Oxaliplatin desensitization for ovarian cancer in pregnancy: A case report.

•Incidence of cancer in pregnancy is rising and successful treatment of these patients requires expert multidisciplinary care.•Platinum hypersensitivity reactions in ovarian cancer are commonly treated with desensitization protocols.•To our knowledge, chemotherapy desensitization in pregnant patients has not been previously reported.•Oxaliplatin desensitization during pregnancy may be safe and feasible.

Mapping the Postpartum Experience Through Obstetric Patient Navigation for Low-Income Individuals.

Background: Although the postpartum period is an opportunity to address long-term health, fragmented care systems, inadequate attention to social needs, and a lack of structured transition to primary care threaten patient wellbeing, particularly for low-income individuals. Postpartum patient navigation is an emerging innovation to address these disparities. Methods: This mixed-methods analysis uses data from the first year of an ongoing randomized controlled trial to understand the needs of low-income postpartum individuals through 1 year of patient navigation. We designed standardized logs for navigators to record their services, tracking mode, content, intensity, and target of interactions. Navigators also completed semistructured interviews every 3 months regarding relationships with patients and care teams, care system gaps, and navigation process. Log data were categorized, quantified, and mapped temporally through 1 year postpartum. Qualitative data were analyzed using the constant comparative method. Results: Log data from 50 participants who received navigation revealed the most frequent needs related to health care access (45.4%), health and wellness (18.2%), patient-navigator relationship building (14.8%), parenting (13.6%), and social determinants of health (8.0%). Navigation activities included supporting physical and mental recovery, accomplishing health goals, connecting patients to primary and specialty care, preparing for health system utilization beyond navigation, and referring individuals to community resources. Participant needs fluctuated, yielding a dynamic timeline of the first postpartum year. Conclusion: Postpartum needs evolved throughout the year, requiring support from various teams. Navigation beyond the typical postpartum care window may be useful in mitigating health system barriers, and tracking patient needs may be useful in optimizing postpartum care. Clinical Trial Registration: Registered April 19, 2019, enrollment beginning January 21, 2020, NCT03922334, https://clinicaltrials.gov/ct2/show/NCT03922334.

Decline in Prenatal Buprenorphine/Naloxone Fills during the COVID-19 Pandemic in the United States.

OBJECTIVES: Pregnancy provides a critical opportunity to engage individuals with opioid use disorder in care. However, before the COVID-19 pandemic, there were multiple barriers to accessing buprenorphine/naloxone during pregnancy. Care disruptions during the pandemic may have further exacerbated these existing barriers. To quantify these changes, we examined trends in the number of individuals filling buprenorphine/naloxone prescriptions during the COVID-19 pandemic. METHODS: We estimated an interrupted time series model using linked national pharmacy claims and medical claims data from prepandemic (May 2019 to February 2020) to the pandemic period (April 2020 to December 2020). We estimated changes in the growth rate in the monthly number of individuals filling buprenorphine/naloxone prescriptions in the 6 months preceding a delivery claim, per 100,000 pregnancies, during the COVID-19 pandemic. RESULTS: We identified 2947 pregnant individuals filling buprenorphine/naloxone prescriptions. Before the pandemic, there was positive growth in the monthly number of individuals filling buprenorphine/naloxone prescriptions (4.83%; 95% confidence interval [CI], 3.82-5.84%). During the pandemic, this monthly growth rate declined for both individuals on commercial insurance and individuals on Medicaid (all payers: -5.53% [95% CI, -6.65% to -4.41%]; Medicaid: -7.66% [95% CI, -10.14% to -5.18%]; Commercial: -3.59% [95% CI, -5.32% to -1.87%]). CONCLUSION: The number of pregnant individuals filling buprenorphine/naloxone prescriptions was increasing, but this growth has been lost during the pandemic.

Society for Maternal-Fetal Medicine Special Statement: Utilizing telemedicine to address disparities in maternal-fetal medicine: a call to policy action.

