A Crossover Trial Evaluating Coconut Oil as an Alternative to Commercial Ultrasound Gel in Obstetrical Ultrasounds.

OBJECTIVE: Our objective was to evaluate the quality of obstetrical ultrasound images obtained with coconut oil compared with commercial ultrasound gel and to assess patient acceptability. STUDY DESIGN: This was a randomized two-period crossover study in which 40 pregnant patients had standard biometry images obtained with both coconut oil and commercial ultrasound gel during their growth or anatomy ultrasound. All images were then rated by two blinded maternal-fetal medicine physicians on quality, resolution, and detail using a 0 to 100 scale. Contrasts obtained from linear mixed models were used to estimate the differences in image parameters between the agents. Participant experience was evaluated with an acceptability survey which included five items measured on a five-point Likert scale. RESULTS: Image quality, as rated by physicians, was found to be equivalent between commercial ultrasound gel and coconut oil. Additionally, there was not a statistically significant difference in image resolution or detail between the two coupling agents. The overall patient experience was significantly lower for commercial ultrasound gel when compared with coconut oil (mean difference = - 5.48, 95% confidence interval = [-6.89, -4.06]). CONCLUSION: Ultrasound images collected with coconut oil as the coupling agent are equivalent in quality to those collected using commercial ultrasound gel. Patients also preferred the use of coconut oil during their ultrasound, making its use a possible way to improve the patient ultrasound experience. Coconut oil has the potential as an alternative coupling agent that could significantly increase access to ultrasound use in resource-limited settings. KEY POINTS: · Coconut oil produces quality images during obstetrical ultrasounds.. · Patients prefer the use of coconut oil to standard ultrasound gel during obstetrical ultrasounds.. · Coconut oil is a coupling agent that could increase ultrasound use in resource-limited settings..

Abortion Care After the Dobbs Decision: An Academic Health System's Response to a Statewide Ban.

ABSTRACT: Indiana was the first state to pass legislation severely restricting access to abortion care following the Dobbs v. Jackson Women's Health Organization decision. Indiana Senate Enrolled Act 1 (SEA 1) outlaws all abortions with few exceptions. Indiana University Health (IU Health), the largest and only academic health system in the state, has a unique relationship with the Indiana University School of Medicine and a vision to improve the health of Indiana residents. IU Health employed the Hospital Incident Command System model to create a plan to ensure its patients continue to have access to safe, high-quality family planning, maternal, and neonatal care services and that clinicians are protected against criminal penalties and threats to personal safety. This article provides an overview of the Incident Command structure used to rapidly work across many disciplines, tackle complex issues, respond to concerns, and design and implement changes. The article also outlines the key considerations and decisions made by Incident Command leaders, such as where abortions that met the new law's criteria should be performed, changes to clinical workflows and protocols, and the creation of a rapid response team. The article then examines the operational, legal, and clinical challenges encountered by clinicians and health care team members, including a lack of peer support or idea sharing with other health systems in the state; accurate estimation of abortion, live birth, and neonatal intensive care unit volumes; and ambiguity in the law and lack of guidance from the state government. Recommendations regarding communication with clinicians and other health care team members and engaging information technology early are offered for health systems and medical schools that may face legislative barriers to health care delivery in the future. Finally, IU Health's commitment to tracking the impact of SEA 1 on patients, clinicians, employees, and the state is outlined.

Outcomes Following Extracorporeal Membrane Oxygenation for Severe COVID-19 in Pregnancy or Post Partum.

