Contraception
Conditions
Keywords
intrauterine device, contraception
Brief summary
The GyneFix-Viz is a frameless copper intrauterine device (IUD) used for contraception. The GyneFix IUD has been marketed in Europe and Asia for about 10 years. The new anchor in the GyneFix IUD was designed to be more visible on ultrasound and this could improve safety by reducing failed insertions and perforations. We now need to know how easy it is for doctors to see and measure the distance of the anchor to the outside of the uterus. The purpose of this open, prospective, observational study is to assess the feasibility of measuring the distance from the serosa of the uterus to the anchor following insertion of the GyneFix-Viz and at follow-up 6-8 weeks later. Secondary objectives are to assess the ease and pain of insertion, the acceptability of the device to Canadian women and any complications. We will also compare expulsion rates in post-abortion and other women.
Interventions
DEVICEGyneFix Viz
insertion of GyneFix Viz and measurment of the SA distance
Sponsors
Wiebe, Ellen, M.D.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
16 Years to 50 Years
Healthy volunteers
Yes
Inclusion criteria
1. healthy women requesting intrauterine contraception 2. willing to have a GyneFix IUD for pregnancy prevention 3. able to return for a follow-up ultrasound 4. able to read and understand consent form
Exclusion criteria
1. Any contraindications precluding insertion of an IUD (e.g., infection, cancer of the uterus, malformation etc.) 2. Immediately after a pregnancy interruption \> 10 weeks gestation
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Serosal-anchor Measurement | 6-8 weeks | endovaginal ultrasound measurement of the distance from the anchor of the device and the serosal surface of the uterus |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Complications | 5 years | Number of participants with complications and removals at the end of the 5-year follow-up period |
Countries
Canada
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Women Enrolled to Have GF Inserted All women requesting a GF and eligible for insertion who signed the informed consent document. | 1,030 |
| Total | 1,030 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Follow-up | Lost to Follow-up | 32 |
| Primary Outcome SA Measurment | failed insertion | 18 |
Baseline characteristics
| Characteristic | Women Enrolled to Have GF Inserted |
|---|---|
| Age, Continuous | 28.7 years STANDARD_DEVIATION 6 |
| Region of Enrollment Canada | 1030 participants |
| Sex: Female, Male Female | 1030 Participants |
| Sex: Female, Male Male | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 1,012 |
| other Total, other adverse events | 180 / 1,012 |
| serious Total, serious adverse events | 9 / 1,012 |
Outcome results
Primary
Serosal-anchor Measurement
endovaginal ultrasound measurement of the distance from the anchor of the device and the serosal surface of the uterus
Time frame: 6-8 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Women Who Have a GyneFix Viz Inserted | Serosal-anchor Measurement | 6.2 mm | Standard Deviation 2.7 |
Secondary
Complications
Number of participants with complications and removals at the end of the 5-year follow-up period
Time frame: 5 years
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Women Who Have a GyneFix Viz Inserted | Complications | Explusion | 36 Participants |
| Women Who Have a GyneFix Viz Inserted | Complications | Perforation | 9 Participants |
| Women Who Have a GyneFix Viz Inserted | Complications | Pregnancy | 11 Participants |
| Women Who Have a GyneFix Viz Inserted | Complications | Removed to conceive | 97 Participants |
| Women Who Have a GyneFix Viz Inserted | Complications | Removed because no longer needed | 19 Participants |
| Women Who Have a GyneFix Viz Inserted | Complications | Removed because >5 years | 95 Participants |
| Women Who Have a GyneFix Viz Inserted | Complications | Removed due to symptoms and other reasons | 150 Participants |
| Women Who Have a GyneFix Viz Inserted | Complications | Removed, missing reason | 83 Participants |
| Women Who Have a GyneFix Viz Inserted | Complications | GyneFix in place | 420 Participants |
| Women Who Have a GyneFix Viz Inserted | Complications | Missing | 92 Participants |