Phase 4
Completed N=711
RAPID EC - Rct Assessing Pregnancy With Intrauterine Devices for EC
Source: ClinicalTrials.gov NCT02175030 ↗Enrolled (actual)
711
Serious AEs
0.0%
Results posted
Jun 2022
Primary outcomePrimary: Percentage of Participants Reporting a Pregnancy — 0; 0.3 % of participants reporting pregnancy
◆ Published Evidence
Highly cited
129citations · ~26 / year
Levonorgestrel vs. Copper Intrauterine Devices for Emergency Contraception.
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.
Linked Publications (4)
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Levonorgestrel vs. Copper Intrauterine Devices for Emergency Contraception.
-
Risk of Pregnancy With Levonorgestrel-Releasing Intrauterine System Placement 6-14 Days After Unprotected Sexual Intercourse.
-
Pregnancy Risk by Frequency and Timing of Unprotected Intercourse Before Intrauterine Device Placement for Emergency Contraception.
-
One-year pregnancy and continuation rates after placement of levonorgestrel or copper intrauterine devices for emergency contraception: a randomized controlled trial.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants Reporting a Pregnancy |
0; 0.3 | — |
| SECONDARY Number of Participants With Unintended Pregnancy After Initiating the Levonorgestrel IUD Versus the Copper T380 IUD for EC at One Year. |
7; 7 | — |
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
Data sourced from ClinicalTrials.gov (NCT02175030) and the linked publication. Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.