Does Tennessee's Mandatory Waiting Period Law Systematically Prevent Residents of the Most Economically Disadvantaged Zip Codes from Accessing Abortion? An Exploratory Analysis.

BACKGROUND: In 2015, Tennessee enacted a law requiring a 48-hour wait and two clinic visits to obtain an abortion. METHODS: Using data from a Tennessee clinic in 2016, we explore whether abortion seekers from the most economically disadvantaged ZIP codes and those who lived farther from the clinic were less likely to return for the abortion procedure at the second visit. RESULTS: Rates of non-return were 44%-91% higher among residents of neighborhoods in which ≥25% of the population was below federal poverty level, ≥25% of the female population was below federal poverty level, and median annual household income was <$35,000. Mean clinic distance was also consistently greater among those who did not return. CONCLUSIONS: Residents of the most economically disadvantaged ZIP codes may be disproportionately burdened by Tennessee's waiting period law, rendering them less able to return for the abortion procedure than residents of less economically disadvantaged ZIP codes. Furthermore, greater clinic distance may also impede access under this law.

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.

Exploring potential interest in missed period pills in two US states.

OBJECTIVE: Missed period pills (MPP) are uterine evacuation medications used for treatment of delayed menses without prior pregnancy confirmation. This study explores potential interest in missed period pills in two US states. STUDY DESIGN: We enrolled people seeking pregnancy test services at nine health centers in two US states between June 2015 and October 2017. Participants completed an anonymous questionnaire containing closed- and open-ended questions about background characteristics, reproductive practices, pregnancy feelings and intentions, abortion attitudes, and MPP interest. We used ordered logistic regression to identify factors associated with MPP interest and inductive content analysis to identify recurring qualitative themes related to MPP interest or disinterest. RESULTS: In all, 678 people completed the survey and 286/678 (42%) indicated interest in missed period pills. Interest was greatest (129/185 or 70%) among those who would be unhappy if pregnant. Variables associated with interest in the multivariate analyses were age ≥ 35, nulliparity, prior abortion and contraceptive use, recent use of emergency contraception, pregnancy feelings and intentions, and abortion attitudes (p < .05). Variables not associated with interest included state of residence, educational attainment, ethnicity, religious affiliation, and frequency of religious attendance. Key reasons for interest were to prevent, avoid or terminate pregnancy; and psychological or emotional benefits, including management of abortion stigma. Reasons for non-interest included concerns about safety or side effects, desire to be pregnant or have a baby, and not wanting to abort or hurt the fetus/baby. CONCLUSION: If missed period pills were available in the United States, demand might be substantial and wide-ranging across demographic groups. IMPLICATIONS: Our findings suggest that some people with missed periods do not desire pregnancy confirmation before taking medications that might disrupt a pregnancy. As a result, provision of missed period pills in the United States would expand reproductive service options and could improve the delivery of patient-centered care.

Scaling up interventions: findings and lessons learned from an external evaluation of Niger's National Initiative to reduce postpartum hemorrhage.

BACKGROUND: Niger has one of the highest maternal mortality ratios in Sub Saharan Africa, of which postpartum hemorrhage is the leading cause. In 2014, Health and Development International and the Ministry of Health of Niger launched an initiative to introduce and scale-up three PPH interventions in health facilities nationwide: misoprostol, uterine balloon tamponade, and the non-pneumatic anti-shock garment. METHODS: A two-phase mixed-methods evaluation was conducted to assess implementation of the initiative. Health facility assessments, provider interviews, and household surveys were conducted in May 2016 and November 2017. RESULTS: All evaluation facilities received misoprostol prevention doses. However, shortages in misoprostol treatment doses, UBT kits, and NASG stock were documented. Health provider training increased while knowledge of each PPH intervention varied. Near-universal uterotonic coverage for PPH prevention and treatment was achieved and sustained throughout the evaluation period. Use of UBT and NASG to manage PPH was rare and differed by health facility type. Among community deliveries, fewer than 22% of women received misoprostol at antenatal care for self-administered prophylaxis. Among those who did, almost all reported taking the drugs for PPH prevention in each phase. CONCLUSIONS: This study is the first external evaluation of a comprehensive PPH program taking misoprostol, UBT, and NASG to national scale in a low resource setting. Although gaps in service delivery were identified, results demonstrate the complexities of training, managing stock, and implementing system-wide interventions to reach women in varying contexts. The experience provides important lessons for other countries as they develop and expand evidence-based programs for PPH care.

