Venous Thromboembolism Prophylaxis Should Be Recommended for Antepartum Admissions and Cesarean Delivery if Age and Body Mass Index are Greater Than 35.

OBJECTIVE: Venous thromboembolism (VTE) is a major cause of maternal morbidity and mortality. Current expanded treatment recommendations result in the inclusion of a large percentage of the obstetric population, which has limited their adoption. The purpose of this study was to identify a population at high risk for VTE, with minimal impact on the number of patients that would qualify for expanded treatment. STUDY DESIGN: We performed a retrospective analysis of a large obstetric population. International Classification of Diseases, 10th Revsion (ICD-10) codes for VTE were used to identify patients presenting for obstetric or postpartum (PP) care from January 2016 to March 2018. The review focused on high-risk factors (history of VTE or high-risk thrombophilia), antepartum hospital admissions that were >72 hours in the previous 30 days, use of sequential compression devices, body mass index (BMI; kg/m2), age, and mode of delivery. Pharmacologic treatment efficacy was set at 90, 75, or 50%. RESULTS: During the 27-month review period, there were 120,235 deliveries and 93 had a VTE event in the index pregnancy or within 4 weeks PP (7.7/10,000 births). A history of VTE or high-risk thrombophilia was seen in 25.8% of cases. Antepartum admission was noted in 40.9%, and the combination of cesarean delivery (CD) with age and BMI ≥35 (Age + BMI + CD) was noted in 17.3% of PP cases. Targeting these latter two groups for VTE prophylaxis with a 75% efficacy suggests that 34% of the VTE events would likely have been prevented while increasing the total population treated by approximately 2%. CONCLUSION: Expanding pharmacologic prophylactical coverage to include an antepartum admission of >72 hours and those with Age + BMI + CD would result in about a one-third reduction in total VTE events with about 2% requiring treatment. These data support some of the suggested recommendations for expanded pharmacological deep venous thrombosis prophylaxis. KEY POINTS: · CD, and BMI and age >35 are high-risk factors for VTE.. · Antepartum admission >72 hours is a high-risk factor for VTE.. · Targeting antepartum admissions, CD, and BMI and age >35 would reduce VTE events by about 33%..

Randomized controlled trial of prepregnancy lifestyle intervention to reduce recurrence of gestational diabetes mellitus.

BACKGROUND: Preconception lifestyle intervention holds potential for reducing gestational diabetes mellitus, but clinical trial data are lacking. OBJECTIVE: This study aimed to determine the effects of a prepregnancy weight loss intervention on gestational diabetes mellitus recurrence in women with overweight/obesity and previous gestational diabetes mellitus. STUDY DESIGN: A 2-site, randomized controlled trial comparing a prepregnancy lifestyle intervention with educational control was conducted between December 2017 and February 2022. A total of 199 English- and Spanish-speaking adults with overweight/obesity and previous gestational diabetes mellitus were randomized to a 16-week prepregnancy lifestyle intervention with ongoing treatment until conception or educational control. The primary outcome was gestational diabetes mellitus recurrence. Analyses excluded 6 participants who conceived but did not have gestational diabetes mellitus ascertained by standard methods. RESULTS: In the 63 (33%) women who conceived and had gestational diabetes mellitus ascertained (Ns=38/102 [37%] intervention vs 25/91 [28.0%] control; P=.17), those in the intervention group had significantly greater weight loss at 16 weeks compared with controls (4.8 [3.4-6.0] vs 0.7 [-0.9 to 2.3] kg; P=.001) and a greater proportion lost ≥5% of body weight (50.0% [17/34] vs 13.6% [3/22]; P=.005). There was no significant difference in the incidence of gestational diabetes mellitus recurrence between the intervention (57.9% [ns=23/38]) and the control group (44.0% [ns=11/25]; odds ratio, 1.8 [0.59-5.8]). Independent of group, greater prepregnancy weight loss predicted 21% lower odds of gestational diabetes mellitus recurrence (odds ratio, 0.79 [0.66-0.94]; P=.008). A ≥5% weight loss before conception reduced the odds of gestational diabetes mellitus recurrence by 82% (odds ratio, 0.18 [0.04-0.88]; P=.03). CONCLUSION: Lifestyle intervention produced considerable prepregnancy weight loss but did not affect gestational diabetes mellitus rates. Given that the conception rate was 50% lower than expected, this study was underpowered.

