Abortion Training in Family Medicine Residency Programs: A National Survey of Program Directors 5 Months After the Dobbs Decision.

BACKGROUND AND OBJECTIVES: Routine abortion training during family medicine (FM) residency leads to higher rates of postresidency provision; increased availability of abortion care in the FM setting could greatly improve access. Especially in the post-Dobbs context, understanding the landscape of abortion training in US family medicine residency programs (FMRPs) is critical. METHODS: We invited all directors of US FMRPs accredited by the Accreditation Council for Graduate Medical Education to complete a larger omnibus online survey that included questions on abortion training. We compiled descriptive statistics and conducted χ2 tests and multivariate regression analyses to detect associations with abortion training. RESULTS: The response rate was 42% (N=286). Nineteen percent of programs had routine medication abortion (MAB) training and 10% had routine aspiration training. In addition, 58% of programs offered elective MAB training and 52% offered elective aspiration training. In multivariate regression, the presence of abortion training was associated with a program having 31 or more residents, being in a state with protected abortion access, not having a Catholic affiliation, and having a program director who believed abortion training should be routine in FMRPs. CONCLUSIONS: While more than half of responding FMRPs reported some abortion training, much of it was elective, and 40% of programs lacked abortion training completely. Although abortion training is severely limited or prohibited in states with abortion bans, more training opportunities in the states where abortion is possible could increase access to abortion within primary care.

Abortion Provision by Family Physicians After Integrated Opt-Out Training in Residency.

BACKGROUND AND OBJECTIVES: Reproductive Health Education In Family Medicine(RHEDI) supports family medicine residency programs to establish a required rotation in sexual and reproductive health (SRH), including abortion. We evaluated long-term training effects by examining the practice patterns of family physicians 2 to 6 years after residency graduation, to determine whether and how the practices and abortion provision of those with enhanced SRH training differ from those who did not receive this training. METHODS: We invited 1,949 family physicians who completed residency training between 2010 and 2018 to complete an anonymous online survey about residency training and current provision of SRH services. RESULTS: We received 714 completed surveys, a 36.6% response rate. Of those who received routine abortion training during residency (n=445), 24% had provided abortion after graduation, significantly more than the 13% providing abortion who had not received routine training during residency, and much higher than the 3% provision rate found in a recent representative study. Abortion-trained respondents were also more likely than the comparison group to have provided other SRH care. For both medication and procedural abortion, respondents who trained in the family medicine setting were significantly more likely to have provided abortion after residency than those who trained only in dedicated abortion clinics (31% vs 18%, and 33% vs 13%, respectively). CONCLUSIONS: Abortion training during family medicine residency is strongly linked to postresidency abortion provision, and is crucial in preparing family physicians to meet the full range of their patients' reproductive health care needs.

"It was close enough, but it wasn't close enough": A qualitative exploration of the impact of direct-to-patient telemedicine abortion on access to abortion care.

OBJECTIVE: To understand how obtaining a medication abortion by mail with telemedicine counseling versus traditional in-clinic care impacted participants' access to care. STUDY DESIGN: We conducted a qualitative study with semi-structured telephone interviews with individuals who completed a medication abortion by mail through the TelAbortion study. We asked participants how they learned about telemedicine abortion, reasons for choosing it, what their alternative would have been, and about their experience. We transcribed, coded, and performed qualitative content analysis of the interviews and are presenting a subset of themes related to access to care when the restrictions on clinic dispensing of mifepristone are removed. RESULTS: We interviewed 45 people from January to July 2020. Direct-to-patient telemedicine abortion was more convenient and accessible than in-clinic abortion care when considering the burdens of travel, clinic availability, logistics, and cost that were associated with in-clinic abortion. Stigma led to a prioritization of privacy, and by going to a clinic, participants feared a loss of privacy whereas obtaining a medication abortion by mail made it easier to maintain confidentiality. Faced with these barriers, 13% of participants stated they would have continued their pregnancy if TelAbortion had not been an option. Participants found direct-to-patient telemedicine abortion to be acceptable and recommended it to others. Benefits of telemedicine were amplified during the COVID-19 pandemic due to concerns around infection exposure with in-clinic care. CONCLUSION: Going to a clinic was a burden for participants, to the point where some would not have otherwise been able to get an abortion. Medication abortion by mail with telemedicine counseling was a highly acceptable alternative. IMPLICATIONS: Medication abortion by mail can increase access to abortion with the added benefits of increased perceived privacy and decreased logistical burdens. Removing the in-person dispensing requirement for mifepristone would allow direct-to-patient telemedicine abortion to be implemented outside of a research setting without compromising the patient experience.

