Reducing decisional conflict in decisions about prenatal genetic testing: the impact of a dyadic intervention at the start of prenatal care.

OBJECTIVES: Decisional conflict and regret about prenatal genetic screening and diagnostic tests may have important consequences in the current pregnancy and for future reproductive decisions. Identifying mechanisms that reduce conflict associated with the decision to use or decline these options is necessary for optimal patient counseling. METHODS: We conducted a cluster-randomized controlled trial of a shared decision-making tool (NEST) at the beginning of prenatal care. Enrolled patients completed follow-up surveys at the time of testing (QTT) and in the second-third trimester (QFF), including the Decision Conflict Scale (DCS). Total DCS scores were analyzed using a multivariate linear mixed-effect model. RESULTS: Of the total number of participants (n=502) enrolled, 449 completed the QTT and QFF surveys. The mean age of participants was 31.6±3.8, with most parous at the time of study participation (n=321; 71.7 %). Both the NEST (the intervention) and control groups had lower median total DCS scores at QFF (NEST 13.3 [1.7, 25.0] vs. control 16.7 [1.7, 25.0]; p=0.24) compared to QTT (NEST 20.8 [5.0, 25.0] vs. control 18.3 [3.3, 26.7]; p=0.89). Participants exposed to NEST had lower decisional conflict at QFF compared to control (ß -3.889; [CI -7.341, -0.437]; p=0.027). CONCLUSIONS: Using a shared decision-making tool at the start of prenatal care decreased decisional conflict regarding prenatal genetic testing. Such interventions have the potential to provide an important form of decision-making support for patients facing the unique type of complex and preference-based choices about the use of prenatal genetic tests.

COVID testing hesitancy among pregnant patients: Lessons learned from the COVID-19 pandemic about the unique needs and challenges of medically complex populations.

Background Pregnant patients were a significant population to consider during the pandemic, given the impact of SARS-CoV-2 infection on obstetric outcomes. While COVID testing was a central pillar of infection control, it became apparent that a subset of the population declined to test. At the same time, data emerged about pregnant persons also declining to test. Yet, it was unknown why pregnant patients declined tests and if those reasons were similar or different from those of the general population. We conducted this study to explore pregnant patients' attitudes, access, and utilization of COVID-19 testing to support healthcare for infection prevention management for this unique and medically complex population. Methods We conducted a qualitative study of patients who were currently or recently pregnant during the early stages of the pandemic and received outpatient prenatal care at one of the participating study sites. An interview guide was used to conduct in-depth telephone interviews. Coding was performed using NVivo, and analysis was conducted using Grounded Theory. Results The average age of the participants (N = 37) was 32 (SD 4.21) years. Most were < 35 years of age (57%) and self-described as White (68%). Qualitative analysis identified themes related to barriers to COVID-19 testing access and use during pregnancy, including concerns about test accuracy, exposure to COVID-19 in testing facilities, isolation and separation during labor and delivery, and diminished healthcare quality and patient experience. Conclusions The implementation of widespread and universal COVID testing policies did not address the unique needs and challenges of pregnant patients as a medically complex population. It is important to understand the reasons and implications for pregnant patients who declined COVID testing during the current pandemic to inform strategies to prevent infection spread in future public health emergencies.

Virtual prenatal visits associated with high measures of patient experience and satisfaction among average-risk patients: a prospective cohort study.

BACKGROUND: Virtual visits have the potential to decrease barriers to prenatal care stemming from transportation, work, and childcare concerns. However, data regarding patient experience and satisfaction with virtual visits remain limited in obstetrics. To address this gap, we explore average-risk pregnant women's experiences with virtual visits and compare satisfaction with virtual vs. in-person visits as a secondary aim. METHODS: In this IRB-approved, prospective cohort study, we surveyed pregnant women after their first virtual visit between October 7, 2019 and March 20, 2020. Using heterogeneous purposive sampling, we identified a subset of respondents with diverse experiences and opinions for interviews. For comparison, Consumer Assessment of Healthcare Providers and Systems (CAHPS) satisfaction data were collected after in-person visits during the study timeframe from a control cohort with the same prenatal providers. Logistic regression controlling for age, previous pregnancies, and prior live births compared satisfaction data between virtual and in-person visits. Other quantitative survey data were analyzed through descriptive statistics. Free text survey responses and interview data were analyzed using content analysis. RESULTS: Ninety five percent (n = 165/174) of surveys and 90% (n = 18/20) of interviews were completed. Most participants were Caucasian, married, and of middle to high income. 69% (114/165) agreed that their virtual appointment was as good as in-person; only 13% (21/165) disagreed. Almost all (148/165, 90%) would make another virtual appointment. Qualitative data highlighted ease of access, comparable provider-patient communication, confidence in care quality, and positive remote monitoring experiences. Recognizing these advantages but also inherent limitations, interviews emphasized interspersing telemedicine with in-person prenatal encounters. CAHPS responses after in-person visits were available for 60 patients. Logistic regression revealed no significant difference in three measures of satisfaction (p = 0.16, 0.09, 0.13) between virtual and in-person visits. CONCLUSIONS: In an average-risk population, virtual prenatal visits provide a patient-centered alternative to traditional in-person encounters with high measures of patient experience and no significant difference in satisfaction. Obstetric providers should explore telemedicine to improve access - and, during the ongoing pandemic, to minimize exposures - using patients' experiences for guidance. More research is needed regarding virtual visits' medical quality, integration into prenatal schedules, and provision of equitable care for diverse populations.

