Adverse Delivery and Neonatal Outcomes Among Women with Severe Maternal Morbidity in Illinois, 2018-2019.

Objective: To examine adverse delivery outcomes from 2018 to 2019 severe maternal morbidity (SMM) cases that were reviewed by facility-level review committees in Illinois (n = 666) and describe the burden of adverse delivery outcomes among demographic subgroups, SMM etiology, and whether the SMM event was potentially preventable. Materials and Methods: This is a descriptive analysis of the SMM review cohort. Consistent with expert recommendations to identify SMM for hospital quality review, SMM was defined as any intensive care or critical care unit admission and/or transfusion of four or more units of packed red blood cells from conception to 42 days postpartum. Adverse delivery outcomes were fetal death, low birthweight, preterm birth, neonatal intensive care unit admission, and 5-minute Apgar score <7. Chi square and Fisher's exact tests compared maternal demographic and delivery characteristics between the SMM sample and 2018-2019 deliveries in Illinois. Logistic regression modeled the associations between primary cause of morbidity, maternal race/ethnicity, adverse delivery outcomes, and opportunities to alter the outcome to assess whether the burden of adverse birth outcomes was distributed evenly across subcategories of the cohort. Results: Overall, 53.9% of women with SMM had at least one adverse delivery outcome. SMM events owing to preeclampsia/eclampsia (adjusted odds ratio [aOR] = 4.41, 95% confidence interval [CI] = 2.37-8.24) and infection/sepsis (aOR = 4.40, 95% CI = 1.79-11.04) were more likely to be accompanied by adverse delivery outcomes compared with hemorrhage-related SMM. Non-Hispanic Black women with SMM were more likely to have an adverse delivery outcome compared with non-Hispanic White women with SMM (aOR = 1.74, 95% CI = 1.01-3.02). Conclusion: A greater proportion of the SMM review cohort experienced adverse delivery outcomes compared with the overall birthing population in the state. Non-Hispanic Black women with SMM were almost twice as likely to have an adverse delivery outcome compared with non-Hispanic White women.

Federally Funded Randomized Controlled Trials Increase Analysis and Reporting of Study Outcomes by Sex, Race, and Ethnicity.

Background: We previously examined National Institutes of Health (NIH)-funded randomized controlled trials (RCTs) published in 2004, 2009, and 2015 and found low compliance with NIH policies on inclusion, analysis, and reporting results for female and minoritized subgroups, with no improvement over time. We conducted a fourth wave of data collection using RCTs published in 2021, comparing current results with previous years. Materials and Methods: The authors used PubMed to find 657 RCTs published in print in 14 leading US medical journals in 2021. Of those, 93 (14.2%) were eligible for analysis. We reviewed all parts of eligible studies and any published commentary. Fisher's exact statistics compared proportions of studies analyzing or reporting results for subgroups in 2021 compared with RCTs studied in previous waves. Posthoc analysis compared eligible RCTs about the Covid-19 pandemic to eligible RCTs on other topics. Results: Twenty-five of 93 studies (26.9%) analyzed or reported outcomes by race or ethnicity, an increase over previous years (p < 0.01). Among 79 RCTs with participants of both sexes, the median proportion of female participants was 43%. Moreover, 34 (43.0%) reported an outcome by sex, included sex as a covariate in statistical analysis, or reported results by sex, also an increase over previous waves (p < 0.01). Eleven eligible studies (11.8%) were on a SARS-CoV-2 topic; there was no difference between SARS-CoV-2 RCTs and RCTs on other topics. Conclusions: Analysis and reporting by sex, race, and ethnicity for NIH-funded RCTs published in 2021 significantly increased from previous waves, despite no corresponding increase in enrollment.

Comparing State-Level and Facility-Based Review to Assess Quality of Severe Maternal Morbidity Reviews.