Expansion of a direct-to-patient telemedicine abortion service in the United States and experience during the COVID-19 pandemic.

OBJECTIVE: To present updated evidence on the safety, efficacy and acceptability of a direct-to-patient telemedicine abortion service and describe how the service functioned during the COVID-19 pandemic. STUDY DESIGN: We offered the study at 10 sites that provided the service in 13 states and Washington DC. Interested individuals obtained any needed preabortion tests locally and had a videoconference with a study clinician. Sites sent study packages containing mifepristone and misoprostol by mail and had remote follow-up consultations within one month by telephone (or by online survey, if the participant could not be reached) to evaluate abortion completeness. The analysis was descriptive. RESULTS: We mailed 1390 packages between May 2016 and September 2020. Of the 83% (1157/1390) of abortions for which we obtained outcome information, 95% (1103/1157) were completed without a procedure. Participants made 70 unplanned visits to emergency rooms or urgent care centers for reasons related to the abortion (6%), and 10 serious adverse events occurred, including 5 transfusions (0.4%). Enrollment increased substantially with the onset of COVID-19. Although a screening ultrasound was required, sites determined in 52% (346/669) of abortions that occurred during COVID that those participants should not get the test to protect their health. Use of urine pregnancy test to confirm abortion completion increased from 67% (144/214) in the 6 months prior to COVID to 90% (602/669) in the 6 months during COVID. Nearly all satisfaction questionnaires (99%, 1013/1022) recorded that participants were satisfied with the service. CONCLUSIONS: This direct-to-patient telemedicine service was safe, effective, and acceptable, and supports the claim that there is no medical reason for mifepristone to be dispensed in clinics as required by the Food and Drug Administration. In some cases, participants did not need to visit any facilities to obtain the service, which was critical to protecting patient safety during the COVID-19 pandemic. IMPLICATIONS: Medical abortion using telemedicine and mail is effective and can be safely provided without a pretreatment ultrasound. This method of service delivery has the potential to greatly improve access to abortion care in the United States.

"False positive" urine pregnancy test results after successful medication abortion.

OBJECTIVE: To examine the proportion of high-sensitivity urine pregnancy test (HSPT) results that were positive by time after successful medication abortion. STUDY DESIGN: We used data from an ongoing study that provides mifepristone and misoprostol for medication abortion by direct-to-patient telemedicine and mail. Providers evaluated abortion outcomes by patient interview and clinical tests per clinical judgment and participant preference. We identified all participants enrolled July 2016 to September, 2020 who had an HSPT result and no indication of viable pregnancy after treatment. We used logistic regression to examine the association between the timing of the initial post-treatment HSPT, gestational age, and the proportion of HSPTs that gave a positive result. RESULTS: Of the 472 participants in our analysis, 88 (19%) had positive initial HSPTs. The proportions that were positive at ≤20 days, 21 to 27 days, 28 to 34 days, and ≥35 days after mifepristone ingestion was 14 of 29 (48%), 15 of 58 (26%), 49 of 258 (19%), and 10 of 127 (8%), respectively (p < 0.001). Gestational age at mifepristone ingestion was not significantly related to positive HSPT results (p = 0.28). Multivariable logistic regression confirmed both findings and did not identify a statistically significant interaction between these variables. In the 67 participants who relied solely on further HSPTs to confirm abortion outcome, the median interval between the initial positive test and first negative test was 14 days. CONCLUSIONS: The proportion of participants with positive HSPTs declined with time after successful medication abortion. However, nearly one-fifth of participants with complete abortion had positive tests 4 weeks after treatment. IMPLICATIONS: HSPTs provide an inexpensive, convenient option for confirming success of medication abortion at home. However, a substantial minority of patients without ongoing pregnancy have positive HSPT results. Development of a symptom-based strategy for medication abortion outcome assessment without any confirmatory tests should be a priority.

