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Contraception Journal
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Contraception Highlights September 2015

Editorial

Fifteen years: looking back and looking forward
Beverly Winikoff, Carolyn Westhoff
Fifteen years ago this fall, in September 2000, the US Food and Drug Administration (FDA) approved the sale of mifepristone for medical abortion in the United States. This action gave women in the US access to what is arguably the most important reproductive health innovation since the advent of the oral contraceptive pill several decades earlier.
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Commentaries

Aligning mifepristone regulation with evidence: driving policy change using 15 years of excellent safety data
Kelly Cleland, Nicole Smith
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Mifepristone label laws and trends in use: recent experiences in four US states
Wendy R. Sheldon, Beverly Winikoff
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Mifepristone by prescription: a dream in the United States but reality in Australia
Daniel Grossman, Philip Goldstone
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Reaching women where they are: eliminating the initial in-person medical abortion visit
Elizabeth G. Raymond, Daniel Grossman, Ellen Wiebe, Beverly Winikoff
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If we can do it for misoprostol, why not for mifepristone? The case for taking mifepristone out of the office in medical abortion
Marji Gold, Erica Chong
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Outpatient medical abortion is safe and effective through 70days gestation
Dina Abbas, Erica Chong, Elizabeth G. Raymond
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From qualified physician to licensed health care professional: the time has come to change mifepristone's label
Angel M. Foster, Courtney B. Jackson, Kathryn J. LaRoche, Katherine Simmonds, Diana Taylor
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Off-label indications for mifepristone in gynecology and obstetrics
Ilana G. Dzuba, Daniel Grossman, Courtney A. Schreiber
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Review

Continuing pregnancy after mifepristone and “reversal” of first-trimester medical abortion: a systematic review
Daniel Grossman, Kari White, Lisa Harris, Matthew Reeves, Paul D. Blumenthal, Beverly Winikoff, David A. Grimes
Objective: We conducted a systematic review of the literature on the effectiveness of medical abortion “reversal” treatment. Since the usual care for women seeking to continue pregnancies after ingesting mifepristone is expectant management with fetal surveillance, we also performed a systematic review of continuing pregnancy after mifepristone alone.
Implications: Legislation requiring physicians to inform patients about abortion reversal transforms an unproven therapy into law and represents legislative interference in the patient–physician relationship.
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Original Research Articles

