Contraceptive; Complications, Intrauterine
Conditions
Keywords
Contraception, Intrauterine Device, UT380
Brief summary
The study is a long term Post Market Surveillance Study involving women who will received UT 380® device as a contraceptive method.
Detailed description
Prospective data on contraceptive performance of the UT380® from a large number of women are not yet available. Here we describe a long term Post Market Surveillance Study involving women who will received UT 380® device as a contraceptive method. Reports of case series usually contain detailed information about the individual patients. This includes demographic information (e.g. age and gender) and information on diagnosis, treatment, response to treatment, follow-up after treatment and patients experience of the treatment. In addition, it also include the health care staff's experience of the use of the UT 380. The result of this study will be used for different purposes e.g. marketing activities such as posters, folders, or targeted journals and/or conferences.
Interventions
None listed
Sponsors
Prodimed S.A.
CCD
Quanta Medical
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Woman \> 18 years old * nulliparous, uniparous and multiparous * not currently using a contraceptive method or are willing to switch to a new reversible contraceptive * with an indication of implantation of a UT380® IUD * agreeing to participate in the study
Exclusion criteria
* Patient with risk of post implantation bleeding or high level of bleeding during menstruation period * Patient with a risk of infection * Patient that meet any of the absolute contraindication of UT 380® * Any other elements that the investigator may think relevant and cannot allow the use of UT380®
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Unintended pregnancy rate | 5 years | Unintended pregnancy rate |
| Device expulsion rate | 5 years | Device expulsion rate |
| Discontinuation rate | 5 years | Discontinuation rate |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Removal rate of the UT380® due to excessive bleeding | 5 years | — |
| Removal rate of the UT380® due to pain | 5 years | — |
| Removal rate of the UT380® due to pelvic inflammatory diseases | 5 years | — |
| Removal rate of the UT380® due to other disease relevant in the contexte of the trial | 5 years | — |
| Removal rate of the UT380® due to desired pregnancy | 5 years | — |
| Extra uterine pregnancy rate | 5 years | Extra uterine pregnancy rate |
| Removal rate of the UT380® due to investigator decision | 5 years | — |
| Safety data such as uterin perforation | 5 years | Uterin perforation rate |
| Safety data such as any issue occurring immediately after the implantation of the device | 5 years | Rate of issue occurring immediately after the implantation of the device |
| Safety data such as any issue occurring between two visits: Abdominopelvic or uterine pain outside the menstrual cycle, bleeding, | 5 years | Rate of issue occurring between two visits |
| Safety data such as any issue during the device removal (such as pain, breaking device, excessive pulling force…) | 5 years | Rate of issue during the device removal |
| Removal rate of the UT380® due to any other personal reason | 5 years | — |
| Assessment of physicians satisfaction regarding the use of the UT380 using 5 points likert scale (1: not at all satisfied 5: very satisfied) | 5 years | Physicians satisfaction regarding the use of the UT 380 will be assessed at post implantation visit (2 visits the fisrt year, and one visit per years during the following 4 years) using 5 points likert scale (1: not at all satisfied 5: very satisfied) |
| Assessment of patients satisfaction regarding the use of the UT 380® using 5 points likert scale (1: not at all satisfied 5: very satisfied) | 5 years | Patients satisfaction regarding the use of the UT 380® will be assessed at post implantation visit (2 visits the fisrt year, and one visit per years during the following 4 years) using 5 points likert scale (1: not at all satisfied 5: very satisfied) |
Countries
France
Outcome results
None listed