Prenatal care in US birth centers: Midwives' perceptions of contributors to birthing People's confidence in physiologic birth.

OBJECTIVE: The purpose of this study was to describe US freestanding birth center models of prenatal care and to examine how the components of this care contribute to birthing people's confidence in their ability to have a physiologic birth. DESIGN: This was a qualitative descriptive study utilizing semi-structured interviews with birth center midwives. Data were analyzed using thematic analysis, constant comparative method and consensus coding to ensure rigor. SETTING AND PARTICIPANTS: Midwives from six urban and rural freestanding birth centers in a Midwestern US state were interviewed. Twelve birth center midwives participated. FINDINGS: Six themes emerged: the birth center physical space and organization of care, dimensions of midwifery care within the birth center, continuity of care and seamless service, the empowered birthing person, physiologic birth as normative, and the hospital paradigm and US cultures of birth. KEY CONCLUSIONS: We identified significant components of birth center models of prenatal care that midwives believe enhance birthing people's confidence for physiologic childbirth. These components may be considered for application to other settings and may improve perinatal care and outcomes.

Randomized trial examining the effect of exercise and wellness interventions on preventing postpartum depression and perceived stress.

BACKGROUND: Approximately 13-19% of postpartum women experience postpartum depression and a majority report at least some stress during the postpartum phase. Traditional interventions such as psychotherapy and antidepressant medications are often not feasible or desirable. The purpose of this study was to examine two low cost, brief, accessible interventions designed to prevent postpartum depression and perceived stress among women at high risk. METHODS: Participants (n = 450) who were on average four weeks postpartum, had a history of depression before pregnancy, and exercised less than 60 min per week were randomly assigned to one of the following three conditions: (1) 6-month telephone-based exercise intervention; (2) 6-month telephone-based wellness/support intervention (e.g., healthy eating, sleep, and perceived stress); or (3) usual care. RESULTS: Overall, 2.4% of participants met criteria for depression at 6 months and 3.6% at 9 months with no differences between groups. At 6 months following randomization, median symptoms of depression were significantly lower among wellness participants compared to usual care participants (b = - 1.00, SE = 0.46, p = .03). Perceived stress at 6 months post-randomization was significantly lower among exercise vs. usual care participants (b = - 2.00, SE = .98, p = .04) and exercise vs. wellness participants (b = - 2.20, SE = 1.11, p = .04). CONCLUSIONS: The wellness intervention was efficacious for preventing symptoms of depression; however, postpartum depression that met the diagnostic criteria was surprisingly low in all conditions among this at risk sample of postpartum women. Exercise interventions may have a protective effect on perceived stress among women at risk for postpartum depression. Practitioners should consider integrating exercise and wellness interventions into postpartum care. TRIAL REGISTRATION: Clinical Trials Number: NCT01883479 (06/21/2013).

The effect of sleep pattern changes on postpartum depressive symptoms.

BACKGROUND: Research indicates that poor sleep is associated with postpartum depression; however, little is known regarding this relationship among postpartum women who are at high for postpartum depression. This study examined the relationship between changes in self-reported sleep patterns (from six weeks to seven months postpartum) and depressive symptoms at seven months postpartum among women who were at high risk for postpartum depression. METHODS: Participants (n = 122) were postpartum women who were at an increased risk for postpartum depression (personal or maternal history of depression) and had participated in a randomized exercise intervention trial. For the current trial, participants completed the Pittsburgh Sleep Quality Index and Patient Health Questionnaire-9 (PHQ-9; assessed depression) at six weeks and seven months postpartum. RESULTS: Overall, sleep problems significantly improved from six weeks to seven months postpartum. However, linear regression analyses indicated that worsening or minimal improvement of sleep problems were associated with higher depressive symptoms at seven month postpartum. Regarding the specific types of sleep problems, self-reported changes in sleep latency (i.e., how long it takes to fall asleep at night), daytime dysfunction (i.e., difficulty staying awake during the day), and sleep quality (i.e., subjective rating of sleep quality) were associated with higher levels of depressive symptoms. CONCLUSIONS: Sleep problems typically improve during the postpartum phase. However, postpartum women who are at high risk for postpartum depression are at an increased risk for depressive symptoms later in the postpartum phase if sleep problems worsen or show only minimal improvement over time. Therefore, at the six-week postpartum clinic visit, women should receive education regarding potential worsening of sleep patterns and strategies for preventing sleep-related problems. TRIAL REGISTRATION: Registered with ClinicalTrials.gov ( NCT00961402 ) on August 18, 2009 prior to the start of the trial.

