Understanding Factors Affecting Health Providers' Perceptions of Pharmacist Roles in HPV Vaccine Administration.

Human papillomavirus (HPV) is a viral infection that sexually active females and males may be exposed to in their lifetime. The HPV vaccine is highly recommended especially among children to protect them before their anticipated exposure to HPV, however, vaccination uptake in Hawai'i remains low. As of 2017, legislation allows pharmacists to vaccinate for adolescent vaccines with the potential to increase access and opportunities for patients to complete the HPV vaccine series. Physicians in Hawai'i were surveyed to examine physicians' awareness of this law, their perceptions of the role of pharmacists, and willingness to send adolescent patients to pharmacies; 137 responses were received and analyzed. Overall, 72% (n=99) of respondents were willing while 28% (n=38) were unwilling to send patients to pharmacies for vaccines. Physicians view pharmacists' role as helpful but have concerns regarding correct administration and tracking doses given. Results show potential for more physician-pharmacist collaborations through further education and trainings for pharmacists and health providers to increase physician referrals for adolescent vaccine services in pharmacies.

Unmet Reproductive Health Needs of Transgender and Gender Diverse People in Hawai'i: A Qualitative Needs Assessment.

The purpose of this study was to assess the reproductive health experiences of transgender and gender diverse people in Hawai'i, identify reproductive health needs that were unmet, and explore opportunities for addressing those needs. This was a qualitative, semi-structured individual interview study. Adults who identified as transgender or gender diverse were interviewed about their experiences accessing reproductive health services, their needs, and their ideas about clinical settings in which to receive reproductive health care services. Interviews were conducted until thematic saturation was reached. Six trans men, 6 trans women, and 4 people who identified as non-binary or genderqueer were interviewed. Negative experiences in health care settings, particularly when seeking reproductive health care services, were common. Participants often had multiple providers and gender-affirming care was often accessed separately from other health care services. Desires for fertility and pregnancy varied widely between participants but were often not addressed at the initiation of gender-affirming care. Finding trans-friendly providers was notably difficult and participants often relied on friends and other members of the transgender community for guidance. Obstetrics and gynecology clinics present a potential opportunity for access to reproductive health services although their gendered environment was concerning for some participants. Transgender and gender diverse people in Hawai'i have access to some reproductive health services but experience stigma in certain settings. There is a need for ongoing improvement in reproductive health care services in Hawai'i to improve access for transgender and gender nonconforming people in Hawai'i.

COVID-19 Vaccine Hesitancy in the Perinatal Period: A Survey Among Residents of Hawaii.

Introduction: This study describes the vaccination status among people in Hawaii who are attempting pregnancy, currently pregnant, recently delivered (<6 months), and/or breastfeeding and documents common concerns and information sources associated with vaccine decision making. Methods: We conducted a cross-sectional online survey between April and September 2022 throughout Hawaii. The anonymous surveys were disseminated through flyers and online links posted by physician offices and community partners throughout Hawaii. Results: Final analyses included 165 responses. Almost half of the respondents (n=75, 45%) were unvaccinated, 38% (n=62) were fully vaccinated, and 17% (n=28) were partially vaccinated. The most influential sources for vaccine decision making for vaccinated respondents were their healthcare providers (n=28, 45%) and official healthcare organizations (n=22, 36%), whereas unvaccinated respondents reported friends/family (n=28, 37%) and their healthcare providers (n=26, 35%) as their most influential sources. Top COVID-19 vaccine concerns for unvaccinated individuals were reactions to vaccine (n=78, 76%) and concerns for safety of the vaccine (n=75, 73%). Conclusions: Efforts should be made to increase and expand vaccine education about the benefits and safety of vaccines during pregnancy beyond the pregnant person to create more supportive social norms for COVID-19 vaccination in the perinatal period. Consistent and unequivocal support across medical specialties, including obstetrics, pediatrics, and family medicine, is also crucial for encouraging the uptake of the vaccine during pregnancy or when breastfeeding.

