Home or Office Visit for the Insertion of Implantable Birth Control
NCT ID: NCT01816932
Last Updated: 2022-01-28
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
40 participants
INTERVENTIONAL
2013-06-30
2014-02-28
Brief Summary
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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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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
NONE
Study Groups
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Home Visit
20 participants will be randomized to receive a home visit for the insertion of their implantable birth control rather than the standard office visit.
Home Visit
The intervention is the location of the insertion visit.
Office Visit
20 participants will be randomized to receive an office visit (standard of care).
Office visit
Interventions
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Home Visit
The intervention is the location of the insertion visit.
Office visit
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
FEMALE
Yes
Sponsors
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University Hospitals Cleveland Medical Center
OTHER
Case Western Reserve University
OTHER
Responsible Party
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Suji Uhm
MD/MPH Student
Principal Investigators
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Suji Uhm, B.S.
Role: PRINCIPAL_INVESTIGATOR
Case Western Reserve University
Lisa Perriera, M.D./M.P.H.
Role: STUDY_DIRECTOR
University Hospitals
Locations
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University Hospitals
Cleveland, Ohio, United States
Countries
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References
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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.
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.
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.
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.
Shulman JJ, Merritt CG. Postpartum contraception: subsequent pregnancy, delivery, and abortion rates. Fertil Steril. 1976 Jan;27(1):97-103.
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.
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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.
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.
Zilberman B. [Influence of short interpregnancy interval on pregnancy outcomes]. Harefuah. 2007 Jan;146(1):42-7, 78. Hebrew.
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.
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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.
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.
Silverman J, Torres A, Forrest JD. Barriers to contraceptive services. Fam Plann Perspect. 1987 May-Jun;19(3):94-7, 101-2.
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.
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.
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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.
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.
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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.
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.
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.
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.
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.
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.
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.
Other Identifiers
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01-13-41
Identifier Type: -
Identifier Source: org_study_id
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