Overview

This trial is active, not recruiting.

Condition contraception
Treatment home visit
Sponsor Case Western Reserve University
Collaborator University Hospitals of Cleveland
Start date June 2013
End date April 2014
Trial size 50 participants
Trial identifier NCT01816932, 01-13-41

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Intervention model parallel assignment
Masking open label
Primary purpose prevention
Arm
(Experimental)
20 participants will be randomized to receive a home visit for the insertion of their implantable birth control rather than the standard office visit.
home visit
The intervention is the location of the insertion visit.
(Placebo Comparator)
20 participants will be randomized to receive an office visit (standard of care).

Primary Outcomes

Measure
Insertion rates of implantable birth control
time frame: Two weeks post-implant insertion at the follow-up telephone call

Secondary Outcomes

Measure
Interest in home visit option
time frame: Within 6-8 weeks of enrollment
Rates of return for postpartum follow-up
time frame: Within 6-8 weeks of enrollment

Eligibility Criteria

Female participants at least 18 years old.

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

Additional Information

Official title Home or Office Visit for Insertion of Etonogestrel Implant: A Pilot Study
Principal investigator Suji Uhm, B.S.
Trial information was received from ClinicalTrials.gov and was last updated in March 2014.
Information provided to ClinicalTrials.gov by Case Western Reserve University.