Feasibility of Multilevel Pregnancy Tests for Telemedicine Abortion Service Follow-Up: A Pilot Study.

CONTEXT: Telemedicine clients wishing to confirm a successful medication abortion outside of a clinic setting are commonly instructed to use high-sensitivity urine pregnancy tests, which can take up to four weeks to yield accurate results. Multilevel urine pregnancy tests (MLPTs), which provide accurate results in one week, are a promising alternative, but their use has not been evaluated within telemedicine services. METHODS: From November 2017 to May 2018, 165 eligible and consenting pregnant people who contacted safe2choose-an organization providing telemedicine abortion services internationally-for medication abortion were enrolled in a pilot study and mailed a package containing medication abortion drugs, two MLPTs and instructions. Data on 118 participants who completed a web-based evaluation survey two weeks after the package was sent were analyzed to examine participant experiences and satisfaction with the service. RESULTS: Responding participants were from 11 countries, including Mexico, the Philippines and Singapore. Ninety-three percent used both MLPTs, and 91% of those who used both tests used them at the correct time intervals. Among the 95% of participants whose MLPT results indicated that their pregnancy hormone levels decreased from before to after medication abortion, 86% correctly interpreted the results to mean that they were no longer pregnant. Satisfaction was high, with all indicating that the supplied information was helpful; more than nine out of 10 noted that they would want to use the MLPTs again. CONCLUSIONS: Incorporating MLPTs into telemedicine abortion services is feasible and associated with high client satisfaction. Enabling people to manage their own abortion follow-up care could greatly improve their overall abortion experience.

RESUMEN Contexto: Las clientas de telemedicina que desean confirmar el éxito de un aborto con medicamentos fuera del entorno de una clínica, generalmente reciben instrucciones para usar pruebas de alta sensibilidad de embarazo en orina, que pueden tomar hasta cuatro semanas para producir resultados precisos. Las pruebas multinivel de embarazo en orina (PMEO), que brindan resultados precisos en una semana, son una alternativa prometedora, pero su uso no ha sido evaluado en el contexto de los servicios de telemedicina. Métodos: De noviembre de 2017 a mayo de 2018, 165 mujeres embarazadas elegibles y que dieron su consentimiento se comunicaron con safe2choose ­organización que brinda servicios de aborto por telemedicina a nivel internacional­para obtener un aborto con medicamentos y se inscribieron en un estudio piloto que les envió por correo un paquete que contenía medicamentos para el aborto, dos PMEO e instrucciones. Se analizaron los datos de 118 participantes que completaron una encuesta de evaluación en línea dos semanas después de que se envió el paquete para examinar las experiencias de las participantes y la satisfacción con el servicio. Resultados: Las participantes que respondieron eran de 11 países, incluidos México, Filipinas y Singapur. El 93% utilizó ambos PMEO y el 91% de quienes utilizaron ambas pruebas las utilizaron en los intervalos de tiempo correctos. Del 95% de las participantes cuyos resultados de PMEO indicaron que sus niveles de hormonas del embarazo disminuyeron desde antes hasta después del aborto con medicamentos, el 86% interpretó correctamente los resultados en el sentido de que ya no estaban embarazadas. La satisfacción fue alta, y todas indicaron que la información proporcionada fue útil; más de nueve de cada 10 señalaron que querrían volver a utilizar los PMEO. Conclusiones: La incorporación de PMEO en los servicios de aborto por telemedicina es factible y está asociada con una alta satisfacción del cliente. Permitir que las mujeres manejen su propia atención de seguimiento del aborto podría mejorar en gran medida su experiencia general del aborto.