Early abortion with buccal versus sublingual misoprostol alone: a multicenter, randomized trial.

OBJECTIVE: To compare efficacy, safety/side effects and acceptability of buccal versus sublingual administration of a misoprostol-only regimen commonly used for early medical abortion. STUDY DESIGN: We conducted a randomized trial at six clinics in two Latin American countries. We randomized women seeking early abortion to buccal or sublingual administration of three doses of misoprostol 800 mcg repeated every 3 h. At initial follow-up (7-14 days after misoprostol), we offered women without a complete abortion aspiration or additional misoprostol plus waiting 7 more days. The primary outcome was continuing pregnancy at initial follow-up. Secondary outcomes included continuing pregnancy at final follow-up, incomplete abortion, successful abortion, side effects, acceptability and complications. We analyzed all outcomes as intention to treat. RESULTS: We enrolled 401 women and randomized 202 into the buccal arm and 199 into the sublingual arm. Continuing pregnancy at initial follow-up occurred in 11/201 (5.5%) and 2/189 (1.1%) women, respectively (p=.02). Additional misoprostol at follow-up increased success, defined as complete abortion, from 170/201 (84.6%) to 184/199 (92.5%) in the buccal arm and 165/189 (87.3%) to 177/189 (93.7%) in the sublingual arm. We found no differences by gestational age. Women reported similar acceptability and side effects across groups except for chills and fever, which women using sublingual misoprostol reported more frequently (p<.05). CONCLUSIONS: Sublingual administration was superior to buccal administration in reducing continuing pregnancy risk after a three-dose regimen of 800 mcg misoprostol. Complete abortion rates were comparable across groups, and in both cases, additional misoprostol at follow-up increased success. IMPLICATIONS: If the primary goal is to avoid continuing pregnancy, sublingual administration of misoprostol 800 mcg every 3 h for three doses should be recommended. If chills or fever are a concern and the primary goal is to avoid surgery, buccal administration may be preferable. For either route, additional misoprostol can be given for incomplete abortion or continuing pregnancy.

Results of a pilot study in the U.S. and Vietnam to assess the utility and acceptability of a multi-level pregnancy test (MLPT) for home monitoring of hCG trends after assisted reproduction.

BACKGROUND: To evaluate the utility and acceptability of using multi-level pregnancy tests (MLPTs) at home to monitor hCG trends following assisted reproductive technology (ART). METHODS: One hundred and four women presenting for ART at either Stanford Medicine Fertility and Reproductive Health Clinic (Stanford, CA) or Hung Vuong Hospital (Ho Chi Minh City, Vietnam) participated in this pilot study. Women were asked to perform the MLPT at home, primarily on days when they were also scheduled to receive standard clinic-based serum hCG testing. These tests were administered up to 6 times over the 6-week period following embryo transfer or intrauterine insemination (IUI). Concordance of serial hCG readings for each time point was assessed by comparing trends in urine MLPT results with trends in serum hCG. Stable or increasing hCG level was interpreted as an indication of a progressing pregnancy, while a declining hCG was interpreted as a lack of established or progressing pregnancy. At study end, all participants were asked about the acceptability and convenience of using the MLPT at home for monitoring hCG trends following ART. RESULTS: Data from both urine and serum testing are available for 156 of 179 clinic visits (87.2%). There was high concordance of serial trend results between the two types of tests: among the 156 sets of serum and urine hCG data points, 150 (96.2%) showed a matching trend in hCG pattern and 6 (3.8%) resulted in a discordant trend. Seventy-three percent of women reported being satisfied or very satisfied with using the MLPTs at home. Almost all (96.6%) said that the MLPT was easy or very easy to use. CONCLUSION: The MLPT offers women and health care providers a client-friendly diagnostic tool to detect very early pregnancy and monitor its progress. TRIAL REGISTRATION: This study was registered on clinicaltrials.gov as NCT01846403 (May 1, 2013), and NCT01919502 (August 5, 2013).

