RAPID EC - Rct Assessing Pregnancy With Intrauterine Devices for EC
| Status: | Recruiting |
|---|---|
| Conditions: | Contraception, Contraception |
| Therapuetic Areas: | Reproductive |
| Healthy: | No |
| Age Range: | 18 - 35 |
| Updated: | 3/15/2019 |
| Start Date: | August 2016 |
| End Date: | December 2020 |
| Contact: | Marie Gibson |
| Email: | marie.gibson@hsc.utah.edu |
| Phone: | 801-213-2845 |
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.
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.
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.
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.
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 (24-35 days)
- Know their last menstrual period (+/-3 days)
- Be willing to comply with the study requirements
- Participants current preferred phone number must be functioning at the time of study
entry and will be tested prior to enrollment
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
We found this trial at
1
site
West Valley City, Utah 84119
Principal Investigator: David K Turok, MD
Phone: 801-213-2845
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