OBJECTIVE: To compare results from facility-level and state-level severe maternal morbidity (SMM) reviews in Illinois. DESIGN: We report descriptive characteristics about SMM cases and compare the results of both review processes, including the primary cause, assessment of preventability, and factors that contributed to the severity of the SMM cases. SETTING: All birthing hospitals in Illinois. PARTICIPANTS: A total of 81 SMM cases were reviewed by a facility-level committee and the state-level review committee. SMM was defined as any intensive care or critical care unit admission and/or transfusion of 4 or more units of packed red blood cells from conception to 42 days postpartum. RESULTS: Among the cases reviewed by both committees, hemorrhage was the primary cause of morbidity, with 26 (32.1%) and 38 (46.9%) hemorrhage cases identified by the facility-level and state-level committees, respectively. Both committees identified infection/sepsis (n = 12) and preeclampsia/eclampsia (n = 12) as the next most common causes of SMM. State-level review found more cases potentially preventable (n = 29, 35.8% vs n = 18, 22.2%) and more cases not preventable but improvement in care needed (n = 31, 38.3% vs n = 27, 33.3%). State-level review found more provider and system opportunities to alter the SMM outcome and fewer patient opportunities than facility-level review. CONCLUSION: State-level review found more SMM cases potentially preventable and identified more opportunities to improve care than facility-level review. State-level review has the potential to strengthen facility-level reviews by identifying opportunities to improve the review process and develop recommendations and tools to aid facility-level reviews.

Racial and Ethnic Disparities in Pregnancy-Related Mortality in Illinois, 2002-2015.

Background: Little is known about racial or ethnic differences in the potential preventability of pregnancy-related deaths, or the provider, systems, or patient factors associated with those deaths. Materials and Methods: This is a retrospective cohort study of pregnancy-related deaths among black, Hispanic, and white women between 2002 and 2015 in Illinois using Illinois Department of Public Health maternal mortality data. We compared the distribution of women's characteristics and calculated race- and ethnicity-specific pregnancy-related mortality ratios (PRMRs) per 100,000 live births. We describe the proportion of deaths that were determined to be potentially preventable by race and ethnicity and critical factors associated with pregnancy-related deaths by cause. Results: There were 130, 33, and 109 pregnancy-related deaths of black, Hispanic, and white women, respectively, in Illinois during the study period. Overall, black women's PRMR was nearly four times that of white women (32.6 vs. 8.9 per 100,000 live births). The PRMR for Hispanic women under 30 years was lower than for white women, but that advantage disappeared after age 30. Emboli and vascular accidents were the most common underlying cause of death overall. Over a third of deaths were potentially preventable. Provider factors, particularly delays in diagnosis and treatment and inappropriate treatment, were cited in 56.1%, 71.4%, and 50.0% of black, Hispanic, and white women's preventable deaths, respectively. Conclusion: Surprisingly, racial disparities in maternal mortality were not associated with statistically significant differences in the cause of death or class of contributing critical factors in this small, single-state analysis; further study in aggregate or pooled data with deeper qualitative assessment of individual cases is, therefore, required to understand how to narrow racial disparities in maternal outcome. If aggregate or pooled analysis showed systematic racial or ethnic differences in committee findings, it would be important to assess whether those differences were due to committee bias or other factors.

Racial and Ethnic Disparities in Severe Maternal Morbidity in the United States.

Severe maternal morbidity (SMM) is 50 to 100 times more common than maternal death, and has increased disproportionately among ethnic/racial minority women in the United States. However, specific knowledge about how the types and timing of severe maternal morbidities deferentially affect ethnic/racial minority women is poorly understood. This study examines racial/ethnic disparities in severe maternal morbidity during antepartum (AP), intrapartum (IP), and postpartum (PP) hospital admissions in the United States (US) for 2002-2014. We identified AP, IP, and PP hospitalizations in the National Inpatient Sample. Distribution of sociodemographic, behavioral and hospital characteristics, insurance, comorbidities, and SMM occurrence was summarized using descriptive statistics. Through Joinpoint regression, temporal SMM trends of hospitalizations were examined and stratified by race. Multivariate logistic regression assessed the association between race and SMM. We found black women have the highest proportion of SMM across all pregnancy intervals with a 70% greater risk of SMM during AP after adjusting for all cofactors. In the PP period, Hispanic women's risk of SMM is 19% less when compared to white women. Racial/ethnic disparities in SMM vary in timing and SMM type. Systematic investigation is needed to understand risks to black women and the protective factors associated with Hispanic women in the PP. Addressing racial disparities in maternal morbidity and mortality requires national policies and initiatives tailored to black women that address the specific types and timings of life-threatening obstetric complications.

