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Maintaining Intrauterine Devices (IUDs) in Teens (MINT): A Randomization Trial

2014-07-24 14:18:10 | BioPortfolio

Summary

This is a pilot study to determine the feasibility for a randomized controlled trial of two forms of intrauterine contraception: the Levonorgestrel intrauterine system (LNG-IUS) and the Copper T 380A. Teenagers have the highest percentage of unintended pregnancies, and often struggle to comply with daily methods of contraception. The intrauterine device (IUD) provides safe, long-term protection and rates highly for patient satisfaction. It also does not require repeat prescriptions or clinic visits, making it a potentially attractive method among teens. However, in adolescent populations, there is both a lack of information about the IUD, as well as few studies that have examined the use of these devices. This study will examine whether a larger scale study on this topic is feasible. IT will address the feasibility of recruiting, consenting, screening, enrolling, randomizing, and retaining adolescents randomized to the LNG-IUS or Copper T 380a.

Study Design

Allocation: Randomized, Control: Active Control, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Conditions

Contraception

Intervention

Levonorgestrel-releasing intrauterine device (LNG-IUS) - Mirena IUD, Paraguard (Copper T380A)

Location

University of Chicago
Chicago
Illinois
United States
60637

Status

Completed

Source

University of Chicago

Results (where available)

View Results

Links

Published on BioPortfolio: 2014-07-24T14:18:10-0400

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PubMed Articles [3802 Associated PubMed Articles listed on BioPortfolio]

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Medical and Biotech [MESH] Definitions

The shifting in position or location of an INTRAUTERINE DEVICE from its original placement.

Intrauterine contraceptive devices that depend on the release of metallic copper.

Spontaneous loss of INTRAUTERINE DEVICES from the UTERUS.

Contraceptive devices placed high in the uterine fundus with a string extending from the device through the cervical as into the vagina. (UMDNS, 1999)

Unstable isotopes of copper that decay or disintegrate emitting radiation. Cu atoms with atomic weights 58-62, 64, and 66-68 are radioactive copper isotopes.

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