Use of combined hormonal contraception and stroke: A case-control study of the impact of migraine type and estrogen dose on ischemic stroke risk.

OBJECTIVE: To clarify how factors such as estrogen dose and migraine history (including migraine subtype) impact ischemic stroke risks associated with combined hormonal contraceptive (CHC) use. BACKGROUND: CHC use in those with migraine with aura has been restricted due to concerns about stroke risk. METHODS: We conducted a case-control analysis of stroke risk associated with estrogen dose and migraine history among CHC users in a large tertiary care center. All women aged 18-55 who used a CHC between January 1, 2010, and December 31, 2019, were identified. Those with a stroke diagnosis were identified using ICD codes and confirmed via chart and imaging review. Details of personal and family medical history, stroke evaluation, ethinyl estradiol dosing (EE; ≥30 vs. <30 µg), and demographics were collected. From a random sample of 20,000 CHC users without stroke, a control cohort (n = 635) was identified and matched based on patient characteristics, medical and family histories, as well as stroke risk factors, to assess association between migraine diagnosis, migraine subtype, estrogen dose, and stroke. RESULTS: Of the 203,853 CHC users in our cohort, 127 had confirmed stroke (0.06%; CI 0.05%, 0.07%). In unadjusted analyses, a higher number of patients in the case cohort had a diagnosis of migraine (34/127, 26.8%) compared to controls (109/635, 17.2%; p = 0.011). Stroke risk was higher with ≥30-µg EE doses compared to those using a <30-µg dose (OR, 1.52; CI 1.02, 2.26; p = 0.040). Compared to no migraine, personal history of migraine increased the odds of stroke (OR, 2.00; CI 1.27, 3.17; p = 0.003). Compared to no migraine, stroke risk was not significantly increased in those with migraine with aura, but migraine without aura increased the risk (OR, 2.35; CI 1.32, 4.2; p = 0.004). CONCLUSIONS: Overall stroke risk in our cohort of CHC users was low. When CHCs are used in those with migraine, formulations containing ≤30 µg EE are preferred. Shared decision-making should include discussions about ischemic stroke risks in patients with migraine, even those without aura.

Impact of Telehealth on the Delivery of Prenatal Care During the COVID-19 Pandemic: Mixed Methods Study of the Barriers and Opportunities to Improve Health Care Communication in Discussions About Pregnancy and Prenatal Genetic Testing.

BACKGROUND: The COVID-19 pandemic brought significant changes in health care, specifically the accelerated use of telehealth. Given the unique aspects of prenatal care, it is important to understand the impact of telehealth on health care communication and quality, and patient satisfaction. This mixed methods study examined the challenges associated with the rapid and broad implementation of telehealth for prenatal care delivery during the pandemic. OBJECTIVE: In this study, we examined patients' perspectives, preferences, and experiences during the COVID-19 pandemic, with the aim of supporting the development of successful models to serve the needs of pregnant patients, obstetric providers, and health care systems during this time. METHODS: Pregnant patients who received outpatient prenatal care in Cleveland, Ohio participated in in-depth interviews and completed the Coronavirus Perinatal Experiences-Impact Survey (COPE-IS) between January and December 2021. Transcripts were coded using NVivo 12, and qualitative analysis was used, an approach consistent with the grounded theory. Quantitative data were summarized and integrated during analysis. RESULTS: Thematic saturation was achieved with 60 interviews. We learned that 58% (35/60) of women had telehealth experience prior to their current pregnancy. However, only 8% (5/60) of women had used both in-person and virtual visits during this pregnancy, while the majority (54/60, 90%) of women participated in only in-person visits. Among 59 women who responded to the COPE-IS, 59 (100%) felt very well supported by their provider, 31 (53%) were moderately to highly concerned about their child's health, and 17 (29%) reported that the single greatest stress of COVID-19 was its impact on their child. Lead themes focused on establishing patient-provider relationships that supported shared decision-making, accessing the information needed for shared decision-making, and using technology effectively to foster discussions during the COVID-19 pandemic. Key findings indicated that participants felt in-person visits were more personal, established greater rapport, and built better trust in the patient-provider relationship as compared to telehealth visits. Further, participants felt they could achieve a greater dialogue and ask more questions regarding time-sensitive information, including prenatal genetic testing information, through an in-person visit. Finally, privacy concerns arose if prenatal genetic testing or general pregnancy conversations were to take place outside of the health care facility. CONCLUSIONS: While telehealth was recognized as an option to ensure timely access to prenatal care during the COVID-19 pandemic, it also came with multiple challenges for the patient-provider relationship. These findings highlighted the barriers and opportunities to achieve effective and patient-centered communication with the continued integration of telehealth in prenatal care delivery. It is important to address the unique needs of this population during the pandemic and as health care increasingly adopts a telehealth model.

