Clinical trial NCT02175030: RAPID EC - Rct Assessing Pregnancy With Intrauterine Devices for EC
Official title: RAPID EC - Randomized Controlled Trial Assessing Pregnancy With Intrauterine Devices for Emergency Contraception
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Contraception
Keywords: Emergency contraception
Levonorgestrel IUD
Copper IUD
Lead sponsor: University of Utah
Sponsor class: OTHER
First posted: 2014-06-26
Enrollment: 711
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

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

Primary outcomes:
measure: Percentage of Participants Reporting a Pregnancy
timeFrame: 1 month after enrollment
Secondary outcomes:
measure: Number of Participants With Unintended Pregnancy After Initiating the Levonorgestrel IUD Versus the Copper T380 IUD for EC at One Year.
timeFrame: 1 year after enrollment
Other outcomes:
Locations:
city: Logan
country: United States
facility: Planned Parenthood Association of Utah
state: Utah
city: Ogden
country: United States
facility: Planned Parenthood Association of Utah
state: Utah
city: Orem
country: United States
facility: Planned Parenthood Association of Utah
state: Utah
city: Salt Lake City
country: United States
facility: Planned Parenthood Association of Utah
state: Utah
city: South Jordan
country: United States
facility: Planned Parenthood Association of Utah
state: Utah
city: West Valley City
country: United States
facility: Planned Parenthood Association of Utah
state: Utah
Study officials:
affiliation: University of Utah
name: David Turok, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.