Clinical trial NCT01816932: Home or Office Visit for the Insertion of Implantable Birth Control
Official title: Home or Office Visit for Insertion of Etonogestrel Implant: A Pilot Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Contraception
Lead sponsor: Case Western Reserve University
Sponsor class: OTHER
Collaborators: name: University Hospitals Cleveland Medical Center
First posted: 2013-03-22
Enrollment: 40
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.


Eligibility criteria: 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

Primary outcomes:
measure: Insertion rates of implantable birth control
timeFrame: Two weeks post-implant insertion at the follow-up telephone call
Secondary outcomes:
measure: Interest in home visit option
timeFrame: Within 6-8 weeks of enrollment
measure: Rates of return for postpartum follow-up
timeFrame: Within 6-8 weeks of enrollment
Other outcomes:
Locations:
city: Cleveland
country: United States
facility: University Hospitals
state: Ohio
Study officials:
affiliation: Case Western Reserve University
name: Suji Uhm, B.S.
role: PRINCIPAL_INVESTIGATOR
affiliation: University Hospitals
name: Lisa Perriera, M.D./M.P.H.
role: STUDY_DIRECTOR
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