The combination of deserts in maternal-fetal medicine coverage across the United States and the COVID-19 pandemic accelerated the implementation of telemedicine programs for maternal-fetal medicine care delivery. Although telemedicine-based care has the potential to facilitate timely access to maternal-fetal medicine services, which can improve maternal and neonatal outcomes, telemedicine is a relatively novel healthcare modality that needs to be implemented strategically. As with any medical service, telemedicine care requires rigorous evaluation to assess outcomes and ensure quality. Important health policy considerations, including access to services and insurance coverage, have substantial implications for equity in the implementation of telemedicine, particularly for reproductive healthcare following the 2022 United States Supreme Court decision in Dobbs v Jackson Women's Health Organization that overturned the constitutional right to an abortion. Investing resources and advocating for a rigorous, widely accessible telemedicine infrastructure at this crucial moment will establish an important foundation for more equitable pregnancy care. Key advocacy priorities for maternal-fetal medicine telemedicine include (1) expanding insurance coverage of telemedicine across payers, regardless of geographic location; (2) advocating for interstate licensure parity; (3) increasing access to affordable Internet and digital literacy training; and (4) ensuring access to reproductive healthcare, including abortion care, delivered via telemedicine.

Disparity dashboards: an evaluation of the literature and framework for health equity improvement.

The growing recognition of differences in health outcomes across populations has led to a slow but increasing shift towards transparent reporting of patient outcomes. In addition, pay-for-equity initiatives, such as those proposed by the Centers for Medicare and Medicaid, will require the reporting of health outcomes across subgroups over time. Dashboards offer one means of visualising data in the health-care context that can highlight essential disparities in clinical outcomes, guide targeted quality-improvement efforts, and ultimately improve health equity. In this Viewpoint, we evaluate all studies that have reported the successful development of a disparity dashboard and share the data collected and unintended consequences reported. We propose a framework for systematic equality improvement through incentivisation of the collecting and reporting of health data and through implementation of reward systems to reduce health disparities.

Facilitating positive birth experience when preferences are not met: A qualitative analysis.

INTRODUCTION: High-quality health systems rely on care that centers on patient preferences. Realization of patient preferences can improve the birth experience. However, in the dynamic setting of birth, birth preferences can diverge from what is medically indicated. Through studying women and birthing peoples' experiences of unplanned labor procedures, we aimed to identify ways in which practitioners can support women and birthing people through unexpected or unwanted aspects of their delivery. Specifically, we focused on labor induction. METHODS: In one large US academic center, women and birthing people participated in prenatal and postpartum surveys regarding their desires, expectations, and experiences of labor induction. From April to November 2021, participants were eligible if they showed discordance between having labor induction and whether it was initially wanted or expected. Interviews focused on attitudes toward birth preferences and outcomes, with attention to discordances. We analyzed interviews through a modified grounded theory approach. RESULTS: Of 22 participants, our sample was predominantly white (91%). Participants in this sample reported discordance between wanting and experiencing (73%) and/or expecting and experiencing (54%) an induction. We identified two themes: "Discordance without mitigation is perceived as a negative experience" and "Practitioner interaction can buffer against negative experience" which includes three ways in which participants prefer support in instances of discordance: preparation, communication, and care and comfort. These methods of support foster patient autonomy and can lead to positive patient experiences. CONCLUSIONS: While medical systems should work to support patient preferences, our results suggest that patients can still have positive birth experiences, even when preferences are not fulfilled. Early practitioner preparation, positive communication, and responsive care and comfort may help to improve patient birth experience when challenges arise.

Development of a Maternal Equity Safety Bundle to Eliminate Racial Inequities in Massachusetts.

OBJECTIVE: The PNQIN (Perinatal-Neonatal Quality Improvement Network of Massachusetts) sought to adapt the Reduction of Peripartum Racial and Ethnic Disparities Conceptual Framework and Maternal Safety Consensus Bundle by selecting and defining measures to create a bundle to address maternal health inequities in Massachusetts. This study describes the process of developing consensus-based measures to implement the PNQIN Maternal Equity Bundle across Massachusetts hospitals participating in the Alliance for Innovation on Maternal Health Initiative. METHODS: Our team used a mixed-methods approach to create the PNQIN Maternal Equity Bundle through consensus including a literature review, expert interviews, and a modified Delphi process to compile, define, and select measures to drive maternal equity-focused action. Stakeholders were identified by purposive and snowball sampling and included obstetrician-gynecologists, midwives, nurses, epidemiologists, and racial equity scholars. Dedoose 9.0 was used to complete an inductive analysis of interview transcripts. A modified Delphi method was used to reach consensus on recommendations and measures for the PNQIN Maternal Equity Bundle. RESULTS: Twenty-five interviews were completed. Seven themes emerged, including the need for 1) data stratification by race, ethnicity and language; 2) performance of a readiness assessment; 3) culture shift toward equity; 4) inclusion of antiracism and bias training; 5) addressing challenges of nonacademic hospitals; 6) a life-course approach; and 7) selection of timing of implementation. Twenty initial quality measures (structure, process, and outcome) were identified through expert interviews. Group consensus supported 10 measures to be incorporated into the bundle. CONCLUSION: Structure, process, and outcome quality measures were selected and defined for a maternal equity safety bundle that seeks to create an equity-focused infrastructure and equity-specific actions at birthing facilities. Implementation of an equity-focused safety bundle at birthing facilities may close racial gaps in maternal outcomes.

