Surveillance Study of the Contraceptive Intrauterine Device UT380® (CCDDIUUT)

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

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

Study Overview

• Status: Recruiting
• Conditions: Contraceptive; Complications, Intrauterine

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.

• Study Type: Observational
• Enrollment (Anticipated): 200

Contacts and Locations

• Study Contact: Name: GHADRI RAMAZ, Doctor; Phone Number: 02 38 22 65 55; Email: GHADRI@RAMAZ.com

Study Locations

• France
  • Rueil-Malmaison, France, 92500
    • Recruiting
    • Quanta Medical
    • Contact: QUANTA MEDICAL

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

• Sampling Method: Probability Sample

Study Population

The patients will be recruited in France city privates practicing gynaecologist.

Description

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®

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Quanta Medical
• Collaborators: Prodimed S.A.; CCD

Study record dates

Study Major Dates

• Study Start (Actual): July 26, 2018
• Primary Completion (Anticipated): July 16, 2024
• Study Completion (Anticipated): July 16, 2024

Study Registration Dates

• First Submitted: July 16, 2018
• First Submitted That Met QC Criteria: August 20, 2018
• First Posted (Actual): August 22, 2018

Study Record Updates

• Last Update Posted (Actual): September 16, 2020
• Last Update Submitted That Met QC Criteria: September 15, 2020
• Last Verified: September 1, 2020

More Information

Terms related to this study

• Keywords: Contraception; Intrauterine Device; UT380
• Other Study ID Numbers: 2868

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No