Patient costs and outcomes before and after the institution of a pre-eclampsia quality improvement initiative in a southwestern tertiary facility.

The study objective was to evaluate the effect of the California Maternal Quality Care Collaborative (CMQCC) initiative, as implemented in a southwestern U.S. tertiary hospital, on associated patient costs and outcomes. Using a quasi-experimental study design, we collected existing data (cost and patient outcomes) comparing two six-month period at the baseline and one-year follow-up. Following descriptive statistics, Chi-square tests and t-tests were used to compare categorical and continuous variables, respectively. One hundred and eighty-nine women met the inclusion criteria for the study (93 and 96 women in the baseline and follow-up period, respectively). There was no significant difference in maternal health outcomes between both periods. However, there was a significant difference for newborns with almost 90% (95%CI = 0.06-0.92; p = .027) reduction in stillbirths in the follow-up period. There was also a significant reduction in the days between discharge and follow-up appointments (p < .01). Importantly, the initiative bears no additional financial burden on patients, as hospitalisation cost was unchanged. Impact statement What is already known on this subject? In 2013, the California Maternal Quality Care Collaborative (CMQCC) set up a task force to develop guidelines for managing patients with preeclampsia based on global best practices. A previous study showed that despite system-level implementation challenges, the initiative led to significant increase in blood pressure treatments within one-hour and reduced severe maternal morbidity. What do the results of this study add? This study follows patients from admission, beyond the one-hour post-treatment and into the post-partum phase, to understand if outcomes of the initiative extend beyond the admission. While the study findings do not show any statistically significant difference in readmission before and after the initiative, nor any marked difference in maternal outcomes, it shows a significant difference in the prevalence of stillbirths at no additional cost to the patient. What are the implications of these findings for clinical practice and/or further research? Based on these findings, there is a case for scaling-up the initiative as in addition to its evidenced improvements in maternal outcomes; it is effective in improving newborn health outcomes at no additional cost. Further research, using larger sample size and exploring different care levels would be useful to verify these findings.

A Standardized Approach for Category II Fetal Heart Rate with Significant Decelerations: Maternal and Neonatal Outcomes.

OBJECTIVE: To determine if a standardized intervention process for Category II fetal heart rates (FHRs) with significant decels (SigDecels) would improve neonatal outcome and to determine the impact on mode of delivery rates. STUDY DESIGN: Patients with Category II FHRs from six hospitals were prospectively managed using a standardized approach based on the presence of recurrent SigDecels. Maternal and neonatal outcomes were compared between pre- (6 months) and post-(11 months) implementation. Neonatal outcomes were: 5-minute APGAR scores of <7, <5, <3, and severe unexpected newborn complications (UNC). Maternal outcomes included primary cesarean and operative vaginal birth rates of eligible deliveries. RESULTS: Post implementation there were 8,515 eligible deliveries, 3,799 (44.6%) were screened, and 361 (9.5%) met criteria for recurrent SigDecels. Compliance with the algorithm was 97.8%. The algorithm recommended delivery in 68.0% of cases. Relative to pre-implementation, 5-minute APGAR score of <7 were reduced by 24.6% (p < 0.05) and severe UNC by -26.6%, p = < .05. The rate of primary cesarean decreased (19.8 vs 18.3%, p < 0.05), while there were nonsignificant increases in vaginal (74.6 vs 75.8%, p = 0.13) and operative vaginal births (5.7 vs 5.9%, p = 0.6). CONCLUSION: Standardized management of recurrent SigDecels reduced the rate of 5-minute APGAR scores of < 7 and severe UNC.

A Comparison of the Nulliparous-Term-Singleton-Vertex and Society of Maternal-Fetal Medicine Cesarean Birth Metrics Based on Hospital Size.

