| IUB Inserted | Acceptability | 15 participants |
Secondary
Complication
infection, perforation, pregnancy
Time frame: 12 months
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| IUB Inserted | Complication | 1 participants |