Home or Office Visit for the Insertion of Implantable Birth Control

Case Western Reserve University

Status: Completed

Conditions: Contraception

Treatments: Procedure: Home Visit; Procedure: Office visit

Study type: Interventional

Funder types: Other

Identifiers

NCT01816932

01-13-41

Details and patient eligibility

About

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.

Enrollment: 40 patients

Sex: Female

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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40 participants in 2 patient groups, including a placebo group

Home Visit

Experimental group

Description:

20 participants will be randomized to receive a home visit for the insertion of their implantable birth control rather than the standard office visit.

Treatment:

Procedure: Home Visit

Office Visit

Placebo Comparator group

Description:

20 participants will be randomized to receive an office visit (standard of care).

Treatment:

Procedure: Office visit