Clinical trial NCT03642171: Surveillance Study of the Contraceptive Intrauterine Device UT380®
Official title: A Post Market Surveillance Study of the Performance and Safety of UT 380® Contraceptive Intra Uterine Device in Nulliparous, Uniparous and Multiparous Women
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Contraceptive; Complications, Intrauterine
Keywords: Contraception
Intrauterine Device
UT380
Lead sponsor: Quanta Medical
Sponsor class: INDUSTRY
Collaborators: name: Prodimed S.A.
name: CCD
First posted: 2018-08-22
Enrollment: 200
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: The patients will be recruited in France city privates practicing gynaecologist.

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.

Eligibility criteria: 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®

Primary outcomes:
measure: Unintended pregnancy rate
timeFrame: 5 years
measure: Device expulsion rate
timeFrame: 5 years
measure: Discontinuation rate
timeFrame: 5 years
Secondary outcomes:
measure: Extra uterine pregnancy rate
timeFrame: 5 years
measure: Assessment of physicians satisfaction regarding the use of the UT380 using 5 points likert scale (1: not at all satisfied 5: very satisfied)
timeFrame: 5 years
measure: Assessment of patients satisfaction regarding the use of the UT 380® using 5 points likert scale (1: not at all satisfied 5: very satisfied)
timeFrame: 5 years
measure: Removal rate of the UT380® due to excessive bleeding
timeFrame: 5 years
measure: Removal rate of the UT380® due to pain
timeFrame: 5 years
measure: Removal rate of the UT380® due to pelvic inflammatory diseases
timeFrame: 5 years
measure: Removal rate of the UT380® due to other disease relevant in the contexte of the trial
timeFrame: 5 years
measure: Removal rate of the UT380® due to desired pregnancy
timeFrame: 5 years
measure: Removal rate of the UT380® due to any other personal reason
timeFrame: 5 years
measure: Removal rate of the UT380® due to investigator decision
timeFrame: 5 years
measure: Safety data such as uterin perforation
timeFrame: 5 years
measure: Safety data such as any issue occurring immediately after the implantation of the device
timeFrame: 5 years
measure: Safety data such as any issue occurring between two visits: Abdominopelvic or uterine pain outside the menstrual cycle, bleeding,
timeFrame: 5 years
measure: Safety data such as any issue during the device removal (such as pain, breaking device, excessive pulling force…)
timeFrame: 5 years
Other outcomes:
Locations:
city: Boulogne-Billancourt
country: France
facility: Quanta Medical
Study officials:
References: