Publications by authors named "Laurence Shields"

28 Publications

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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.

Trials 2021 Apr 7;22(1):256. Epub 2021 Apr 7.

Weight Control and Diabetes Research Center, The Miriam Hospital, Providence, USA.

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.
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http://dx.doi.org/10.1186/s13063-021-05204-wDOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8024941PMC
April 2021

Labor and delivery guidance for coronavirus disease 2019.

Am J Obstet Gynecol MFM 2020 08 17;2(3):100157. Epub 2020 Jun 17.

Women's and Infant's Clinical Institute, Common Spirit Health, 116 S. Palisade Drive, Suite 104, Santa Maria, CA 93454.

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http://dx.doi.org/10.1016/j.ajogmf.2020.100157DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7297690PMC
August 2020

Obstetrical hemorrhage reporting and systems learning.

Semin Perinatol 2019 Feb 14;43(1):60-64. Epub 2018 Nov 14.

Dignity Health Patient Safety, 185 Berry St #300, San Francisco, CA 94107, USA.

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.
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http://dx.doi.org/10.1053/j.semperi.2018.11.010DOI Listing
February 2019

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

Am J Perinatol 2018 12 12;35(14):1405-1410. Epub 2018 Jun 12.

Department of Obstetrics and Gynecology, University of California Davis, Sacramento, California.

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% ( < 0.05) and severe UNC by -26.6%,  = < .05. The rate of primary cesarean decreased (19.8 vs 18.3%,  < 0.05), while there were nonsignificant increases in vaginal (74.6 vs 75.8%,  = 0.13) and operative vaginal births (5.7 vs 5.9%,  = 0.6).

Conclusion: Standardized management of recurrent SigDecels reduced the rate of 5-minute APGAR scores of < 7 and severe UNC.
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http://dx.doi.org/10.1055/s-0038-1660459DOI Listing
December 2018

Implementing Obstetric Early Warning Systems.

AJP Rep 2018 Apr 20;8(2):e79-e84. Epub 2018 Apr 20.

Division of Maternal Fetal Medicine, Marian Regional Medical Center, Santa Maria, California.

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.
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http://dx.doi.org/10.1055/s-0038-1641569DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC5910060PMC
April 2018

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

Am J Perinatol 2018 Mar 3;35(4):390-396. Epub 2017 Nov 3.

Department of Obstetrics and Gynecology, University of Washington, Seattle, Washington.

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.
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http://dx.doi.org/10.1055/s-0037-1607985DOI Listing
March 2018

Consensus Bundle on Severe Hypertension During Pregnancy and the Postpartum Period.

J Obstet Gynecol Neonatal Nurs 2017 Sep - Oct;46(5):776-787. Epub 2017 Jul 11.

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.
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http://dx.doi.org/10.1016/j.jogn.2017.05.003DOI Listing
May 2018

Consensus Bundle on Severe Hypertension During Pregnancy and the Postpartum Period.

J Midwifery Womens Health 2017 Jul 11;62(4):493-501. Epub 2017 Jul 11.

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.
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http://dx.doi.org/10.1111/jmwh.12647DOI Listing
July 2017

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

Obstet Gynecol 2017 08;130(2):347-357

Montefiore Medical Center/Albert Einstein College of Medicine, Bronx, New York; University of Mississippi, Jackson, Mississippi; Baptist Healthcare Lexington, Lexington, Kentucky; Marian Regional Medical Center, Santa Maria, California; Dignity Health, San Francisco, California; Stanford University, Stanford, California; the Society for Obstetric Anesthesia and Perinatology, Milwaukee, Wisconsin; the University of Chicago, Chicago, Illinois; the American Academy of Family Physicians, Leawood, Kansas; the California Maternal Quality Care Collaborative, Stanford, California; the Association of Women's Health, Obstetric and Neonatal Nurses, Washington, DC; the American College of Nurse-Midwives, Silver Spring, Maryland; Frontier Nursing University, Hyden, Kentucky; the Preeclampsia Foundation, Melbourne, Florida; the American College of Obstetricians and Gynecologists, Washington, DC; the Society for Maternal-Fetal Medicine; Washington, DC; and the University of North Carolina, Chapel Hill, North Carolina.