Importance: Existing reports of pregnant patients with COVID-19 disease who require extracorporeal membrane oxygenation (ECMO) are limited, with variable outcomes noted for the maternal-fetal dyad. Objective: To examine maternal and perinatal outcomes associated with ECMO used for COVID-19 with respiratory failure during pregnancy. Design, Setting, and Participants: This retrospective multicenter cohort study examined pregnant and postpartum patients who required ECMO for COVID-19 respiratory failure at 25 hospitals across the US. Eligible patients included individuals who received care at one of the study sites, were diagnosed with SARS-CoV-2 infection during pregnancy or up to 6 weeks post partum by positive nucleic acid or antigen test, and for whom ECMO was initiated for respiratory failure from March 1, 2020, to October 1, 2022. Exposures: ECMO in the setting of COVID-19 respiratory failure. Main outcome and measures: The primary outcome was maternal mortality. Secondary outcomes included serious maternal morbidity, obstetrical outcomes, and neonatal outcomes. Outcomes were compared by timing of infection during pregnancy or post partum, timing of ECMO initiation during pregnancy or post partum, and periods of circulation of SARS-CoV-2 variants. Results: From March 1, 2020, to October 1, 2022, 100 pregnant or postpartum individuals were started on ECMO (29 [29.0%] Hispanic, 25 [25.0%] non-Hispanic Black, 34 [34.0%] non-Hispanic White; mean [SD] age: 31.1 [5.5] years), including 47 (47.0%) during pregnancy, 21 (21.0%) within 24 hours post partum, and 32 (32.0%) between 24 hours and 6 weeks post partum; 79 (79.0%) had obesity, 61 (61.0%) had public or no insurance, and 67 (67.0%) did not have an immunocompromising condition. The median (IQR) ECMO run was 20 (9-49) days. There were 16 maternal deaths (16.0%; 95% CI, 8.2%-23.8%) in the study cohort, and 76 patients (76.0%; 95% CI, 58.9%-93.1%) had 1 or more serious maternal morbidity events. The largest serious maternal morbidity was venous thromboembolism and occurred in 39 patients (39.0%), which was similar across ECMO timing (40.4% pregnant [19 of 47] vs 38.1% [8 of 21] immediately postpartum vs 37.5% postpartum [12 of 32]; P > .99). Conclusions and Relevance: In this multicenter US cohort study of pregnant and postpartum patients who required ECMO for COVID-19-associated respiratory failure, most survived but experienced a high frequency of serious maternal morbidity.

Mode of delivery preference in prenatal genetic counseling between English- and Spanish-speaking patients at two US medical institutions.

Although Hispanic individuals are at an increased risk for various genetic conditions, they have lower uptake of genetic counseling and genetic testing. Virtual appointments have many advantages that may help Spanish-speaking patients access genetic services more readily. Despite these benefits, there are limitations that may make them less attractive options for these individuals. This study aimed to determine if satisfaction with genetic counseling or mode of delivery preference differs between English- and Spanish-speaking individuals who have had a virtual prenatal genetic counseling session. Participants were recruited from prenatal genetic counseling clinics at Indiana University Health and Eskenazi Hospital. A REDCap survey was sent to all eligible participants. Survey questions included mode of delivery preference for future genetic counseling sessions (virtual versus in-person), the validated Genetic Counseling Satisfaction Scale, and questions inquiring about the importance of various factors affecting mode of delivery preference. Spanish-speaking individuals preferred future visits to be in-person, while English-speaking individuals preferred future visits to be virtual (Fisher's exact p = 0.003). Several factors were associated with these preferences, including waiting time, ability to leave/take off work for an appointment, length of session, childcare arrangements, and people attending the appointment (all p < 0.05). Both language groups reported similar mean satisfaction with the genetic counseling provided during their previous virtual appointments (p = 0.51). This study found that certain aspects of virtual genetic counseling appointments make them less appealing to Spanish-speaking individuals. Making virtual genetic counseling appointments more appealing while continuing to offer in-person appointments may help Spanish-speaking individuals receive necessary genetics services. Continued research into disparities and barriers to telemedicine for Spanish-speaking patients is necessary to increase access to this service delivery model for genetic counseling.

Moderate intensity exercise in pregnant patients with cardiovascular disease: A pilot study.

