Clinical trial NCT04678817: Same Day Oral EC and Implant Initiation
Official title: 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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Contraception
Keywords: emergency contraception
contraceptive implant
Lead sponsor: University of Utah
Sponsor class: OTHER
First posted: 2020-12-22
Enrollment: 306
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Study population will be recruited from participating Planned Parenthood of Utah clinics.

Brief 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.

Eligibility criteria: 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

Primary outcomes:
measure: Pregnancy Rate at One-month
timeFrame: one month
measure: Comparing Proportions of EC Clients Desiring ENG Implant With Oral EC vs IUD
timeFrame: 2 years
Secondary outcomes:
measure: Continuation Rate
timeFrame: 12 months
measure: Discontinuation Rate and Reasons
timeFrame: 12 months
Other outcomes:
Locations:
city: Salt Lake City
country: United States
facility: Planned Parenthood Association of Utah
state: Utah
city: West Valley City
country: United States
facility: Planned Parenthood Association of Utah
state: Utah
Study officials:
affiliation: University of Utah
name: Lori Gawron, MD
role: PRINCIPAL_INVESTIGATOR
References: