Home or Office Visit for the Insertion of Implantable Birth Control

NCT01816932 | Completed

• 1 other identifier: 01-13-41
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Contraception

Outcome Measures

Primary Outcomes (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.

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

Secondary Outcomes (2)

• Interest in home visit option

  Within 6-8 weeks of enrollment

• Rates of return for postpartum follow-up

  Within 6-8 weeks of enrollment

Study Arms (2)

Home Visit

EXPERIMENTAL

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

Office Visit

PLACEBO COMPARATOR

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

Procedure: Office visit

Interventions

Home Visit PROCEDURE

The intervention is the location of the insertion visit.

Home Visit

Office visit PROCEDURE

Also known as: Placebo

Office Visit

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Case Western Reserve University: lead
• University Hospitals Cleveland Medical Center: collaborator

Study Sites (1)

University Hospitals

Cleveland, Ohio, 44106, United States

Location

Related Publications (30)

• 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.

  PMID: 16772190 BACKGROUND

• 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.

  PMID: 21465725 BACKGROUND

• 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.

  BACKGROUND

• 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.

  PMID: 14596957 BACKGROUND

• 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.

  PMID: 10775745 BACKGROUND

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

  PMID: 1245250 BACKGROUND

• 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.

  PMID: 16307964 BACKGROUND

• 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.

  PMID: 12850599 BACKGROUND

• 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.

  PMID: 16532609 BACKGROUND

• 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.

  PMID: 10029642 BACKGROUND

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

  PMID: 17294848 BACKGROUND

• 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.

  PMID: 17565622 BACKGROUND

• 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.

  PMID: 10894258 BACKGROUND

• 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.

  PMID: 10073208 BACKGROUND

• 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.

  PMID: 2729465 BACKGROUND

• Silverman J, Torres A, Forrest JD. Barriers to contraceptive services. Fam Plann Perspect. 1987 May-Jun;19(3):94-7, 101-2.

  PMID: 3622744 BACKGROUND

• Frost JJ, Darroch JE. Factors associated with contraceptive choice and inconsistent method use, United States, 2004. Perspect Sex Reprod Health. 2008 Jun;40(2):94-104. doi: 10.1363/4009408.

  PMID: 18577142 BACKGROUND

• Hatcher RA, Trussell J, Nelson AL, Cates W Jr, Stewart F, Kowal D, editors. Contraceptive technology. 19th rev. ed. New York (NY): Ardent Media, Inc.; 2007.

  BACKGROUND

• Mosher WD, Jones J. Use of contraception in the United States: 1982-2008. Vital Health Stat 23. 2010 Aug;(29):1-44.

  PMID: 20939159 BACKGROUND

• Harper CC, Blum M, de Bocanegra HT, Darney PD, Speidel JJ, Policar M, Drey EA. Challenges in translating evidence to practice: the provision of intrauterine contraception. Obstet Gynecol. 2008 Jun;111(6):1359-69. doi: 10.1097/AOG.0b013e318173fd83.

  PMID: 18515520 BACKGROUND

• Madden T, Allsworth JE, Hladky KJ, Secura GM, Peipert JF. Intrauterine contraception in Saint Louis: a survey of obstetrician and gynecologists' knowledge and attitudes. Contraception. 2010 Feb;81(2):112-6. doi: 10.1016/j.contraception.2009.08.002. Epub 2009 Sep 16.

  PMID: 20103447 BACKGROUND

• Trussell J, Lalla AM, Doan QV, Reyes E, Pinto L, Gricar J. Cost effectiveness of contraceptives in the United States. Contraception. 2009 Jan;79(1):5-14. doi: 10.1016/j.contraception.2008.08.003. Epub 2008 Sep 25.

  PMID: 19041435 BACKGROUND

• Secura GM, Allsworth JE, Madden T, Mullersman JL, Peipert JF. The Contraceptive CHOICE Project: reducing barriers to long-acting reversible contraception. Am J Obstet Gynecol. 2010 Aug;203(2):115.e1-7. doi: 10.1016/j.ajog.2010.04.017. Epub 2010 Jun 11.

  PMID: 20541171 BACKGROUND

• ACOG Practice Bulletin No. 121: Long-acting reversible contraception: Implants and intrauterine devices. Obstet Gynecol. 2011 Jul;118(1):184-196. doi: 10.1097/AOG.0b013e318227f05e. No abstract available.

  PMID: 21691183 BACKGROUND

• Peipert JF, Zhao Q, Allsworth JE, Petrosky E, Madden T, Eisenberg D, Secura G. Continuation and satisfaction of reversible contraception. Obstet Gynecol. 2011 May;117(5):1105-1113. doi: 10.1097/AOG.0b013e31821188ad.

  PMID: 21508749 BACKGROUND

• 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.

  PMID: 22631865 BACKGROUND

• Tocce K, Sheeder J, Python J, Teal SB. Long acting reversible contraception in postpartum adolescents: early initiation of etonogestrel implant is superior to IUDs in the outpatient setting. J Pediatr Adolesc Gynecol. 2012 Feb;25(1):59-63. doi: 10.1016/j.jpag.2011.09.003. Epub 2011 Nov 3.

  PMID: 22051792 BACKGROUND

• Melnick AL, Rdesinski RE, Creach ED, Choi D, Harvey SM. The influence of nurse home visits, including provision of 3 months of contraceptives and contraceptive counseling, on perceived barriers to contraceptive use and contraceptive use self-efficacy. Womens Health Issues. 2008 Nov-Dec;18(6):471-81. doi: 10.1016/j.whi.2008.07.011. Epub 2008 Oct 15.

  PMID: 18926726 BACKGROUND

• Peipert JF, Madden T, Allsworth JE, Secura GM. Preventing unintended pregnancies by providing no-cost contraception. Obstet Gynecol. 2012 Dec;120(6):1291-7. doi: 10.1097/aog.0b013e318273eb56.

  PMID: 23168752 BACKGROUND

• Uhm S, Pope R, Schmidt A, Bazella C, Perriera L. Home or office etonogestrel implant insertion after pregnancy: a randomized trial. Contraception. 2016 Nov;94(5):567-571. doi: 10.1016/j.contraception.2016.06.018. Epub 2016 Jun 29.

  PMID: 27373542 DERIVED

MeSH Terms

Interventions

House Calls; Office Visits

Intervention Hierarchy (Ancestors)

Professional Practice; Organization and Administration; Health Services Administration

Study Officials

• Suji Uhm, B.S.

  Case Western Reserve University

  PRINCIPAL INVESTIGATOR

• Lisa Perriera, M.D./M.P.H.

  University Hospitals

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD/MPH Student

Study Record Dates

• First Submitted: March 20, 2013
• First Posted: March 22, 2013
• Study Start: June 1, 2013
• Primary Completion: February 1, 2014
• Study Completion: February 1, 2014
• Last Updated: January 28, 2022

Record last verified: 2022-01

Locations

US (1)