BACKGROUND: Exercise in pregnancy has proven health benefits, yet the safety of exercise in patients with pre-existing cardiovascular disease (CVD) has not been established. Our aim was to determine the feasibility and safety profile of moderate intensity exercise during pregnancy in patients with CVD, compared with those without CVD. METHODS: This is a prospective single center pilot study of a moderate intensity exercise regimen, with data collection through wearable fitness trackers and personal exercise logs in pregnant patients with and without pre-existing CVD. The primary outcome was Doppler umbilical artery systolic to diastolic (S/D) ratio measured between 32 and 34 weeks' gestation. The secondary outcomes were adverse maternal and fetal events, trends in wearable fitness tracker data, C-reactive protein levels, and weight changes. RESULTS: At baseline, the CVD group (62% congenital heart disease) took part in more prepregnancy walking, less weightlifting, and had a higher body mass index compared to the control group, and on average walked 539 fewer steps per day during pregnancy than the control group. Resting heart rate (HR) was found to increase in both groups up to 30 weeks' gestation. The cardiovascular disease group displayed an overall lower exercise intensity, as measured by the ability to increase HR with exercise over resting heart rate 1 hour prior to exercise at study baseline (45% vs 59% P < .001). Umbilical artery S/D ratio was normal in both groups. No differences were seen in adverse events between groups. CONCLUSIONS: This pilot study of moderate intensity exercise in pregnant individuals with pre-existing CVD demonstrated that patients with CVD were not able to increase their HR during exercise throughout pregnancy compared to those in the control group. Although a small study group, this data supports the hypothesis that exercise interventions during pregnancy for patients with CVD are feasible without evidence abnormal fetal Doppler profiles. Further studies using wearable fitness trackers may provide the opportunity to understand how to safely tailor exercise programs to pregnant individuals with CVD.

Clinical significance of intermittent absent end-diastolic flow of the umbilical artery in fetal growth restriction.

BACKGROUND: Fetal growth restriction can result from a variety of maternal, fetal, and placental conditions. Umbilical artery Doppler assesses the impedance to blood flow along the fetal component of the placental unit. An abnormal umbilical artery waveform reflects the presence of placental insufficiency and can help differentiate a growth-restricted fetus from the constitutionally small, thus guiding further management. The presence of persistently absent end-diastolic flow and reversed end-diastolic flow is an indication for inpatient antenatal surveillance and preterm delivery. There is no consensus on the optimal management of intermittent absent end-diastolic flow owing to a lack of data to support the ideal delivery timing for growth-restricted fetuses with this finding. OBJECTIVE: This study aimed to estimate the risks of adverse perinatal outcomes among growth-restricted pregnancies with persistently elevated, intermittently absent, and persistently absent end-diastolic flow. Fetal growth restriction is a common condition that is associated with an increased risk of fetal morbidity and mortality. Intermittently absent umbilical artery end-diastolic flow may be identified among pregnancies with fetal growth restriction. The fetal risks associated with persistently absent end-diastolic flow have been described. However, the risks associated with intermittent absent end-diastolic flow are not as well-known. STUDY DESIGN: We performed a retrospective cohort study including nonanomalous, singleton, growth-restricted pregnancies that received umbilical artery Doppler assessment at our institution from 2009 to 2020. Fetuses were classified into the following 3 categories: elevated umbilical artery Doppler, intermittent absent end-diastolic flow, and persistently absent end-diastolic flow. The Doppler categories were classified by the most severe in the pregnancy. The primary outcome was a composite of neonatal morbidity. RESULTS: Total 233 fetuses met the criteria. Of which 78 (33.0%) had elevated umbilical artery Doppler waveforms, 37 (16.0%) had intermittent absent end-diastolic flow, and 119 (51.0%) had absent end-diastolic flow. The composite outcome was statistically different between the groups, occurring in 16.9% with elevated umbilical artery Doppler waveforms (13/77), 35.1% (12/39) with intermittent absent end-diastolic flow, and 56.3% (65/127) with absent end-diastolic flow (P<.001). The odds ratio for the composite outcome was significantly increased in absent end-diastolic flow (odds ratio, 6.15; 95% confidence interval, 3.14-12.80) and was not significantly increased for intermittently absent end-diastolic flow (odds ratio, 2.46; 95% confidence interval, 0.98-6.19) when compared with elevated umbilical artery Doppler waveforms. When adjusted for gestational age at delivery and antenatal steroids, no difference was seen in the primary outcome for intermittent absent end-diastolic flow (adjusted odds ratio, 0.73; 95% confidence interval, 0.20-2.68) and absent end-diastolic flow (adjusted odds ratio, 1.44; 95% confidence interval, 0.51-4.07). CONCLUSION: Among growth-restricted pregnancies, intermittent absent end-diastolic flow is associated with a similar rate of composite neonatal morbidity as persistently elevated Doppler waveforms. In addition, there is no difference in composite neonatal morbidity between the 3 groups when corrected for gestational age at delivery and antenatal steroid administration. These similar outcomes should be considered when creating an antenatal surveillance plan and discussing the potential for outpatient management.