A global view of severe maternal morbidity: moving beyond maternal mortality.

BACKGROUND: Maternal mortality continues to be of great public health importance, however for each woman who dies as the direct or indirect result of pregnancy, many more women experience life-threatening complications. The global burden of severe maternal morbidity (SMM) is not known, but the World Bank estimates that it is increasing over time. Consistent with rates of maternal mortality, SMM rates are higher in low- and middle-income countries (LMICs) than in high-income countries (HICs). SEVERE MATERNAL MORBIDITY IN HIGH-INCOME COUNTRIES: Since the WHO recommended that HICs with low maternal mortality ratios begin to examine SMM to identify systems failures and intervention priorities, researchers in many HICs have turned their attention to SMM. Where surveillance has been conducted, the most common etiologies of SMM have been major obstetric hemorrhage and hypertensive disorders. Of the countries that have conducted SMM reviews, the most common preventable factors were provider-related, specifically failure to identify "high risk" status, delays in diagnosis, and delays in treatment. SEVERE MATERNAL MORBIDITY IN LOW AND MIDDLE INCOME COUNTRIES: The highest burden of SMM is in Sub-Saharan Africa, where estimates of SMM are as high as 198 per 1000 live births. Hemorrhage and hypertensive disorders are the leading conditions contributing to SMM across all regions. Case reviews are rare, but have revealed patterns of substandard maternal health care and suboptimal use of evidence-based strategies to prevent and treat morbidity. EFFECTS OF SMM ON DELIVERY OUTCOMES AND INFANTS: Severe maternal morbidity not only puts the woman's life at risk, her fetus/neonate may suffer consequences of morbidity and mortality as well. Adverse delivery outcomes occur at a higher frequency among women with SMM. Reducing preventable severe maternal morbidity not only reduces the potential for maternal mortality but also improves the health and well-being of the newborn. CONCLUSION: Increasing global maternal morbidity is a failure to achieve broad public health goals of improved women's and infants' health. It is incumbent upon all countries to implement surveillance initiatives to understand the burden of severe morbidity and to implement review processes for assessing potential preventability.

Implementing Statewide Severe Maternal Morbidity Review: The Illinois Experience.

CONTEXT: Severe maternal morbidity (SMM) rates in the United States more than doubled between 1998 and 2010. Advanced maternal age and chronic comorbidities do not completely explain the increase in SMM or how to effectively address it. The Centers for Disease Control and Prevention and American College of Obstetricians and Gynecologists have called for facility-level multidisciplinary review of SMM for potential preventability and have issued implementation guidelines. IMPLEMENTATION: Within Illinois, SMM was identified as any intensive or critical care unit admission and/or 4 or more units of packed red blood cells transfused at any time from conception through 42 days postpartum. All cases meeting this definition were counted during statewide surveillance. Cases were selected for review on the basis of their potential to yield insights into factors contributing to preventable SMM or best practices preventing further morbidity or death. If the SMM review committee deemed a case potentially preventable, it identified specific factors associated with missed opportunities and made actionable recommendations for quality improvement. EVALUATION: Approximately 1100 cases of SMM were identified from July 1, 2016, to June 30, 2017, yielding a rate of 76 SMM cases per 10 000 pregnancies. Reviews were conducted on 142 SMM cases. Most SMM cases occurred during delivery hospitalization and more than half were delivered by cesarean section. Hemorrhage was the primary cause of SMM (>50% of the cases). DISCUSSION: Facility-level SMM review was feasible and acceptable in statewide implementation. States that are planning SMM reviews across obstetric facilities should permit ample time for translation of recommendations to practice. Although continued maternal mortality reviews are valuable, they are not sufficient to address the increasing rates of SMM and maternal death. In-depth multidisciplinary review offers the potential to identify factors associated with SMM and interventions to prevent women from moving along the continuum of severity.

The More Things Change, the More They Stay the Same: A Study to Evaluate Compliance With Inclusion and Assessment of Women and Minorities in Randomized Controlled Trials.