The Impact of Outpatient Prenatal Care Visitor Restrictions on Pregnant Patients and Partners During the COVID-19 Pandemic.

Introduction: During the early months of the COVID-19 pandemic, several health care facilities enacted visitor restrictions to help reduce the spread of SARS-CoV-2 among patients, front-line workers in health care systems, and communities. The impact and burden of policy updates on visitor restrictions put forth by the COVID-19 pandemic can be seen on patients and families, most often in the acute care setting and skilled nursing facilities. Yet, the effects of visitor restrictions in the prenatal care setting were unknown. We conducted a study to investigate the impact of these policies on pregnant patients who received outpatient prenatal care. Methods: We conducted a qualitative study to explore pregnant patients' experiences with prenatal health care delivery between May and July 2020. In-depth interviews were conducted with pregnant patients in the first and second trimester of pregnancy, who received their prenatal care at the onset of the pandemic in the United States. Results: Participants noted increased maternal concern, anxiety, and mental health concerns stemming from the lack of in-person partner support. They noted disappointment and lost experiences for the patient during pregnancy, seeking support from her partner during pregnancy, experiences felt to be critical for postpartum health and wellbeing. There was also concern about the negative impact of restrictions on prenatal care quality and experience. Conclusions: This study demonstrates the impact of visitor restrictions on patients' prenatal care experience and perception of health care quality during the COVID-19 pandemic. Future public health strategies should be individualized to different patient populations addressing knowledge, health literacy, and socioeconomic status, and developed in conjunction with pregnant patients as key stakeholders in the delivery of prenatal health care.

The Successes and Challenges of Implementing Telehealth for Diverse Patient Populations Requiring Prenatal Care During COVID-19: Qualitative Study.

BACKGROUND: Although telehealth appears to have been accepted among some obstetric populations before the COVID-19 pandemic, patients' receptivity and experience with the rapid conversion of this mode of health care delivery are unknown. OBJECTIVE: In this study, we examine patients' prenatal care needs, preferences, and experiences during the COVID-19 pandemic, with the aim of supporting the development of successful models to serve the needs of pregnant patients, obstetric providers, and health care systems during this time. METHODS: This study involved qualitative methods to explore pregnant patients' experiences with prenatal health care delivery at the onset of the COVID-19 pandemic. We conducted in-depth interviews with pregnant patients in the first and second trimester of pregnancy who received prenatal care in Cleveland, Ohio, from May to July 2020. An interview guide was used to probe experiences with health care delivery as it rapidly evolved at the onset of the pandemic. RESULTS: Although advantages of telehealth were noted, there were several concerns noted with the broad implementation of telehealth for prenatal care during the pandemic. This included concerns about monitoring the pregnancy at home; the need for additional reassurance for the pregnancy, given the uncertainties presented by the pandemic; and the ability to have effective patient-provider discussions via a telehealth visit. The need to tailor telehealth to prenatal health care delivery was noted. CONCLUSIONS: Although previous studies have demonstrated that telehealth is a flexible and convenient alternative for some prenatal appointments, our study suggests that there may be specific needs and concerns among the diverse patient groups using this modality during the pandemic. More research is needed to understand patients' experiences with telehealth during the pandemic and develop approaches that are responsive to the needs and preferences of patients.

Beyond babies: Implications of human genome editing for women, children, and families.