The Impact of COVID-19 on Postpartum Depression and the Responsibility of the Healthcare System.

Peripartum depression is a common complication of pregnancy with the potential for dangerous consequences to maternal and infant health if left untreated. The disorder was previously classified as a global public health issue due to the high prevalence of the disorder and the mismatch between available treatment options and successful completion of those options. The coronavirus disease 2019 (COVID-19) pandemic increased the incidence of mental health disorders globally, with an even greater effect on peripartum mothers. A preliminary study on fetal implications suggests the resulting increased maternal stress and depressive mood symptoms correlates to worsened fetal brain development. The pandemic highlighted existing barriers to the treatment of peripartum mood disorders. The drastic increase in the use of telemedicine as a modality of treatment in response to the public health crisis has the potential to address some of these barriers. Future global disasters are inevitable with peripartum mothers highly susceptible to worsened mental health outcomes. We are thus highlighting the responsibility of clinicians, professional organizations, and policymakers to support, identify, and facilitate the treatment of postpartum depression for this vulnerable population to prevent short-term and long-term repercussions.

OBGYN providers' lack of knowledge and management of genetic risks due to advanced paternal age underscore the need for updated practice guidance.

The objective of this pilot study was to characterize healthcare professionals' knowledge of advanced paternal age (APA), the associated risks, as well as current clinical practices regarding APA. Our study utilized an online survey that questioned providers who see children with genetic conditions and patients who are or may become pregnant regarding demographic information, APA knowledge, APA guideline familiarity, and their clinical practices. A total of 67 providers responded to the survey. We had responses from 54 physician participants in the specialties of medical genetics (GEN), maternal fetal medicine (MFM), and obstetrics and gynecology (OBGYN). OBGYN, but not MFM, reported significantly lower agreement that current data supports an association between APA and certain genetic diseases compared to GEN. Furthermore, OBGYN were less likely to identify established risks associated with APA and more likely to incorrectly identify unestablished risks compared to GEN and MFM. Regardless of specialty, the majority of physicians were unfamiliar with the most recently published APA guidelines. This study revealed a desire for more information regarding APA risks and management among our participants. Our data suggest that GEN, MFM, and OBGYN would benefit from updated and more visible guidelines regarding APA. Additionally, OBGYN consistently showed knowledge gaps and misconceptions regarding the risks of APA. Targeted educational or guidance materials regarding APA may also be beneficial for OBGYNs.

Association of N-Terminal Pro-Brain Natriuretic Peptide Concentration in Early Pregnancy With Development of Hypertensive Disorders of Pregnancy and Future Hypertension.