RÉSUMÉ Contexte: Les patientes en télémédecine soucieuses de confirmer la réussite d'un avortement médicamenteux effectué en dehors d'une clinique sont généralement invitées à utiliser les tests urinaires de grossesse à haute sensibilité, qui peuvent produire des résultats inexacts jusqu'à quatre semaines après l'intervention. Les tests urinaires de grossesse multiniveaux (TGMN), qui produisent des résultats exacts en l'espace d'une semaine, offrent une autre solution prometteuse, mais leur utilisation n'a pas été évaluée en télémédecine. Méthodes: De novembre 2017 à mai 2018, 165 personnes enceintes admises et consentantes qui s'étaient adressées à l'organisation safe2choose ­ prestataire de services d'avortement par télémédecine à l'échelle internationale ­ pour un avortement médicamenteux ont été inscrites à une étude pilote et un colis contenant des médicaments abortifs, deux TGMN et les instructions à suivre leur a été envoyé. Les données relatives à 118 participantes ayant répondu à un questionnaire d'évaluation en ligne deux semaines après l'envoi du colis ont été analysées pour examiner leur expérience et leur satisfaction concernant le service. Résultats: Les participantes qui avaient répondu au questionnaire étaient originaires de 11 pays, dont le Mexique, les Philippines et Singapour. Quatre-vingt-treize pour cent avaient utilisé les deux TGMN et, parmi elles, 91% les avaient utilisés aux intervalles adéquats. Parmi les 95% de participantes dont les TGMN indiquaient des niveaux d'hormone de grossesse en baisse entre les moments où elles avaient effectué les tests avant et après l'avortement médicamenteux, 86% avaient interprété correctement leurs résultats comme indiquant qu'elles n'étaient plus enceintes. Le niveau de satisfaction était élevé, toutes les participantes indiquant que l'information fournie leur avait été utile. Plus de neuf sur 10 faisaient remarquer qu'elles seraient disposées à réutiliser les TGMN. Conclusions: L'incorporation des TGMN dans les services d'avortement par télémédecine est faisable et associée à un haut degré de satisfaction. L'habilitation à gérer ses propres soins de suivi après avortement pourrait améliorer grandement l'expérience générale de l'intervention.

A non-inferiority study of outpatient mifepristone-misoprostol medical abortion at 64-70 days and 71-77 days of gestation.

OBJECTIVES: This open-label non-inferiority study assessed efficacy of a common outpatient medical abortion regimen among people with pregnancies 64-70 days and 71-77 days of gestation. STUDY DESIGN: We defined non-inferiority by a 6% margin of method success. People with intrauterine pregnancies 64-77 days' gestational age by abdominal ultrasound seeking medical abortion at one of eight clinics and met eligibility criteria were offered participation. Consenting participants took mifepristone 200 mg followed 24-48 h later by misoprostol 800 mcg buccally, and returned after one week for provider evaluation and abdominal ultrasound to determine abortion status. Participants recorded medication use, pregnancy expulsion, daily bleeding and pain scores until the one-week follow up. Clinic staff interviewed participants prior to study discharge to assess acceptability. RESULTS: Seven hundred and nineteen participants were enrolled, 393 and 326 in the respective groups. Successful expulsion without surgical intervention was achieved in 92.3% of the earlier gestational age group and 86.7% of the later group (difference in proportions 5.6%, 1-sided 95% CI 9.6). Ongoing pregnancy accounted for 3.6% and 8.7% (p = 0.007) of outcomes, respectively. Participants in the 71-77 day group reported nausea and weakness more frequently. Pain, bleeding and acceptability measures between groups were similar. CONCLUSION: Although the success rate at 71-77 days of gestation was within the non-inferiority margin, we cannot rule out that it is statistically worse than in the previous gestational week. Significantly more ongoing pregnancies in the later group raise concerns about using the regimen at 71-77 days.

TelAbortion: evaluation of a direct to patient telemedicine abortion service in the United States.

