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

Phase 4

Completed

Interventions: Device: Levonorgestrel-releasing intrauterine device (LNG-IUS)
Device: Copper T380A intrauterine device (CuT380A)

Brief 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.

Detailed Description: 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.

Recruitment & Eligibility

Inclusion Criteria

Healthy, sexually active females age 14 to 18 who:

Exclusion Criteria

Sexually active females age over the age of 18 or who:

Arm && Interventions

Group	Intervention	Description
Mirena IUD [LNG-IUS]	Levonorgestrel-releasing intrauterine device (LNG-IUS)	Participants in this arm had a Levonorgestrel-releasing intrauterine device (LNG-IUS), also known as the Mirena IUD, inserted within the first 5 days of the adolescent's menstrual cycle, at least 7 weeks after a vaginal or cesarean delivery or second-trimester abortion or at least 3 weeks after a first-trimester abortion. For participants who had used depot-medroxyprogesterone acetate, insertions occurred at least 6 months after the participant's last injection. Participants were blinded to the device type; however, investigators and research assistants were not.
Paragard IUD [Copper T380A]	Copper T380A intrauterine device (CuT380A)	Participants in this arm had a Copper T380A intrauterine device (CuT380A), also known as the Paragard IUD, inserted within the first 5 days of the adolescent's menstrual cycle, at least 7 weeks after a vaginal or cesarean delivery or second-trimester abortion or at least 3 weeks after a first-trimester abortion. For participants who had used depot-medroxyprogesterone acetate, insertions occurred at least 6 months after the participant's last injection. Participants were blinded to the device type; however, investigators and research assistants were not.

Primary Outcome Measures

Name	Time	Method
Retention Rate	6 months	Percentage of participants who completed the final visit (i.e., not subject to early termination or loss to follow-up)

Secondary Outcome Measures

Name	Time	Method
Heavy Bleeding Rates	6 months	Rates of participants experiencing heavy bleeding among teens randomized to the LNG-IUS or Copper T 380A.
Pregnancy Rates	6 months	Proportion of subjects who became pregnant within 6 months of IUD insertion
Expulsion Rates	6 months	Rates of partial or complete expulsion for teens randomized to the LNG-IUS or Copper T 380A. Patients experiencing partial expulsion had IUDs visible on speculum exam. Complete expulsion is characterized by complete evacuation of the IUD.
Device Satisfaction Rates	6 months	Satisfaction rate is the proportion of subjects who report being "happy" or "very happy" with their assigned intrauterine contraceptive method on the date of their 6 month study visit.