RAPID EC - Rct Assessing Pregnancy With Intrauterine Devices for EC

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

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.

Study Overview

• Status: Completed
• Conditions: Contraception
• Intervention / Treatment: Drug: Copper IUD; Drug: Levonorgestrel IUD

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.

• Study Type: Interventional
• Enrollment (Actual): 711
• Phase: Phase 4

Contacts and Locations

Study Locations

• United States
  • Utah
    • Logan, Utah, United States, 84321
      • Planned Parenthood Association of Utah
    • Ogden, Utah, United States, 84403
      • Planned Parenthood Association of Utah
    • Orem, Utah, United States, 84057
      • Planned Parenthood Association of Utah
    • Salt Lake City, Utah, United States, 84102
      • Planned Parenthood Association of Utah
    • South Jordan, Utah, United States, 84095
      • Planned Parenthood Association of Utah
    • West Valley City, Utah, United States, 84119
      • Planned Parenthood Association of Utah

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 35 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Copper T380 IUD; Randomized to copper T380 IUD for EC (emergency contraception)	Drug: Copper IUD; Randomization to copper/Paragard IUD for emergency contraception; Other Names: Paragard IUD
Active Comparator: LNG20 IUD; Randomized to LNG20 IUD for EC (emergency contraception)	Drug: Levonorgestrel IUD; Randomization to Levonorgestrel/Mirena IUD for emergency contraception; 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

Collaborators and Investigators

• Sponsor: University of Utah

Publications and helpful links

General Publications

• Boraas CM, Sanders JN, Schwarz EB, Thompson I, Turok DK. Risk of Pregnancy With Levonorgestrel-Releasing Intrauterine System Placement 6-14 Days After Unprotected Sexual Intercourse. Obstet Gynecol. 2021 Apr 1;137(4):623-625. doi: 10.1097/AOG.0000000000004118.
• BakenRa A, Gero A, Sanders J, Simmons R, Fay K, Turok DK. Pregnancy Risk by Frequency and Timing of Unprotected Intercourse Before Intrauterine Device Placement for Emergency Contraception. Obstet Gynecol. 2021 Jul 1;138(1):79-84. doi: 10.1097/AOG.0000000000004433.
• Turok DK, Gero A, Simmons RG, Kaiser JE, Stoddard GJ, Sexsmith CD, Gawron LM, Sanders JN. Levonorgestrel vs. Copper Intrauterine Devices for Emergency Contraception. N Engl J Med. 2021 Jan 28;384(4):335-344. doi: 10.1056/NEJMoa2022141.

Study record dates

Study Major Dates

• Study Start: August 1, 2016
• Primary Completion (Actual): February 1, 2020
• Study Completion (Actual): December 1, 2020

Study Registration Dates

• First Submitted: June 23, 2014
• First Submitted That Met QC Criteria: June 24, 2014
• First Posted (Estimate): June 26, 2014

Study Record Updates

• Last Update Posted (Actual): June 29, 2022
• Last Update Submitted That Met QC Criteria: June 27, 2022
• Last Verified: June 1, 2022

More Information

Terms related to this study

• Keywords: Emergency contraception; Copper IUD; Levonorgestrel IUD
• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Trace Elements; Micronutrients; Contraceptive Agents, Hormonal; Contraceptive Agents; Reproductive Control Agents; Contraceptives, Oral; Contraceptive Agents, Female; Contraceptives, Oral, Synthetic; Copper; Levonorgestrel
• Other Study ID Numbers: 73554

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No