Maternal seafood consumption is associated with improved selenium status: Implications for child health.

Selenium (Se) is required for synthesis of selenocysteine (Sec), an amino acid expressed in the active sites of Se-dependent enzymes (selenoenzymes), including forms with essential functions in fetal development, brain activities, thyroid hormone metabolism, calcium regulation, and to prevent or reverse oxidative damage. Homeostatic mechanisms normally ensure the brain is preferentially supplied with Se to maintain selenoenzymes, but high methylmercury (CH3Hg) exposures irreversibly inhibit their activities and impair Sec synthesis. Due to Hg's high affinity for sulfur, CH3Hg initially binds with the cysteine (Cys) moieties of thiomolecules which are selenoenzyme substrates. These CH3Hg-Cys adducts enter selenoenzyme active sites and transfer CH3Hg to Sec, thus irreversibly inhibiting their activities. High CH3Hg exposures are uniquely able to induce a conditioned Se-deficiency that impairs synthesis of brain selenoenzymes. Since the fetal brain lacks Se reserves, it is far more vulnerable to CH3Hg exposures than adult brains. This prompted concerns that maternal exposures to CH3Hg present in seafood might impair child neurodevelopment. However, typical varieties of ocean fish contain far more Se than CH3Hg. Therefore, eating them should augment Se-status and thus prevent Hg-dependent loss of fetal selenoenzyme activities. To assess this hypothesis, umbilical cord blood and placental tissue samples were collected following delivery of a cohort of 100 babies born on Oahu, Hawaii. Dietary food frequency surveys of the mother's last month of pregnancy identified groups with no (0 g/wk), low (0-12 g/wk), or high (12 + g/wk) levels of ocean fish consumption. Maternal seafood consumption increased Hg contents in fetal tissues and resulted in ∼34% of cord blood samples exceeding the EPA Hg reference level of 5.8 ppb (0.029 µM). However, Se concentrations in these tissues were orders of magnitude higher and ocean fish consumption caused cord blood Se to increase ∼9.4 times faster than Hg. Therefore, this study supports the hypothesis that maternal consumption of typical varieties of ocean fish provides substantial amounts of Se that protect against Hg-dependent losses in Se bioavailability. Recognizing the pivotal nature of the Hg:Se relationship provides a consilient perspective of seafood benefits vs. risks and clarifies the reasons for the contrasting findings of certain early studies.

Patient Barriers to Discontinuing Long-Acting Reversible Contraception.

OBJECTIVES: To describe how frequently a national sample of patients with experience discontinuing or desiring discontinuation of long-acting reversible contraception (LARC) experienced barriers to discontinuation. METHODS: We conducted an online survey of individuals ages 18 to 50 in the United States who had previously used and discontinued or attempted to discontinue LARC. We recruited respondents using the Amazon platform MTurk. Respondents provided demographic information and answered questions regarding their experience discontinuing LARC, including reasons removal was deferred or denied. We analyzed frequency of types of barriers encountered and compared these by demographic factors. RESULTS: Of the 376 surveys analyzed, 99 (26%) described experiencing at least one barrier to removal. Barriers were disproportionately reported by those who had public health insurance, a history of abortion, and a history of birth compared to those who did not report barriers to removal. They also more frequently identified as Latinx, Asian, or Middle Eastern. Most barriers were provider-driven and potentially modifiable. CONCLUSIONS FOR PRACTICE: Barriers to LARC discontinuation are common and may be provider- or systems-driven. Providers should be mindful of biases in their counseling and practices to avoid contributing to these barriers.

Roots, Leaves, and Flowers: A Narrative Review of Herbs and Botanicals Used for Self-Managed Abortion in Asia and the Pacific.

