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Completed

NCT Number: NCT01816932

Home or Office Visit for the Insertion of Implantable Birth Control

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.

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Key information

Conditions

Contraception

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

University Hospitals

Cleveland, Ohio, 44106, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Home visit

Procedure

The intervention is the location of the insertion visit.

Office visit

Procedure

Other names: Placebo

Primary outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

Case Western Reserve University

Other

Collaborators

  • University Hospitals Cleveland Medical Center

Registry information

Official study title

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

Important dates

Study start
2013
Primary completion
2014
Study completion
2014
First posted
Mar 22, 2013
Registry last updated
Jan 28, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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