RAPID EC - Rct Assessing Pregnancy With Intrauterine Devices for EC

Contraception Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02175030
• Other study ID #: 73554
• Status: Completed
• Phase: Phase 4
• Start date: August 2016
• Est. completion date: December 2020

Study information

• Verified date: June 2022
• Source: University of Utah
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 711
• Est. completion date: December 2020
• Est. primary completion date: February 2020
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 35 Years

Eligibility

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

Related Conditions & MeSH terms

• Contraception

Intervention

Drug:
• Copper IUD
Randomization to copper/Paragard IUD for emergency contraception
• Levonorgestrel IUD
Randomization to Levonorgestrel/Mirena IUD for emergency contraception

Locations

Country	Name	City	State
United States	Planned Parenthood Association of Utah	Logan	Utah
United States	Planned Parenthood Association of Utah	Ogden	Utah
United States	Planned Parenthood Association of Utah	Orem	Utah
United States	Planned Parenthood Association of Utah	Salt Lake City	Utah
United States	Planned Parenthood Association of Utah	South Jordan	Utah
United States	Planned Parenthood Association of Utah	West Valley City	Utah

Sponsors (1)

Lead Sponsor	Collaborator
University of Utah

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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