RAPID EC - Rct Assessing Pregnancy With Intrauterine Devices for EC

Study Overview
=================
Brief Summary
-----------------
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.

Detailed Description
-----------------
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.

Official Title
-----------------
RAPID EC - Randomized Controlled Trial Assessing Pregnancy With Intrauterine Devices for Emergency Contraception

Conditions
-----------------
Contraception

Intervention / Treatment
-----------------
* Drug: Copper IUD
* Drug: Levonorgestrel IUD


Participation Criteria
=================
Eligibility Criteria
-----------------
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 35 Years

Sexes Eligible for Study
-----------------
Female

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Copper T380 IUD<br>Randomized to copper T380 IUD for EC (emergency contraception) | Drug: Copper IUD<br>* Randomization to copper/Paragard IUD for emergency contraception<br>* Other names: Paragard IUD;|
| Active Comparator: LNG20 IUD<br>Randomized to LNG20 IUD for EC (emergency contraception) | Drug: Levonorgestrel IUD<br>* Randomization to Levonorgestrel/Mirena IUD for emergency contraception<br>* Other names: Mirena IUD, LNG20 IUD, Levonorgestrel IUD, Liletta IUD;|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of Participants Reporting a Pregnancy | Urine pregnancy tests within 30 days after IUD insertion will be performed either at home or in clinic. We will use the total number of pregnancies per ARM and the overall number of participants analyzed per ARM to calculate, for each ARM, the percentage of participants reporting a pregnancy in the first month of use of the IUD. | 1 month after enrollment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants With Unintended Pregnancy After Initiating the Levonorgestrel IUD Versus the Copper T380 IUD for EC at One Year. | Participants will be followed for pregnancies at regular intervals throughout the year and pregnancies will be recorded. | 1 year after enrollment | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Emergency contraception, Levonorgestrel IUD, Copper IUD