Home Visits With A Registered Nurse Did Not Affect Prenatal Care In A Low-Income Pregnant Population.

There is an urgent need to improve maternal and neonatal health outcomes and decrease their racial disparities in the US. Prenatal nurse home visiting programs could help achieve this by increasing the use and quality of prenatal care and facilitating healthy behaviors during pregnancy. We conducted a randomized controlled trial of 5,670 Medicaid-eligible pregnant people in South Carolina to evaluate how a nurse home visiting program affected prenatal health care and health outcomes. We compared outcomes between the treatment and control groups and found little evidence of statistically significant differences in the intensity of prenatal care use, receipt of guideline-based prenatal care services, other health care use, or gestational weight gain. Nor did we find treatment effects in subgroup analyses of socially vulnerable participants (46.9 percent of the sample) or non-Hispanic Black participants (52.0 percent of the sample). Compared with the broader Medicaid population, our trial participants had more health and social risk factors, more engagement with prenatal care, and similar pregnancy outcomes. Delivering intensive nurse home visiting programs to the general Medicaid population might not be an efficient method to improve prenatal care for those who need the most support during pregnancy.

Self-monitoring of blood glucose levels among pregnant individuals with gestational diabetes: a systematic review and meta-analysis.

Introduction: The World Health Organization (WHO) recommends treatment and management of gestational diabetes (GD) through lifestyle changes, including diet and exercise, and self-monitoring blood glucose (SMBG) to inform timely treatment decisions. To expand the evidence base of WHO's guideline on self-care interventions, we conducted a systematic review of SMBG among pregnant individuals with GD. Setting: Following PRISMA guidelines, we searched PubMed, CINAHL, LILACS, and EMBASE for publications through November 2020 comparing SMBG with clinic-based monitoring during antenatal care (ANC) globally. Primary and secondary outcome measures: We extracted data using standardized forms and summarized maternal and newborn findings using random effects meta-analysis in GRADE evidence tables. We also reviewed studies on values, preferences, and costs of SMBG. Results: We identified 6 studies examining SMBG compared to routine ANC care, 5 studies on values and preferences, and 1 study on costs. Nearly all were conducted in Europe and North America. Moderate-certainty evidence from 3 randomized controlled trials (RCTs) showed that SMBG as part of a package of interventions for GD treatment was associated with lower rates of preeclampsia, lower mean birthweight, fewer infants born large for gestational age, fewer infants with macrosomia, and lower rates of shoulder dystocia. There was no difference between groups in self-efficacy, preterm birth, C-section, mental health, stillbirth, or respiratory distress. No studies measured placenta previa, long-term complications, device-related issues, or social harms. Most end-users supported SMBG, motivated by health benefits, convenience, ease of use, and increased confidence. Health workers acknowledged SMBG's convenience but were wary of technical problems. One study found SMBG by pregnant individuals with insulin-dependent diabetes was associated with decreased costs for hospital admission and length of stay. Conclusion: SMBG during pregnancy is feasible and acceptable, and when combined in a package of GD interventions, is generally associated with improved maternal and neonatal health outcomes. However, research from resource-limited settings is needed. Systematic Review Registration: PROSPERO CRD42021233862.

Implementation of postpartum navigation for low-income individuals at an urban academic medical center.