PURPOSE: The National Institutes of Health (NIH) Revitalization Act of 1993 requires NIH-funded clinical trials to include women and minorities as participants and assess outcomes by sex and race or ethnicity. The objective of this study was to investigate current levels of compliance with these guidelines for inclusion, analysis, and reporting in NIH-funded randomized controlled trials (RCTs) and compare the results with those from 2009 and 2004, which the authors reported previously. METHOD: The authors identified 782 RCTs published in 14 leading U.S. medical journals in 2015 with a PubMed search. Of those, 142 were the primary report of an NIH-funded RCT, conducted in the United States, and eligible for analysis. The authors reviewed abstract, text, and tables of each eligible study as well as any follow-up published commentary to determine compliance with NIH guidelines. RESULTS: Thirty-five studies limited enrollment to one sex. The median enrollment of women in the remaining 107 studies was 46%, but 16 (15.0%) enrolled less than 30% women. Twenty-eight of the 107 (26%) reported at least one outcome by sex or explicitly included sex as a covariate in statistical analysis. Of the 142 studies, 19 (13.4%) analyzed or reported outcomes by race or ethnicity. There were no statistically significant changes in inclusion, analysis, or reporting by sex, race, or ethnicity compared with the previous studies. CONCLUSIONS: NIH policies have not resulted in significant increases in reporting results by sex, race, or ethnicity. The authors recommend strong journal policies to increase compliance with NIH policies.

Addressing maternal deaths due to violence: the Illinois experience.

Homicide, suicide, and substance abuse accounted for nearly one fourth of all pregnancy-associated deaths in Illinois from 2002 through 2013. Maternal mortality review in Illinois has been primarily focused on obstetric and medical causes and little is known about the circumstances surrounding deaths due to homicide, suicide, and substance abuse, if they are pregnancy related, and if the deaths are potentially preventable. To address this issue, we implemented a process to form a second statewide maternal mortality review committee for deaths due to violence in late 2014. We convened a stakeholder group to accomplish 3 tasks: (1) identify appropriate committee members; (2) identify potential types and sources of information that would be required for a meaningful review of violent maternal deaths; and (3) revise the Maternal Mortality Review Form. Because homicide, suicide, and substance abuse are closely linked to the social determinants of health, the review committee needed to have a broad membership with expertise in areas not required for obstetric maternal mortality review, including social service and community organizations. Identifying additional sources of information is critical; the state Violent Death Reporting System, case management data, and police and autopsy reports provide contextual information that cannot be found in medical records. The stakeholder group revised the Maternal Mortality Review Form to collect information relevant to violent maternal deaths, including screening history and psychosocial history. The form guides the maternal mortality review committee for deaths due to violence to identify potentially preventable factors relating to the woman, her family, systems of care, the community, the legal system, and the institutional environment. The committee has identified potential opportunities to decrease preventable death requiring cooperation with social service agencies and the criminal justice system in addition to the physical and mental health care systems. Illinois has demonstrated that by engaging appropriate members and expanding the information used, it is possible to conduct meaningful reviews of these deaths and make recommendations to prevent future deaths.

Maternal Cardiovascular Mortality in Illinois, 2002-2011.

OBJECTIVE: To describe the demographic characteristics of women in Illinois who died from cardiovascular disease during pregnancy or up until 1 year postpartum, addressing specific etiologies, timing of death, proportion of potentially preventable mortality, and factors associated with preventability. METHODS: This is a retrospective analysis from the Illinois Department of Public Health Maternal Mortality Review process using International Classification of Diseases, 9th Revision codes that attributed cardiovascular disease as the immediate or underlying cause of maternal death in Illinois from 2002 to 2011. We categorized the etiology of cardiovascular mortality, analyzed demographic factors associated with cardiovascular mortality in comparison with noncardiovascular causes, defined the relationship to pregnancy, and identified factors associated with preventability. RESULTS: There were 636 deaths in Illinois from 2002 to 2011 of pregnant women or within 1 year postpartum. One hundred forty women (22.2%) died of cardiovascular causes, for a cardiovascular mortality rate of 8.2 (95% confidence interval 6.9-9.6) per 100,000 live births. Women with cardiovascular mortality were likely to be older and die postpartum. The most common etiologies were related to acquired cardiovascular disease (97.1%) as compared with congenital heart disease (2.9%). Cardiomyopathy was the most common etiology (n=39 [27.9%]), followed by stroke (n=32 [22.9%]), hypertensive disorders (n=18 [12.9%]), arrhythmias (n=15 [10.7%]), and coronary disease (n=13 [9.3%]). Nearly 75% of cardiac deaths were related to pregnancy as compared with 35.3% of noncardiac deaths. More than one fourth of cardiac deaths (28.1%) were potentially preventable, attributable primarily to health care provider and patient factors. CONCLUSION: From 2002 to 2011, more than one fifth of maternal deaths in Illinois were attributed to cardiovascular disease such as cardiomyopathy. More than one fourth of these deaths were potentially preventable. Health care provider and patient factors were identified, which may be modifiable through education and intensive postpartum monitoring, which may diminish mortality. State maternal mortality reviews can identify opportunities for reducing maternal deaths.