OBJECTIVE: The purpose of this study was to compare the nulliparous-term-singleton-vertex (NTSV) and the Society of Maternal-Fetal Medicine (SMFM) cesarean birth metrics as tools for quality improvement efforts based on hospital size. MATERIALS AND METHODS: Cesarean birth rates from 275 hospitals from six states were used to evaluate the NTSV metric and 81 hospitals from four states for the SMFM metric. Data were assessed based on delivery volume, their use as an effective tool for ongoing quality improvement programs, and their ability to serve as performance-based payline indicators. RESULTS: The average NTSV and SMFM cesarean birth rates were 25.6 and 13.0%, respectively. The number of deliveries included in the NTSV metric was stable across all hospital sizes (33.1-36.2%). With the SMFM metric, there was a progressive decline in the number of deliveries included, 90.0 versus 69.6%, in relatively small to large facilities. Variability was less and precision increased with the SMFM metric, which reduced the number of hospitals that could be incorrectly categorized when using performance-based predefined cesarean birth rate paylines. CONCLUSION: The SMFM metric appears to be better suited as a tool for rapid process improvement programs aimed at reducing cesarean birth rates in low-risk patients.

Early standardized treatment of critical blood pressure elevations is associated with a reduction in eclampsia and severe maternal morbidity.

BACKGROUND: Hypertensive disorders of pregnancy result in significant maternal morbidity and mortality. State and national guidelines have been proposed to increase treatment of patients with hypertensive emergencies or critically elevated blood pressures. There are limited data available to assess the impact of these recommendations on maternal morbidity. OBJECTIVE: The purpose of this prospective quality improvement project was to determine if maternal morbidity would be improved using a standardized approach for treatment of critically elevated blood pressures. STUDY DESIGN: In all, 23 hospitals participated in this project. Treatment recommendations included the use of an intravenous blood pressure medication and magnesium sulfate when there was a sustained blood pressure of ≥160 mm Hg systolic and/or ≥110 mm Hg diastolic. Compliance with the metric recommendations was monitored based on the number of patients treated with an intravenous blood pressure medication, use of magnesium sulfate, and if they received a timely postpartum follow-up appointment. The metric was scored as all or none; missing any of the 3 metric components was considered noncompliant. From January through June 2015 baseline data were collected and hospitals were made aware that ongoing monitoring of compliance would begin in July 2015 through June 2016. The primary outcomes were composite metric compliance, the incidence of eclampsia per 1000 births, and severe maternal morbidity. RESULTS: During the 18 months of this study there were 69,449 births. Within this population, 2034 met criteria for a critically elevated blood pressure, preeclampsia, or superimposed preeclampsia with severe features. Of this group, 1520 had a sustained critical blood elevation. Initial compliance with treatment recommendations was low (50.5%) and increased to >90% after April 2016 (P < .001). Compliance with utilization of intravenous blood pressure medication increased by 33.2%, from a baseline of 57.1-90.3% (P < .01) during the last 6 months of monitoring. Compliance with utilization of magnesium sulfate increased by 10.8%, from a baseline of 85.4-96.2% (P < .01). The incidence of eclampsia declined by 42.6% (1.15 ± 0.15/1000 to 0.62 ± 0.09/1000 births). Severe maternal morbidity decreased by 16.7% from 2.4 ± 0.10% to 2.0 ± 0.15% (P < .01). CONCLUSION: We noted 3 important findings: (1) compliance with state and national treatment guidelines is low without monitoring; (2) high levels of compliance can be achieved in a relatively short period of time; and (3) early intervention with intravenous blood pressure medication and magnesium sulfate for verified sustained critical maternal blood pressures resulted in a significant reduction in the rate of eclampsia and severe maternal morbidity. The reduction in the rate of eclampsia could only partially be attributed to the increase in the use of magnesium sulfate, suggesting an additive or synergistic effect of the combined treatment of an antihypertensive medication and magnesium sulfate on the rate of eclampsia and severe maternal morbidity.

The development and implementation of checklists in obstetrics.

Checklists have been long used as a cognitive aid in various high-stakes environments to improve the reliability and performance of individuals and teams. When designed well, implemented thoughtfully, and monitored closely, they offer the opportunity to improve the performance of health care teams and advance patient safety. There are different types of checklists; examples include task lists, troubleshooting lists, coordination lists, discipline lists, and to-do lists. Each is useful in different situations and requires different implementation strategies. Checklists also are different from algorithms, care maps and protocols, and educational tools. Therefore, they are not useful in all situations. In appropriate selected clinical circumstances, checklists are tools that can help standardize care, improve communication, and help teams perform optimally.