BACKGROUND: Patient navigation, a patient-centered intervention to promote comprehensive health care, is an emerging innovation in obstetrics to optimize postpartum care. We aimed to evaluate the implementation of a novel postpartum patient navigation program at an urban academic medical center. METHODS: This mixed-methods study analyzed the implementation of a postpartum patient navigation program within an ongoing randomized control trial. This study analyzed three navigators' logs of interactions with 50 patients, care team members, and community organizations throughout patients' first year postpartum. We categorized and quantified interactions by topic addressed, care team member interacted with, and communication mode used. We also conducted semi-structured interviews with each navigator every three months (5 interviews per navigator), emphasizing navigation experiences, relationships with patients and care teams, integration in the care team, and healthcare system gaps. Interview data were analyzed using the constant comparative method to identify themes using the constructs of the Consolidated Framework for Implementation Research (CFIR). RESULTS: Analysis of navigator logs revealed a high patient need level, especially in the first 3 months postpartum. CFIR-guided analysis of intervention characteristics revealed positive perceptions of navigation's utility due to its adaptability. Navigation's complexity, however, posed an early obstacle to implementation that diminished over time. Outer setting analysis indicated navigators addressed patient needs through interactions with multiple systems. Despite clinicians' initial unfamiliarity with navigation, inner setting analysis suggested ongoing communication and electronic medical record use facilitated integration into the care team. Regarding individual and process characteristics, findings emphasized how navigator self-efficacy and confidence increased with experience (individual) and was facilitated by comprehensive training and reflection (process). Overall, barriers to implementation included unfamiliarity, varied patient engagement, and innovation complexity. Facilitators included high patient need, communication with outside organizations, medical record usage, navigator characteristics (self-efficacy, communication skills, and personal growth), a comprehensive training period, consistent reflection, high relative advantage, and high adaptability to patient need. CONCLUSION: Patient navigation is a promising innovation to improve postpartum care coordination and support care team efforts. The successful implementation of navigation in this study indicates that, if shown to improve patient outcomes, obstetric navigation could be a component of patient-centered postpartum care.

Mobilizing the fourth trimester to improve population health: interventions for postpartum transitions of care.

Birthing people in the United States, particularly those from marginalized communities, experience an unexpectedly high rate of morbidity and mortality. Optimal postpartum care is an opportunity to address immediate maternal health concerns while providing a connection to further high-value primary care. However, postpartum care in the United States is fragmented and incomplete. In response to this failure, the American College of Obstetricians and Gynecologists has called for obstetricians to develop individualized care plans that facilitate transitions from obstetrical to primary care after delivery. In this clinical opinion, we review previous interventions that have aimed to increase postpartum care engagement and bridge gaps in care. Although numerous interventions have been trialed, few have been both successful and scalable. We provide recommendations on ways to reimagine equitable and effective postpartum care interventions with multidisciplinary collaboration.

Effect of an Intensive Nurse Home Visiting Program on Adverse Birth Outcomes in a Medicaid-Eligible Population: A Randomized Clinical Trial.

Importance: Improving birth outcomes for low-income mothers is a public health priority. Intensive nurse home visiting has been proposed as an intervention to improve these outcomes. Objective: To determine the effect of an intensive nurse home visiting program on a composite outcome of preterm birth, low birth weight, small for gestational age, or perinatal mortality. Design, Setting, and Participants: This was a randomized clinical trial that included 5670 Medicaid-eligible, nulliparous pregnant individuals at less than 28 weeks' gestation, enrolled between April 1, 2016, and March 17, 2020, with follow-up through February 2021. Interventions: Participants were randomized 2:1 to Nurse Family Partnership program (n = 3806) or control (n = 1864). The program is an established model of nurse home visiting; regular visits begin prenatally and continue through 2 postnatal years. Nurses provide education, assessments, and goal-setting related to prenatal health, child health and development, and maternal life course. The control group received usual care services and a list of community resources. Neither staff nor participants were blinded to intervention group. Main Outcomes and Measures: There were 3 primary outcomes. This article reports on a composite of adverse birth outcomes: preterm birth, low birth weight, small for gestational age, or perinatal mortality based on vital records, Medicaid claims, and hospital discharge records through February 2021. The other primary outcomes of interbirth intervals of less than 21 months and major injury or concern for abuse or neglect in the child's first 24 months have not yet completed measurement. There were 54 secondary outcomes; those related to maternal and newborn health that have completed measurement included all elements of the composite plus birth weight, gestational length, large for gestational age, extremely preterm, very low birth weight, overnight neonatal intensive care unit admission, severe maternal morbidity, and cesarean delivery. Results: Among 5670 participants enrolled, 4966 (3319 intervention; 1647 control) were analyzed for the primary maternal and neonatal health outcome (median age, 21 years [1.2% non-Hispanic Asian, Indigenous, or Native Hawaiian and Pacific Islander; 5.7% Hispanic; 55.2% non-Hispanic Black; 34.8% non-Hispanic White; and 3.0% more than 1 race reported [non-Hispanic]). The incidence of the composite adverse birth outcome was 26.9% in the intervention group and 26.1% in the control group (adjusted between-group difference, 0.5% [95% CI, -2.1% to 3.1%]). Outcomes for the intervention group were not significantly better for any of the maternal and newborn health primary or secondary outcomes in the overall sample or in either of the prespecified subgroups. Conclusions and Relevance: In this South Carolina-based trial of Medicaid-eligible pregnant individuals, assignment to participate in an intensive nurse home visiting program did not significantly reduce the incidence of a composite of adverse birth outcomes. Evaluation of the overall effectiveness of this program is incomplete, pending assessment of early childhood and birth spacing outcomes. Trial Registration: ClinicalTrials.gov Identifier: NCT03360539.

