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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
Sponsor:
Collaborator:
University Hospitals Cleveland Medical Center
Information provided by (Responsible Party):
Suji Uhm, Case Western Reserve University

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.


Condition or disease Intervention/treatment Phase
Contraception Procedure: Home Visit Not Applicable

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Birth Control

Arm Intervention/treatment
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).



Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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)

  2. 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.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

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


Locations
United States, Ohio
University Hospitals
Cleveland, Ohio, United States, 44106
Sponsors and Collaborators
Case Western Reserve University
University Hospitals Cleveland Medical Center
Investigators
Principal Investigator: Suji Uhm, B.S. Case Western Reserve University
Study Director: Lisa Perriera, M.D./M.P.H. University Hospitals

Publications:
Gold RB, Sonfield A, Richards CL and Frost JJ. Next Steps for America's Family Planning Program: Leveraging the Potential of Medicaid and Title X in an Evolving Health Care System. <http://www.guttmacher.org/pubs/NextSteps.pdf>. New York: Guttmacher Institute, 2009.
Hatcher RA, Trussell J, Nelson AL, Cates W Jr, Stewart F, Kowal D, editors. Contraceptive technology. 19th rev. ed. New York (NY): Ardent Media, Inc.; 2007.

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Suji Uhm, MD/MPH Student, Case Western Reserve University
ClinicalTrials.gov Identifier: NCT01816932     History of Changes
Other Study ID Numbers: 01-13-41
First Posted: March 22, 2013    Key Record Dates
Last Update Posted: March 11, 2014
Last Verified: March 2014