NCT04678817

Same Day Oral EC and Implant Initiation

A Prospective Observational Study of Preference for and Efficacy of Oral Levonorgestrel Emergency Contraception With Same Day Etonogestrel Contraceptive Implant Compared to Established Pregnancy Rates With Oral Levonorgestrel Emergency Contraception Alone

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 306 (actual)
• Sponsor: University of Utah · Academic / Other
• Sex: Female
• Age: 18 Years – 35 Years
• Healthy volunteers: Not accepted

Summary

This is a study for clients presenting for emergency contraception (EC). EC is used to prevent pregnancy after unprotected intercourse. Clients presenting for EC may be offered either the copper or hormonal IUD or oral EC. Current guidelines allow for same-day implant initiation at the time of an EC encounter, as long as oral LNG EC is co-administered. This study will look at pregnancy rates and clients willingness to receive same-day implant + oral EC and same-day IUDs.

Detailed description

Recommended options for EC include oral EC (levonorgestrel (LNG), ulipristal acetate (UPA), or combination oral contraceptive pills), or the copper intrauterine device (IUD). Recent data will also allow women presenting for EC to be offered the LNG IUD. These recommendations leave out the only other long-acting reversible contraceptive (LARC), the ENG implant. Current guidelines allow for same-day ENG implant initiation at the time of an EC encounter, as long as oral LNG EC is co-administered. We lack data on pregnancy risk for the EC-eligible population desiring same-day ENG implant placement and oral EC. Women presenting for EC often need ongoing contraception, but clinical practice is not standardized in same-day counseling and initiation due to system, provider, and client-level barriers. Interest in LARC use continues to increase as well as same-day contraception initiation at the time of an EC encounter. Women presenting for EC may not have considered LARC options before. Generating estimates and continuation rates for same-day initiation with an EC encounter will improve contraceptive options for women seeking EC.

Conditions

• Contraception

Interventions

Type	Name	Description
DEVICE	Etonogestrel contraceptive implant with oral levonorgestrel	Participants who present for emergency contraception and select the Etonogestrel contraceptive implant with oral levonorgestrel
DEVICE	Levonorgestrel intrauterine device	Participants who present for emergency contraception and select the Levonorgestrel intrauterine device
DEVICE	Copper T380A intrauterine device	Participants who present for emergency contraception and select the Copper T380A intrauterine device

Timeline

• Start date: 2021-02-17
• Primary completion: 2023-04-27
• Completion: 2024-03-15
• First posted: 2020-12-22
• Last updated: 2025-04-15
• Results posted: 2025-04-15

Locations

2 sites across 1 country: United States