Self-monitoring of blood pressure among women with hypertensive disorders of pregnancy: a systematic review.

BACKGROUND: The World Health Organization (WHO) recommends self-monitoring of blood pressure (SMBP) for hypertension management. In addition, during the COVID-19 response, WHO guidance also recommends SMBP supported by health workers although more evidence is needed on whether SMBP of pregnant individuals with hypertension (gestational hypertension, chronic hypertension, or pre-eclampsia) may assist in early detection of pre-eclampsia, increase end-user autonomy and empowerment, and reduce health system burden. To expand the evidence base for WHO guideline on self-care interventions, we conducted a systematic review of SMBP during pregnancy on maternal and neonatal outcomes. METHODS: We searched for publications that compared SMBP with clinic-based monitoring during antenatal care. We included studies measuring any of the following outcomes: maternal mortality, pre-eclampsia, long-term risk and complications, autonomy, HELLP syndrome, C-section, antenatal hospital admission, adverse pregnancy outcomes, device-related issues, follow-up care with appropriate management, mental health and well-being, social harms, stillbirth or perinatal death, birthweight/size for gestational age, and Apgar score. After abstract screening and full-text review, we extracted data using standardized forms and summarized findings. We also reviewed studies assessing values and preferences as well as costs of SMBP. RESULTS: We identified 6 studies meeting inclusion criteria for the effectiveness of SMBP, 6 studies on values and preferences, and 1 study on costs. All were from high-income countries. Overall, when comparing SMBP with clinic-monitoring, there was no difference in the risks for most of the outcomes for which data were available, though there was some evidence of increased risk of C-section among pregnant women with chronic hypertension. Most end-users and providers supported SMBP, motivated by ease of use, convenience, self-empowerment and reduced anxiety. One study found SMBP would lower health sector costs. CONCLUSION: Limited evidence suggests that SMBP during pregnancy is feasible and acceptable, and generally associated with maternal and neonatal health outcomes similar to clinic-based monitoring. However, more research is needed in resource-limited settings. SYSTEMATIC REVIEW REGISTRATION: PROSPERO CRD42021233839 .

Maternal weight and birth outcomes among women on antiretroviral treatment from conception in a birth surveillance study in Botswana.

