Surveillance Study of the Contraceptive Intrauterine Device UT380®

Study Overview
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Brief Summary
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The study is a long term Post Market Surveillance Study involving women who will received UT 380® device as a contraceptive method.

Detailed Description
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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.

Official Title
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A Post Market Surveillance Study of the Performance and Safety of UT 380® Contraceptive Intra Uterine Device in Nulliparous, Uniparous and Multiparous Women

Conditions
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Contraceptive; Complications, Intrauterine

Participation Criteria
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Eligibility Criteria
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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®

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Unintended pregnancy rate | Unintended pregnancy rate | 5 years | 
| Device expulsion rate | Device expulsion rate | 5 years | 
| Discontinuation rate | Discontinuation rate | 5 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Extra uterine pregnancy rate | Extra uterine pregnancy rate | 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) | 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) | 5 years | 
| Assessment of patients satisfaction regarding the use of the UT 380® using 5 points likert scale (1: not at all satisfied 5: very satisfied) | 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) | 5 years | 
| 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 | 
| Removal rate of the UT380® due to any other personal reason |  | 5 years | 
| Removal rate of the UT380® due to investigator decision |  | 5 years | 
| Safety data such as uterin perforation | Uterin perforation rate | 5 years | 
| Safety data such as any issue occurring immediately after the implantation of the device | Rate of issue occurring immediately after the implantation of the device | 5 years | 
| Safety data such as any issue occurring between two visits: Abdominopelvic or uterine pain outside the menstrual cycle, bleeding, | Rate of issue occurring between two visits | 5 years | 
| Safety data such as any issue during the device removal (such as pain, breaking device, excessive pulling force…) | Rate of issue during the device removal | 5 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Contraception, Intrauterine Device, UT380