Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| GF | Experimental | Women who have a GyneFix Viz inserted |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| GyneFix Viz | Device | insertion of GyneFix Viz and measurment of the SA distance |
|
| Measure | Description | Time Frame |
|---|---|---|
| Serosal-anchor Measurement | endovaginal ultrasound measurement of the distance from the anchor of the device and the serosal surface of the uterus | 6-8 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Complications | Number of participants with complications and removals at the end of the 5-year follow-up period | 5 years |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Ellen R WIEBE, MD | University of BC | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Willow Women's Clinic | Vancouver | British Columbia | V5Z1H9 | Canada |
Not provided
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Women Who Enrolled to Have a GyneFix Viz Inserted | GyneFix Viz: insertion of GyneFix Viz and measurment of the SA distance |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary Outcome SA Measurment |
|
| ||||||||||||||||||
| Follow-up |
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Women Enrolled to Have GF Inserted | All women requesting a GF and eligible for insertion who signed the informed consent document. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Serosal-anchor Measurement | endovaginal ultrasound measurement of the distance from the anchor of the device and the serosal surface of the uterus | Posted | Mean | Standard Deviation | mm | 6-8 weeks |
|
|
Not provided
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Women Who Have a GyneFix Viz Inserted | GyneFix Viz: insertion of GyneFix Viz and measurment of the SA distance |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| perforation | Reproductive system and breast disorders | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| expulsion | Reproductive system and breast disorders | Systematic Assessment | IUD expulsion |
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Ellen Wiebe | principal investigator | 6047095611 | ellenwiebe@gmail.com |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
|
| Secondary | Complications | Number of participants with complications and removals at the end of the 5-year follow-up period | Posted | Count of Participants | Participants | 5 years |
|
|
|
| 0 |
| 1,012 |
| 9 |
| 1,012 |
| 180 |
| 1,012 |
| pregnancy | Reproductive system and breast disorders | Systematic Assessment |
|
| too much bleeding | Reproductive system and breast disorders | Systematic Assessment |
|
| too much pain | Reproductive system and breast disorders | Systematic Assessment |
|
| vaginal discharge | Reproductive system and breast disorders | Systematic Assessment |
|
Not provided
Not provided
| Removed to conceive |
|
| Removed because no longer needed |
|
| Removed because >5 years |
|
| Removed due to symptoms and other reasons |
|
| Removed, missing reason |
|
| GyneFix in place |
|
| Missing |
|