The New York State Safe Motherhood Initiative: Early Impact of Obstetric Hemorrhage Bundle Implementation.

OBJECTIVE: To determine the effects of the Safe Motherhood Initiative's (SMI) obstetric hemorrhage bundle in New York State (NYS). STUDY DESIGN: In 2013, the SMI convened interprofessional workgroups on hemorrhage, venous thromboembolism, and hypertension tasked with developing evidence-based care bundles. Participating hospitals submitted data measured before, during, and after implementation of the hemorrhage bundle: maternal mortality, intensive care unit (ICU) admission, cardiovascular collapse, hysterectomy, and transfusion of ≥4 units of red blood cells (RBCs). Data were analyzed for trends stratified by implementation status. RESULTS: Of the 123 maternity hospitals in NYS, 117 participated, of which 113 submitted data. Of 250,719 births, transfusion of ≥4 units RBCs (1.8 per 1,000) and ICU admissions (1.1 per 1,000) were the most common morbidities. Four hemorrhage-related maternal deaths (1.6 per 100,000) and 10 cases of cardiovascular collapse requiring cardiopulmonary resuscitation (4.0 per 100,000) occurred. Hemorrhage morbidity did not change over the five quarters studied. Risks were similar across hospital level of care and implementation status. CONCLUSION: Statewide implementation of bundles is feasible with resources critical to success. The low hemorrhage-related maternal death rate makes changes in mortality risk difficult to detect over short time intervals. Long-term and timely data collection with individual expert case review will be required.

Implementing Obstetric Venous Thromboembolism Protocols on a Statewide Basis: Results from New York State's Safe Motherhood Initiative.

OBJECTIVE: To determine whether a state-level initiative to reduce obstetric venous thromboembolism (VTE) risk affected outcomes and process measures. METHODS: In 2013, the Safe Motherhood Initiative (SMI) developed a VTE safety bundle to reduce obstetric VTE risk. A total of 117 of 124 hospitals providing obstetrical services in New York participated in SMI. Data evaluating thromboembolism events (deep vein thrombosis and pulmonary embolism) and thromboprophylaxis process measures were collected from March through November 2015. RESULTS: A total of 107 hospitals, in any individual quarter, reported data on each of the VTE bundle outcomes and measures. Centers that provided low-risk care (Level 1 centers) reported the lowest rate of bundle implementation at the end of the study period (55.6%). Mechanical prophylaxis for a cesarean was common at all centers. Hospitals that adopted the bundle were more likely to provide routine pharmacologic prophylaxis for women undergoing cesarean. The risk of VTE did not differ by bundle implementation. CONCLUSION: While adoption of the SMI VTE bundle occurred at a majority of centers across New York, uptake was less likely at low-acuity centers. Bundle adoption was associated with implementation of recommended practices. The rare nature of VTE events underscores the need for large data samples to determine the best prophylaxis strategies.

Cerclage in twin pregnancy with dilated cervix between 16 to 24 weeks of gestation: retrospective cohort study.

