Intrauterine devices (IUDs) are highly effective to prevent pregnancy when used for emergency contraception (following unprotected intercourse in the last 3 days), but data are lacking for people who desire an etonogestrel (ENG) contraceptive implant in this situation. This proposal will identify the most effective way to start an implant for emergency contraception using a randomized controlled trial comparing pregnancy risk between those receiving the implant vs. the implant plus oral emergency contraception (EC). Data from this project will inform clinical practice and add another option, the implant, for those desiring a long acting, highly effective contraceptive method when they present for emergency contraception.
Between 18-35 years old
Unprotected intercourse within 72 hours
Biologically capable of pregnancy (intact uterus without prior sterilization surgery
Fluent in English and/or Spanish
Current pregnancy (+urine pregnancy test in clinic)
Breastfeeding
Contraindication to ENG or LNG based on CDC MEC/SPR
Sterilization, hysterectomy, or has an IUD or contraceptive implant in place
Parallel
Etonogestrel implant with Oral Levonorgestrel emergency contraception 1.5mg
DrugSingle pill of oral levonorgestrel 1.5mg X 1 dose (e.g. Plan B) same day as contraceptive implant insertion
Etonogestrel implant with oral placebo
DeviceSingle pill of placebo same day as contraceptive implant insertion
Efficacy of the etonogestrel contraceptive implant with placebo for emergency contraception
Pregnancy rate = number of pregnancies / participants in the placebo arm
Efficacy of the etonogestrel contraceptive implant with placebo for emergency contraception by BMI category
Pregnancy rate = # of pregnancies / participants in the placebo arm stratified by BMI category
Efficacy of the etonogestrel contraceptive implant with oral levonorgestrel for emergency contraception
Pregnancy rate = # of pregnancies / participants in the oral levonorgestrel arm
Efficacy of the etonogestrel contraceptive implant with oral levonorgestrel for emergency contraception by BMI category
Pregnancy rate = # of pregnancies / participants in the oral levonorgestrel arm stratified by BMI category
Implant continuation
Participants continuing implant use at one month as a proportion of all participants having successful placement of implant at study entry. Measured by probabilities estimated using Kaplan-Meier approach.
Implant satisfaction
Likelihood of satisfaction by study group using ordinal regression. Measured by 5-point ordinal scale (5-point ordinal scale: (1) very unsatisfied, (2) unsatisfied, (3) neutral, (4) satisfied, (5) very satisfied). Measured by
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Lori Gawron
Lead sponsor
University of Utah
Sponsor institution
Planned Parenthood Association of Utah
Collaborator