Abortion has existed throughout history, often outside of formal health care systems. This type of care, now called self-managed abortion, has historically been achieved in part through botanicals and traditional medicines. Their use continues into the modern day, especially in Asia, Hawai'i, and other Pacific Islands, where indigenous medicine traditions practice alongside allopathic medicine. Many of these botanicals, such as papaya leaves, hibiscus flowers, and young ki, and traditional medicines, such as tianhuafen, yuanhua, and Shenghua Decoction, have undergone scientific and clinical investigation of their potential abortifacient and antifertility action. The incidence of self-managed abortion with such abortifacients in countries with severe abortion restrictions are only estimates, leading to the possibility that legal rulings and societal pressures may cause underreporting. The Asian American, Native Hawaiian, and Pacific Islander communities in the United States also suffer from a lack of abortion access in addition to unique health disparities and barriers to reproductive health care. As difficulties in abortion access increases due to the Supreme Court decision in Dobbs v. Jackson Women's Health Organization, some may seek or even prefer self-managed abortion through traditional methods that have been passed down in their communities. Midwives and other health care providers may then be contacted during this process. This narrative review provides an overview of the literature on the use of botanicals, herbs, and traditional medicines used for self-managed abortion, specifically in Asia, Hawai‧i, and other Pacific Islands. Their implications for practice for providers in the United States and further opportunities for research are also presented.

Data Equity for Asian American and Native Hawaiian and Other Pacific Islander People in Reproductive Health Research.

Though racial and ethnic disparities in sexual and reproductive health outcomes are receiving greater interest and research funding, the experiences of Asian American and Native Hawaiian and Other Pacific Islander (NHPI) people are often combined with those of other racial and ethnic minority groups or excluded from data collection altogether. Such treatment is often rationalized because Asian American and NHPI groups comprise a smaller demographic proportion than other racial or ethnic groups, and the model minority stereotype assumes that these groups have minimal sexual and reproductive health needs. However, Asian American and NHPI people represent the fastest-growing racial-ethnic groups in the United States, and they face disparities in sexual and reproductive health access, quality of care, and outcomes compared with those of other races and ethnicities. Disaggregating further by ethnicity, people from certain Asian American and NHPI subgroups face disproportionately poor reproductive health outcomes that suggest the need for culturally targeted exploration of the unique drivers of these inequities. This commentary highlights the evidence for sexual and reproductive health disparities both in and between Asian American and NHPI groups. We also examine the failures of national data sets and clinical studies to recruit Asian American and NHPI people in proportion to their share of the U.S. population or to consider how the cultural and experiential diversity of Asian American and NHPI people influence sexual and reproductive health. Lastly, we provide recommendations for the equitable inclusion of Asian American and NHPI people to promote and systematize the study and reporting of sexual and reproductive health behaviors and outcomes in these culturally, religiously, and historically diverse groups.

A qualitative study of perspectives on research participation among individuals who recently experienced an abortion in Hawai'i.

OBJECTIVES: The United States Code of Federal Regulations mandates extra protections for research involving pregnant participants seeking abortions. This study aims to understand the perspectives of abortion patients regarding recruitment, decision-making, and participation in research. STUDY DESIGN: We recruited adults in Hawai'i who reported at least one induced abortion in the previous 6 months. Recruitment strategies included online advertisements and flyers posted in reproductive health clinics. We conducted in-person, semistructured interviews exploring research preferences. The authors collaboratively reviewed the resulting transcripts and created a code dictionary. We reviewed, organized, condensed, and diagrammed the resulting data to identify dominant themes. RESULTS: Between February and November 2019, we interviewed 25 participants aged 18-41 years who had medication (n = 14) or procedural (n = 11) abortions. Interviews ranged from 32 to 77 minutes (mean = 48 minutes). Four themes emerged: (1) people having abortions are capable of making informed decisions about research participation, (2) abortion-related stigma influences research decision-making, (3) people having abortions prefer to learn about study opportunities early and through participant-driven recruitment methods, and (4) the ideal role of the abortion provider in research is unclear. CONCLUSIONS: Abortion patients in this study want to be informed of research opportunities and feel capable of deciding about participation in research studies. Current federally mandated protections and common research practices could be revisited and revised to better reflect these preferences. IMPLICATIONS: Revision of federal regulations and optimization of recruitment methods may allow researchers to improve the research experience for patients having an abortion.