National Partnership for Maternal Safety: Consensus Bundle on Severe Hypertension During Pregnancy and the Postpartum Period.

Complications arising from hypertensive disorders of pregnancy are among the leading causes of preventable severe maternal morbidity and mortality. Timely and appropriate treatment has the potential to significantly reduce hypertension-related complications. To assist health care providers in achieving this goal, this patient safety bundle provides guidance to coordinate and standardize the care provided to women with severe hypertension during pregnancy and the postpartum period. This is one of several patient safety bundles developed by multidisciplinary work groups of the National Partnership for Maternal Safety under the guidance of the Council on Patient Safety in Women's Health Care. These safety bundles outline critical clinical practices that should be implemented in every maternity care setting. Similar to other bundles that have been developed and promoted by the Partnership, the hypertension safety bundle is organized into four domains: Readiness, Recognition and Prevention, Response, and Reporting and Systems Learning. Although the bundle components may be adapted to meet the resources available in individual facilities, standardization within an institution is strongly encouraged. This commentary provides information to assist with bundle implementation.

Use of Maternal Early Warning Trigger tool reduces maternal morbidity.

BACKGROUND: Maternal mortality in the United States has increased unabated for the past 20 years. Maternal morbidity is also affecting an increasingly large number of women in the United States. A number of national and state organizations have recommend the use of maternal early warning tools as a method to combat this problem. There are limited data suggesting that the use of these types of clinical assessment tools can reduce maternal morbidity. OBJECTIVE: We sought to determine if maternal morbidity could be reduced with the implementation of a clinical pathway-specific Maternal Early Warning Trigger (MEWT) tool. STUDY DESIGN: The tool was developed internally and prospectively implemented as a pilot project in 6 of 29 hospitals within a large hospital system. The primary goal was early assessment and treatment of patients suspected of clinical deterioration. The tool addressed the 4 most common areas of maternal morbidity: sepsis, cardiopulmonary dysfunction, preeclampsia-hypertension, and hemorrhage. To be considered positive, triggers needed to be sustained for >20 minutes and were defined as severe (single abnormal value): maternal heart rate (HR) >130 beats/min (bpm), respiratory rate >30/min, mean arterial pressure <55 mm Hg, oxygen saturation <90%, or nurse concern; or nonsevere (required 2 abnormal values): temperature >38 or <36°C, blood pressure >160/110 or <85/45 mm Hg, HR >110 or <50 bpm, respiratory rate >24 or <10/min, oxygen saturation <93%, fetal HR >160 bpm, altered mental status, or disproportionate pain. Within each group, recommended management or assessment was also provided. Outcome measures were Centers for Disease Control and Prevention (CDC)-defined severe maternal morbidity, composite maternal morbidity, and intensive care unit (ICU) admissions. Two time intervals were used to analyze the effect of the MEWT tool: a 24-month baseline control period and a 13-month MEWT study period. To determine that the findings noted were not simply changes that would have occurred without the utilization of the early warning tool, we also compared a control population from nonpilot sites during the same baseline and 13-month time periods. RESULTS: There were 36,832 deliveries at the pilot sites (24,221 pre- and 12,611 post-MEWT testing) and 146,359 at the nonpilot sites (95,718 pre- and 50,641 post-MEWT testing) during the 2 study time periods. Use of the MEWT tool resulted in significant reductions in CDC severe maternal morbidity (P < 0.01) and composite morbidity (P < 0.01). ICU admissions were unchanged. At nonpilot sites CDC severe maternal morbidity, composite morbidity, and ICU admissions were unchanged between baseline and the post-MEWT testing time period. CONCLUSION: The use of the MEWT tool in this study, designed to address 4 of the most common causes of maternal morbidity, as well as provide assessment and management recommendations, resulted in significant improvement in maternal morbidity. The variation in hospital delivery services at the pilot sites suggests that this maternal early warning tool would be suitable for use in the majority of maternity centers in the United States.

Comprehensive maternal hemorrhage protocols reduce the use of blood products and improve patient safety.