Scholarship on human germline editing has centered on the risks to the genetically-modified child. However, far less emphasis is focused on women who will become pregnant with a genetically modified embryo as part of human subject research or the families that raise children whose genomes were modified as an embryo. The lack of attention on women and families places these key stakeholders in genomic technologies at significant medical, ethical, and personal harm as research rapidly moves forward to advance the science of genomic modification. Now is the time to address how the interests of women and families should be represented in the ethical and scientific frameworks of human genomic modification, with specific considerations for Institutional Review Boards who review protocols for rigorous human subject protections and scientists who develop scientific methodologies that dictate the potential risks conferred to research participants. In this paper, we examine the implications of genomic modification of human embryo for women, children, and families to explore how to review a first-in-human clinical protocol of human genomic officiation responsibly.

Decision-making for prenatal genetic screening: how will pregnant women navigate a growing number of aneuploidy and carrier screening options?

BACKGROUND: Prenatal genetic screens, including carrier screening (CS) and aneuploidy screening (AS), comprise an important component of reproductive healthcare delivery. Clinical practice guidelines emphasize the importance of informed decision-making and patient's preferences regarding the use of these screens. Yet, it is unclear how to achieve this ideal as prenatal genetic screening options rapidly become more complex and increasingly available to patients. With increased complexity and availability of reproductive testing options, decision-support strategies are critical to prepare patients to consider AS and/or CS. METHODS: A self-administered survey evaluated knowledge and decision-making preferences for expanded carrier (CS) and aneuploidy (AS) prenatal screening. The survey was administered to participants before their first prenatal visit to assess baseline decision-making needs and preference at the initiation of prenatal care. Analysis was approached as a descriptive process. RESULTS: Participants had similar familiarity with the concepts associated with AS compared to CS; mean knowledge scores for CS was 0.59 [possible range 0.00 to 1.00] and 0.55 for AS. Participants reported preferences to learn about a range of conditions, including those with severe or mild impact, childhood-onset, and adult-onset. Decision-making preference with respect to learning about the associated disease phenotypes for the contained on AS and CS panel shifted with the complexity of the panel, with a greater preference to learn about conditions post-test compared pre-test education as panels increased from 5 to 100 conditions. CONCLUSION: Patients' baseline knowledge of prenatal genetic screens coupled with evolving decision-making preferences presents challenges for the delivery of prenatal genetic screens. This calls for the development and implementation of innovative approaches to support pregnant patients' decision-making commensurate with advances in prenatal genomics.

Uterus transplantation: state of the art in 2021.

PURPOSE: To provide a comprehensive review of uterus transplantation in 2021, including a discussion of pregnancy outcomes of all reported births to date, the donor and recipient selection process, the organ procurement and transplant surgeries, reported complications, postoperative monitoring, preimplantation preparation, and ethical considerations. METHODS: Literature review and expert commentary. RESULTS: Reports of thirty-one live births following uterus transplantation have been published from both living and deceased donors. The proper selection of donors and recipients is a labor-intensive process that requires advanced planning. A multidisciplinary team is critical. Reported complications in the recipient include thrombosis, infection, vaginal stricture, antenatal complications, and graft failure. Graft rejection is a common occurrence but rarely leads to graft removal. While most embryo transfers are successful, recurrent implantation failures in uterus transplant patients have been reported. Rates of preterm delivery are high but appear to be declining; more data, including long-term outcome data, is needed. CONCLUSIONS: Uterus transplantation is an emerging therapy for absolute uterine factor infertility, a condition previously without direct treatment options. It is paramount that reproductive health care providers are familiar with the uterus transplantation process as more patients seek and receive this treatment.

The impact of the emergence of COVID-19 on women's prenatal genetic testing decisions.

OBJECTIVE: We conducted a study to examine the impact of COVID on patients' access and utilization of prenatal genetic screens and diagnostic tests at the onset of the COVID-19 pandemic in the United States. METHODS: We conducted telephone interviews with 40 patients to examine how the pandemic affected prenatal genetic screening and diagnostic testing decisions during the initial months of the pandemic in the United States. An interview guide queried experiences with the ability to access information about prenatal genetic testing options and to utilize the tests when desired. Audio recordings were transcribed and coded using NVivo 12. Analysis was conducted using Grounded Theory. RESULTS: The pandemic did not alter most participants' decisions to undergo prenatal genetic testing. Yet, it did impact how participants viewed the risks and benefits of testing and timing of testing. There was heightened anxiety among those who underwent testing, stemming from the risk of viral exposure and the fear of being alone if pregnancy loss or fetal abnormality was identified at the time of an ultrasound-based procedure. CONCLUSION: The pandemic may impact patients' access and utilization of prenatal genetic tests. More research is needed to determine how best to meet pregnant patients' decision-making needs during this time.