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.
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http://dx.doi.org/10.1097/AOG.0000000000002115DOI Listing
August 2017

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

Anesth Analg 2017 08;125(2):540-547

From the *Division of Maternal Fetal Medicine, †Department of Obstetrics and Gynecology, Montefiore Medical Center/Albert Einstein College of Medicine, Bronx, New York; ‡University of Mississippi, Jackson, Mississippi; §Maternal-Fetal Medicine, Baptist Healthcare Lexington, Lexington, Kentucky; ‖Maternal Fetal Medicine, Marian Regional Medical Center, Santa Maria, California; ¶Perinatal Safety for Dignity Health, San Francisco, California; #Department of Obstetrics and Gynecology, Stanford University, Stanford, California; **Department of Anesthesia & Critical Care, ††Department of Obstetrics & Gynecology, University of Chicago, Chicago, Illinois; ‡‡Health of the Public and Science Division, American Academy of Family Physicians, Leawood, Kansas; §§California Maternal Quality Care Collaborative, Stanford, California; ‖‖Women's Health Programs, Association of Women's Health, Obstetric and Neonatal Nurses, Washington, DC; ¶¶American College of Nurse-Midwives, Silver Spring, Maryland; ##Frontier Nursing University, Hyden, Kentucky; ***Preeclampsia Foundation, Melbourne, Florida; †††American College of Obstetricians and Gynecologists, Washington, DC; ‡‡‡Department of Obstetrics and Gynecology, University of North Carolina, Chapel Hill, North Carolina.

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.
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http://dx.doi.org/10.1213/ANE.0000000000002304DOI Listing
August 2017

The development and implementation of checklists in obstetrics.

Am J Obstet Gynecol 2017 08 23;217(2):B2-B6. Epub 2017 May 23.

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.
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http://dx.doi.org/10.1016/j.ajog.2017.05.032DOI Listing
August 2017

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

Am J Obstet Gynecol 2017 Apr 30;216(4):415.e1-415.e5. Epub 2017 Jan 30.

Sacramento Maternal-Fetal Medicine Medical Group Inc, Sacramento, CA.

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.
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http://dx.doi.org/10.1016/j.ajog.2017.01.008DOI Listing
April 2017

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

Int J Gynaecol Obstet 2017 Feb 21;136(2):162-167. Epub 2016 Nov 21.

Patient Safety, Dignity Health, San Francisco, CA, USA.

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.
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http://dx.doi.org/10.1002/ijgo.12034DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC5245184PMC
February 2017

Use of Maternal Early Warning Trigger tool reduces maternal morbidity.

Am J Obstet Gynecol 2016 Apr 28;214(4):527.e1-527.e6. Epub 2016 Feb 28.

Sacramento Maternal Fetal Medicine Medical Group Inc, Sacramento, CA.

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.
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http://dx.doi.org/10.1016/j.ajog.2016.01.154DOI Listing
April 2016

Baseline assessment of a hospital-specific early warning trigger system for reducing maternal morbidity.

Int J Gynaecol Obstet 2016 Mar 2;132(3):337-41. Epub 2015 Dec 2.

Dignity Health Patient Safety and Quality, San Francisco, CA, USA; Marian Regional Medical Center, Obstetrics and Gynecology, Santa Maria, CA, USA.

Objective: To determine whether predefined maternal early warning triggers (MEWTs) can predict pregnancy morbidity.

Methods: In a retrospective case-control study, obstetric patients admitted to the intensive care unit (ICU) between 2012 and 2013 at seven pilot US hospitals were compared with control patients who had a normal delivery outcome. Six MEWTs were assessed.

Results: The case and control groups each contained 50 patients. Hemorrhage (15/50, 30%), sepsis (12/50, 24%), cardiac dysfunction (8/50, 16%), and pre-eclampsia (6/50, 12%) were the most common reasons for ICU admission. Significant associations were recorded between ICU admission and tachycardia (OR 5.0, 95% CI 2.1-11.7), mean arterial pressure less than 65 mm Hg (OR 4.5, 95% CI 1.9-10.8), temperature of at least 38°C (OR 44.1, 95% CI 13.0-839.1), and altered mental state (OR 44.1, 95% CI 13.1-839.0). Two or more triggers were persistent for 30 minutes or more in 36 (72%) ICU patients versus 2 (4%) controls (OR 61.7, 95% CI 13.2-288.0). Earlier medical intervention might have led to a lesser degree of maternal morbidity for 31 (62%) ICU patients with at least one MEWT.