Postpartum hemorrhage prevention in Nepal: a program assessment.

BACKGROUND: In 2009, the Nepal Ministry of Health and Population launched a national program for prevention of postpartum hemorrhage (PPH) during home births that features advance distribution of misoprostol to pregnant women. In the years since, the government has scaled-up the program throughout much of the country. This paper presents findings from the first large-scale assessment of the effectiveness of the advance distribution program. METHODS: Data collection was carried out in nine districts and all three ecological zones. To assess knowledge, receipt and use of misoprostol, household interviews were conducted with 2070 women who had given birth within the past 12 months. To assess supply and provision of misoprostol, interviews were conducted with 270 Female Community Health Volunteers (FCHVs) and staff at 99 health facilities. RESULTS: Among recently delivered women, only 15% received information about misoprostol and 13% received misoprostol tablets in advance of delivery. Yet 87% who received advance misoprostol and delivered at home used it for PPH prevention. Among FCHVs, 96% were providing advance misoprostol for PPH prevention; however 81% had experienced at least one misoprostol stock out within the past year. About one-half of FCHVs were providing incomplete information about the use of misoprostol; in addition, many did not discuss side effects, how to recognize PPH or where to go if PPH occurs. Among health facilities, just one-half had sufficient misoprostol stock, while 95% had sufficient oxytocin stock, at the time of this assessment. CONCLUSIONS: In Nepal, women who receive advance misoprostol are both willing and able to use the medication for PPH prevention during home births. However the supply and personnel challenges identified raise questions about scalability and impact of the program over the long-term. Further assessment is needed.

Serial multilevel urine pregnancy testing to assess medical abortion outcome: a meta-analysis.

OBJECTIVES: To summarize data on the accuracy of a strategy designed to exclude ongoing pregnancy after medical abortion treatment by observing a decline in urine human chorionic gonadotropin (hCG) concentration as estimated by multilevel urine pregnancy tests (MLPTs) performed before and after treatment. STUDY DESIGN: We collated original data from seven studies performed by our organization that evaluated the accuracy of the MLPT strategy for assessment of outcome of medical abortion. Our first analysis included data from the five studies in which each participant was evaluated both with the MLPT strategy and with ultrasound or other clinical assessment. Our second analysis combined data from two randomized trials that compared the MLPT strategy to assessment by ultrasound. Both analyses included only participants treated at ≤63 days of gestation. RESULTS: In the first analysis, 1482 (93%) of 1599 participants had a decline in hCG concentration after treatment. Twenty-one (1.3%) had an ongoing pregnancy, none of whom had a decline (predictive value 100%, 95% CI 93.3%, 100%). The remaining 96 women (6.0%) had no decline without an ongoing pregnancy. The second analysis, which included 3762 participants with follow-up, found no significant difference in the rates of ongoing pregnancy ascertained in the randomized groups (RR 0.88; 95% CI 0.50, 1.54). Nearly all of the post-treatment MLPTs in the seven studies (3484/3535; 99%) were performed by the participants themselves. CONCLUSIONS: Serial multilevel urine pregnancy testing is a highly reliable and efficient strategy for excluding ongoing pregnancy after medical abortion at≤63 days of gestation. IMPLICATIONS STATEMENT: Serial urine testing using MLPTs can obviate the need for routine ultrasound or examination after medical abortion treatment and can allow most women to avoid an in-person follow-up visit to the abortion facility.

Randomized trial assessing home use of two pregnancy tests for determining early medical abortion outcomes at 3, 7 and 14days after mifepristone.