A Qualitative Study on Preventing Gestational Diabetes in Native Hawaiian and Pacific Islander Adolescent Females: Perspectives from an Expert Panel of Health Care Providers.

The authors examined perspectives of health care providers (HCPs) who serve Native Hawaiian and Pacific Islander (NH/PI) adolescents to inform the adaption of an existing American Indian and Alaska Native-specific gestational diabetes mellitus (GDM) risk reduction and preconception counseling program entitled Stopping GDM, for NH/PI adolescents. Hawai'i-based HCPs (n=14) who care for NH/PI adolescent females volunteered for this expert panel focus group study. These HCP participants served as an expert panel specific to their experiences in providing primary care and reproductive health care/family planning, and their perspectives regarding GDM risk reduction for NH adolescents. Several key themes emerged from these expert panel focus groups: (1) importance of multi-generational family involvement and support; (2) need to address the social determinants of health; (3) strengths-based strategies and recommendations to engage adolescents in a preconception counseling and GDM risk-reduction education program. Findings will inform the adaptation of Stopping GDM into a more holistic, multi-level, strengths-based, culturally tailored GDM risk reduction intervention that fosters empowerment and builds on the resilience of NH/PI communities.

Oxytocin and Hypotension During Dilation and Evacuation Procedures at 18-24 Weeks Gestation.

Oxytocin is a neurohormone that is routinely administered to patients during dilation and evacuation procedures (D&E) to control bleeding despite minimal evidence in support of this common practice. In this study, the authors sought to evaluate patients with hypotension after receiving oxytocin during D&E procedures. The secondary data from a double-blind, randomized, placebo-controlled trial involving 112 patients who underwent a D&E at 18-24 weeks gestation and prophylactically received an intravenous bolus of either 30 units of oxytocin in 500 mL of normal saline or 500 mL of saline alone at the start of the procedure were analyzed. Anesthesia providers measured blood pressure before, at the time of, and after study medication administration in 5-minute increments until the end of the procedure. No differences in demographic characteristics or mean blood pressure between the 2 groups were observed. The proportion of hypotensive patients was not statistically different at 5 minutes following fluid bolus (oxytocin 25% versus placebo 13%, P=.09). The proportion of hypotensive patients was similar by 10 minutes (oxytocin 20% versus placebo 16%, P=.62). A sample size of 112 provided the ability to detect a 23% difference in the proportion of patients who experienced hypotension (2-sided 95% CI, power of 80%). These findings suggest that oxytocin may have a transient hypotensive effect.

Person-centered, high-quality care from a distance: A qualitative study of patient experiences of TelAbortion, a model for direct-to-patient medication abortion by mail in the United States.

CONTEXT: Direct-to-patient telemedicine abortion allows people to receive mifepristone and misoprostol for medication abortion in their home without requiring an in-person visit with a healthcare provider. This method has high efficacy and safety, but less is known about the person-centered quality of care provided with telemedicine. METHODS: We interviewed 45 participants from the TelAbortion study of direct-to-patient telemedicine abortion in the United States from January to July 2020. Semi-structured qualitative interviews queried their choices, barriers to care, expectations for care, actual abortion experience, and suggestions for improvement. We developed a codebook through an iterative, inductive process and performed content and thematic analyses. RESULTS: The experience of direct-to-patient telemedicine abortion met the person-centered domains of dignity, autonomy, privacy, communication, social support, supportive care, trust, and environment. Four themes relate to the person-centered framework for reproductive health equity: (1) Participants felt well-supported and safe with TelAbortion; (2) Participants had autonomy in their care which led to feelings of empowerment; (3) TelAbortion exceeded expectations; and (4) Challenges arose when interfacing with the healthcare system outside of TelAbortion. Participants perceived abortion stigma which often led them to avoid traditional care and experienced enacted stigma during encounters with non-study healthcare workers. CONCLUSION: TelAbortion is a high quality, person-centered care model that can empower patients seeking care in an increasingly challenging abortion context.