Conclusion: Persistent MEWTs were present in most obstetric ICU cases. Retrospectively, MEWTs in this cohort seemed to separate normal obstetric patients from those for whom ICU admission was indicated; their use might reduce maternal morbidity.
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http://dx.doi.org/10.1016/j.ijgo.2015.07.036DOI Listing
March 2016

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

Am J Obstet Gynecol 2015 Mar 12;212(3):272-80. Epub 2014 Jul 12.

Patient Safety, Dignity Health, San Francisco, CA.

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.
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http://dx.doi.org/10.1016/j.ajog.2014.07.012DOI Listing
March 2015

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

Am J Obstet Gynecol 2011 Oct 29;205(4):368.e1-8. Epub 2011 Jun 29.

Department of Obstetrics and Gynecology, Marian Medical Center, Santa Maria, CA, USA.

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.
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http://dx.doi.org/10.1016/j.ajog.2011.06.084DOI Listing
October 2011

In utero transplantation of monocytic cells in cats with alpha-mannosidosis.

Transplantation 2009 Aug;88(3):323-9

Division of Hematology, Department of Medicine, University of Washington, Seattle, WA 98195-7710, USA.

Background: Lysosomal storage diseases are devastating illnesses, in large part because of their neurologic consequences. Because significant morbidity occurs prenatally, in utero (IU) therapy is an attractive therapeutic approach.

Methods: We studied the feasibility and efficacy of IU injections of monocytic cells (derived from normal marrow) in feline alpha-mannosidosis. Heterozygous cats were interbred to produce affected (homozygous) and control (heterozygous and wild-type) offspring. Thirty-seven pregnancies were studied in which fetuses were transplanted intraperitoneally (1x10 cells/kg recipient) at gestational days 27 to 33 and then each week for 2 weeks (term=63 days). After birth, affected kittens were evaluated clinically and pathologically, tissue alpha-mannosidase levels were assayed, and in many studies, the numbers of alpha-mannosidase-containing cells were enumerated. When male donor cells were transplanted into female recipients, engraftment was also quantified using polymerase chain reaction to amplify a Y chromosome-specific sequence.

Results: We establish methods to transplant cats intraperitoneally while IU using ultrasound guidance, thus, describing a new large animal model for prenatal therapy. We show that the donor monocytic cells engraft and persist (for up to 125 days) in the brain, liver, and spleen, albeit at levels below those needed to alter the clinical or pathological progression of the alpha-mannosidosis.

Conclusions: This is the first study of monocyte transplantation in a large animal model of a lysosomal storage disorder and demonstrates its feasibility, safety, and promise. Delivering cells IU may be a useful strategy to prevent morbidities before a definitive therapy, such as hematopoietic stem-cell transplantation, can be administered after birth.
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http://dx.doi.org/10.1097/TP.0b013e3181b0d264DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC2742773PMC
August 2009

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

Am J Obstet Gynecol 2007 Oct;197(4):396.e1-9

Fetal Care Center of Cincinnati, Division of Pediatric General, Thoracic, and Fetal Surgery, Cincinnati Children's Hospital, MLC #2023, 3333 Burnet Avenue, Cincinnati, OH 45229, USA.

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.
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http://dx.doi.org/10.1016/j.ajog.2007.07.020DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC2754290PMC
October 2007

Phenotypic and cytolytic activity of Macaca nemestrina natural killer cells isolated from blood and expanded in vitro.

Am J Primatol 2006 Aug;68(8):753-64

Department of Obstetrics and Gynecology, University of Washington, Seattle, Washington 98195-6460, USA.

Natural killer (NK) cells from nonhuman primates have not been completely characterized, and methods for expanding nonhuman primates NK cells in vitro have been described only in rhesus species. The purpose of this report was to characterize NK cells in pigtail macaques (Macaca nemestrina), a species that is frequently used in studies of transplantation biology/immunology, virology, vaccine development, and reproductive biology. NK cells from Macaca nemestrina peripheral blood were best defined by the expression of CD16 and CD8alpha, and the absence of CD3. Subsets of these cells express CD56, NKp30, and NKp46. An enhanced ability to kill K562 cells was not present in fluorescence activated cell sorted (FACS)-purified CD16-/CD3+ and CD16-/CD56+ cells isolated from fresh peripheral blood. However, FACS-purified CD16+/CD3- and CD16+/CD56- cells were highly efficient killers of K562 cells. Macaca nemestrina NK cells can be expanded by in vitro culturing of FACS-purified CD16+/CD2-/CD3-/CD56- cells, or from peripheral blood cells depleted of cells expressing CD3, CD4, and HLA-DR. Cells in these cultures expand 70-fold after 21 days of culturing. After culturing, these cells express high levels of natural cytotoxicity receptors (NCRs) NKp30 and NKp46. NK cell populations obtained from FACS-purified CD16+/CD3-, CD16+/CD56- cells and CD3/CD4/HLA-DR-depleted cells were highly efficient killers of K562 cells. These data suggest that a population of highly enriched cytolytic NK cells can be obtained from purified CD16+/CD3- and CD16+/CD56- cells obtained from peripheral blood, as well as from cells that have been cultured and expanded from peripheral blood that is depleted of CD3/CD4/HLA-DR-expressing cells.
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http://dx.doi.org/10.1002/ajp.20276DOI Listing
August 2006