OBJECTIVES: To evaluate the safety, feasibility, and acceptability of a direct-to-patient telemedicine service that enabled people to obtain medical abortion without visiting an abortion provider in person. STUDY DESIGN: We offered the service in five states. Each participant had a videoconference with a study clinician and had pre-treatment laboratory tests and ultrasound at facilities of her choice. If the participant was eligible for medical abortion, the clinician sent a package containing mifepristone, misoprostol, and instructions to her by mail. After taking the medications, the participant obtained follow-up tests and had a follow-up consultation with the clinician by telephone or videoconference to evaluate abortion completeness. The analysis was descriptive. RESULTS: Over 32 months, we conducted 433 study screenings and shipped 248 packages. The median interval between screening and mailing was 7 days (91st percentile 17 days), and no participant took the mifepristone at ≫71 days of gestation. We ascertained abortion outcomes of 190/248 package recipients (77%): 177/190 (93%) had complete abortion without a procedure. Of the 217/248 package recipients who provided meaningful follow-up data (88%), one was hospitalized for postoperative seizure and another for excessive bleeding, and 27 had other unscheduled clinical encounters, 12 of which resulted in no treatment. A total of 159/248 participants who received packages (64%) completed satisfaction questionnaires at study exit; all were satisfied with the service. CONCLUSIONS: This direct-to-patient telemedicine abortion service was safe, effective, efficient, and satisfactory. The model has the potential to increase abortion access by enhancing the reach of providers and by offering people a new option for obtaining care conveniently and privately. IMPLICATIONS: Provision of medical abortion by direct-to-patient telemedicine and mail has the potential to increase abortion access by increasing the reach of providers and by offering people the option of obtaining abortion care without an in-person visit to an abortion provider.

A direct-to-patient telemedicine abortion service in Australia: Retrospective analysis of the first 18 months.

BACKGROUND: In 2015, the Tabbot Foundation launched a nationwide direct-to-patient telemedicine service to enable women to obtain medical abortion without visiting an abortion provider. AIMS: We aimed to describe results from the first 18 months of this service. MATERIALS AND METHODS: To have an abortion through the Foundation, a woman obtained screening tests locally and had a telephone consultation with a Foundation doctor. If she was eligible, mifepristone, misoprostol and other medications were sent to her by mail. After taking the drugs, the woman obtained follow-up tests at local facilities and had a consultation with Foundation professionals. The Foundation charged $250 to patients with Medicare eligibility and $600 otherwise. We summarised clinical data collected by the service. RESULTS: Between June 2015 and December 2016, 1010 women received medications, of whom 56% lived outside of major cities. Ninety-five percent of packages were sent within 15 days after registration. Of the 965 women who took misoprostol, outcomes were definitively documented for 754 (78%), of whom 96% had a complete abortion without surgical intervention, and 95% had no face-to-face clinical encounter after treatment. Of women with Medicare cards, 72% paid no out-of-pocket charges other than to the Foundation. Nearly all women (781/802; 97%) were highly satisfied. CONCLUSIONS: The direct-to-patient telemedicine medical abortion service was effective, safe, inexpensive and satisfactory. It disproportionately served women in parts of Australia with limited access to abortion facilities. This experience may be instructive for others desiring to use telemedicine to enhance access to abortion.

Oral-health-related quality of life of dental patients: a hospital based study in far north Queensland, Australia.

OBJECTIVE: To investigate the prevalence, extent, and severity of oral-health-related quality of life among dental patients in far north Queensland, Australia. METHODS: A questionnaire was designed consisting of two parts: socio-demographic questions and the short form of Oral Health Impact Profile (OHIP-14) in part 1 and 2 respectively. The survey was conducted from July to August 2014 among patients attending the James Cook University Dental Clinic. RESULTS: Five hundred and nineteen questionnaires were distributed and collected. Of these, 40 were excluded from the analysis due to being incomplete. Therefore, a total of 479 questionnaires were available for the analysis. Half the respondents (50.9%) reported one or more of the 14 impacts as "fairly often" or "very often." The individual OHIP items with the highest prevalence recorded were physical pain and psychological discomfort. Females (52.2%) experienced a slightly higher prevalence compared to males (49.3%) but this difference was not statistically significant (Chi-square test: P > 0.05). Participants who identified as Indigenous Australian or Torres Strait Islanders and those in the 36-50 age group recorded the highest prevalence (Kruskal-Wallis test: P < 0.05). Indigenous Australians and Torres Strait Islanders also reported the highest mean extent score (4.39) and mean severity score (23.19). CONCLUSION: This study revealed comparatively higher prevalence, extent, and severity scores reflecting a significantly poor oral-health-related quality of life among dental patients living in far north Queensland, Australia.