Early medical abortion without prior ultrasound
Elizabeth G. Raymond, Hillary Bracken
Objective: To explore the potential for using last menstrual period (LMP) rather than ultrasound to establish gestational age (GA) eligibility for medical abortion.
Implications: Gestational dating using LMP rather than ultrasound may be reasonable for selected patients before medical abortion.
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A prospective, non-randomized study of home use of mifepristone for medical abortion in the U.S.
Erica Chong, Laura J. Frye, Jen Castle, Gillian Dean, Laurel Kuehl, Beverly Winikof
Objective: To determine the acceptability of taking mifepristone at home for early medical abortion in the United States.
Implications: Offering the option of home use of mifepristone to medical abortion patients can provide women and clinics with more flexibility while maintaining a safe, effective and acceptable service. These results provide support for telemedicine or pharmacy distribution.
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Comparison of remote and in-clinic follow-up after methotrexate/misoprostol abortion
Sheila Dunn, Dilzayn Panjwani, Melini Gupta, Christopher Meaney, Rebecca Morgan, Erika Feuerstein
Objective: This study compared adherence to follow-up and clinical outcomes between standard in-clinic and remote follow-up after methotrexate/misoprostol abortion.
Implications statement: Since standard and remote follow-up after methotrexate/misoprostol abortion are associated with similar adherence to follow-up and similar safety profiles, women should be offered their choice of follow-up method.
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Abortion access and state variation in observed unintended pregnancy
Amanda Jean Stevenson, Joseph E. Potter
Objective: The state-level proportion of pregnancies that are unintended is an important social and public health indicator, and comparisons between states inform policy discussions. Unintended pregnancy is measured as a composite of abortions and unintended births, each of which is measured with error. We investigate whether between-state differences in abortion access and demand may bias comparisons between states’ unintended pregnancy proportions when pregnancy intentions are misreported.
Implications: Estimates of unintended pregnancy should be adjusted for nonsampling error and include variances based on sampling and nonsampling error in order to permit robust comparisons between states, between populations, and across time. More research on the fidelity of retrospective reporting of pregnancy intention would facilitate this endeavor.
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Misoprostol 1 to 3 h preprocedure vs. overnight osmotic dilators prior to early second-trimester surgical abortion
Shanthi Ramesh, Alicia Roston, Lindsay Zimmerman, Ashlesha Patel, E. Steve Lichtenberg, Julie Chor
Objective: We sought to compare the effectiveness of at least 1 h of 400 mcg of buccal misoprostol to overnight osmotic dilators for early second-trimester surgical abortion cervical preparation.
Implications: In this small, retrospective review, at least 1 h of preprocedure buccal misoprostol decreased the duration from cervical preparation initiation to procedure completion in early second-trimester procedures performed by an experienced surgeon. These results should be considered as a pilot evaluation, and further prospective study is needed to further clarify whether this short interval could be applied in general practice.
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Induction of fetal demise before pregnancy termination: practices of family planning providers
Colleen C. Denny, Michele B. Baron, Lauren Lederle, Eleanor A. Drey, Jennifer L. Kerns
Objectives: Our survey aimed to characterize the practice of inducing fetal demise before pregnancy termination among abortion providers, including its technical aspects and why providers have chosen to adopt it.
Implications: Our study documents the widespread practice of inducing fetal demise before second-trimester abortion and further describes wide variation in providers’ methods and rationales for inducing demise. It is important for abortion providers as a professional group to come to a formal consensus on the appropriate use of these techniques and to determine whether such practices should be encouraged, tolerated or even permitted.
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The impact of psychiatric history on women's pre- and postabortion experiences
Jenneke van Ditzhuijzen, Margreet ten Have, Ron de Graaf, Carolus H.C.J. van Nijnatten, Wilma A.M. Vollebergh
Objective: The objective of this study is to investigate to what extent psychiatric history affects preabortion decision difficulty, experienced burden, and postabortion emotions and coping. Women with and without a history of mental disorders might respond differently to unwanted pregnancy and subsequent abortion.
Implications: Negative abortion experiences may, at least partially, stem from prior or underlying mental health problems.
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Assessing the potential of the Woman’s Condom for vaginal drug delivery
Lindsay F. Kramzer, Jessica Cohen, Jesse Schubert, Charlene S. Dezzutti, Bernard J. Moncla, David Friend, Lisa C. Rohan
Background: The Woman’s Condom is a new female condom that uses a dissolvable polyvinyl alcohol capsule to simplify vaginal insertion. This preclinical study assessed the feasibility to incorporate an antiviral drug, UC781, into the Woman’s Condom capsule, offering a unique drug delivery platform
Implications: We determined the proof-of-concept feasibility of incorporation of an HIV-preventative microbicide into the Woman’s Condom capsule. This study highlights various in vitro physical and chemical evaluations as well as bioactivity and safety assessments necessary for vaginal product development related to female sexual and reproductive health.
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A randomized noninferiority crossover controlled trial of the functional performance and safety of new female condoms: an evaluation of the Velvet, Cupid2, and FC2
Mags Beksinska, Ross Greener, Immo Kleinschmidt, Lavanya Pillay, Virginia Maphumulo, Jennifer Smit
Objectives: New designs of female condoms have been developed to lower cost and/or improve acceptability. To secure regulatory approvals, clinical studies are required to verify performance. We aimed to assess the functional performance and safety of two new female condom types — Velvet and Cupid2 female condom — against the existing FC2 female condom.
Implications: Data from this study have been submitted to WHO/UNFPA and will contribute to the prequalification submission requirements for the Cupid2 and Velvet female condoms.
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Intimate partner violence and postpartum contraceptive use: the role of race/ethnicity and prenatal birth control counseling
Susan Cha, Derek A. Chapman, Wen Wan, Candace W. Burton, Saba W. Masho
Objectives: Intimate partner violence (IPV) is a major problem that could affect reproductive decision making. The aim of this study is to examine the association between IPV and contraceptive use and assess whether the association varies by receipt of prenatal birth control counseling and race/ethnicity.
Implications: Consistent with national recommendations by the U.S. Preventive Service Task Force, clinicians and public health workers are strongly encouraged to screen for IPV. Health providers should educate women on effective contraceptive options and discuss long-acting reversible contraceptives that are not partner dependent within the context of abusive relationships.
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Correspondence

Hormonal contraceptives and HIV: hazards of pronouncing “negative” studies with low power
Erica L. Gollub
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Authors' reply: Hormonal contraceptives and HIV: Hazards of pronouncing “negative” studies with low power
Kristin M. Wall, William Kilembe, Bellington Vwalika, Lisa Haddad, Susan Allen
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