Women With an ENG Contraceptive Implant
Conditions
Keywords
implant removal, Nexplanon, Implanon, contraception, ENG
Brief summary
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.
Detailed description
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. 1. 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. 2. Create an image gallery of office and radiology department obtained images of ENG implant localization. This will include: 1. Ultrasound images obtained in women with palpable or non-palpable ENG implants in place at various time intervals after insertion who desire ENG implant continuation (office imaging only). 2. Ultrasound images obtained in women seeking removal of non-palpable ENG implants, primarily referred patients who have either failed outside implant removal or have a non-palpable implant on presentation for removal. 3. 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.
Interventions
PROCEDUREremoval of ENG implant
the researcher(s) will ask you to: Visit 1 - SCREENING VISIT * questions about your medical/contraception history * Review medical record * physical examination * urine sample for pregnancy test Visit 2a - Radiology * Have an ultrasound of your arm * The radiologist will mark your arm at the location of the implant. Visit 2b * ultrasound of your arm to locate the implant. This is done by feeling the area. * Have your ENG implant removed through a numbed small cut. The researcher will apply a pressure bandage to the site(s). This will reduce bleeding/decrease swelling. * Have the removal procedure video recorded. Visit 3 - FOLLOW UP VISIT approximately 2 weeks after Visit 2: * Provide a urine sample for pregnancy test * Have the implant removal site examined
PROCEDUREcontinuation of ING implant
the researcher(s) will ask you to: * To answer questions about your medical and contraception history * Review your medical record * Have a physical examination by the researcher * Provide a urine sample for pregnancy test * Have an ultrasound of your arm
Sponsors
University of California, Los Angeles
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 50 Years
Healthy volunteers
Yes
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
* Known or suspected pregnancy * Does not meet inclusion criteria * Known ENG implant location outside of arm * Current anticoagulation use (removal group only)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Creation of image gallery | 18 months | Creating an image gallery in order to locate ENG implant using ultrasound and radiological images |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Creation of an instructional video and reference guide for ENG implant removal. | 18 months | If ultrasound/radiological images are successful at locating ENG implant, this data could lead to the creation of a reference guide for other providers. |
Countries
United States
Outcome results
None listed