BACKGROUND: Cervical dilation in the second trimester is associated with a greater than 90% rate of spontaneous preterm birth and a poor perinatal prognosis. OBJECTIVE: To compare the perinatal outcomes of twin pregnancies with dilated cervix in women who underwent either cerclage or expectant management. STUDY DESIGN: Retrospective cohort study of asymptomatic twin pregnancies identified with cervical dilation of ≥1 cm at 16-24 weeks (1997-2014) at 7 institutions. Exclusion criteria were genetic or major fetal anomaly, multifetal reduction at >14 weeks, prior cerclage placement, monochorionic-monoamniotic placentation, active vaginal bleeding, labor, chorioamnionitis, elective termination of pregnancy, or medically indicated preterm birth. The primary outcome was incidence of spontaneous preterm birth at <34 weeks. Secondary outcomes were incidence of spontaneous preterm birth at <32 weeks, <28 weeks, and <24 weeks; perinatal mortality; and composite adverse neonatal outcome (respiratory distress syndrome, intraventricular hemorrhage, necrotizing enterocolitis, and sepsis). RESULTS: A total of 76 women with twin pregnancy with dilated cervix of 1.0-4.5 cm were managed with either cerclage (n = 38) or expectant management (n = 38). Demographic characteristics were not significantly different. Analysis was adjusted for amniocentesis and vaginal progesterone use. In the cerclage group, 29 women (76%) received prophylactic indomethacin and 36 (94%) received prophylactic antibiotics, whereas the expectant management group did not. Interval from time at diagnosis of open cervix to delivery in the cerclage group was 10.46 ± 5.6 weeks vs 3.7 ± 3.2 weeks in the expectant management group, with a mean difference of 6.76 weeks (95% confidence interval [CI], 4.71-8.81). There were significant decreases in spontaneous preterm birth at <34 weeks (52.6% vs 94.7%; adjusted odds ratio [aOR], 0.06; 95% CI, 0.03-0.34), at <32 weeks (44.7% vs 89.4%; aOR, 0.08; 95% CI, 0.03-0.34); at <28 weeks (31.6% vs 89.4%; aOR, 0.05; 95% CI, 0.01-0.2); and at <24 weeks (13.1% vs 47.3%; aOR, 0.17; 95% CI, 0.05-0.54). There were also significant reductions in perinatal mortality (27.6% vs 59.2%; aOR, 0.24; 95% CI, 0.11-0.5), neonatal intensive care unit admission (75.9% vs 97.6%; aOR, 0.07; 95% CI, 0.01-0.66), and composite adverse neonatal outcome (33.9% vs 90.5%; aOR, 0.05; 95% CI, 0.01-0.21). CONCLUSION: Cerclage, indomethacin, and antibiotics in twin pregnancies with dilated cervix ≥1 cm before 24 weeks were associated with significant longer latency period from diagnosis to delivery (6.7 weeks), decreased incidence of spontaneous preterm birth at any given gestational age, and improved perinatal outcome when compared with expectant management.

Efficacy of ultrasound-indicated cerclage in twin pregnancies.

OBJECTIVE: We sought to compare the perinatal outcomes in twin pregnancies with short cervical length (CL) with ultrasound-indicated cerclage (UIC) vs no cerclage (control). STUDY DESIGN: This was a retrospective cohort study of asymptomatic twin pregnancies with transvaginal ultrasound (TVU) CL ≤25 mm at 16-24 weeks from 1995 through 2012 at 4 separate institutions. Exclusion criteria were: genetic or major fetal anomaly, multifetal reduction >14 weeks, monochorionic-monoamniotic placentation, or medically indicated preterm birth (PTB). Primary outcome was spontaneous PTB (SPTB) <34 weeks. Secondary outcome was SPTB <28, <32, and <37 weeks. We also planned to evaluate primary and secondary outcome for the subgroup of twin pregnancies with CL ≤15 mm. RESULTS: In all, 140 women with twin pregnancy and TVU-CL ≤25 mm were managed with either UIC (n = 57) or no cerclage (n = 83). Demographic characteristics were not significantly different except women who underwent UIC presented at an earlier gestational age (GA) at diagnosis of short CL. After adjusting for GA at presentation, there were no differences in GA at delivery or SPTB <28 weeks: 12 (21.2%) vs 20 (24.1%) (adjusted odds ratio [aOR], 0.3; 95% confidence interval [CI], 0.68-1.37), <32 weeks: 22 (38.6%) vs 36 (43.4%) aOR, 0.34; 95% CI, 0.1-1.13), or <34 weeks: 29 (50.9%) vs 53 (63.9%) (aOR, 0.37; 95% CI, 0.16-1.1). In the subgroup of women with CL ≤15 mm (32 with UIC and 39 controls) the interval between diagnosis to delivery was significantly prolonged by 12.5 ± 4.5 vs 8.8 ± 4.6 weeks (P < .001); SPTB <34 weeks was significantly decreased: 16 (50%) vs 31 (79.5%) (aOR, 0.51; 95% CI, 0.31-0.83) as was admission to neonatal intensive care unit: 38/58 (65.5%) vs 63/76 (82.9%) (aOR, 0.42; 95% CI, 0.24-0.81) when the UIC group was compared with the control group, respectively. CONCLUSION: UIC in asymptomatic twin pregnancies with TVU-CL ≤25 mm was not associated with significant effects on perinatal outcomes compared to controls. However, in the planned subgroup analysis of asymptomatic twin pregnancies with TVU-CL ≤15 mm before 24 weeks, UIC was associated with a significant prolongation of pregnancy by almost 4 more weeks, significantly decreased SPTB <34 weeks by 49%, and admission to neonatal intensive care unit by 58% compared with controls.

