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

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Contraception

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.

• Study Type: Observational
• Enrollment (Actual): 297

Contacts and Locations

• Study Contact: Name: Corinne Sexsmith; Phone Number: 801-213-2522; Email: corinne.sexsmith@hsc.utah.edu
• Study Contact Backup: Name: Marie Gibson; Phone Number: 801-213-2845; Email: marie.gibson@hsc.utah.edu

Study Locations

• United States
  • Utah
    • Salt Lake City, Utah, United States, 84102
      • Planned Parenthood Association of Utah
    • West Valley City, Utah, United States, 84119
      • Planned Parenthood Association of Utah

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 35 years (Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Probability Sample

Study Population

Study population will be recruited from participating Planned Parenthood of Utah clinics.

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pregnancy rate at one-month	To determine a point estimate for the one-month pregnancy rate following guideline supported same-day initiation of an etonogestrel (ENG) implant plus oral levonorgestrel (LNG) emergency contraception (EC).	one month
Comparing Proportions of EC clients desiring ENG implant with oral EC vs IUD	To determine the proportion of EC clients willing to initiate a same-day ENG implant with oral LNG EC compared to same-day initiation of intrauterine devices for EC.	2 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Continuation Rates	6- and 12-month continuation rates of the ENG implant with same-day initiation at an EC encounter.	6 and 12 months
Discontinuation Timing and Reasons	Timing and reasons for ENG implant discontinuation in the 12 months following same-day initiation at an EC encounter.	12 months

Collaborators and Investigators

• Sponsor: University of Utah
• Investigators: Principal Investigator: Lori Gawron, MD, University of Utah

Study record dates

Study Major Dates

• Study Start (Actual): January 15, 2021
• Primary Completion (Actual): May 15, 2023
• Study Completion (Estimated): January 1, 2025

Study Registration Dates

• First Submitted: December 16, 2020
• First Submitted That Met QC Criteria: December 16, 2020
• First Posted (Actual): December 22, 2020

Study Record Updates

• Last Update Posted (Estimated): November 14, 2023
• Last Update Submitted That Met QC Criteria: November 13, 2023
• Last Verified: November 1, 2023

More Information

Terms related to this study

• Keywords: emergency contraception; contraceptive implant
• Additional Relevant MeSH Terms: Pathologic Processes; Disease Attributes; Emergencies
• Other Study ID Numbers: 137011

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Individual participant data will not be available to share with other researchers.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No