The purpose of this study was to assess the effectiveness of instituting a comprehensive protocol for the treatment of maternal hemorrhage within a large health care system. A comprehensive maternal hemorrhage protocol was initiated within a health care system with 29 different delivery units and with >60,000 annual births. Compliance with key elements of the protocol was assessed monthly by a dedicated perinatal safety nurse at each site and validated during site visits by system perinatal nurse specialist. Outcome variables were the total number of units of blood transfused and the number of puerperal hysterectomies. Three time points were assessed: (1) 2 months before implementation of the protocol, (2) a 2-month period that was measured at 5 months after implementation of the protocol, and (3) a 2-month period at 10 months after implementation. There were 32,059 deliveries during the 3 study periods. Relative to baseline, there was a significant reduction in blood product use per 1000 births (-25.9%; P < .01) and a nonsignificant reduction (-14.8%; P = .2) in the number of patients who required puerperal hysterectomy. Within a large health care system, the application of a standardized method to address maternal hemorrhage significantly reduced maternal morbidity, based on the need for maternal transfusion and peripartum hysterectomy. These data support implementation of standardized methods for postpartum care and treatment of maternal hemorrhage and support that this approach will reduce maternal morbidity.

Performance Characteristics of Sepsis Screening Tools During Antepartum and Postpartum Admissions.

OBJECTIVE: To evaluate the performance characteristics of existing screening tools for the prediction of sepsis during antepartum and postpartum readmissions. METHODS: This was a case-control study using electronic health record data obtained between 2016 and 2021 from 67 hospitals for antepartum sepsis admissions and 71 hospitals for postpartum readmissions up to 42 days. Patients in the sepsis case group were matched in a 1:4 ratio to a comparison cohort of patients without sepsis admitted antepartum or postpartum. The following screening criteria were evaluated: the CMQCC (California Maternal Quality Care Collaborative) initial sepsis screen, the non-pregnancy-adjusted SIRS (Systemic Inflammatory Response Syndrome), the MEWC (Maternal Early Warning Criteria), UKOSS (United Kingdom Obstetric Surveillance System) obstetric SIRS, and the MEWT (Maternal Early Warning Trigger Tool). Time periods were divided into early pregnancy (less than 20 weeks of gestation), more than 20 weeks of gestation, early postpartum (less than 3 days postpartum), and late postpartum through 42 days. False-positive screening rates, C-statistics, sensitivity, and specificity were reported for each overall screening tool and each individual criterion. RESULTS: We identified 525 patients with sepsis during an antepartum hospitalization and 728 patients with sepsis during a postpartum readmission. For early pregnancy and more than 3 days postpartum, non-pregnancy-adjusted SIRS had the highest C-statistics (0.78 and 0.83, respectively). For more than 20 weeks of gestation and less than 3 days postpartum, the pregnancy-adjusted sepsis screening tools (CMQCC and UKOSS) had the highest C-statistics (0.87-0.94). The MEWC maintained the highest sensitivity rates during all time periods (81.9-94.4%) but also had the highest false-positive rates (30.4-63.9%). The pregnancy-adjusted sepsis screening tools (CMQCC, UKOSS) had the lowest false-positive rates in all time periods (3.9-10.1%). All tools had the lowest C-statistics in the periods of less than 20 weeks of gestation and more than 3 days postpartum. CONCLUSION: For admissions early in pregnancy and more than 3 days postpartum, non-pregnancy-adjusted sepsis screening tools performed better than pregnancy-adjusted tools. From 20 weeks of gestation through up to 3 days postpartum, using a pregnancy-adjusted sepsis screening tool increased sensitivity and minimized false-positive rates. The overall false-positive rate remained high.

Performance Characteristics of Sepsis Screening Tools During Delivery Admissions.