OBJECTIVE: To evaluate the accuracy, feasibility and acceptability of two urine pregnancy tests in assessing abortion outcomes at three time points after mifepristone administration. STUDY DESIGN: This randomized trial enrolled women seeking early medical abortion at two hospitals in Vietnam. Investigators randomly allocated participants to at-home administration of a multilevel urine pregnancy test (MLPT) or a high sensitivity urine pregnancy test (HSPT) to assess their abortion outcomes. A baseline test was administered on the same day as mifepristone. Participants performed and interpreted results of pregnancy tests taken 3, 7 and 14days after mifepristone. Ultrasound exam determined continuing pregnancy. RESULTS: Six hundred women enrolled, and 300 received each test. A percentage of 97.4 (584) had follow-up, of whom 13 women had continuing pregnancies. The specificity of MLPT at detecting absence of continuing pregnancy was 63.9%, 90.4% and 97.1% at study day 3, 7 and 14. The specificity of HSPT was 6.0%, 19.8% and 62.2%, respectively. The positive predictive value (PPV) of MLPT at detecting continuing pregnancy was 6.4% at day 3 and rose to 46.7% at day 14. In contrast, the PPV for HSPT was 2.2% at day 3 and rose to 6.5% at day 14. At all three time points, the sensitivity and negative predictive values for both tests were 100.0%. Most women found their assigned tests easy to use and would prefer future home follow-up with a pregnancy test. CONCLUSIONS: The MLPT enables women to assess their abortion outcomes more reliably than with HSPT. With MLPT, women can know their outcomes as early as 3 days after mifepristone. IMPLICATIONS: Medical abortion service delivery with an MLPT to obtain a baseline (preabortion) human chorionic gonadotropin (hCG) estimate and a second follow-up MLPT 1 to 2 weeks later can establish whether there has been a drop in hCG, signifying absence of a continuing pregnancy. Used this way, MLPTs can enable women to assess their abortion status outside of a clinic setting and without serum hCG testing and/or ultrasound.

How effective are the components of active management of the third stage of labor?

BACKGROUND: Active management of the third stage of labor is recommended for the prevention of post-partum hemorrhage and commonly entails prophylactic administration of a uterotonic agent, controlled cord traction, and uterine massage. While oxytocin is the first-choice uterotonic, it is not known whether its effectiveness varies by route of administration. There is also insufficient evidence regarding the value of controlled cord traction or uterine massage. This analysis assessed the independent and combined effectiveness of all three interventions, and the effect of route of oxytocin administration on post-partum blood loss. METHODS: Secondary data were analyzed from 39202 hospital-based births in four countries and two clinical regimens: one in which oxytocin was administered following delivery of the baby; the other in which it was not. We used logistic regression to examine associations between clinical and demographic variables and post-partum blood loss ≥ 700 mL. RESULTS: Among those with no oxytocin prophylaxis, provision of controlled cord traction reduced hemorrhage risk by nearly 50% as compared with expectant management (P < 0.001). Among those with oxytocin prophylaxis, provision of controlled cord traction reduced hemorrhage risk by 66% when oxytocin was intramuscular (P < 0.001), but conferred no benefit when oxytocin was intravenous. Route of administration was important when oxytocin was the only intervention provided: intravenous administration reduced hemorrhage risk by 76% as compared with intramuscular administration (P < 0.001); when combined with other interventions, route of administration had no effect. In both clinical regimens, uterine massage was associated with increased hemorrhage risk. CONCLUSIONS: Recommendations for active management of the third stage of labor should account for setting-related differences such as the availability of oxytocin and its route of administration. The optimal combination of interventions will vary accordingly.

Male circumcision for HIV prevention: clinical practices and attitudes among healthcare providers in South Africa and Zimbabwe.

