RAPID EC - Rct Assessing Pregnancy With Intrauterine Devices for EC

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

711 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-08-31

Study Completion Date

2020-12-31

Brief Summary

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This study is a randomized trial of two IUDs for emergency contraception: the copper IUD, the most effective method of emergency contraception vs. the levonorgestrel IUD, the most preferred IUD which has never been tested as an emergency contraceptive. This research has the potential to increase use of highly effective contraception in a high-risk population and lower the persistently elevated rate of U.S. unintended pregnancy.

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Detailed Description

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Unintended pregnancy has multiple adverse effects on both maternal and child health. The United States continues to have one of the highest rates of unintended pregnancy among developed countries. To combat this problem, we are studying initiation of the highly effective intrauterine device (IUD) for women presenting for emergency contraception (EC). This is an ideal population to initiate highly effective reversible contraception (HERC) as they are at high risk of unintended pregnancy and are acting to reduce that risk. We have recently demonstrated significantly lower pregnancy rates 12 months after presenting for EC among women who selected the copper IUD versus those who selected oral Levonorgestrel (LNG).

Not only is the copper IUD the most effective method of EC, it is considered a top tier anticipatory contraception method and its ability to prevent pregnancy is on par with tubal sterilization (less than 1% in the first year with lower failure rates in subsequent years). However, women selecting intrauterine contraception have shown a strong preference for the LNG IUD. The LNG IUD, is as effective at preventing pregnancy as the Copper IUD, and has some non-contraceptive effects that many women see as benefits such as the reduction or elimination of menstrual bleeding and menstrual related discomfort. Of currently available reversible contraceptives, the LNG IUD has the highest levels of user satisfaction and continuation. However, its effectiveness as an emergency contraceptive remains unknown. A randomized control trial is necessary to assess the safety and efficacy of the LNG IUD as EC. Demonstrating the efficacy, safety, and acceptability of the LNG IUD for EC will improve options for women seeking EC and who desire a highly effective method of contraception.

Conditions

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Contraception

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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Copper T380 IUD

Randomized to copper T380 IUD for EC (emergency contraception)

Group Type ACTIVE_COMPARATOR

Copper IUD

Intervention Type DRUG

Randomization to copper/Paragard IUD for emergency contraception

LNG20 IUD

Randomized to LNG20 IUD for EC (emergency contraception)

Group Type ACTIVE_COMPARATOR

Levonorgestrel IUD

Intervention Type DRUG

Randomization to Levonorgestrel/Mirena IUD for emergency contraception

Interventions

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Copper IUD

Randomization to copper/Paragard IUD for emergency contraception

Intervention Type DRUG

Levonorgestrel IUD

Randomization to Levonorgestrel/Mirena IUD for emergency contraception

Intervention Type DRUG

Other Intervention Names

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Paragard IUD Mirena IUD, LNG20 IUD, Levonorgestrel IUD, Liletta IUD

Eligibility Criteria

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Inclusion Criteria

* Females between 18-35 years old
* In need of EC (had unprotected intercourse within 120 hours - 5 days)
* Desire to prevent pregnancy for 1 year
* Fluent in English and/or Spanish
* Have a regular menstrual cycle (21-35 days)
* Know their last menstrual period (+/-3 days)
* Be willing to comply with the study requirements
* Desire to initiate an IUD
* Negative urine pregnancy test

Exclusion Criteria

* Current pregnancy
* Breastfeeding
* Intrauterine infection within the past three months
* Sterilization
* Already have an IUD or contraception implant (Nexplanon) in place
* Vaginal bleeding of unknown etiology
* Known Gonorrhea or Chlamydia infection in the last 30 days (unless successfully treated at least 7 days prior to study entry)
* Known abnormalities of the uterus that distort the uterine cavity
* Allergy to copper
* Use of oral Emergency Contraception in the preceeding 5 days

Minimum Eligible Age

18 Years

Maximum Eligible Age

35 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No