Second trimester medical abortion with mifepristone followed by unlimited dosing of buccal misoprostol in Armenia.

OBJECTIVES: The aim of the study was to assess the efficacy and acceptability of a regimen using mifepristone and buccal misoprostol with unlimited dosing for second trimester abortion in Armenia. METHODS: Women seeking to terminate 13-22 week pregnancies were enrolled in the study. Participants swallowed 200 mg mifepristone in the clinic and were instructed to return to the hospital for induction 24-48 h later. During induction, women were given 400 µg buccal misoprostol every 3 h until the fetus and placenta were expelled. The abortion was considered a success if complete uterine evacuation was achieved without oxytocin or surgery. RESULTS: A total of 120 women with a median gestational age of 18 weeks participated in the study. All women began misoprostol induction around 24 h after taking mifepristone. Complete uterine evacuation was achieved in 119 (99.2%) women. The median induction-to-abortion interval was 10.3 h (range 4-17.4) with a mean of 9.5 ± 2.5 h. A median of four misoprostol doses (range 2-6) with a mean of 4 ± 1 misoprostol doses were administered. The induction-to-abortion interval, number of misoprostol doses, pain score and analgesia use increased as gestational age advanced. Acceptability of the method was high among both patients and providers. CONCLUSION: The medical abortion regimen of 200 mg mifepristone followed 24 h later by induction with 400 µg buccal misoprostol administered every 3 h, with no limit on the number of doses used for the termination of pregnancies of 13-22 weeks' gestation is an effective and acceptable option for women.

Neither vaginal nor buccal administration of 800 µg misoprostol alters mucosal and systemic immune activation or the cervicovaginal microbiome: a pilot study.

OBJECTIVES: The aim of the study was to assess the extent to which misoprostol alters mucosal or systemic immune responses following either buccal or vaginal administration. METHODS: This was a prospective, crossover pilot study of 15 healthy, reproductive-age women. Women first received 800 µg misoprostol either via buccal or vaginal administration and were crossed over 1 month later to receive the drug via the other route. Cervicovaginal lavage samples, cervical Cytobrush samples, cervicovaginal swabs, urine and blood were obtained immediately prior to drug administration and the following day. Parameters assessed included urine and cervicovaginal misoprostol levels, whole blood cytokine responses (by ELISA) to immune stimulation with lipopolysaccharide, peripheral blood and cervical lymphocyte phenotyping by flow cytometry, cervicovaginal antimicrobial peptide measurement by ELISA and vaginal microbial ecology assessment by 16S rRNA sequencing. RESULTS: Neither buccal nor vaginal misoprostol significantly altered local or systemic immune and microbiological parameters. CONCLUSION: In this pilot study, we did not observe significant alteration of mucosal or systemic immunology or vaginal microbial ecology 1 day after drug administration following either the buccal or vaginal route.

Acceptability and feasibility of 400 µg buccal misoprostol after 200 mg mifepristone for early medical abortion in Georgia.

OBJECTIVES: The aim of the study was to examine the acceptability and feasibility of early medical abortion using 200 mg mifepristone and 400 µg buccal misoprostol in Georgia, outside the capital city of Tbilisi. METHODS: A total of 622 women in four regions of western and eastern Georgia who presented for termination of pregnancy at up to 63 d of gestation were enrolled in the study. In the western regions, women took one 200 mg pill of mifepristone in the clinic and were given the option of administering 400 µg misoprostol buccally, either at the clinic or at home, 24-48 h later. In the eastern region, women were given the option to take both drugs at home. Abortion status was determined 2 weeks after mifepristone administration. RESULTS: Ninety-five percent of participants had a successful abortion. Twenty-one percent of women in the eastern region elected to take mifepristone at home; nearly all participants in both regions (98%) chose to take misoprostol at home. Ninety-five percent of women were very satisfied or satisfied with the method, and 95% said they would prefer medical abortion for a future procedure. CONCLUSIONS: Medical abortion with mifepristone and 400 µg buccal misoprostol is an acceptable and feasible option for women in Georgia, outside the capital city of Tbilisi.

