Same Day Oral EC and Implant Initiation

Utah System of Higher Education (USHE)

Status: Completed

Conditions: Contraception

Treatments: Device: Etonogestrel contraceptive implant with oral levonorgestrel; Device: Copper T380A intrauterine device; Device: Levonorgestrel intrauterine device

Study type: Observational

Funder types: Other

Identifiers

NCT04678817

137011

Details and patient eligibility

About

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.

Full 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.

Enrollment: 306 patients

Sex: Female

Ages: 18 to 35 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Healthy women
• Age 18-35 years
• Fluent in English and/or Spanish
• BMI < 30 kg/m2
• No known contraindication to either the ENG contraceptive implant or oral LNG EC using the CDC Medical Eligibility Criteria for Contraceptive Use 2016
• Negative urine pregnancy test
• Willing to abstain from further UPI in the 7 days following insertion
• Know the date of their last menstrual period
• Regular menstrual cycle (24-35 days)
• Be willing to comply with the study requirements
• Desiring to avoid pregnancy for at least 12 months

Exclusion criteria

• Current pregnancy or breastfeeding
• Previous use of oral EC in the current cycle
• Report of UPI beyond 5 days in current cycle
• Vaginal bleeding of unknown etiology
• Allergy to LNG or ENG, IUD or implant in-place
• History of permanent contraception through sterilization or hysterectomy
• Monogamous partner with a vasectomy
• Depo-provera injection within past 15 weeks

Trial design

306 participants in 3 patient groups

Etonogestrel contraceptive implant with oral levonorgestrel

Description:

Participants who select the Etonogestrel implant with oral levonorgestrel for emergency contraception

Treatment:

Device: Etonogestrel contraceptive implant with oral levonorgestrel

Levonorgestrel intrauterine device

Description:

Participants who select the levonorgestrel intrauterine device for emergency contraception

Treatment:

Device: Levonorgestrel intrauterine device

Copper T380A intrauterine device

Description:

Participants who select the Copper T380A intrauterine device for emergency contraception

Treatment:

Device: Copper T380A intrauterine device