Hydroxyprogesterone caproate and progesterone increase tumor necrosis factor-alpha production in lipopolysaccharide stimulated whole blood from non-pregnant women.

J Perinat Med 2005 ;33(6):506-9

Department of Obstetrics and Gynecology, University of Washington Seattle, WA 98195, USA.

Objective: Hydroxyprogesterone caproate (17-P) and progesterone have been shown to decrease the rate of preterm birth in high-risk pregnant women, but the mechanism of action is unknown. We hypothesized that 17-P or progesterone would reduce production of the pro-inflammatory cytokine, tumor necrosis factor-alpha (TNF-alpha), after lipopolysaccharide (LPS) stimulation of whole blood.

Study Design: Whole blood collected from 10 non-pregnant women in the follicular phase was treated with LPS (1000 ng/mL) alone or with either 17-P or progesterone (125 ng/mL and 1250 ng/mL) and LPS. Supernatant collected after 24 h was tested for TNF-alpha by enzyme immunoassay. Results were compared using the Wilcoxon rank sum test.

Results: Whole blood treated with 17-P or progesterone in addition to LPS produced significantly higher TNF-alpha concentrations than blood treated with LPS alone.

Conclusion: 17-P and progesterone appear to have a pro-inflammatory effect during LPS stimulation of blood from non-pregnant women in vitro. Our data suggest that the reduction in pre-term birth in women treated with progesterone is not mediated through an anti-inflammatory effect on peripheral blood cells.
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http://dx.doi.org/10.1515/JPM.2005.089DOI Listing
February 2006

The use of CD 34(+) mobilized peripheral blood as a donor cell source does not improve chimerism after in utero hematopoietic stem cell transplantation in non-human primates.

J Med Primatol 2005 Aug;34(4):201-8

Department of Obstetrics and Gynecology, Division of Perinatal Medicine, University of Washington, Seattle, WA, USA.

In utero hematopoietic stem cell transplantation is a therapeutic procedure that could potentially cure many developmental diseases affecting the immune and hematopoietic systems. In most clinical and experimental settings of fetal hematopoietic transplantation the level of donor cell engraftment has been low, suggesting that even in the fetus there are significant barriers to donor cell engraftment. In postnatal hematopoietic transplantation donor cells obtained from mobilized peripheral blood engraft more rapidly than cells derived from marrow. We tested the hypothesis that use of donor hematopoietic/stem cells obtained from mobilized peripheral blood would improve engraftment and the level of chimerism after in utero transplantation in non-human primates. Despite the potential competitive advantage from the use of CD 34(+) from mobilized peripheral blood, the level of chimerism was not appreciably different from a group of animals receiving marrow-derived CD 34(+) donor cells. Based on these results, it is unlikely that this single change in cell source will influence the clinical outcome of fetal hematopoietic transplantation.
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http://dx.doi.org/10.1111/j.1600-0684.2005.00110.xDOI Listing
August 2005

Second-trimester biparietal diameter/nasal bone length ratio is an independent predictor of trisomy 21.

J Ultrasound Med 2005 Jun;24(6):805-10

Department of Obstetrics and Gynecology, Division of Maternal-Fetal Medecine of Perinatal Medecine and University of Washington, Seattle, WA 98195, USA.

Objective: The purpose of this study was to evaluate the association between the second-trimester fetal biparietal diameter/nasal bone length (BPD/NBL) ratio and trisomy 21.

