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This study will investigate in-office ultrasound localization vs localization in radiology for identification and removal of non palpable etonogestrel (ENG) contraceptive implants and aims to help establish best practices in this domain. Investigators will also create an ultrasound image gallery of palpable and non palpable as well as instructional video for non palpable ENG implant removal.
This is a descriptive study to establish best practices for ENG implant localization and non-palpable ENG implant removal.
Women presenting to UCLA Obstetrics and Gynecology service for ENG non-palpable and palpable implant removal or with ENG implant in place but desiring continuation will be enrolled. Investigators aim to enroll 20 women in each group. Screening data will be reviewed to determine subject eligibility. Subjects who meet all inclusion criteria will be entered into the study.
Study duration for each participant is one visit for continuation group and two weeks for group desiring implant removal. Total study duration is expected to be 18 months.
For women desiring implant removal: document ENG implant using in-office imaging of ENG implant in the FP clinic with standard ob/gyn office ultrasound (abdominal 15 MHz linear probe with color doppler) and the same, using high frequency vascular probe (20+ MHz) in the radiology department.
Create an image gallery of office and radiology department obtained images of ENG implant localization. This will include:
Document and describe all cases of non palpable ENG implant removal with standard, in-office US versus radiology ultrasound equipment. Investigators will collect radiographic images, clinical findings, instruments used, patient characteristics (BMI, weight gain, time since of insertion), success of procedure, duration of procedure, number of attempts, final location of implant, and need for referral to general or vascular surgeon.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| removal of ENG implant group | Other | 20 women who have an ENG implant that is difficult to feel on exam and would like to have it removed. |
|
| continuation of ENG implant | Other | 20 women who have are continuing to use their ENG implant. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| removal of ENG implant | Procedure | the researcher(s) will ask you to: Visit 1 - SCREENING VISIT
Visit 2a - Radiology
Visit 2b
Visit 3 - FOLLOW UP VISIT approximately 2 weeks after Visit 2:
|
| Measure | Description | Time Frame |
|---|---|---|
| Creation of image gallery | Creating an image gallery in order to locate ENG implant using ultrasound and radiological images | 18 months |
| Measure | Description | Time Frame |
|---|---|---|
| Creation of an instructional video and reference guide for ENG implant removal. | If ultrasound/radiological images are successful at locating ENG implant, this data could lead to the creation of a reference guide for other providers. | 18 months |
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Inclusion Criteria:
Women age 18 - 50 years old
English or Spanish speaking
ENG implant in place
Removal group
o Women with non palpable ENG implant desiring ENG implant removal
Continuation group o Women with palpable or non-palpable ENG implant desiring continuation
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| UCLA Dept. OB/GYN Div. of Family Planning | University of California, Los Angeles | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| UCLA Dept. OB/GYN, Women's Health CRU, 10833 Le Conte Ave, CHS 22-265 | Los Angeles | California | 90095 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 22939402 | Background | Mommers E, Blum GF, Gent TG, Peters KP, Sordal TS, Marintcheva-Petrova M. Nexplanon, a radiopaque etonogestrel implant in combination with a next-generation applicator: 3-year results of a noncomparative multicenter trial. Am J Obstet Gynecol. 2012 Nov;207(5):388.e1-6. doi: 10.1016/j.ajog.2012.08.002. Epub 2012 Aug 10. | |
| 24081828 |
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|
| continuation of ING implant | Procedure | the researcher(s) will ask you to:
|
|
| Pillai M, Gazet AC, Griffiths M. Continuing need for and provision of a service for non-standard implant removal. J Fam Plann Reprod Health Care. 2014 Apr;40(2):126-32. doi: 10.1136/jfprhc-2013-100619. Epub 2013 Sep 30. |
| 25081861 | Background | Guiahi M, Tocce K, Teal S, Green T, Rochon P. Removal of a Nexplanon implant located in the biceps muscle using a combination of ultrasound and fluoroscopy guidance. Contraception. 2014 Dec;90(6):606-8. doi: 10.1016/j.contraception.2014.06.030. Epub 2014 Jun 27. |
| 26444124 | Background | Chen MJ, Creinin MD. Removal of a Nonpalpable Etonogestrel Implant With Preprocedure Ultrasonography and Modified Vasectomy Clamp. Obstet Gynecol. 2015 Nov;126(5):935-938. doi: 10.1097/AOG.0000000000001082. |
| 16857066 | Background | Singh M, Mansour D, Richardson D. Location and removal of non-palpable Implanon implants with the aid of ultrasound guidance. J Fam Plann Reprod Health Care. 2006 Jul;32(3):153-6. doi: 10.1783/147118906777888549. |