IMPORTANCE: Hypertensive disorders of pregnancy are associated with future cardiovascular disease, perhaps because of subclinical cardiac dysfunction before pregnancy leading to impaired adaptation to pregnancy. Natriuretic peptides are promising biomarkers for detecting subclinical cardiac dysfunction outside of pregnancy. OBJECTIVE: To investigate whether higher concentrations of N-terminal pro-brain natriuretic peptide (NT-proBNP) in early pregnancy would be associated with hypertensive disorders of pregnancy and hypertension 2 to 7 years post partum. DESIGN, SETTING, AND PARTICIPANTS: This cohort study used data from the The Nulliparous Pregnancy Outcomes Study: Monitoring Mothers-to-Be Heart Health Study, a prospective multicenter observational study. A total of 4103 nulliparous women with complete data and no prepregnancy hypertension or diabetes who were treated at 8 clinical sites were included. Women were followed up with for 2 to 7 years after pregnancy. Data were collected from October 2010 to October 2017, and data were analyzed from August 2020 to November 2021. EXPOSURES: NT-proBNP concentration, measured using an electrochemiluminescence immunoassay from a first-trimester blood sample. MAIN OUTCOMES AND MEASURES: Hypertensive disorders of pregnancy and incident hypertension (systolic blood pressure of 130 mm Hg or diastolic blood pressure of 80 mm Hg or use of antihypertensive agents) at follow-up visit. RESULTS: A total of 4103 women met inclusion criteria; the mean (SD) age was 27.0 (5.6) years. Among these women, 909 (22.2%) had an adverse pregnancy outcome, and 817 (19.9%) had hypertension at the follow-up visit. Higher NT-proBNP concentrations were associated with a lower risk of hypertensive disorders of pregnancy (adjusted odds ratio per doubling, 0.81; 95% CI, 0.73-0.91), which persisted after adjustment for age, self-reported race and ethnicity, early-pregnancy body mass index, smoking, and aspirin use. Similarly, higher NT-proBNP concentration in early pregnancy was also associated with a lower risk of incident hypertension 2 to 7 years after delivery (adjusted odds ratio per doubling, 0.84; 95% CI, 0.77-0.93), an association that persisted after controlling for confounders, including hypertensive disorders of pregnancy. CONCLUSIONS AND RELEVANCE: In this cohort study, higher NT-proBNP concentrations in early pregnancy were associated with a lower risk of hypertensive disorders of pregnancy and hypertension 2 to 7 years post partum. These findings suggest that normal early-pregnancy cardiovascular physiology, as assessed by NT-proBNP concentration, may provide biologic insights into both pregnancy outcome and cardiovascular disease risk.

Timing of Delivery in Women with Cardiac Disease.

OBJECTIVE: Guidelines do not exist to determine timing of delivery for women with cardiovascular disease (CVD) in pregnancy. The neonatal benefit of a term delivery as compared with an early term delivery is well described. We sought to examine maternal outcomes in women with CVD who delivered in the early term period (370/7 through 386/7 weeks) compared with those who delivered later. STUDY DESIGN: This is a prospective cohort study examining cardiac and obstetric outcomes in women with CVD delivering between September 2011 and December 2016. The associations between gestational age at delivery and maternal, fetal, and obstetric characteristics were evaluated. RESULTS: Two-hundred twenty-five women with CVD were included, 83 (37%) delivered in the early term period and 142 (63%) delivered at term. While the early term group had significantly higher rates of any hypertension during pregnancy (18.1 vs. 7%, p = 0.01) and intrauterine growth restriction (22.9 vs. 2.8%, p < 0.001), there was no difference in high-risk cardiac or obstetric characteristics. No difference in composite cardiac morbidity was found (4.8 vs. 3.5%, p = 0.24). Women in the early term group were more likely to undergo cesarean delivery than women in the term group (43.4 vs. 24.7%, p = 0.004). CONCLUSION: There is no maternal benefit of an early term delivery in otherwise healthy women with CVD. Given the known fetal consequences of early term delivery, this study offers support to existing literature suggesting term delivery in these women. KEY POINTS: · Question of delivery timing in women with cardiac disease.. · No difference in cardiac morbidity, term versus early term.. · Term delivery in women with asymptomatic cardiac disease..

Allies Welcomed to Advance Racial Equity (AWARE) Faculty Seminar Series: Program Design and Implementation.