Preventing Maternal Morbidity from Obstetric Hemorrhage: Implications of a Provider Training Initiative.

Objective The objective of this study was to compare severe morbidity due to obstetrical hemorrhage and its potential preventability before and after a mandated provider training initiative on obstetric hemorrhage. Study Design Cases of severe morbidity due to obstetric hemorrhage during 2006 (n = 64 before training initiative) and 2010 (n = 71 after training initiative) were identified by a two-factor scoring system of intensive care unit admission and/or transfusion of ≥ 3 units of blood products and reviewed by an expert panel. Preventable factors were categorized as provider, system, and/or patient related. Results Potential preventability did not differ between 2006 and 2010, p = 0.19. Provider factors remained the most common preventable factor (88.2% in 2006 vs. 97.4% in 2010, p = 0.18), but the distribution in types of preventable factors improved over time for delay or failure in assessment (20.6 vs. 0%, p < 0.01) and delay or inappropriate treatment (76.5 vs. 39.5%, p < 0.01). System factors also differed (32.4 vs. 7.9%, p = 0.015) with a notable decline in factors related to policies and procedures (26.5 vs. 2.6%, p < 0.01) between 2006 and 2010. Conclusion We found significant improvement in provider assessment and treatment of obstetric hemorrhage and a significant reduction in preventable factors related to policies and procedures after the training initiative.

Higher Risk of Homicide Among Pregnant and Postpartum Females Aged 10-29 Years in Illinois, 2002-2011.

OBJECTIVE: To examine whether being pregnant or postpartum was associated with excess risk for homicide among females in Illinois and to describe the association between pregnancy status and homicide by race, ethnicity, and age group. METHODS: This is a retrospective, multicohort, ecologic study of females of reproductive age in Illinois between 2002 and 2011 using Illinois Department of Public Health maternal mortality data and vital records data. We compared pregnancy-associated homicides with live births using χ tests. Among maternal deaths in the state, we calculated mortality rates per 100,000 live births for homicide and other violent causes and the leading direct obstetric causes. We calculated aggregate, pregnancy-associated, and nonpregnancy associated homicide rates stratified by race or ethnicity and age group. RESULTS: There were 636 pregnancy-associated deaths in Illinois from 2002 to 2011. Of these, 82 (13%) were the result of homicide (5.0 [95% confidence interval (CI) 4.0-6.2]/100,000 live births). There were 931 homicides among females of reproductive age not associated with pregnancy (2.88 [95% CI 2.70-3.07]/100,000 population). More than half of the homicides were women aged 20-29 years (n=53 [64.6%]), non-Hispanic black women (n=43 [52.4%]), women residing in Cook County (n=47 [57.3%]), and unmarried women (n=57 [69.5%]). Pregnant and postpartum females aged 10-29 years were at twice the risk of homicide compared with their nonpregnant or postpartum counterparts (relative risk 2.20 [95% CI 1.70-2.85]). Non-Hispanic black and Hispanic females experienced higher rates of homicide than non-Hispanic white females irrespective of pregnancy or age. CONCLUSION: Although all violence against women must be addressed, we recommend that state maternal mortality review committees, in addition to reviewing deaths resulting from obstetric and clinical causes, should conduct in-depth reviews of pregnancy-associated homicides and other violent deaths.