OBJECTIVE: To evaluate the screening performance characteristics of existing tools for the diagnosis of sepsis during delivery admissions. METHODS: This was a case-control study using electronic health record data, including vital signs and laboratory results, for all delivery admissions of patients with sepsis from 59 nationally distributed hospitals. Patients with sepsis were matched by gestational age at delivery in a 1:4 ratio with patients without sepsis to create a comparison group. Patients with chorioamnionitis and sepsis were compared with a complete cohort of patients with chorioamnionitis without sepsis. Multiple screening criteria for sepsis were evaluated: the CMQCC (California Maternal Quality Care Collaborative), SIRS (Systemic Inflammatory Response Syndrome), the MEWC (the Maternal Early Warning Criteria), UKOSS (United Kingdom Obstetric Surveillance System), and the MEWT (Maternal Early Warning Trigger Tool). Sensitivity, false-positive rates, and C-statistics were reported for each screening tool. Analyses were stratified into cohort 1, which excluded patients with chorioamnionitis-endometritis, and cohort 2, which included those patients. RESULTS: Delivery admissions at 59 hospitals were extracted for patients with sepsis. Cohort 1 comprised 647 patients with sepsis, including 228 with end-organ injury, matched with a control group of 2,588 patients without sepsis. Cohort 2 comprised 14,591 patients with chorioamnionitis-endometritis, of whom 1,049 had sepsis and 238 had end-organ injury. In cohort 1, the CMQCC and the UKOSS pregnancy-adjusted criteria had the lowest false-positive rates (6.9% and 9.6%, respectively) and the highest C-statistics (0.92 and 0.91, respectively). Although other screening criteria, such as SIRS and the MEWC, had similar sensitivities, it was at the cost of much higher false-positive rates (21.3% and 38.3%, respectively). In cohort 2, including all patients with chorioamnionitis-endometritis, the highest C-statistics were again for the CMQCC (0.67) and UKOSS (0.64). All screening tools had high false-positive rates, but the false-positive rates for the CMQCC and UKOSS were substantially lower than those for SIRS and the MEWC. CONCLUSION: During delivery admissions, the CMQCC and UKOSS pregnancy-adjusted screening criteria have the lowest false-positive results while maintaining greater than 90% sensitivity rates. Performance of all screening tools was degraded in the setting of chorioamnionitis-endometritis.

A Systemwide Postpartum Inpatient Maternal Mental Health Education and Screening Program.

OBJECTIVE: To expand a hospital system's maternal mental health program to standardize screening for perinatal mood and anxiety disorders. DESIGN: Quality improvement initiative using a continuous Plan-Do-Study-Act (PDSA) cycle. SETTING/LOCAL PROBLEM: In a hospital system consisting of 66 maternity care centers across the United States, there was significant variation in maternal mental health screening, referral, and education practices. The COVID-19 pandemic and increasing rates of severe maternal morbidity further elevated system-level concern about the quality of maternal mental health care being provided. PARTICIPANTS: Perinatal nurses. METHODS: An "all-or-none" bundle methodology was used to measure adherence to a system standard for maternal mental health screening, referral, and education. INTERVENTIONS: A toolkit was designed internally to support streamlined implementation and ensure standardization for screening, referral, and education. This comprehensive toolkit includes screening forms, a referral algorithm, staff education, patient education literature, and a community resource list template. Training on how to use the toolkit was provided to nurses, chaplains, and social workers. RESULTS: The initial system bundle adherence rate was 76% (2017) in the first year of the program. The following year, the bundle adherence rate increased to 97% (2018). Despite the disruption caused by the COVID-19 pandemic, this mental health initiative has maintained an overall adherence rate of 92% (2020-2022). CONCLUSION: This nurse-led quality improvement initiative has been successfully implemented across a geographically and demographically diverse hospital system. The initial and sustained high rates of adherence with the system standard for screening, referral, and education illustrate perinatal nurses' commitment to the delivery of high-quality maternal mental health care in the acute care setting.

Comprehensive maternal hemorrhage protocols improve patient safety and reduce utilization of blood products.

OBJECTIVE: The purpose of this study was to assess the effectiveness of instituting a comprehensive protocol for the treatment of maternal hemorrhage. STUDY DESIGN: The protocol was separated into 4 stages, designated 0-3, based on the degree of blood loss and the patient response to interventions. Key components included admission risk assessment, measurement of blood loss, early but limited use of uterotonic agents, early presence of obstetrical and anesthesia staff, and transfusion with fixed ratios of blood products. Data were collected retrospectively and prospectively relative to the start of the protocol. RESULTS: We noted a significant shift toward resolution of maternal bleeding at an earlier stage (P < .01), use of fewer blood products (P < .01), and a 64% reduction in the rate of disseminated intravascular coagulation. In addition, there were significant improvements in staff and physician perceptions of patient safety (P < .01). CONCLUSION: Comprehensive maternal hemorrhage treatment protocols improve patient safety and reduce utilization of blood products.

