Surveillance Study of the Contraceptive Intrauterine Device UT380®

Quanta Medical200 enrolled

Overview

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

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.

Study Type

OBSERVATIONAL

Enrollment

200

Conditions

Contraceptive; Complications, Intrauterine

Eligibility

Sex: FEMALEMin age: 18 Years

Medical Language ↔ Plain English

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®

Locations (1)

Quanta Medical

Boulogne-Billancourt, France

Outcomes

Primary Outcomes

Unintended pregnancy rate

Time frame: 5 years

Device expulsion rate

Time frame: 5 years

Discontinuation rate

Time frame: 5 years

Secondary Outcomes

Extra uterine pregnancy rate

Time frame: 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)

Time frame: 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)

Time frame: 5 years

Removal rate of the UT380® due to excessive bleeding

Time frame: 5 years

Removal rate of the UT380® due to pain

Data from ClinicalTrials.gov

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