Fetal tissue donation for research at the time of abortion: A qualitative study of individuals who experienced an abortion in Hawaii in 2018-19.

OBJECTIVES: This qualitative study explores how individuals recently experiencing abortions feel about donating fetal tissue for research. In addition, we sought to identify motivating or discouraging factors that influence decision making for these individuals. STUDY DESIGN: We recruited individuals living in Hawaii who reported undergoing an abortion in the previous 6 months for one-on-one semi-structured interviews as part of a broader study investigating views on peri-abortion research practices and protections. We devoted approximately 15 minutes of each 1-hour interview to discussing the donation of aborted fetal tissue for research. We double coded transcribed interviews and identified themes related to fetal tissue donation. RESULTS: We interviewed 25 respondents and identified 4 themes. (1) Individuals viewed fetal tissue donation as an opportunity to help others. (2) Respondents preferred for aborted fetal tissue to be used rather than discarded. (3) Respondents viewed the fetal tissue to be an extension of themselves, so informed consent is critical. (4) Information found online promotes mistrust of fetal tissue handling. CONCLUSIONS: Individuals who have had an abortion are open to fetal tissue donation for research purposes. Pre-abortion counseling could be improved by clarifying the process of fetal tissue handling and, when available, discussing options for fetal tissue donation. IMPLICATIONS: Informed pregnant individuals who have had an abortion appear to be supportive of fetal tissue research and their views can differ from the concerns of ethicists, politicians, and scientists. The perspective of the individuals donating fetal tissue should be included in future discussions of fetal tissue research.

Intranasal fentanyl for first-trimester uterine aspiration pain: A randomized controlled trial.

OBJECTIVE: To evaluate whether administration of intranasal fentanyl reduces reported pain during first-trimester uterine aspiration. STUDY DESIGN: We conducted a multicenter, randomized, double-blind, placebo-controlled trial of patients with pregnancies less than or equal to 14 weeks gestation seeking uterine aspiration for induced abortion, early pregnancy loss, or failed medication abortion. We randomized participants 1:1 to either intranasal fentanyl 100 mcg or intranasal placebo. All participants received ibuprofen and a standardized paracervical block. The primary outcome was pain indicated at the time of uterine aspiration on a 100 mm visual analog scale (VAS). We designed the study to detect a 15 mm difference in mean pain scores, which required 53 people in each arm for a total of 106 participants. Secondary outcomes included postprocedure pain and patient satisfaction with pain control. RESULTS: From March 2017 through June 2018, we screened 355 people for eligibility and enrolled 107 participants. Those who received intranasal fentanyl reported similar uterine aspiration pain to participants who received placebo (58.4 ± 28.0 fentanyl vs 58.6 ± 24.5 placebo, p = 0.97). Participants who received intranasal fentanyl also reported similar postprocedure pain scores compared to participants who received placebo (19.1 ± 19.4 fentanyl vs 17.2 ± 19 placebo, p = 0.63), and were equally satisfied with procedure pain control (66.8 ± 31.2 fentanyl vs 63.3 ± 29.2 placebo, p = 0.57). CONCLUSION: Intranasal fentanyl did not decrease reported pain with first-trimester uterine aspiration, nor did it decrease postprocedure pain compared to placebo. As an adjunct to ibuprofen and paracervical block, intranasal fentanyl did not improve patient satisfaction with pain control. IMPLICATIONS: Intranasal fentanyl does not reduce reported pain with first-trimester uterine aspiration, however abortion-seeking patients are amenable to receiving intranasal medications for pain management.

A Scoping Review on Gestational Diabetes in Hawai'i: A "Window of Opportunity" to Address Intergenerational Risk for Type 2 Diabetes Mellitus.

