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Same Day Oral EC and Implant Initiation

Sponsor
University of Utah (Other)
Overall Status
Recruiting
CT.gov ID
NCT04678817
Collaborator
(none)
300
Enrollment
2
Locations
23.5
Anticipated Duration (Months)
150
Patients Per Site
6.4
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase

    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 Design

    Study Type:
    Observational
    Anticipated Enrollment :
    300 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    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
    Actual Study Start Date :
    Jan 15, 2021
    Anticipated Primary Completion Date :
    Jan 1, 2023
    Anticipated Study Completion Date :
    Jan 1, 2023

    Outcome Measures

    Primary Outcome Measures

    1. Pregnancy rate at one-month [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).

    2. Comparing Proportions of EC clients desiring ENG implant with oral EC vs IUD [2 years]

      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.

    Secondary Outcome Measures

    1. Continuation Rates [6 and 12 months]

      6- and 12-month continuation rates of the ENG implant with same-day initiation at an EC encounter.

    2. Discontinuation Timing and Reasons [12 months]

      Timing and reasons for ENG implant discontinuation in the 12 months following same-day initiation at an EC encounter.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 35 Years
    Sexes Eligible for Study:
    Female
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Planned Parenthood Association of Utah Salt Lake City Utah United States 84102
    2 Planned Parenthood Association of Utah West Valley City Utah United States 84119

    Sponsors and Collaborators

    • University of Utah

    Investigators

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

    Study Documents (Full-Text)

    More Information

    Publications

    None provided.
    Responsible Party:
    University of Utah
    ClinicalTrials.gov Identifier:
    NCT04678817
    Other Study ID Numbers:
    • 137011
    First Posted:
    Dec 22, 2020
    Last Update Posted:
    Apr 25, 2022
    Last Verified:
    Apr 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by University of Utah
    emergency contraception
    contraceptive implant
    Additional relevant MeSH terms:
    Emergencies

    Study Results

    No Results Posted as of Apr 25, 2022