INTRODUCTION: In the wake of George Floyd's murder, White faculty in our department began to express the desire to gain a greater understanding of structural racism and racial inequity. To facilitate this learning, support allyship, and mitigate the emotional labor and taxation that frequently falls on faculty of color to respond to these appeals, we developed AWARE (Allies Welcomed to Advance Racial Equity), a faculty seminar series primarily designed for and led by a majority White faculty to tackle the topics of structural racism, Whiteness, and Anti-racist action. METHODS: We developed a 6-session seminar series, identifying 5 White faculty as lecturers and a cadre of Black and White volunteer facilitators, to lead 60-minute sessions comprised of lecture, facilitated small group reflection, and large group sharing, that reviewed key topics/texts on structural racism, Whiteness, and Anti-racism. RESULTS: Attendance ranged from 26 to 37 participants at each session. About 80% of faculty participated in at least 1 session of the program. The majority of participants (85%) felt "more empowered to influence their current environment to be more inclusive of others" and were "better equipped to advocate for themselves or others." Most (81%) felt "more connected to their colleagues following completion of the program." Ultimately, faculty thought highly of the program upon completion with 26/27 (96%) stating they would recommend the program to a colleague. DISCUSSION: We offer a reproducible model to improve departmental climate by engaging in the shared labor of educating our colleagues and communities about structural racism, Whiteness, and Anti-racism to create a point of entry into reflection, dialogue, and deliberate actions for change.

A National Survey of Obstetrician/Gynecologists' Knowledge, Attitudes, and Beliefs Regarding Adult Human Papillomavirus Vaccination.

Background: Many women see an obstetrician/gynecologist (OB/GYN) annually and receive their primary care from an OB/GYN. Understanding OB/GYNs' human papillomavirus (HPV) vaccination practices, including knowledge of and barriers to vaccination, is essential to design effective interventions to increase vaccination. This study evaluated OB/GYN knowledge, attitudes, and beliefs regarding vaccinating both younger (18-26 years) and mid-adult (27-45 years) women. Materials and Methods: Data were collected from OB/GYN providers in October 2019 through a nationwide web-based survey. Items included the following: HPV-related vaccination practices, recommendation strength, knowledge (seven items), benefits (four items), and barriers (eight items). Results: The sample (n = 224) was majority were White (69%), men (56%), and practice in suburban clinics (55%). Most (84%) reported they usually or always recommend HPV vaccine to eligible patients, but estimated only about half (51%) of other OB/GYNs did the same. Recommendation strength varied by patient age with 84% strongly recommending it to patients ≤18 years, compared with 79% and 25% strongly recommending to younger and mid-adult patients, respectively (p < 0.01). Participants reported lower benefits (p = 0.007) and higher barriers (p < 0.001) for 27- to 45-year-old patients compared with younger patients. Cost was the most frequently reported barrier, regardless of patient age. Overall knowledge was high (m = 5.2/7) but 33% of participants did not know the vaccine was safe while breastfeeding. Conclusions: Although providers reported strongly and consistently recommending the HPV vaccination to their adult patients, there were gaps in knowledge and attitudinal barriers that need to be addressed. Provider performance feedback may be important in improving HPV vaccination awareness among providers.

Human Papillomavirus Vaccination Prevalence Among Adults Aged 19-45 Years: An Analysis of the 2017 National Health Interview Survey.

INTRODUCTION: In 2018, the U.S. Food and Drug Administration extended the licensure for human papillomavirus vaccination to include everyone aged 27-45 years. In 2019, the Advisory Committee on Immunization Practices issued a recommendation that adults aged 27-45 years and their providers engage in shared clinical decision making about human papillomavirus vaccination. In addition, in 2019, the Advisory Committee on Immunization Practices reiterated that all previously unvaccinated individuals receive catch-up vaccination through age 26 years. This study estimates the pre-recommendation prevalence of human papillomavirus vaccination and factors associated with vaccination in 2 age groups (19-26 years [young adults] and 27-45 years [mid-adults]), forming a baseline to monitor future coverage among U.S. adults. METHODS: The final sample included 9,744 individuals (2,522 young adults and 7,222 mid-adults) who participated in the 2017 National Health Interview Survey. The main outcomes were receipt of 1 or more human papillomavirus vaccination and whether the participant had been vaccinated as an adult. Demographic characteristics and healthcare factors were included as covariates in statistical analyses. RESULTS: Population estimate of receiving 1 or more human papillomavirus vaccine doses among young adults was 36.3% (female: 51.5%, male: 21.2%; p<0.001) and 9.7% for mid-adults (females: 15.8%, males: 3.2%; p<0.001). In the best-fit model, age was inversely associated with vaccination for mid-adults (female: OR=0.84, 95% CI=0.81, 0.86; male: OR=0.86; 95% CI=0.82, 0.90) and male young adults (OR=0.79, 95% CI=0.71, 0.88). Of the entire vaccinated sample aged 19-45 years, 26.6% had received their first vaccination as an adult (95% CI=23.9, 29.4). CONCLUSIONS: These data emphasize the continued need for vaccinating adolescents aged 11-12 years given that few adults were vaccinated against human papillomavirus.

