RAPID EC - Rct Assessing Pregnancy With Intrauterine Devices for EC

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.

• Copper IUD (Drug), also known as Paragard IUD: Randomization to copper/Paragard IUD for emergency contraception
• Levonorgestrel IUD (Drug), also known as Mirena IUD, LNG20 IUD, Levonorgestrel IUD, Liletta IUD: Randomization to Levonorgestrel/Mirena IUD for emergency contraception

Primary outcomes

• Percentage of Participants Reporting a Pregnancy [1 month after enrollment]: 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.

Secondary outcomes

• Number of Participants With Unintended Pregnancy After Initiating the Levonorgestrel IUD Versus the Copper T380 IUD for EC at One Year. [1 year after enrollment]: Participants will be followed for pregnancies at regular intervals throughout the year and pregnancies will be recorded.

Sex: Female, ages: 18 Years to 35 Years

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

Participant flow

Outcome results

• Percentage of Participants Reporting a Pregnancy (Primary), Number, % of participants reporting pregnancy: Copper T380 IUD 0 (0 to 1.1); LNG20 IUD 0.3 (0.01 to 1.7)
• Number of Participants With Unintended Pregnancy After Initiating the Levonorgestrel IUD Versus the Copper T380 IUD for EC at One Year. (Secondary), Count of participants, Participants: Copper T380 IUD 7; LNG20 IUD 7

Adverse events

Time frame: Adverse event data was collected during the year of follow-up collectively and defined as all events requiring additional medical care in the first month of use of IUD.

Other adverse events by term

Limitations and caveats: This was a randomized trial. Implications for clinical care may vary when people choose their treatment options.

• Results publication: Kaiser JE, Turok DK, Gero A, Gawron LM, Simmons RG, Sanders JN. One-year pregnancy and continuation rates after placement of levonorgestrel or copper intrauterine devices for emergency contraception: a randomized controlled trial. Am J Obstet Gynecol. 2023 Apr;228(4):438.e1-438.e10. doi: 10.1016/j.ajog.2022.11.1296. Epub 2022 Nov 23. PMID 36427600
• Results publication: 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. PMID 34259467
• Results publication: 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. PMID 33706343
• Results publication: 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. PMID 33503342

• Study Protocol and Statistical Analysis Plan (PDF, 2022-01-10)
• Informed Consent Form (PDF, 2019-11-26)

• David Turok, MD, Principal investigator, University of Utah