Vaginal and Rectal Clostridium sordellii and Clostridium perfringens Presence Among Women in the United States.

OBJECTIVE: To characterize the presence of Clostridium sordellii and Clostridium perfringens in the vagina and rectum, identify correlates of presence, and describe strain diversity and presence of key toxins. METHODS: We conducted an observational cohort study in which we screened a diverse cohort of reproductive-aged women in the United States up to three times using vaginal and rectal swabs analyzed by molecular and culture methods. We used multivariate regression models to explore predictors of presence. Strains were characterized by pulsed-field gel electrophoresis and tested for known virulence factors by polymerase chain reaction assays. RESULTS: Of 4,152 participants enrolled between 2010 and 2013, 3.4% (95% confidence interval [CI] 2.9-4.0) were positive for C sordellii and 10.4% (95% CI 9.5-11.3) were positive for C perfringens at baseline. Among the 66% with follow-up data, 94.7% (95% CI 88.0-98.3) of those positive for C sordellii and 74.4% (95% CI 69.0-79.3) of those positive for C perfringens at baseline were negative at follow-up. At baseline, recent gynecologic surgery was associated with C sordellii presence, whereas a high body mass index was associated with C perfringens presence in adjusted models. Two of 238 C sordellii isolates contained the lethal toxin gene, and none contained the hemorrhagic toxin gene. Substantial strain diversity was observed in both species with few clusters and no dominant clones identified. CONCLUSION: The relatively rare and transient nature of C sordellii and C perfringens presence in the vagina and rectum makes it inadvisable to use any screening or prophylactic approach to try to prevent clostridial infection. CLINICAL TRIAL REGISTRATION: ClinicalTrials.gov, www.clinicaltrials.gov, NCT01283828.

A prospective, non-randomized study of home use of mifepristone for medical abortion in the U.S.

OBJECTIVE: To determine the acceptability of taking mifepristone at home for early medical abortion in the United States. STUDY DESIGN: This prospective, non-randomized, open-label study at six Planned Parenthood centers gave women with pregnancies up to 63 days' gestation seeking medical abortion the choice of taking mifepristone in the center or at home. Participants were interviewed at a follow-up visit 1-2 weeks after mifepristone administration to assess their experience with the option they selected. RESULTS: Four-hundred women were enrolled between April 2013 and June 2014 of which 32% (n=128) chose to take mifepristone at home. Abortion success rates did not differ between home and center users (96% and 97%). Among home users, 82% reported taking the mifepristone at the time they planned with their provider and no participant took it after 63 days' gestation. The most common reason cited for selecting home use was scheduling flexibility and significantly more home users took misoprostol on the weekend (50% vs. 36%, p=.02). Home users were more likely than center users to report missing no days of work due to the abortion (47% vs. 28%, p=.08). Ninety-nine percent of home users reported that they would take mifepristone at home again and 96% would recommend home use to a friend. Offering this option did not increase the service delivery burden on study providers, who would recommend home use in the future for most participants. CONCLUSIONS: Home use of mifepristone is a highly acceptable practice for which there is current demand, and it should be offered as part of routine medical abortion services. 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.

Outpatient medical abortion is safe and effective through 70 days gestation.

Data show that an outpatient regimen of 200-mg mifepristone followed by a single dose of misoprostol is safe and effective for medical abortion for up to 70 days from last menstrual period (LMP). Yet, many clinics only provide services up to 63 days LMP, and some practice guidelines do not recommend the higher gestational age limit. We review the studies published to date that include women 64 to 70 days LMP and conclude that outpatient medical abortion is safe and effective in this interval and that there are no clinically meaningful differences between outcomes at 57 to 63 days LMP and 64 to 70 days LMP. Updating clinical protocols and revising the Food and Drug administration label for Mifeprex® to change the indication for termination of pregnancies through 70 days LMP will give women more choices and expand access to safe abortion services.

