Contraception
Conditions
Brief summary
This is a pilot study in which women who desire an etonogestrel implant will be randomized to either a home or office insertion visit. The purpose of this research is to study the interest in, feasibility of, and rates of insertion for implantable birth control (Implanon®/Nexplanon®) when inserted at home visit appointments compared to standard office visit appointments. The ultimate goal of the study is to reduce barriers to insertion of the etonogestrel implant and increase consistent and correct contraception use by introducing a previously unexplored method of access, the home visit.
Interventions
PROCEDUREHome Visit
The intervention is the location of the insertion visit.
PROCEDUREOffice visit
Sponsors
University Hospitals Cleveland Medical Center
Case Western Reserve University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* Women aged 18 and over * Was pregnant within the last 10 weeks * Interested in using the etonogestrel implant for contraception * Willing to have investigators come to the home for an insertion visit * Presenting to University Hospitals for delivery or contraception. * Has running water and a working bathroom in the home * Has a safe and private location in the home for the implant to be inserted
Exclusion criteria
* Current or history of thrombosis or thromboembolic disorders * Liver tumors or active liver disease * Undiagnosed abnormal genital bleeding * Known or suspected breast cancer or history of breast cancer * Allergic reaction to components (ethylene vinylacetate, etonogestrel, barium sulfate) of etonogestrel implant or local anesthetics * Women currently taking hepatic enzyme inducers including but not exclusive to barbiturates, bosentan, carbamazepine, felbamate, griseofulvin, oxcarbazepine, phenylbutazone, phenytoin, rifampin, topiramate, protease inhibitors, and St. John's wort * Uncontrolled hypertension * Housing located greater than 10 miles from University Hospitals Center for Women's Health * The location of the home is in a place that would not be safe for investigators * Participant is homeless
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Insertion rates of implantable birth control | Two weeks post-implant insertion at the follow-up telephone call | Assess rates of insertion of etonogestrel contraceptive implant in women randomly assigned to home visits or standard office visits. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Interest in home visit option | Within 6-8 weeks of enrollment | Questionnaires will be distributed at enrollment (Enrollment Questionnaire) and at the insertion visit (Post-Implant Insertion Questionnaire) |
| Rates of return for postpartum follow-up | Within 6-8 weeks of enrollment | Data will be collected via electronic medical records to assess if women returned to clinic for their scheduled postpartum visits. |
Countries
United States
Outcome results
None listed