Home or Office Visit for the Insertion of Implantable Birth Control
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|ClinicalTrials.gov Identifier: NCT01816932|
Recruitment Status : Unknown
Verified March 2014 by Suji Uhm, Case Western Reserve University.
Recruitment status was: Active, not recruiting
First Posted : March 22, 2013
Last Update Posted : March 11, 2014
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.
|Condition or disease||Intervention/treatment||Phase|
|Contraception||Procedure: Home Visit||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||50 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Home or Office Visit for Insertion of Etonogestrel Implant: A Pilot Study|
|Study Start Date :||June 2013|
|Estimated Primary Completion Date :||April 2014|
|Estimated Study Completion Date :||April 2014|
Experimental: Home Visit
20 participants will be randomized to receive a home visit for the insertion of their implantable birth control rather than the standard office visit.
Procedure: Home Visit
The intervention is the location of the insertion visit.
Placebo Comparator: Office Visit
20 participants will be randomized to receive an office visit (standard of care).
- Insertion rates of implantable birth control [ Time Frame: 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.
- Interest in home visit option [ Time Frame: 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 [ Time Frame: 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01816932
|United States, Ohio|
|Cleveland, Ohio, United States, 44106|
|Principal Investigator:||Suji Uhm, B.S.||Case Western Reserve University|
|Study Director:||Lisa Perriera, M.D./M.P.H.||University Hospitals|