The Perinatal Birth Environment: Communication Strategies and Processes for Adherence to a Standardized Guideline in Women Undergoing Second-Stage Labor With Epidural Anesthesia.

Key to any perinatal safety initiative is buy-in and strong leadership from obstetric and pediatric providers, advanced practice nurses, and labor and delivery nurses in collaboration with ancillary staff. In the fall of 2007, executives of a large Midwestern hospital system created the Zero Birth Injury Initiative. This multidisciplinary group sought to eliminate birth injury using the Institute of Healthcare Improvement Perinatal Bundles. Concurrently, the team implemented a standardized second-stage labor guideline for women who choose epidural analgesia for pain management to continue the work of eliminating birth injuries in second-stage labor. The purpose of this article was to describe the process of the modification and adaptation of a standardized second-stage labor guideline, as well as adherence rates of these guidelines into clinical practice. Prior to implementation, a Web-based needs assessment survey of providers was conducted. Most (77% of 180 respondents) believed there was a need for an evidence-based guideline to manage the second stage of labor. The guideline was implemented at 5 community hospitals and 1 academic health center. Data were prospectively collected during a 3-month period for adherence assessment at 1 community hospital and 1 academic health center. Providers adhered to the guideline in about 57% of births. Of patients whose provider followed the guideline, 75% of women were encouraged to delay pushing compared with only 28% of patients delayed pushing when the provider did not follow the guideline.

Midwifery care and patient-provider communication in maternity decisions in the United States.

UNLABELLED: To characterize reasons women chose midwives as prenatal care providers and to measure the relationship between midwifery care and patient-provider communication in the U.S. CONTEXT: Retrospective analysis of data from a nationally-representative survey of women who gave birth in 2011-2012 to a single newborn in a U.S. hospital (n = 2,400). We used multivariate logistic regression models to characterize women who received prenatal care from a midwife, to describe the reasons for this choice, and to examine the association between midwife-led prenatal care and women's reports about communication. Preference for a female clinician and having a particular clinician assigned was associated with higher odds of midwifery care (AOR = 2.65, 95 % CI 1.70, 4.14 and AOR = 1.63, 95 % CI 1.04, 2.58). A woman with midwifery care had lower odds of reporting that she held back questions because her preference for care was different from her provider's recommendation (AOR = 0.46, 95 % CI 0.23, 0.89) or because she did not want to be perceived as difficult (AOR = 0.48, 95 % CI 0.28, 0.81). Women receiving midwifery care also had lower odds of reporting that the provider used medical words were hard for them to understand (AOR = 0.58, 95 % CI 0.37, 0.91) and not feeling encouraged to discuss all their concerns (AOR = 0.54, 95 % CI 0.34, 0.89). Women whose prenatal care was provided by midwives report better communication compared with those cared for by other types of clinicians. Systems-level interventions, such as assigning a clinician, may improve access to midwifery care and the associated improvements in patient-provider communication in maternity care.

A Second-Generation Oral SARS-CoV-2 Main Protease Inhibitor Clinical Candidate for the Treatment of COVID-19.

Despite the record-breaking discovery, development and approval of vaccines and antiviral therapeutics such as Paxlovid, coronavirus disease 2019 (COVID-19) remained the fourth leading cause of death in the world and third highest in the United States in 2022. Here, we report the discovery and characterization of PF-07817883, a second-generation, orally bioavailable, SARS-CoV-2 main protease inhibitor with improved metabolic stability versus nirmatrelvir, the antiviral component of the ritonavir-boosted therapy Paxlovid. We demonstrate the in vitro pan-human coronavirus antiviral activity and off-target selectivity profile of PF-07817883. PF-07817883 also demonstrated oral efficacy in a mouse-adapted SARS-CoV-2 model at plasma concentrations equivalent to nirmatrelvir. The preclinical in vivo pharmacokinetics and metabolism studies in human matrices are suggestive of improved oral pharmacokinetics for PF-07817883 in humans, relative to nirmatrelvir. In vitro inhibition/induction studies against major human drug metabolizing enzymes/transporters suggest a low potential for perpetrator drug-drug interactions upon single-agent use of PF-07817883.

Dihydropteroate synthase mutations in Pneumocystis pneumonia: impact of applying different definitions of prophylaxis, mortality endpoints and mutant in a single cohort.