Comparing Two Review Processes for Determination of Preventability of Maternal Mortality in Illinois.

OBJECTIVES: To compare the results of two maternal death review processes conducted from 2002 to 2012 by Illinois regionalized perinatal centers with those conducted by the Illinois Department of Public Health's (IDPH's) statewide multidisciplinary external Maternal Mortality Review Committee (MMRC). METHODS: This is a retrospective record review linking MMRC case assessment forms to the IDPH's Maternal Mortality Review Form database to compare causes of death and potential preventability as determined by both review processes. RESULTS: MMRC records for 76 maternal death reviews were linked to the IDPH maternal mortality review form database. Most deaths reviewed by the statewide MMRC were due to pregnancy-related causes. The statewide MMRC differed from the regional perinatal centers on cause of death in 55.3% (n = 42) of cases and on the disposition of potential preventability in 48.7% (n = 37) of cases. The statewide MMRC judged 69.7% (n = 53) of cases potentially preventable, compared with 40.8% (n = 31) for the regional perinatal centers. The MMRC identified more preventable provider and systems factors for potentially preventable deaths compared with regional perinatal centers which identified more preventable patient factors. CONCLUSIONS FOR PRACTICE: The statewide MMRC found more potential preventability and determined that preventability was associated with provider and systems factors, not patient factors. Observed discrepancies between regional perinatal center and statewide MMRC reviews were likely due to the complexity of cases selected for review, the multidisciplinary external composition of the review team, and the de-identification of cases. Multidisciplinary statewide expert panels should be implemented in addition to local and regionalized reviews.

Training intervention study participants to disseminate health messages to the community: a new model for translation of clinical research to the community.

Peer education offers a novel strategy for the translation of health promotion interventions in hard-to-reach communities. We describe the development, implementation, and evaluation of a program where research participants from a cardiovascular risk reduction intervention were invited to be trained as peer educators. The goal of the "Heart-to-Heart" intervention was to promote healthy behaviors among peers to reduce cardiovascular disease risk. We recruited and trained 32 peer educators from a rural, Midwestern community to implement the program, and 18 educators reached 175 women and men. A mixed-method analysis revealed that those who opted to become peer educators were more likely to be African American than participants of the study population from which they were recruited. Peer educators reported positive assessments of their encounters with respect to preparation and confidence, as well as reinforced personal health behaviors. Peer educators' success was evident in reports from the individuals they reached, who reported learning new concepts and intention to change behavior. Interviews with peer educators revealed their motivations, peer education barriers, and recommendations. The Heart-to-Heart model for training research participants to serve as peer educators to disseminate behavior change messages warrants further investigation as a strategy for the translation of research to communities.

Assessing preventability of maternal mortality in Illinois: 2002-2012.

OBJECTIVE: We sought to describe the potential preventability of pregnancy-related deaths in Illinois from 2002 through 2012 as determined by perinatal centers following the Illinois maternal death review process. STUDY DESIGN: We conducted a retrospective review of all known maternal deaths in the state from 2002 through 2012 with complete records in the Illinois Department of Public Health's Maternal Mortality Review Form database. The association between causes of death and potential preventability was analyzed for pregnancy-related deaths. RESULTS: There were 610 maternal deaths in Illinois during the study period (31.8 per 100,000 live births). One-third of maternal deaths (n = 210) were directly or indirectly related to pregnancy, 7.0% (n = 43) were possibly related, and 52.6% (n = 321) were unrelated. Vascular causes were the most common cause of pregnancy-related death, followed by cardiac causes and hemorrhage. One-third of deaths directly or indirectly related to pregnancy were deemed potentially preventable. Hemorrhage and deaths due to psychiatric causes were most likely to be considered avoidable, while cancer and vascular-related deaths were generally not considered preventable. CONCLUSION: This analysis of pregnancy-related deaths in Illinois, the first in >60 years, found similar causes of death and potential preventability as pregnancy-related death reviews in other states. Analyzing the causes of pregnancy-related death is a critical and necessary step in improving maternal health outcomes, particularly in decreasing potentially preventable pregnancy-related deaths. Greater attention should be directed toward intervening on the provider, systems, and patient factors contributing to preventable deaths.