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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Etonogestrel contraceptive implant with oral levonorgestrel | Participants who select the Etonogestrel implant with oral levonorgestrel for emergency contraception |
| |
| Levonorgestrel intrauterine device | Participants who select the levonorgestrel intrauterine device for emergency contraception |
| |
| Copper T380A intrauterine device | Participants who select the Copper T380A intrauterine device for emergency contraception |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Etonogestrel contraceptive implant with oral levonorgestrel | Device | Participants who present for emergency contraception and select the Etonogestrel contraceptive implant with oral levonorgestrel |
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Continuation Rate | 12-month continuation rate of the ENG implant with same-day initiation at an EC encounter. | 12 months |
| Discontinuation Rate and Reasons | Rate and reasons for ENG implant discontinuation in the 12 months following same-day initiation at an EC encounter. |
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Inclusion Criteria:
Exclusion Criteria:
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Study population will be recruited from participating Planned Parenthood of Utah clinics.
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| Name | Affiliation | Role |
|---|---|---|
| Lori Gawron, MD | University of Utah | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Planned Parenthood Association of Utah | Salt Lake City | Utah | 84102 | United States | ||
| Planned Parenthood Association of Utah |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39241904 | Derived | Carter G, Pangasa M, Sexsmith CD, Elliott S, Turok DK, Gawron LM. Selection of long acting reversible contraception methods by emergency contraception clients: A prospective observational study. Contraception. 2025 Jan;141:110701. doi: 10.1016/j.contraception.2024.110701. Epub 2024 Sep 4. | |
| 38008305 | Derived |
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Individual participant data will not be available to share with other researchers.
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We excluded nine potential participants for long acting reversible contraception contraindications and another four due to failed intrauterine device insertions
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.
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| ID | Title | Description |
|---|---|---|
| FG000 | 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 |
| FG001 | 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 |
| FG002 | 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 |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Customized | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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). | 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. | Posted | Number | 95% Confidence Interval | percentage of participants | one month |
|
30 days post enrollment
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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 |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Lori Gawron, MD | University of Utah | 801-213-4989 | lori.gawron@hsc.utah.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Nov 25, 2020 | Dec 15, 2020 | Prot_SAP_001.pdf |
| ICF | No | No | Yes | Informed Consent Form | Nov 25, 2020 | Dec 15, 2020 | ICF_000.pdf |
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| Levonorgestrel intrauterine device | Device | Participants who present for emergency contraception and select the Levonorgestrel intrauterine device |
|
| Copper T380A intrauterine device | Device | Participants who present for emergency contraception and select the Copper T380A intrauterine device |
|
| 12 months |
| West Valley City |
| Utah |
| 84119 |
| United States |
| Gawron LM, Sexsmith CD, Carter G, Kaiser JE, Pangasa M, Turok DK. Efficacy of oral levonorgestrel emergency contraception with same day etonogestrel contraceptive implant: A prospective observational study. Contraception. 2024 Mar;131:110344. doi: 10.1016/j.contraception.2023.110344. Epub 2023 Nov 25. |
| BG001 |
| 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 |
| BG002 | 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 |
| BG003 | Total | Total of all reporting groups |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
|
| Body mass index | Count of Participants | Participants |
|
|
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| 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. | Number of participants choosing each method out of total 293 enrolled | Posted | Number | percentage of participants | 2 years |
|
|
|
| Secondary | Continuation Rate | 12-month continuation rate of the ENG implant with same-day initiation at an EC encounter. | 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. | Posted | Count of Participants | Participants | 12 months |
|
|
|
| Secondary | Discontinuation Rate and Reasons | Rate and reasons for ENG implant discontinuation in the 12 months following same-day initiation at an EC encounter. | 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. | Posted | Number | percentage of participants | 12 months |
|
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|
| 0 |
| 160 |
| 0 |
| 160 |
| 0 |
| 160 |
| EG001 | 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 | 0 | 61 | 0 | 61 | 0 | 61 |
| EG002 | 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 | 0 | 72 | 0 | 72 | 0 | 72 |
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| Title | Measurements |
|---|---|
|
| Discontinued for bloating |
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| Discontinued for cramping |
|