The health of women over the entire span of their reproductive years is crucial - beginning in adolescence and extending through the postpartum period. This paper provides a scoping review of the relevant literature on risk factors for gestational diabetes mellitus (GDM) and progression from GDM to type 2 diabetes mellitus (T2DM), particularly among women of Native Hawaiian and Pacific Islander (NHPI) and Asian racial/ethnic backgrounds in Hawai'i, using the PubMed database (July 2010 to July 2020). NHPI and Asian populations have a greater likelihood of developing GDM compared to their White counterparts. Risk factors such as advanced maternal age, high maternal body mass index, and lack of education about GDM have varying levels of impact on GDM diagnosis between ethnic populations. Mothers who have a history of GDM are also at higher risk of developing T2DM. Common risk factors include greater increase in postpartum body mass index and use of diabetes medications during pregnancy. However, few studies investigate the progression from GDM to T2DM in Hawai'i's Asian and NHPI populations, and no studies present upstream preconception care programs to prevent an initial GDM diagnosis among Hawai'i's women. Thus, updated reports are necessary for optimal early interventions to prevent the onset of GDM and break the intergenerational cycle of increased susceptibility to T2DM and GDM in both mother and child. Further attention to the development of culturally sensitive interventions may reduce disparities in GDM and improve the health for all affected by this condition.

The experience of pain in real-time during medication abortion.

OBJECTIVE: We aimed to characterize the current pain experience of patients completing an evidence-based mifepristone-misoprostol medication abortion regimen using real-time pain scores. STUDY DESIGN: We collected real-time data on pain experienced by 54 women undergoing medication abortion using an evidence-based regimen of 200 mg mifepristone and 800 mcg buccal misoprostol. These women were enrolled in the placebo arm of a study on the effect of pregabalin for pain during medication abortion. All participants were dispensed ibuprofen and oxycodone/acetaminophen for analgesia. We assessed maximum pain experienced by participants on an 11-point numerical rating scale (NRS), duration of pain, and analgesic usage. Data was collected through electronic surveys sent via text message link at 6 specified points over 72 hours. RESULTS: Of the 54 women randomized to the placebo group, 2 were lost to follow-up. Participants experienced a mean maximum pain score of 5.5 ± 2.2. The mean time to maximum pain was 3.7 ± 2.4 hours after misoprostol. By hour 12 after misoprostol, 60.8% of participants reported no pain, which increased to 76.9% at 24 hours and 82.0% at 72 hours. Participants reported median ibuprofen usage of 2 800 mg tablets and median oxycodone/acetaminophen usage of one-half of a 5/325mg tablet. Approximately 12.0% of participants reported taking zero ibuprofen tablets, and 50.0% reported no opioid usage during the study period. CONCLUSIONS: Our real-time data collection demonstrated lower mean maximum experienced pain scores and shorter duration of pain than previously reported for medication abortion. Analgesic use was lower than previously described. IMPLICATIONS: This updated characterization of pain experienced during an evidence-based medication abortion regimen may allow for better pain-related counseling, tailoring of opioid prescription practices, and improvement in patient satisfaction.

Neonatal Hypoxic Ischemic Encephalopathy and Planned Home Birth.

INTRODUCTION: As planned home births increase, emerging evidence on the perinatal outcomes of newborns who were planned hospital births versus planned home births has been inconsistent, and a growing number of states have attempted to legislate community births. We sought to determine whether an association exists between neonatal hypoxic ischemic encephalopathy (HIE), a complication of ischemic birth injury, and planned location of birth. METHODS: A case-control study design was used to compare data from neonates with HIE obtained from electronic health records at Kapiolani Medical Center for Women and Children in Honolulu, Hawaii, with data from neonates without HIE obtained from Hawaii state birth certificate data. A penalized backward stepwise logistic regression was performed to control for confounders. RESULTS: We included 164 neonates with HIE and 656 neonates in the control group. The odds of having been a planned home birth were 2.77 times higher in neonates with HIE compared with those without HIE (95% CI, 1.05-6.87). After adjusting for insurance, mode of birth, meconium fluid, maternal hypertension, and chorioamnionitis, neonates with HIE were still more likely to have been a planned home birth compared with those without HIE (odds ratio, 11.56; 95% CI, 1.37-118.77). DISCUSSION: Neonates with HIE were more likely to have been a planned home birth compared with neonates without HIE.