Pneumocystis jirovecii dihydropteroate synthase (DHPS) gene mutations are well-reported. Although sulfa prophylaxis generally is associated with DHPS mutant infection, whether mutant infection is associated with poorer clinical outcomes is less clear. The differing definitions of sulfa prophylaxis and the different mortality endpoints used in these studies may be one explanation for the conflicting study results. Applying different definitions of prophylaxis, mortality endpoints and DHPS mutant to 301 HIV-infected patients with Pneumocystis pneumonia, we demonstrate that prophylaxis, irrespective of definition, increased the risk of infection with pure mutant (any prophylaxis: AOR 4.00, 95% CI: 1.83-8.76, P < 0.001) but not mixed genotypes (any prophylaxis: AOR 0.78, 95% CI: 0.26-2.36, P = 0.65). However, infection with mutant DHPS, irrespective of definition, was not associated with increased mortality (all-cause or PCP death) at the three time-intervals examined (all P > 0.05). Future studies should standardize key variables associated with DHPS mutant infection as well as examine DHPS mutant subtypes (pure mutant vs. mixed infections) - perhaps even individual DHPS mutant genotypes - so that data can be pooled to better address this issue.

Improved Self-Assessed Collaboration Through Interprofessional Education: Midwifery Students and Obstetrics and Gynecology Residents Learning Together.

INTRODUCTION: Research suggests that interprofessional education, bringing learners together to learn about, with, and from each other, improves health professions education and can improve health outcomes. Little research has measured outcomes of interprofessional education between midwifery students and obstetrics and gynecology residents. The purpose of this study was to examine self-assessed interprofessional and collaborative competencies among midwifery students and obstetrics and gynecology residents. METHODS: Baseline self-assessed interprofessional and collaborative competencies were compared with follow-up measurements to evaluate learners' experiences over an 11-month study period. Participants were midwifery students and obstetrics and gynecology residents who experienced interprofessional learning activities. The Interprofessional Education Collaborative Competency Self-Assessment Survey (IPEC Survey) and Interprofessional Collaborative Competency Attainment Survey (ICCAS) were used. RESULTS: Of 256 learners at 4 demonstration sites, 223 (87%) completed the baseline, and 121 of 237 eligible learners (51%) completed the follow-up surveys. The IPEC Survey total score (t = 2.31, P = .02) and interaction subscale (t = 2.85, P = .005) and ICCAS score (t = 4.04, P = .001) increased for midwifery students but not obstetrics and gynecology residents on the IPEC Survey (t = 0.32, P = .75) and ICCAS (t = -0.05, P = .96) measures. Midwifery students (87%) and residents (57%) reported improved overall ability to collaborate. Learners responding to 3 open-ended questions valued team-based experiences, including learning how to communicate with each other; appreciated learning each other's education and scope of practice; and recommended skills development including uncommon clinical events, case discussions, and direct clinical care. DISCUSSION: This study advanced knowledge about interprofessional education between midwifery students and obstetrics and gynecology residents. Midwifery students improved in self-assessed interprofessional and collaborative competencies. Most learners reported better interprofessional collaboration skills and were positive about future interprofessional learning. This evaluation approach is available for other programs implementing or extending interprofessional education.

Health education priorities: perspectives from women's voices.

The authors conducted a study to determine women's perceived health information needs in various geographic locations to plan health-related outreach in a Midwestern U.S. state. Eighty-seven women representing diverse communities in both urban and rural locations participated. Themes identified from transcripts of focus groups included confusion and information overload, concerns regarding lifestyle and specific health conditions, a lack of time for self care, factors influencing health-related behavior change, navigating the health system, and a need to ?make this system work for me.? The voices of these women contribute to the search for solutions to provide comprehensive, holistic women's health care in the U.S. and internationally.

Enhanced Antenatal Care: Combining one-to-one and group Antenatal Care models to increase childbirth education and address childbirth fear.

BACKGROUND: We designed and implemented a new model of care, Enhanced Antenatal Care (EAC), which offers a combined approach to midwifery-led care with six one-to-one visits and four group sessions. AIM: To assess EAC in terms of women's satisfaction with care, autonomy in decision-making, and its effectiveness in lowering childbirth fear. METHODS: This was a quasi-experimental controlled trial comparing 32 nulliparous women who received EAC (n=32) and usual antenatal care (n=60). We compared women's satisfaction with care and autonomy in decision-making post-intervention using chi-square test. We administered a Fear of Birth Scale pre- and post-intervention and assessed change in fear of birth in each group using the Cohen's d for effect size. To isolate the effect of EAC, we then restricted this analysis to women who did not attend classes alongside maternal care (n=13 in EAC and n=13 in usual care). FINDINGS: Women's satisfaction with care in terms of monitoring their and their baby's health was similar in both groups. Women receiving EAC were more likely than those in usual care to report having received enough information about the postpartum period (75% vs 30%) and parenting (91% vs 55%). Overall, EAC was more effective than usual care in reducing fear of birth (Cohen's d=-0.21), especially among women not attending classes alongside antenatal care (Cohen's d=-0.83). CONCLUSION: This study is the first to report findings on EAC and suggests that this novel model may be beneficial in terms of providing education and support, as well as lowering childbirth fear.

