Status:
COMPLETED
Home or Office Visit for the Insertion of Implantable Birth Control
Lead Sponsor:
Case Western Reserve University
Collaborating Sponsors:
University Hospitals Cleveland Medical Center
Conditions:
Contraception
Eligibility:
FEMALE
18+ years
Phase:
NA
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, feasibi...
Eligibility Criteria
Inclusion
- 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
Exclusion
Key Trial Info
Start Date :
June 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2014
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT01816932
Start Date
June 1 2013
End Date
February 1 2014
Last Update
January 28 2022
Active Locations (1)
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1
University Hospitals
Cleveland, Ohio, United States, 44106