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ContraceptionNCT01816932

Home or Office Visit for the Insertion of Implantable Birth Control

A study testing Home Visit and Office visit in people with Contraception, run by Case Western Reserve University at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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… Read more about this study

Who is it for?
Ages 18 years and older, women onlyHealthy volunteers can take part
Conditions the study is for
Contraception
What is being tested?
Home Visit and Office visit
Type of treatment
Surgery or procedure
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
40 participants
Where
1 siteUnited States
Study dates
Jun 2013to Feb 2014
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • Women only
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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
Show all 10Show fewer
  • 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 locations and contacts

1 site in 1 country.

United States1 site

  • University Hospitals

    Cleveland, Ohio, 44106

Other trials in United States

About this study

Official title: 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.

Conditions
Contraception
Being tested
Home Visit, Office visit

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Home VisitProcedure or surgery

    The intervention is the location of the insertion visit.

  • Office visitProcedure or surgery

    Also called Placebo

Study groups in NCT01816932
Study groupRoleWhat they receive
Home VisitExperimental20 participants will be randomized to receive a home visit for the insertion of their implantable birth control rather than the standard office visit.
Receives: Procedure: Home Visit
Office VisitPlacebo comparator20 participants will be randomized to receive an office visit (standard of care).
Receives: Procedure: Office visit

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: Two weeks post-implant insertion at the follow-up telephone call

Secondary outcomes (2)

  1. Interest in home visit option

    Questionnaires will be distributed at enrollment (Enrollment Questionnaire) and at the insertion visit (Post-Implant Insertion Questionnaire)

    Measured: Within 6-8 weeks of enrollment

  2. 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.

    Measured: Within 6-8 weeks of enrollment

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted22 Mar 2013 (estimated)
  2. Study startJun 2013
  3. Primary completionFeb 2014
  4. Study completionFeb 2014

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
40 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01816932
Sponsor's protocol ID
01-13-41
Status last verified
Jan 2022
First submitted
20 Mar 2013
Last updated
28 Jan 2022
Results posted
No
Data monitoring committee
No

Publications

  • Finer LB, Henshaw SK. Disparities in rates of unintended pregnancy in the United States, 1994 and 2001. Perspect Sex Reprod Health. 2006 Jun;38(2):90-6. doi: 10.1363/psrh.38.090.06.

    PubMed 16772190

  • Singh S, Sedgh G, Hussain R. Unintended pregnancy: worldwide levels, trends, and outcomes. Stud Fam Plann. 2010 Dec;41(4):241-50. doi: 10.1111/j.1728-4465.2010.00250.x.

    PubMed 21465725

  • 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.

  • Kershaw TS, Niccolai LM, Ickovics JR, Lewis JB, Meade CS, Ethier KA. Short and long-term impact of adolescent pregnancy on postpartum contraceptive use: implications for prevention of repeat pregnancy. J Adolesc Health. 2003 Nov;33(5):359-68. doi: 10.1016/s1054-139x(03)00138-1.

    PubMed 14596957

  • Templeman CL, Cook V, Goldsmith LJ, Powell J, Hertweck SP. Postpartum contraceptive use among adolescent mothers. Obstet Gynecol. 2000 May;95(5):770-6. doi: 10.1016/s0029-7844(00)00787-0.

    PubMed 10775745

  • Shulman JJ, Merritt CG. Postpartum contraception: subsequent pregnancy, delivery, and abortion rates. Fertil Steril. 1976 Jan;27(1):97-103.

    PubMed 1245250

  • Ogburn JA, Espey E, Stonehocker J. Barriers to intrauterine device insertion in postpartum women. Contraception. 2005 Dec;72(6):426-9. doi: 10.1016/j.contraception.2005.05.016. Epub 2005 Aug 9.

    PubMed 16307964

  • Jackson RA, Schwarz EB, Freedman L, Darney P. Advance supply of emergency contraception. effect on use and usual contraception--a randomized trial. Obstet Gynecol. 2003 Jul;102(1):8-16. doi: 10.1016/s0029-7844(03)00478-2.

    PubMed 12850599

  • Chandra A, Martinez GM, Mosher WD, Abma JC, Jones J. Fertility, family planning, and reproductive health of U.S. women: data from the 2002 National Survey of Family Growth. Vital Health Stat 23. 2005 Dec;(25):1-160.

    PubMed 16532609

  • Zhu BP, Rolfs RT, Nangle BE, Horan JM. Effect of the interval between pregnancies on perinatal outcomes. N Engl J Med. 1999 Feb 25;340(8):589-94. doi: 10.1056/NEJM199902253400801.

    PubMed 10029642

  • Zilberman B. [Influence of short interpregnancy interval on pregnancy outcomes]. Harefuah. 2007 Jan;146(1):42-7, 78. Hebrew.

    PubMed 17294848

  • Frost JJ, Singh S, Finer LB. Factors associated with contraceptive use and nonuse, United States, 2004. Perspect Sex Reprod Health. 2007 Jun;39(2):90-9. doi: 10.1363/3909007.

    PubMed 17565622

  • Sable MR, Libbus MK, Chiu JE. Factors affecting contraceptive use in women seeking pregnancy tests: Missouri, 1997. Fam Plann Perspect. 2000 May-Jun;32(3):124-31.

    PubMed 10894258

  • Sable MR, Libbus MK. Beliefs concerning contraceptive acquisition and use among low-income women. J Health Care Poor Underserved. 1998 Aug;9(3):262-75. doi: 10.1353/hpu.2010.0467.

    PubMed 10073208

  • Radecki SE, Bernstein GS. Use of clinic versus private family planning care by low-income women: access, cost, and patient satisfaction. Am J Public Health. 1989 Jun;79(6):692-7. doi: 10.2105/ajph.79.6.692.

    PubMed 2729465

Questions about this trial

What is this clinical trial studying?

A study testing Home Visit and Office visit in people with Contraception, run by Case Western Reserve University at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 28 Jan 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Insertion rates of implantable birth control (time frame: Two weeks post-implant insertion at the follow-up telephone call). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01816932, which also lists 30 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Jan 2022.

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