If we can do it for misoprostol, why not for mifepristone? The case for taking mifepristone out of the office in medical abortion.

Given the highly political nature of abortion in the United States, the provision of medical abortion with mifepristone (Mifeprex®) and misoprostol has always occurred under a unique set of circumstances. The Food and Drug Administration-approved regimen requires clinicians to administer the mifepristone in the office and also requires women to return to the office for the misoprostol. In the US, where off-label drug use is an accepted practice when supportive evidence exists, most clinicians give women the misoprostol at the initial visit for her to take at home, eliminating an unnecessary visit to the office. This commentary suggests that, based on current studies, there is also enough evidence to offer women the option to self-administer mifepristone out of the office and that this is just another feature of off-label use. Six studies, enrolling over 1800 women, found that the option of taking mifepristone out of the office was popular and acceptable among women and providers. Given that it is safe, highly acceptable and not burdensome on providers, outside-office-use of mifepristone should be offered to all women as part of routine medical abortion services.

The introduction of first trimester medical abortion in Armenia.

In Armenia, abortion is the main means of fertility regulation; however, before research activities were initiated only surgical methods were available and the quality of services was low in some areas. Our clinical study from 2008-2011 aimed to show that early medical abortion is an acceptable and feasible option. A total of 700 eligible women with pregnancies up to 63 days LMP presenting for abortion were recruited for the study in five locations. Participants took 200 mg mifepristone and 800 µg buccal misoprostol 24-48 hours later. They returned for a follow-up visit two weeks after mifepristone administration. 95% of the women had successful abortions and 95% were satisfied with the method. In 2012-2013, we conducted a follow-up assessment to examine the ongoing provision and quality of medical abortion services at the former research sites. Medical record reviews, interviews and observations were carried out three times approximately six months apart. The assessment found that all five sites had continued providing medical abortion, with about half of eligible women choosing the medical method. Four of the five sites were achieving high success rates. Staff turnover and the lack of trained providers likely contributed to the higher failure rate at the fifth site. These findings provide evidence that first trimester medical abortion is an acceptable and feasible option for Armenian women and providers, and that high quality services are being delivered.

What happens when we routinely give doxycycline to medical abortion patients?

OBJECTIVES: Routine provision of antibiotics following medical abortion is common yet practitioners and professional societies differ on its utility. Our study compares the side effects experienced by women who were prescribed doxycycline following medical abortion to those who were not and assesses the adherence to one prescribed regimen. STUDY DESIGN: This was a prospective, observational, open-label study from a convenience sample. Women seeking medical abortion were enrolled in nine study sites, including four clinics that routinely prescribe a seven-day course of doxycycline (Doxycycline arm) and five clinics that do not routinely prescribe any antibiotics (No Doxycycline arm). Seven to fourteen days following the administration of mifepristone, women were asked to self-administer a computer-based survey. The survey asked about side effects experienced (both arms) and adherence to the regimen (Doxycycline arm only). RESULTS: Five hundred eighty-one women were enrolled (278 in the Doxycycline arm and 303 in the No Doxycycline arm). There was a trend toward increased nausea in the Doxycycline arm (47.8% vs. 40.9%; p=.056) and a statistically significant difference in vomiting (25.2% vs. 18.5%; p=.032). Almost all women in the Doxycycline arm reported taking at least one pill, however only 28.3% reported "perfect adherence." The most common reasons reported for taking fewer pills than instructed were that participants were still taking them (beyond 7 days) or that they forgot to take them. CONCLUSION: Women who were prescribed doxycycline following medical abortion reported moderate adherence and experienced significantly more vomiting than their counterparts. IMPLICATIONS: In the absence of robust evidence that prescribing 7 days of doxycycline following medical abortion is effective at reducing serious infections, these data can assist the public health community with deciding whether routine provision is the most appropriate strategy.