"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.

Provision of medication abortion in Hawai'i during COVID-19: Practical experience with multiple care delivery models.

OBJECTIVE: To demonstrate the effectiveness of medication abortion with the implementation of telemedicine and a no-test protocol in response to the COVID-19 pandemic. STUDY DESIGN: This is a retrospective cohort study of patients who had a medication abortion up to 77 days gestation at the University of Hawai'i between April and November 2020. Patients had the option of traditional in clinic care or telemedicine with either in clinic pickup or mailing of medications. During this time, a no-test protocol for medication abortion without prior labs or ultrasound was in place for eligible patients. The primary outcome was the rate of successful medication abortion without surgical intervention. Secondary outcomes included abortion-related complications. RESULTS: A total of 334 patients were dispensed mifepristone and misoprostol, 149 (44.6%) with telemedicine with in-person pickup of medications, 75 (22.5%) via telemedicine with medications mailed, and 110 (32.9%) via traditional in person visits. The overall rate of complete medication abortion without surgical intervention was 95.8%, with success rates of 96.8, 97.1, and 93.6% for the clinic pickup, mail, and clinic visit groups, respectively. Success for those without an ultrasound performed prior to the procedure was 96.6%, compared to 95.5% for those with ultrasound. We obtained follow-up data for 87.8% of participants. CONCLUSIONS: Medication abortion was safe and effective while offering multiple modes of care delivery including telemedicine visits without an ultrasound performed prior to dispensing medications. IMPLICATIONS: Incorporating telemedicine and a no-test protocol for medication abortion is safe and has the potential to expand access to abortion care. All care models had low rates of adverse events, which contradicts the idea that the Risk Evaluation and Mitigation Strategyincreases the safety of medication abortion.

Buffered lidocaine for paracervical blocks in first-trimester abortions: a randomized controlled trial.

OBJECTIVE: The objective was to evaluate if buffered lidocaine decreases injection pain as compared to plain lidocaine for paracervical blocks during first-trimester outpatient surgical abortions. STUDY DESIGN: We conducted a randomized, double-blind, placebo-controlled trial among women undergoing outpatient uterine aspiration of a first-trimester pregnancy or an early pregnancy loss. Subjects received a paracervical block with either lidocaine 1% 20 mL or lidocaine 1% 18 mL plus sodium bicarbonate 8.4% 2 mL. The primary outcome was pain from injection of the paracervical block measured on a 100-mm visual analog scale (VAS). Secondary outcomes included pain after cervical dilation, uterine aspiration and overall satisfaction with pain control. Scores were compared using the Mann-Whitney U test. We aimed to detect a 15-mm difference in pain from injection of the paracervical block. RESULTS: From May 2017 to October 2018, 48 women received plain lidocaine and 50 women received buffered lidocaine. Groups were similar in demographics. We found no clinically or statistically meaningful difference in pain when evaluating median VAS scores for paracervical block injection between the buffered and plain lidocaine [30.0 (interquartile range (IQR) 15.3-64.5); 44.5 (IQR 18.3-65), respectively, p = .32]. We found no difference in secondary outcomes between buffered and plain lidocaine. CONCLUSION: Buffered lidocaine for paracervical blocks in first-trimester outpatient surgical abortions does not decrease injection pain as compared to plain lidocaine. IMPLICATIONS STATEMENT: Buffering the paracervical block in first-trimester outpatient surgical abortions does not decrease injection pain as compared to plain lidocaine, nor does it increase patient satisfaction. Eliminating sodium bicarbonate allows for a more cost-effective and readily available solution for paracervical blocks.