BACKGROUND: This study aimed to document the clinical practices and attitudes of health care providers in South Africa and Zimbabwe on male circumcision for human immunodeficiency virus (HIV) prevention. METHODS: We conducted national surveys of physicians and nurses in both countries in 2008-2009 (N = 1444). Data on male circumcision for HIV prevention were analyzed; outcomes were patient counseling, provision of services, and desire for training. We used multivariable logistic regression to examine associations between these outcomes and clinician, practice, and attitudinal variables. RESULTS: Overall, 57% of clinicians reported counseling male patients on male circumcision, 17% were offering services (49% referrals), and 61% desired training. In the multivariable analyses, provision of services was more common in South Africa (P ≤ 0.001) but desire for training higher in Zimbabwe (P ≤ 0.01). Provision of services was highest among physicians (P ≤ 0.01) and in hospital settings (P ≤ 0.001). However, nurses had greater desire for training (P ≤ 0.05) as did younger clinicians (P ≤ 0.001). Clinicians in rural and clinic settings were just as likely to express training interest. Clinician attitudes that patients would be upset due to cultural beliefs and would increase risky behaviors were associated with less counseling and service provision (P ≤ 0.05). CONCLUSIONS: Many clinicians in South Africa and Zimbabwe showed willingness to integrate new HIV prevention evidence into practice and to become trained to offer the procedure to patients. Results suggest that both countries should consider involving nurses in male circumcision for HIV prevention, including those in rural areas, and should help clinicians to address cultural concerns.

Misoprostol for the prevention and treatment of postpartum hemorrhage.

INTRODUCTION: Uterotonic drugs are recommended for the prevention and treatment of postpartum hemorrhage (PPH), and oxytocin is considered the gold standard for both indications due to its established efficacy and safety. Unfortunately, access to oxytocin is still limited in many low-resource settings due to the need for cool storage, sterile equipment and administration by skilled personnel. Misoprostol , an E1 prostaglandin analog, has therefore been explored as an alternative for such settings due to its proven ability to induce uterine contractions, low cost, stability at room temperature and ease of administration. AREAS COVERED: This review covers evidence from 51 randomized controlled trials for both prevention and treatment of PPH. It discusses efficacy and side effects in the context of the various doses that have been studied using oral, sublingual or rectal routes of administration for both indications. EXPERT OPINION: There is now a solid body of evidence to justify the use of misoprostol for postpartum hemorrhage indications in many settings. The evidence supports use of 600 µg orally for the prevention of PPH and 800 µg sublingually for the treatment of PPH. There is no evidence to support the adjunct use of misoprostol following administration of conventional uterotonics for prevention or treatment purposes.

Abused patient's attitudes about mandatory reporting of intimate partner abuse injuries to police.

OBJECTIVES: This study examines abused women's preferences regarding medical clinician reporting of intimate partner abuse injuries to police. It also examines the influence of specific demographic factors on abused women's reporting preferences. METHODS: Telephone interviews were conducted with a random sample of women patients attending one of three public primary care clinics associated with the San Francisco Community Health Network. Participants reporting a history of abuse were asked to identify their preferences regarding the reporting of abuse by medical clinicians to police. RESULTS: Of the 358 abused women interviewed in this study, the majority of them (n = 243, 68%) did not prefer a domestic violence injury reporting system that was mandatory even if against patient wishes. However, almost all women (n = 329, 92%) favored some form of police reporting by medical clinicians. Women who had been abused within the past year were more likely to oppose mandatory reporting than women who had been abused more than one year ago. Younger women were more likely than older women to oppose mandatory reporting requirements, and women whose primary language was English were more likely to oppose mandatory reporting requirements than women whose primary language was Spanish. Current abuse was independently predictive of decreased likelihood to select mandatory reporting in all situations. There were no significant differences in reporting preferences by ethnicity, marital status, education, employment, or the presence of children at home. CONCLUSIONS: Despite broad support among abused women for medical clinician reporting of intimate partner abuse injuries to police, most women do not support mandatory reporting requirements that do not allow for consideration of the abused patients' wishes. More research is needed to ascertain whether the benefits of mandatory reporting outweigh the risks to those intended to benefit from the law.