Health History Skills for Interprofessional Learners in Transgender and Nonbinary Populations.

INTRODUCTION: Transgender and nonbinary peoplehave been identified as vulnerable and clinically underserved and experience health disparities. Lack of health care provider knowledge about transgender and gender diverse populations is a barrier to care, impacting health outcomes. The aim of this project was to develop, implement, and evaluate a simulation learning activity for midwifery and women's health nurse practitioner students and obstetrics and gynecology residents to interact with transgender and nonbinary individuals, with the goal of enhancing health history taking comfort and skills. METHODS: A partnership was formed among University faculty and simulation educators, a community clinic providing gender-affirming care, and members of transgender and gender diverse populations who served as patient-teachers. Two cases frequently encountered in clinics providing care to transgender individuals were developed for the simulation. Learners were divided into interprofessional groups of 3 and completed one of 2 case scenarios with a patient-teacher. Learners and patient-teachers debriefed after the simulation to discuss and reflect on the experience. RESULTS: Thirty-three learners participated in the simulation, 12 midwifery students, 16 women's health nurse practitioner students and 5 obstetrics and gynecology residents. Significant differences were observed for all comfort and skills questions, showing increased perceived comfort and skills from pre- to postsimulation. There were no significant differences in attitude responses. DISCUSSION: We successfully created and implemented a new sexual and reproductive history taking skills simulation in partnership with community clinic staff and transgender and nonbinary persons. The session was well received by learners and patient-teachers. Learners demonstrated significant improvements in comfort and skills in history taking in this setting and provided favorable feedback about the experience. This simulation can serve as a guide to others providing education to future midwives, women's health nurse practitioners, and obstetrician-gynecologists.

An oral SARS-CoV-2 Mpro inhibitor clinical candidate for the treatment of COVID-19.

The worldwide outbreak of COVID-19 caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) has become a global pandemic. Alongside vaccines, antiviral therapeutics are an important part of the healthcare response to countering the ongoing threat presented by COVID-19. Here, we report the discovery and characterization of PF-07321332, an orally bioavailable SARS-CoV-2 main protease inhibitor with in vitro pan-human coronavirus antiviral activity and excellent off-target selectivity and in vivo safety profiles. PF-07321332 has demonstrated oral activity in a mouse-adapted SARS-CoV-2 model and has achieved oral plasma concentrations exceeding the in vitro antiviral cell potency in a phase 1 clinical trial in healthy human participants.

Development and Testing of the Preparation for Labor and Birth Instrument.

OBJECTIVE: To develop and assess the reliability and validity of a new instrument used during the third trimester of pregnancy to measure women's confidence in their ability to achieve physiologic birth, the Preparation for Labor and Birth (P-LAB) instrument. DESIGN: Two-phase instrument development study that consisted of item generation and a prospective field test. SETTING: Field testing occurred in five midwestern U.S. prenatal clinics. PARTICIPANTS: Participants in the field test were 203 nulliparous and parous pregnant women who intended to give birth vaginally. METHODS: Psychometric testing consisted of test-retest reliability testing and assessments of content validity, face validity, and construct validity. We measured construct validity using exploratory factor analysis and correlation with the Sense of Coherence Scale. RESULTS: The 22-item P-LAB showed good content validity, good internal consistency, and stability over time. All items had content validity index scores greater than or equal to 0.8, and the total instrument content validity index was 0.95. We identified four factors related to women's confidence in their ability to achieve physiologic birth: Planned Use of Pain Medication, Relationship With Care Provider and Supportive Birth Environment, Beliefs About Labor, and Labor Support (social and professional). Cronbach's alpha coefficient for the four extracted factors were .93, .76, .73 and .74, respectively. Intraclass correlation [95% confidence interval] for the total questionnaire was .92 [.88, .94]. We found no linear association between total P-LAB scores and sense of coherence. CONCLUSION: Our findings demonstrate acceptable initial psychometric properties for the P-LAB instrument. Additional testing is required to evaluate the instrument's construct, convergent, and divergent validity.