Obstetrics risk Assessment: Evaluation of selection criteria for vaccine research studies in pregnant women.

Vaccines designed for use in pregnancy and vaccine trials specifically involving pregnant women are rapidly expanding. One of the key challenges in designing maternal immunization trials is that developing exclusion criteria requires understanding and quantifying the background risk for adverse pregnancy outcomes in the pregnancy being studied, which can occur independent of any intervention and be unrelated to vaccine administration. The Global Alignment of Immunization Safety Assessment in Pregnancy (GAIA) project has developed and published case definitions and guidelines for data collection, analysis, and evaluation of maternal immunization safety in trials involving pregnant women. Complementing this work, we sought to understand how to best assess obstetric risk of adverse outcomes and differentiate it from the assessment of vaccine safety. Quantification of obstetric risk is based on prior and current obstetric, and maternal medical history. We developed a step-wise approach to evaluate and quantify obstetric and maternal risk factors in pregnancy based on review of published literature and guidelines, and critically assessed these factors in the context of designing inclusion and exclusion criteria for maternal vaccine studies. We anticipate this risk assessment evaluation may assist clinical trialists with study design decisions, including selection of exclusion criteria for vaccine trials involving pregnant women, consideration of sub-group classification, such as high or low risk subjects, or schedule considerations, such as preferred trimester of gestation for an intervention during pregnancy. Additionally, this tool may be utilized in data stratification at time of study analyses.

Planned vaginal delivery and cardiovascular morbidity in pregnant women with heart disease.

BACKGROUND: Although consensus guidelines on the management of cardiovascular disease in pregnancy reserve cesarean delivery for obstetric indications, there is a paucity of data to support this approach. OBJECTIVE: The objective of the study was to compare cardiovascular and obstetric morbidity in women with cardiovascular disease according to the plan for vaginal birth or cesarean delivery. STUDY DESIGN: We assembled a prospective cohort of women delivering at an academic tertiary care center with a protocolized multidisciplinary approach to management of cardiovascular disease between September 2011 and December 2016. Our practice is to encourage vaginal birth in women with cardiovascular disease unless there is an obstetric indication for cesarean delivery. We allow women attempting vaginal birth a trial of Valsalva in the second stage with the ability to provide operative vaginal delivery if pushing leads to changes in hemodynamics or symptoms. Women were classified according to planned mode of delivery: either vaginal birth or cesarean delivery. We then used univariate analysis to compare adverse outcomes according to planned mode of delivery. The primary composite cardiac outcome of interest included sustained arrhythmia, heart failure, cardiac arrest, cerebral vascular accident, need for cardiac surgery or intervention, or death. Secondary obstetric and neonatal outcomes were also considered. RESULTS: We included 276 consenting women with congenital heart disease (68.5%), arrhythmias (11.2%), connective tissue disease (9.1%), cardiomyopathy (8.0%), valvular disease (1.4%), or vascular heart disease (1.8%) at or beyond 24 weeks' gestation. Seventy-six percent (n = 210) planned vaginal birth and 24% (n = 66) planned cesarean delivery. Women planning vaginal birth had lower rates of left ventricular outflow tract obstruction, multiparity, and preterm delivery. All women attempting vaginal birth were allowed Valsalva. Among planned vaginal deliveries 86.2% (n = 181) were successful, with a 9.5% operative vaginal delivery rate. Five women underwent operative vaginal delivery for the indication of cardiovascular disease without another obstetric indication at the discretion of the delivering provider. Four of these patients tolerated trials of Valsalva ranging from 15 to 75 minutes prior to delivery. Adverse cardiac outcomes were similar between planned vaginal birth and cesarean delivery groups (4.3% vs 3.0%, P = 1.00). Rates of postpartum hemorrhage (1.9% vs 10.6%, P < .01) and transfusion (1.9% vs 9.1%, P = .01) were lower in the planned vaginal birth group. There were no differences in adverse cardiac, obstetric, or neonatal outcomes in the cohort overall or the subset of women with high-risk cardiovascular disease or a high burden of obstetric comorbidity. CONCLUSION: These findings suggest that cesarean delivery does not reduce adverse cardiovascular outcomes and lend support to a planned vaginal birth for the majority of women with cardiovascular disease including those with high-risk disease.