INTRODUCTION: Antiretrovirals such as dolutegravir (DTG) and tenofovir alafenamide (TAF) have been associated with excessive weight gain. The objective of this study was to understand the potential impact of ART-associated weight gain on pregnancy outcomes among women living with HIV. METHODS: Using data from the Tsepamo birth outcomes surveillance study in Botswana, we evaluated the relationship between maternal weight (and weight gain) and severe birth outcomes (very preterm delivery <32 weeks, very small for gestational age (SGA) <3rd percentile, perinatal death), macrosomia (birthweight > 4000 g) and maternal hypertension. We estimated the relative risk of each outcome by baseline weight (first weight in pregnancy <24 weeks) and second trimester average weekly weight gain (kg/week from 12 ± 2 to 24 ± 2 weeks) using log binomial regression and evaluated effect modification by ART regimen (DTG vs. Efavirenz (EFV)). RESULTS: Of 22,828 women on ART at conception with singleton deliveries between August 2014 and April 2020, 16,300 (71.4%) had a weight measured <24 weeks' gestation (baseline weight) and 4437 (19.2%) had weight measured both at 12 (±2) weeks and 24 (±2) weeks, allowing second trimester weight gain calculation. Compared to women with baseline weight 60 to 70 kg, low baseline weight (<50 kg) was associated with increased risk of very preterm delivery (aRR 1.30, 95% CI 1.03, 1.65) and very SGA (aRR1.96, 95% CI 1.69, 2.28). High baseline weight (>90 kg) was associated with increased risk of macrosomia (aRR 3.24, 95% CI 2.36, 4.44) and maternal hypertension (aRR 1.79, 95% CI 1.62, 1.97). Baseline weight was not associated with stillbirth or early neonatal death. For all outcomes, second trimester weight gain showed weaker associations than did baseline weight. Duration of pre-pregnancy ART (years) was associated with higher baseline weight for DTG but not for EFV, and the risk of maternal hypertension by baseline weight category was higher for DTG than EFV for all strata. CONCLUSIONS: ART regimens associated with weight gain may reduce the number of women at risk for certain severe adverse pregnancy outcomes associated with low weight but increase the number at risk of macrosomia and maternal hypertension. Further research could determine whether weight-based ART treatment strategies improve maternal and child health.

Bridging the postpartum gap: best practices for training of obstetrical patient navigators.

The postpartum period represents a critical window of opportunity to improve maternal short- and long-term health, including optimizing postpartum recovery, providing effective contraception, caring for mood disorders, managing weight, supporting lactation, initiating preventive care, and promoting cardiometabolic health. However, inadequate postpartum care, especially for individuals facing social and structural barriers, is common in the United States and contributes to suboptimal health outcomes with lasting consequences. Patient navigation is a patient-centered intervention that uses trained personnel to identify financial, cultural, logistical, and educational obstacles to effective healthcare and to mitigate these barriers to facilitate comprehensive and timely access to needed health services. Given the emerging evidence suggesting that patient navigation may be a promising method to improve health among postpartum individuals, our team developed a postpartum patient navigator training guide to be used in the Navigating New Motherhood 2 and other obstetrical navigation programs. Navigating New Motherhood 2 is a randomized trial exploring whether patient navigation by a trained, lay postpartum navigator for individuals with a low income can improve health and patient-reported outcomes during and after the postpartum period. Hiring and training patient navigators without health professional degrees are integral components of initiating a navigation program. However, patient navigator training is highly variable, and no guideline regarding key elements in such a training program exists for obstetrics specifically. Thus, this paper aimed to describe the core principles, content, and rationale for each element in a comprehensive postpartum patient navigator training program. Training should be centered around the following 6 core elements: (1) principles of patient navigation; (2) knowledge of pregnancy and postpartum care; (3) health education and health promotion principles; (4) cultural sensitivity and health equity; (5) care coordination and community resources; and (6) electronic medical record systems. These core elements can serve as a basis for the development of adaptable curricula for several institutions and contexts. In addition, we offer recommendations for the implementation of a navigator training program. A curriculum with built-in flexibility to meet community and institutional needs may promote the effective and sustainable use of patient navigation in the postpartum context.

Controversies in Gestational Diabetes.

Gestational diabetes mellitus (GDM) complicates approximately 7% of pregnancies in the USA. Despite recognition of the benefits of diagnosing and treating GDM, there are several areas of controversy that remain unresolved. There is debate as to whether to screen for GDM with the one-step versus the two-step approach. While the former identifies more pregnancies with potential adverse outcomes, data are lacking as to whether treatment of these pregnancies will improve outcomes, while increasing costs by diagnosing more women. Though it is well established that the diagnosis of even mild GDM, and treatment with lifestyle recommendations and insulin, improves pregnancy outcomes, it is controversial as to which type and regimen of insulin is optimal, and whether oral agents can be used safely and effectively to control glucose levels. Finally, it is recommended that women with GDM get tested for type 2 diabetes within several months of delivery; however, many women do not undergo this testing and alternative approaches are needed. These controversies are discussed with data from both sides of the debate to enable clinicians to make patient-centered decisions until more definitive data are available.