2009 H1N1 vaccination by pregnant women during the 2009-10 H1N1 influenza pandemic.

OBJECTIVE: Pregnant women were identified at greater risk and given priority for 2009 H1N1 vaccination during the 2009 through 2010 H1N1 pandemic. We identified factors associated with acceptance or refusal of 2009 H1N1 vaccination during pregnancy. STUDY DESIGN: We conducted an in-person survey of postpartum women on the labor and delivery service from June 17 through Aug. 13, 2010, at 4 New York hospitals. RESULTS: Of 1325 survey respondents, 34.2% received 2009 H1N1 vaccination during pregnancy. A provider recommendation was most strongly associated with vaccine acceptance (odds ratio [OR], 19.4; 95% confidence interval [CI], 12.7-31.1). Also more likely to take vaccine were women indicating the vaccine was safe for the fetus (OR, 12.4; 95% CI, 8.3-19.0) and those who previously took seasonal flu vaccination (OR, 7.9; 95% CI, 5.8-10.7). Race, education, income, and age were less important in accepting vaccine. CONCLUSION: Greater emphasis on vaccine safety and provider recommendation is needed to increase the number of women vaccinated during pregnancy.

Severe Maternal Morbidity Associated with Systemic Lupus Erythematosus Flare in the Second Trimester of Pregnancy.

Pregnancy in women with systemic lupus erythematosus (SLE) is associated with an increased risk of adverse maternal and fetal outcomes. Here, we present a case of severe maternal morbidity in a 23-year-old primigravida with SLE and secondary Sjögren's syndrome who experienced a life-threatening multisystem flare at 17 weeks of gestational age. She presented to the emergency department complaining of cough with hemoptysis and shortness of breath. She developed hypoxic respiratory failure and was admitted to the intensive care unit. Bronchoscopy confirmed diffuse alveolar hemorrhage. Physical exam and laboratory evaluation were consistent with an active SLE flare, pancytopenia, and new-onset lupus nephritis. After counseling regarding disease severity, poor prognosis, and recommendation for therapy with cytotoxic agents, she agreed to interruption of pregnancy which was achieved by medical induction. Her course was further complicated by thrombotic microangiopathy and generalized tonic-clonic seizures attributable to posterior reversible encephalopathy syndrome versus neuropsychiatric SLE. This case represents one of the most extreme manifestations of lupus disease activity associated with pregnancy that has been reported in the literature and emphasizes the importance of preconception evaluation and counseling and a multidisciplinary management approach in cases with a complex and evolving clinical course.

Shock index and vital-sign reference ranges during the immediate postpartum period.

OBJECTIVE: To determine reference ranges for patient vital signs during the immediate postpartum period. METHODS: A retrospective chart review collected data on the variables of interest for all women with 0-24-hour postpartum data available at two hospitals in the USA, between July 1, 2012, and January 31, 2015. Patients were excluded if they had received antihypertensives, uterotonics, or blood products. Regression lines, with 95% prediction intervals, were constructed for shock index, systolic blood pressure, heart rate, pulse pressure, and rate over pressure evaluation (ROPE) values. RESULTS: There were 8874 patients and 87 336 data measurements included in the analysis. During the 24 hours following delivery, an increase in ROPE values, and decreases in pulse pressure, heart rate, and systolic blood pressure were recorded for all patients; an increase in shock index was observed among patients who had cesarean deliveries. Anomalous values for the shock index (>1.0), and reference ranges for pulse pressure (21.09-69.32 mm Hg), ROPE (1.01-3.22 bpm/mm Hg), heart rate (51-112 bpm), and SBP (81-137 mm Hg) were generated. CONCLUSION: Specific reference ranges for patients during the postpartum period could be used in future studies to determine the parameters, or combinations of parameters, that perform best as early markers of hemodynamic compromise in women experiencing early postpartum hemorrhage.