Protocol for a randomized controlled trial of pre-pregnancy lifestyle intervention to reduce recurrence of gestational diabetes: Gestational Diabetes Prevention/Prevención de la Diabetes Gestacional.

BACKGROUND: Gestational diabetes mellitus (GDM) is associated with several maternal complications in pregnancy, including preeclampsia, preterm labor, need for induction of labor, and cesarean delivery as well as increased long-term risks of type 2 diabetes, metabolic syndrome, and cardiovascular disease. Intrauterine exposure to GDM raises the risk for complications in offspring as well, including stillbirth, macrosomia, and birth trauma, and long-term risk of metabolic disease. One of the strongest risk factors for GDM is the occurrence of GDM in a prior pregnancy. Preliminary data from epidemiologic and bariatric surgery studies suggest that reducing body weight before pregnancy can prevent the development of GDM, but no adequately powered trial has tested the effects of a maternal lifestyle intervention before pregnancy to reduce body weight and prevent GDM recurrence. METHODS: The principal aim of the Gestational Diabetes Prevention/Prevención de la Diabetes Gestacional is to determine whether a lifestyle intervention to reduce body weight before pregnancy can reduce GDM recurrence. This two-site trial targets recruitment of 252 women with overweight and obesity who have previous histories of GDM and who plan to have another pregnancy in the next 1-3 years. Women are randomized within site to a comprehensive pre-pregnancy lifestyle intervention to promote weight loss with ongoing treatment until conception or an educational control group. Participants are assessed preconceptionally (at study entry, after 4 months, and at brief quarterly visits until conception), during pregnancy (at 26 weeks' gestation), and at 6 weeks postpartum. The primary outcome is GDM recurrence, and secondary outcomes include fasting glucose, biomarkers of cardiometabolic disease, prenatal and perinatal complications, and changes over time in weight, diet, physical activity, and psychosocial measures. DISCUSSION: The Gestational Diabetes Prevention /Prevención de la Diabetes Gestacional is the first randomized controlled trial to evaluate the effects of a lifestyle intervention delivered before pregnancy to prevent GDM recurrence. If found effective, the proposed lifestyle intervention could lay the groundwork for shifting current treatment practices towards the interconception period and provide evidence-based preconception counseling to optimize reproductive outcomes and prevent GDM and associated health risks. TRIAL REGISTRATION: ClinicalTrials.gov NCT02763150 . Registered on May 5, 2016.

Obstetrical hemorrhage reporting and systems learning.

Reporting and systems learning provide the backbone for a sustainable comprehensive response to maternal hemorrhage. Reporting back to the institution requires capturing various elements such as compliance, results of debriefs, and comprehensive reviews of cases where there has been severe maternal morbidity. The system then learns from these reviews, and modifies as necessary any areas not performing as desired. Compliance monitoring, aside from review of an adverse event, is also an essential element of the reporting process by assessing for drift, returning to pre-implementation practices.

Implementing Obstetric Early Warning Systems.

Severe maternal morbidity and mortality are often preventable and obstetric early warning systems that alert care providers of potential impending critical illness may improve maternal safety. While literature on outcomes and test characteristics of maternal early warning systems is evolving, there is limited guidance on implementation. Given current interest in early warning systems and their potential role in care, the 2017 Society for Maternal-Fetal Medicine (SMFM) Annual Meeting dedicated a session to exploring early warning implementation across a wide range of hospital settings. This manuscript reports on key points from this session. While implementation experiences varied based on factors specific to individual sites, common themes relevant to all hospitals presenting were identified. Successful implementation of early warnings systems requires administrative and leadership support, dedication of resources, improved coordination between nurses, providers, and ancillary staff, optimization of information technology, effective education, evaluation of and change in hospital culture and practices, and support in provider decision-making. Evolving data on outcomes on early warning systems suggest that maternal risk may be reduced. To effectively reduce maternal, risk early warning systems that capture deterioration from a broad range of conditions may be required in addition to bundles tailored to specific conditions such as hemorrhage, thromboembolism, and hypertension.

A prospective, randomized, multicenter trial of amnioreduction vs selective fetoscopic laser photocoagulation for the treatment of severe twin-twin transfusion syndrome.