Changes in Delivery Timing for High-Risk Pregnancies in the United States.

OBJECTIVE: This study was aimed to assess whether the "39-week" rule is being extended to high-risk pregnancies and if so whether this has led to changes in neonatal morbidity or stillbirth. STUDY DESIGN: Birth certificate data between 2010 and 2014 from 23 states (55% of births in the United States) were used. Pregnancies were classified as high risk if they had any one of the following: maternal age greater than or equal to 40 years, prepregnancy body mass index (BMI) greater than or equal to 40 kg/m2, chronic (prepregnancy) hypertension, or diabetes (pregestational or gestational). Delivery timing changes for all pregnancies at term (37 weeks or greater) were compared with changes in the high-risk population. Neonatal morbidities (neonatal intensive care unit [NICU] admission, need for assisted ventilation, 5-minute Apgar score, and macrosomia), maternal morbidities (intensive care unit [ICU] admission, cesarean delivery, operative vaginal delivery, chorioamnionitis, and severe perineal laceration), and stillbirth rates were compared across time periods. Multivariate logistic regression was used to analyze whether gestational age-specific morbidity changes were due to shifts in delivery timing. RESULTS: For the overall population, there was a shift in delivery timing between 2010 and 2014, a 2.5% decrease in 38-week deliveries, and a 2.3% increase in 39-week deliveries (p < 0.01). This gestational age shift was identical in the high-risk population (2.7% decrease in 38-week deliveries and 2.9% increase in 39-week deliveries). For the high-risk population, NICU admission increased from 5.4 to 6.3% in 2014 (p < 0.01) and assisted ventilation rates declined from 3.8 to 2.9% (p < 0.01). These changes, however, were independent of changes in delivery timing. There was no increase in the rate of stillbirth (0.23% in 2010 and 0.23% in 2014; p = 0.50). CONCLUSION: There was a significant shift in delivery timing for high-risk pregnancies in the United States between 2010 and 2014. This shift, however, did not result in statistically significant changes in either neonatal morbidity or stillbirth. KEY POINTS: · From 2010 to 2014, term deliveries for high-risk pregnancies shifted towards 39 weeks.. · The shift towards 39 weeks in high-risk pregnancies was not accompanied by any improvement in neonatal morbidity.. · The shift towards 39 weeks in high-risk pregnancies did not result in an increase in the stillbirth rate..

Protocol for a randomized controlled trial evaluating the impact of the Nurse-Family Partnership's home visiting program in South Carolina on maternal and child health outcomes.

BACKGROUND: Policy-makers are increasingly seeking rigorous evidence on the impact of programs that go beyond typical health care settings to improve outcomes for low-income families during the critical period around the transition to parenthood and through early childhood. METHODS: This study is a randomized controlled trial evaluating the impact of the Nurse-Family Partnership's expansion in South Carolina. The scientific trial was made possible by a "Pay for Success" program embedded within a 1915(b) Waiver from Medicaid secured by the South Carolina Department of Health and Human Services. This protocol describes study procedures and defines primary and secondary health-related outcomes that can be observed during the intervention period (including pregnancy through the child's first 2 years of life). Primary study outcomes include (1) a composite indicator for adverse birth outcomes including being born small for gestational age, low birth weight (less than 2500 g), preterm birth (less than 37 weeks' gestation), or perinatal mortality (fetal death at or after 20 weeks of gestation or mortality in the first 7 days of life), (2) a composite outcome indicating health care utilization or mortality associated with major injury or concern for abuse or neglect occurring during the child's first 24 months of life, and (3) an indicator for an inter-birth interval of < 21 months. Secondary outcomes are defined similarly in three domains: (1) improving pregnancy and birth outcomes, (2) improving child health and development, and (3) altering the maternal life course through changes in family planning. DISCUSSION: Evidence from this trial on the impact of home visiting services delivered at scale as part of a Medicaid benefit can provide policy-makers and stakeholders with crucial information about the effectiveness of home visiting programs in improving health and well-being for low-income mothers and children and about novel financing mechanisms for cross-silo interventions. TRIAL REGISTRATION: The trial was registered prospectively on the American Economic Association Trial Registry (the primary registry for academic economists doing policy trials) on 16 February 2016 ( AEARCTR-0001039 ). ClinicalTrials.gov NCT03360539 . Registered on 28 November 2017.