Diagnosis of placental abscess in association with recurrent maternal bacteremia in a twin pregnancy.

BACKGROUND: Placental abscess formation is rarely recognized prenatally. We present a case detected ultrasonographically that developed from a central line infection and caused recurrent maternal bacteremia. CASE: A young woman with a 21-week twin gestation presented with recurrent fevers. She had received treatment for bacteremia due to Serratia marcescens. The initial source of the infection was a peripherally inserted central catheter line placed in the first trimester for hyperemesis gravidarum. Fevers continued throughout the second course of antibiotics. An abscess seen sonographically in twin A's placenta was aspirated using a spinal needle, revealing Serratia bacteria. Aspiration was performed at 22 weeks of gestation. Amniotic fluid samples obtained from both sacs were negative for infection. Over 4 weeks, the abscess enlarged and she was delivered. Twin A died of sepsis and twin B had a relatively favorable neonatal course. CONCLUSION: Prenatal diagnosis of placental abscess presents a difficult management dilemma. Traditional amniotic fluid studies did not predict the poor outcome of the affected fetus.

Care bundles for management of obstetrical hemorrhage.

Peripartum hemorrhage is one of the most preventable causes of maternal mortality worldwide. Much effort has been directed toward creating programs that address deficits in maternity care responsible for preventable hemorrhage-related morbidity and mortality. To have a significant impact on outcomes, such programs must address both providers and processes involved in the delivery of maternity care. At the core of a successful program, are standardized care bundles integrating medical and surgical techniques for managing hemorrhage with principles of transfusion medicine and critical care. In this article, we review the components of the safety bundle for obstetric hemorrhage developed by ACOG District II Safe Motherhood Initiative.

Conservative management of placenta previa percreta in a Jehovah's Witness.

BACKGROUND: Hemorrhage is a serious threat with placenta accreta, often requiring aggressive operative intervention by hysterectomy and resuscitative measures with large-volume blood replacement to ensure survival. Refusal to accept transfusion makes management especially difficult. CASE: We report a Jehovah's Witness patient who had 9 previous cesarean deliveries and presented with anemia and placenta previa percreta invading the bladder wall. Management objectives were to enhance the patient's status, using erythropoietin and autologous transfusion, and to minimize the chance of hemorrhage by prophylactic uterine artery embolization. The placenta was left in situ after the delivery with no untoward consequences. Methotrexate was held in readiness, but was not required as adjuvant therapy. CONCLUSION: Effective care of such patients requires close collaborative team effort and advanced planning to ensure a good outcome.

Comprehensive perinatal safety initiative to reduce adverse obstetric events.

A comprehensive perinatal safety initiative (PSI) was incrementally introduced from August 2007 to July 2009 at a large tertiary medical center to reduce adverse obstetrical outcomes. The PSI introduced: (1) evidence-based protocols, (2) formalized team training with emphasis on communication, (3) standardization of electronic fetal monitoring with required documentation of competence, (4) a high-risk obstetrical emergency simulation program, and (5) dissemination of an integrated educational program among all healthcare providers. Eleven adverse outcome measures were followed prospectively via modification of the Adverse Outcome Index (MAOI). Additionally, individual components were evaluated. The logistic regression model found that within the first year, the MAOI decreased significantly to 0.8% from 2% (p<.0004) and was maintained throughout the 2-year period. Significant decreases over time for rates of return to the operating room (p<.018) and birth trauma (p<.0022) were also found. Finally, significant improvements were found in staff perceptions of safety (p<.0001), in patient perceptions of whether staff worked together (p<.028), in the management (p<.002), and documentation (p<.0001) of abnormal fetal heart rate tracings, and the documentation of obstetric hemorrhage (p<.019). This study demonstrates that a comprehensive PSI can significantly reduce adverse obstetric outcomes, thereby improving patient safety and enhancing staff and patient experiences.