Methods: Thirty-one cases of trisomy 21 for which complete ultrasound images included the nasal bone were identified from the University of Washington prenatal diagnosis database and matched to 136 euploid fetuses based on maternal age, indication for referral, and gestational age.

Results: The mean NBL was shorter (mean +/- SD, 2.3+/-1.7 mm versus 3.9+/-1.2 mm; P<.001) and the BPD/NBL ratio was greater (17.7 [range, 6.2-114] versus 11.7 [range, 5.8-80]; P<.001) in the fetuses with trisomy 21. The risk of trisomy 21 increased 2.4-fold (95% confidence interval [CI], 1.7-3.4) with every 1-mm decrease in NBL and increased 1.08-fold (95% CI, 1.03-1.12) with each unit increase in the BPD/NBL ratio (P<.001). A multiple logistic regression model was constructed and included the BPD/NBL ratio, maternal indications (age>or=35 years, positive serum screening results, or both, yielding a risk of <1 per 270 for trisomy 21), and sonographic markers as covariates. The BPD/NBL ratio was found to be an independent predictor of trisomy 21 (odds ratio, 1.08; 95% CI, 1.03-1.11). An analysis of receiver operating characteristic curves revealed an improvement after the BPD/NBL ratio was added to a model containing the current second-trimester screening based on maternal age, serum screening, and sonographic markers (receiver operating characteristic curve area, mean +/-SE, 0.89+/-0.03 for the model with the BPD/NBL ratio versus 0.76+/- 0.06 without the BPD/NBL ratio; P=.009).

Conclusions: The second-trimester BPD/NBL ratio was a significant and independent predictor of trisomy 21. An assessment of the BPD/NBL ratio may improve the diagnosis of trisomy 21 when used with current prenatal screening practices.
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http://dx.doi.org/10.7863/jum.2005.24.6.805DOI Listing
June 2005

Parvovirus B19 capsid protein VP2 inhibits hematopoiesis in vitro and in vivo: implications for therapeutic use.

Exp Hematol 2004 Nov;32(11):1082-7

Division of Clinical Virology, Department of Laboratory Medicine, Karolinska Institutet, Karolinska University Hospital, Stockholm, Sweden.

Objective: To evaluate the capacity of parvovirus B19 capsid protein VP2 to inhibit hematopoiesis in vitro and in vivo. If effective, a VP2-derived construct may have therapeutic and prophylactic utility in diseases associated to overproduction of hematopoietic cells.

Methods: The effect on hematopoiesis in vitro of recombinant VP2, intact and enzymatically fragmented, was evaluated in a colony formation assay, using cells from fetal liver and macaque bone marrow. VP2 was also administered intravenously in macaques and hematological parameters as well as the ex vivo colony formation were assayed during a follow-up period of 33 days.

Results: VP2 inhibited BFU-E colony formation by about 55%. CFU-GM and CFU-GEMM colony formation was also affected. Fragmented VP2 retained the inhibitory effect. The ex vivo colony-forming capacity of macaque bone marrow cells was lower in animals that received VP2 injections, and a drop in hematocrit values was noted in one animal.

Conclusion: VP2 has an inhibitory effect on hematopoiesis in vitro and in vivo. An active region within VP2 is implied, which would be a strong candidate for use as a medicament in diseases such as polycytemia vera.
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http://dx.doi.org/10.1016/j.exphem.2004.07.016DOI Listing
November 2004

Fetal immune suppression as adjunctive therapy for in utero hematopoietic stem cell transplantation in nonhuman primates.

Stem Cells 2004 ;22(5):759-69

Department of Obstetrics and Gynecology, Division of Perinatal Medicine, Box 356460, University of Washington, Seattle 98105-6460, USA.