Interprofessional Education Between Midwifery Students and Obstetrics and Gynecology Residents: An American College of Nurse-Midwives and American College of Obstetricians and Gynecologists Collaboration.

Despite areas of excellence, US perinatal care outcomes lag behind most developed countries. In addition, a shortage and maldistribution of health care providers exists. The American College of Nurse-Midwives and the American College of Obstetricians and Gynecologists (ACOG) partnered to obtain funding to develop interprofessional education modules and other learning activities for midwifery students and obstetrics and gynecology residents in 4 demonstration sites. The multidisciplinary 2016 ACOG document Collaboration in Practice: Implementing Team-Based Care was adopted as a framework. Core competencies of values and ethics, roles and responsibilities, interprofessional communication, and teams and teamwork developed by the Interprofessional Education Collaborative were used to guide the work. Seven modules have been developed including guiding principles, patient-centered care, role clarification, collaborative practice, history and culture, care transition, and difficult conversations. Learners participate in laboratory and simulation activities and work together in clinical care settings. Stakeholder experiences as well as barriers to implementation are discussed. Learning materials and activity descriptions are open resourced and shared on a project website for use by programs interested in implementing an interprofessional curriculum. Ongoing formal evaluation including pilot testing of a program evaluation method is described.

Design and Implementation of a Group Prenatal Care Model for Somali Women at a Low-Resource Health Clinic.

OBJECTIVE: To design and implement group prenatal care (GPC) for Somali women and to evaluate participants' satisfaction, knowledge, and care engagement. DESIGN: Quality improvement project. SETTING/LOCAL PROBLEM: A federally qualified health center in an urban Midwestern setting, which serves a largely East African immigrant and refugee population. PARTICIPANTS: Pregnant Somali women at more than 20 weeks gestation receiving prenatal care at the project site. Many participants were non-English speaking. INTERVENTION/MEASUREMENTS: While honoring the 13 essential elements of CenteringPregnancy, the model was adapted to the East African population at the project site and offered to all eligible women receiving individual prenatal care at the clinic. Women attended biweekly sessions, including individual assessment and education, exposure to integrative health therapies, and group discussion. Pre- and postintervention data were collected in surveys and in-depth interviews from March through August 2017. RESULTS: Seventeen Somali women attended a median of two sessions (range = 1-7). Self-reported results for knowledge of safe exercise in pregnancy (p = .02), exclusive breastfeeding (p = .04), what happens in the hospital (p = .02), and stress management (p = .03) increased after GPC participation. Ninety-three percent of women preferred GPC to individual care. CONCLUSION: When adapted to meet the needs of Somali women, GPC has the potential to improve care satisfaction, increase knowledge, and reduce stress during pregnancy and the postpartum period. This model may interest women and care providers in similar community health care settings.

Women's Perceptions of Prenatal Influences on Maternal Confidence for Physiologic Birth.

INTRODUCTION: A physiologic approach to labor and birth is preferred for most women. The United States spends more on birth than any other country. Cesarean rates are currently 32%, and approximately 23% of women with a singleton pregnancy experience induction or augmentation of labor. Most physiologic birth research has focused on care during labor and birth. The purpose of this study was to describe women's perceptions of the care processes, support, and information received during pregnancy that helped them feel confident for physiologic labor and birth. METHODS: Using a qualitative descriptive design with 2 phases, women were recruited from an urban area and a smaller city in Minnesota. Phase 1 included focus groups with women who had given birth within the previous 6 months. They participated in a discussion about experiences that helped them feel confident for labor and birth. In Phase 2, women who had a physiologic birth, which was defined as term pregnancy, spontaneous labor, no epidural analgesia, and vaginal birth, participated in individual interviews. Focus group and individual interview recordings were transcribed and analyzed using Glaser's constant comparative approach. RESULTS: Thirty-eight women participated in 9 focus groups. Seventeen women had a physiologic birth; 14 participated in individual interviews. Themes derived from the analysis included confidence in the face of uncertainty, belief in the normalcy of birth and the body's ability to birth, research on my own, supportive care partnership, on the same page, and sources of information and support. DISCUSSION: Women who experienced physiologic birth believed that this was possible and expected. They sought information, including searching on their own, from maternity care providers and a broader support system. Relationships with their maternity care providers were important. Prenatal care focused on women's strengths and abilities, while also monitoring pregnancy health and safety, may help reduce unnecessary interventions, improve outcomes, and reduce costs.