Home or Office Visit for the Insertion of Implantable Birth Control

January 13, 2022 updated by: Suji Uhm, Case Western Reserve University

Home or Office Visit for Insertion of Etonogestrel Implant: A Pilot Study

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

40

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Ohio
      • Cleveland, Ohio, United States, 44106
        • University Hospitals

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Female

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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).
Procedure: Office visit
Other Names:
  • Placebo

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Two weeks post-implant insertion at the follow-up telephone call

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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)
Within 6-8 weeks of enrollment
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.
Within 6-8 weeks of enrollment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Case Western Reserve University

Collaborators

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 and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 1, 2013

Primary Completion (Actual)

February 1, 2014

Study Completion (Actual)

February 1, 2014

Study Registration Dates

First Submitted

March 20, 2013

First Submitted That Met QC Criteria

March 20, 2013

First Posted (Estimate)

March 22, 2013

Study Record Updates

Last Update Posted (Actual)

January 28, 2022

Last Update Submitted That Met QC Criteria

January 13, 2022

Last Verified

January 1, 2022

More Information

Terms related to this study

Other Study ID Numbers

  • 01-13-41

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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