OBJECTIVE: The objective of the study was to examine the effect of selective fetoscopic laser photocoagulation (SFLP) vs serial amnioreduction (AR) on perinatal mortality in severe twin-twin transfusion syndrome (TTTS). STUDY DESIGN: This was a 5 year multicenter, prospective, randomized controlled trial. The primary outcome variable was 30 day postnatal survival of donors and recipients. RESULTS: There was no statistically significant difference in 30-day postnatal survival between SFLP or AR treatment for donors at 55% (11 of 20) vs 55% (11 of 20) (P = 1.0, odds ratio [OR] 1, 95% confidence interval [CI] 0.242 to 4.14) or recipients at 30% (6 of 20) vs 45% (9 of 20) (P = .51, OR 1.88, 95% CI 0.44 to 8.64). There was no difference in 30 day survival of 1 or both twins on a per-pregnancy basis between AR at 75% (15 of 20) and SFLP at 65% (13 of 20) (P = .73, OR 1.62, 95% CI 0.34 to 8.09). Overall survival (newborns divided by the number of fetuses treated) was not statistically significant for AR at 60% (24 of 40) vs SFLP 45% (18 of 40) (P = .18, OR 2.01, 95% CI 0.76 to 5.44). There was a statistically significant increase in fetal recipient mortality in the SFLP arm at 70% (14 of 20) vs the AR arm at 35% (7 of 20) (P = .25, OR 5.31, 95% CI 1.19 to 27.6). This was offset by increased recipient neonatal mortality of 30% (6 of 20) in the AR arm. Echocardiographic abnormality in recipient twin Cardiovascular Profile Score is the most significant predictor of recipient mortality (P = .055, OR 3.025/point) by logistic regression analysis. CONCLUSION: The outcome of the trial did not conclusively determine whether AR or SFLP is a superior treatment modality. TTTS cardiomyopathy appears to be an important factor in recipient survival in TTTS.

Decreased rates of shoulder dystocia and brachial plexus injury via an evidence-based practice bundle.

OBJECTIVE: To evaluate whether a standardized approach to identify pregnant women at risk for shoulder dystocia (SD) is associated with reduced incidence of SD and brachial plexus injury (BPI). METHODS: Between 2011 and 2015, prospective data were collected from 29 community-based hospitals in the USA during implementation of an evidence-based practice bundle, including an admission risk assessment, required "timeout" before operative vaginal delivery (OVD), and low-fidelity SD drills. All women with singleton vertex pregnancies admitted for vaginal delivery were included. Rates of SD, BPI, OVD, and cesarean delivery were compared between a baseline period (January 2011-September 2013) and an intervention period (October 2013-June 2015), during which there was a system-wide average bundle compliance of 90%. RESULTS: There was a significant reduction in the incidence of SD (17.6%; P=0.028), BPI (28.6%; P=0.018), and OVD (18.0%; P<0.001) after implementation of the evidence-based practice bundle. There was a nonsignificant reduction in primary (P=0.823) and total (P=0.396) cesarean rates, but no association between SD drills and incidence of BPI. CONCLUSION: Implementation of a standard evidence-based practice bundle was found to be associated with a significant reduction in the incidence of SD and BPI. Utilization of low-fidelity drills was not associated with a reduction in BPI.

National Partnership for Maternal Safety: Consensus Bundle on Severe Hypertension During Pregnancy and the Postpartum Period.

Complications arising from hypertensive disorders of pregnancy are among the leading causes of preventable severe maternal morbidity and mortality. Timely and appropriate treatment has the potential to significantly reduce hypertension-related complications. To assist health care providers in achieving this goal, this patient safety bundle provides guidance to coordinate and standardize the care provided to women with severe hypertension during pregnancy and the postpartum period. This is one of several patient safety bundles developed by multidisciplinary work groups of the National Partnership for Maternal Safety under the guidance of the Council on Patient Safety in Women's Health Care. These safety bundles outline critical clinical practices that should be implemented in every maternity care setting. Similar to other bundles that have been developed and promoted by the Partnership, the hypertension safety bundle is organized into four domains: Readiness, Recognition and Prevention, Response, and Reporting and Systems Learning. Although the bundle components may be adapted to meet the resources available in individual facilities, standardization within an institution is strongly encouraged. This commentary provides information to assist with bundle implementation.