Home or Office Visit for the Insertion of Implantable Birth Control

Contraception Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01816932
• Other study ID #: 01-13-41
• Status: Completed
• Phase: N/A
• Start date: June 2013
• Est. completion date: February 2014

Study information

• Verified date: January 2022
• Source: Case Western Reserve University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: February 2014
• Est. primary completion date: February 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Contraception

Intervention

Procedure:
• Home Visit
The intervention is the location of the insertion visit.
• Office visit

Locations

Country	Name	City	State
United States	University Hospitals	Cleveland	Ohio

Sponsors (2)

Lead Sponsor	Collaborator
Case Western Reserve University	University Hospitals Cleveland Medical Center

Country where clinical trial is conducted

United States, 

References & Publications (29)

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Tocce KM, Sheeder JL, Teal SB. Rapid repeat pregnancy in adolescents: do immediate postpartum contraceptive implants make a difference? Am J Obstet Gynecol. 2012 Jun;206(6):481.e1-7. doi: 10.1016/j.ajog.2012.04.015. Epub 2012 Apr 16. — View Citation

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* Note: There are 29 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Insertion rates of implantable birth control	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	Interest in home visit option	Questionnaires will be distributed at enrollment (Enrollment Questionnaire) and at the insertion visit (Post-Implant Insertion Questionnaire)	Within 6-8 weeks of enrollment
Secondary	Rates of return for postpartum follow-up	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