In utero hematopoietic stem cell transplantation could potentially be used to treat many genetic diseases but rarely has been successful except in severe immunodeficiency syndromes. We explored two ways to potentially increase chimerism in a nonhuman primate model: (a) fetal immune suppression at the time of transplantation and (b) postnatal donor stem cell infusion. Fetal Macaca nemestrina treated with a combination of the corticosteroid betamethasone (0.9 mg/kg) and rabbit thymoglobulin (ATG; 50 mg/kg) were given haploidentical, marrow-derived, CD34+ -enriched donor cells. Animals treated postnatally received either donor-derived T cell-depleted or CD34+ -enriched marrow cells. Chimerism was determined by traditional and real-time polymerase chain reaction from marrow, marrow progenitors, peripheral blood, and mature peripheral blood progeny. After birth, the level of chimerism in the progenitor population was higher in the immune-suppressed animals relative to controls (11.3% +/- 2.7% and 5.1% +/- 1.5%, respectively; p = .057). Chimerism remained significantly elevated in both marrow (p = .02) and fluorescence-activated cell sorted and purified CD34+ cells (p = .01) relative to control animals at > or = 14 months of age. Peripheral blood chimerism, both at birth and long term, was similar in immune-suppressed and control animals. In the animals receiving postnatal donor cell infusions, there was an initial increase in progenitor chimerism; however, at 6-month follow-up, the level of chimerism was unchanged from the preinfusion values. Although fetal immune suppression was associated with an increase in the level of progenitor and marrow chimerism, the total contribution to marrow and the levels of mature donor progeny in the peripheral blood remained low. The level of long-term chimerism also was not improved with postnatal donor cell infusion.
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http://dx.doi.org/10.1634/stemcells.22-5-759DOI Listing
March 2005

A report of dizygous monochorionic twins.

N Engl J Med 2003 Jul;349(2):154-8

Division of Medical Genetics, Department of Medicine, University of Washington, Seattle, USA.

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http://dx.doi.org/10.1056/NEJMoa030050DOI Listing
July 2003

In utero hematopoietic stem cell transplantation in nonhuman primates: the role of T cells.

Stem Cells 2003 ;21(3):304-14

Department of Obstetrics and Gynecology, Division of Perinatal Medicine, University of Washington, Seattle, Washington 98105, USA.

In utero transplantation of hematopoietic stem cells is a promising treatment for immune and hematologic diseases of fetuses and newborns. Unfortunately, there are limited data from nonhuman primates and humans describing optimal transplantation conditions. The purpose of this investigation was to determine the effect of T-cell number on engraftment and the level of chimerism after in utero transplantation in nonhuman primates. CD34(+) allogeneic adult bone marrow cells, obtained from the sire after G-CSF and stem cell factor administration, were transplanted into female fetal recipients. The average CD34(+) cell dose was 3.0 x 10(9)/kg (range, 9.9 x 10(8) to 4.4 x 10(9)) and the T-cell dose ranged from 2.6 x 10(5) to 1.1 x 10(8)/kg. Chimerism was determined in peripheral blood subsets (CD2, CD13, and CD20) and in progenitor cell populations by using polymerase chain reaction. Chimerism was noted in seven of eight live-born animals. The level of chimerism in the progenitor population was related to the fetal T-cell dose (r = 0.64, p < 0.02). At the lowest T-cell dose (2.6 x 10(5)/kg), no chimerism was detected. As the T-cell dose increased to 10(6-7)/kg, the level of chimerism increased. Adjusting the T-cell dose to 1.1 x 10(8)/kg resulted in fatal graft-versus-host disease (GVHD). The results of this study emphasize the importance of T cells in facilitating donor cell engraftment and in producing GVHD in fetal nonhuman primates. Some animals achieved levels of chimerism in the marrow hematopoietic progenitor cell population that would likely have clinical relevance. However, the levels of chimerism in peripheral blood were too low for therapeutic benefit. Further studies are needed to test methods that are likely to enhance donor cell engraftment and peripheral blood levels of donor cells.
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http://dx.doi.org/10.1634/stemcells.21-3-304DOI Listing
February 2004

Fetal hematopoietic stem cell transplantation: a challenge for the twenty-first century.

J Hematother Stem Cell Res 2002 Aug;11(4):617-31

Department of Obstetrics and Gynecology, University of Washington School of Medicine, Seattle WA 98195-6460, USA.

Successful in utero hematopoietic stem cell transplantation will likely represent a major step forward in the management of patients with congenital hematological, metabolic, and immunological disorders. We review the naturally occurring models of hematopoietic chimerism in animals and humans, as well as available experimental animal data and human clinical attempts of fetal transplantation. Data available from naturally occurring models and experimental models of fetal transplantation suggest that this technique should be translatable to the human fetus. However, to date, the success of human fetal hematopoietic stem cell therapy has been limited to fetuses with severe immunologic defects. Evaluation of successful attempts of human transplantation, the ontogeny of fetal immune development, and data available from animals provide insights into innovative approaches to fetal therapy that may bring the reality of successful fetal transplantation closer.
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http://dx.doi.org/10.1089/15258160260194767DOI Listing
August 2002