Contraception
Conditions
Keywords
emergency contraception, contraceptive implant
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.
Interventions
Participants who present for emergency contraception and select the Levonorgestrel intrauterine device
Participants who present for emergency contraception and select the Copper T380A intrauterine device
DEVICEEtonogestrel contraceptive implant with oral levonorgestrel
Participants who present for emergency contraception and select the Etonogestrel contraceptive implant with oral levonorgestrel
Sponsors
University of Utah
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 35 Years
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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). |
| 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
| Measure | Time frame | Description |
|---|---|---|
| Continuation Rate | 12 months | 12-month continuation rate of the ENG implant with same-day initiation at an EC encounter. |
| Discontinuation Rate and Reasons | 12 months | Rate and reasons for ENG implant discontinuation in the 12 months following same-day initiation at an EC encounter. |
Countries
United States
Participant flow
Recruitment details
Emergency contraception clients age 18-35y at four Utah family planning clinics between February 2021 and April 2023 received information about oral emergency contraception and three long acting reversible contraception options: the etonogestrel implant with same-day oral levonogestrel, the 52mf levonogestrel intrauterine device, and the copper T380A intrauterine device.
Pre-assignment details
We excluded nine potential participants for long acting reversible contraception contraindications and another four due to failed intrauterine device insertions
Participants by arm
| Arm | Count |
|---|---|
| Etonogestrel Contraceptive Implant With Oral Levonorgestrel Participants who select the Etonogestrel implant with oral levonorgestrel for emergency contraception
Etonogestrel contraceptive implant with oral levonorgestrel: Participants who present for emergency contraception and select the Etonogestrel contraceptive implant with oral levonorgestrel | 160 |
| Levonorgestrel Intrauterine Device Participants who select the levonorgestrel intrauterine device for emergency contraception
Levonorgestrel intrauterine device: Participants who present for emergency contraception and select the Levonorgestrel intrauterine device | 61 |
| Copper T380A Intrauterine Device Participants who select the Copper T380A intrauterine device for emergency contraception
Copper T380A intrauterine device: Participants who present for emergency contraception and select the Copper T380A intrauterine device | 72 |
| Total | 293 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 |
|---|---|---|---|---|
| Overall Study | Lost to Follow-up | 28 | 0 | 0 |
Baseline characteristics
| Characteristic | Total | Etonogestrel Contraceptive Implant With Oral Levonorgestrel | Levonorgestrel Intrauterine Device | Copper T380A Intrauterine Device |
|---|---|---|---|---|
| Age, Customized 20-24 years | 130 Participants | 72 Participants | 30 Participants | 28 Participants |
| Age, Customized <20 years | 59 Participants | 41 Participants | 8 Participants | 10 Participants |
| Age, Customized 25-29 years | 48 Participants | 24 Participants | 9 Participants | 15 Participants |
| Age, Customized 30+ years | 56 Participants | 23 Participants | 14 Participants | 19 Participants |
| Body mass index 25 - 29.9 kg/m2 | 69 Participants | 36 Participants | 18 Participants | 15 Participants |
| Body mass index < 25 kg/m2 | 148 Participants | 71 Participants | 30 Participants | 47 Participants |
| Body mass index 30+ kg/m2 | 74 Participants | 53 Participants | 12 Participants | 9 Participants |
| Body mass index missing | 2 Participants | 0 Participants | 1 Participants | 1 Participants |
| Race/Ethnicity, Customized Black/ African American | 13 Participants | 9 Participants | 2 Participants | 2 Participants |
| Race/Ethnicity, Customized Hispanic/ Latina | 111 Participants | 80 Participants | 15 Participants | 16 Participants |
| Race/Ethnicity, Customized Race not listed | 21 Participants | 14 Participants | 5 Participants | 2 Participants |
| Race/Ethnicity, Customized White | 148 Participants | 57 Participants | 39 Participants | 52 Participants |
| Region of Enrollment United States | 293 participants | 160 participants | 61 participants | 72 participants |
| Sex: Female, Male Female | 293 Participants | 160 Participants | 61 Participants | 72 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 160 | 0 / 61 | 0 / 72 |
| other Total, other adverse events | 0 / 160 | 0 / 61 | 0 / 72 |
| serious Total, serious adverse events | 0 / 160 | 0 / 61 | 0 / 72 |
Outcome results
Primary
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.
Time frame: 2 years
Population: Number of participants choosing each method out of total 293 enrolled
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Etonogestrel Contraceptive Implant With Oral Levonorgestrel | Comparing Proportions of EC Clients Desiring ENG Implant With Oral EC vs IUD | 54.6 percentage of participants |
| Levonorgestrel Intrauterine Device | Comparing Proportions of EC Clients Desiring ENG Implant With Oral EC vs IUD | 20.8 percentage of participants |
| Copper T380A Intrauterine Device | Comparing Proportions of EC Clients Desiring ENG Implant With Oral EC vs IUD | 24.6 percentage of participants |
Primary
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).
Time frame: one month
Population: Participants who selected the Etonogestrel contraceptive implant with oral levonorgestrel for emergency contraception reported pregnancy test results at 1 month post enrollment. Participants who selected a Levonorgestrel Intrauterine Device or a Copper T380A Intrauterine Device only completed an enrollment survey and were not followed for longitudinal outcomes.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Etonogestrel Contraceptive Implant With Oral Levonorgestrel | Pregnancy Rate at One-month | 1.96 percentage of participants |
Secondary
Continuation Rate
12-month continuation rate of the ENG implant with same-day initiation at an EC encounter.
Time frame: 12 months
Population: Number of participants from Arm 1 who selected an etonogestrel implant and completed a 12 month follow up survey. The outcome measure below is the percentage who reported implant continuation at 12 months. Participants who selected a Levonorgestrel Intrauterine Device or a Copper T380A Intrauterine Device only completed an enrollment survey and were not followed for longitudinal outcomes.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Etonogestrel Contraceptive Implant With Oral Levonorgestrel | Continuation Rate | 79 Participants |
Secondary
Discontinuation Rate and Reasons
Rate and reasons for ENG implant discontinuation in the 12 months following same-day initiation at an EC encounter.
Time frame: 12 months
Population: Number of participants from Arm 1 who selected an etonogestrel implant and reported discontinuation of the implant in the 12 months of follow up survey.s The outcome measures below are the percentage who reported reasons for method implant discontinuation. More than 1 reason could be selected by participants. Participants who selected a Levonorgestrel Intrauterine Device or a Copper T380A Intrauterine Device only completed an enrollment survey and were not followed for longitudinal outcomes.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Etonogestrel Contraceptive Implant With Oral Levonorgestrel | Discontinuation Rate and Reasons | Discontinued for cramping | 20 percentage of participants |
| Etonogestrel Contraceptive Implant With Oral Levonorgestrel | Discontinuation Rate and Reasons | Discontinued for bleeding | 51 percentage of participants |
| Etonogestrel Contraceptive Implant With Oral Levonorgestrel | Discontinuation Rate and Reasons | Discontinued for mood changes | 41 percentage of participants |
| Etonogestrel Contraceptive Implant With Oral Levonorgestrel | Discontinuation Rate and Reasons | Discontinued for weight gain | 37 percentage of participants |
| Etonogestrel Contraceptive Implant With Oral Levonorgestrel | Discontinuation Rate and Reasons | Discontinued for bloating | 24 percentage of participants |