Assessment of the Placental Cord Insertion Using 3-Dimensional Ultrasound at the Time of the Structural Fetal Survey.

OBJECTIVES: The influence of placental morphologic characteristics on pregnancy outcomes is poorly understood. Our objective was to evaluate the relationship of the distance of the placental cord insertion from the placental edge (PCI-D) with associated placental characteristics as well as birth outcomes. METHODS: We performed a retrospective cohort study of nulliparous women with singleton gestations undergoing obstetric ultrasound examinations between 14 and 23 weeks' gestation with a cervical length of greater than 3.0 cm who delivered between 24 and 42 weeks. A 3-dimensional volume of the placenta was evaluated. The PCI-D was obtained with Virtual Organ computer-aided analysis software (GE Healthcare, Milwaukee, WI). Generalized linear regression and generalized additive models were fitted to explore the associations between the PCI-D in relation to demographic and clinical characteristics. RESULTS: A total of 216 pregnancies were included in the analysis. The PCI-D did not correlate with maternal age, gestational age at delivery, mode of delivery, or 5-minute Apgar score. Although not statistically significant, the birth weight z score (P = .09) was associated with a longer PCI-D, and gravidity was associated with a shorter PCI-D (P = .10). A low-lying placenta or placenta previa was associated with a longer PCI-D (P = .03). CONCLUSIONS: The PCI-D is associated with a low placental position in the second trimester. These data are helpful for understanding placental development. The PCI-D may be associated with pregnancy-related factors such as birth weight and multigravidity. More research is required to evaluate the effects of pregnancy-related factors on the PCI-D and the effect of the PCI-D on pregnancy outcomes.

Angle of Progression on Ultrasound in the Second Stage of Labor and Spontaneous Vaginal Delivery.

OBJECTIVE: The objective of this study was to assess the association between the angle of progression (AoP) measured by transperineal ultrasound and mode of delivery and duration of the second stage. STUDY DESIGN: This is a prospective observational study of nulliparous women with a singleton gestation at term in which serial transperineal ultrasound examinations were obtained during the second stage of labor. Multivariable logistic regression and adjusted survival models were used for the analysis. RESULTS: A total of 137 patients were included in the analysis and median AoP for the study group was 153 degrees. The adjusted odds ratio (aOR) of requiring an operative delivery was 2.6 times higher for those patients who had an AoP < 153 degrees and the aOR of requiring a cesarean delivery was almost six times higher when compared with those patients who had an AoP ≥ 153 degrees (95% confidence interval [CI]: 1.0, 6.2; p = 0.04; aOR: 5.8, 95% CI: 1.2-28.3; p = 0.03, respectively). Those patients with an AoP < 153 degrees were at a higher hazard of staying pregnant longer (adjusted hazard ratio: 1.8, 95% CI: 1.2-2.8, p = 0.005). CONCLUSION: The AoP has the potential to predict spontaneous vaginal delivery and the duration of the second stage of labor which may be useful in counseling patients and managing their labor.