Virtual simulation training for postpartum hemorrhage in low-to-moderate-volume hospitals in the US.

Background: Maternal mortality in the United States is rising and many deaths are preventable. Emergencies, such as postpartum hemorrhage, occur less frequently in non-teaching, rural, and urban low-birth volume hospitals. There is an urgent need for accessible, evidence-based, and sustainable inter-professional education that creates the opportunity for clinical teams to practice their response to rare, but potentially devastating events. Objective: To assess the feasibility of virtual simulation training for the management of postpartum hemorrhage in low-to-moderate-volume delivery hospitals. Study design: The study occurred between December 2021 and March 2022 within 8 non-academic hospitals in the United States with low-to-moderate-delivery volumes, randomized to one of two models: direct simulation training and train-the-trainer. In the direct simulation training model, simulation faculty conducted a virtual simulation training program with participants. In the train-the-trainer model, simulation faculty conducted virtual lessons with new simulation instructors on how to prepare and conduct a simulation course. Following this training, the instructors led their own simulation training program at their respective hospitals. The direct simulation training participants and students trained by new instructors from the train-the-trainer program were evaluated with a multiple-choice questionnaire on postpartum hemorrhage knowledge and a confidence and attitude survey at 3 timepoints: prior to, immediately after, and at 3 months post-training. Paired t-tests were performed to assess for changes in knowledge and confidence within teaching models across time points. ANOVA was performed to test cross-sectionally for differences in knowledge and confidence between teaching models at each time point. Results: Direct simulation training participants (n=22) and students of the train-the-trainer instructors (n=18) included nurses, certified nurse midwives and attending physicians in obstetrics, family practice or anesthesiology. Mean pre-course knowledge and confidence scores were not statistically different between direct simulation participants and the students of the instructors from the train-the-trainer course (79%+/-13 versus 75%+/-14, respectively, P-value=.45). Within the direct simulation group, knowledge and confidence scores significantly improved from pre- to immediately post-training (knowledge score mean difference 9.81 [95% CI 3.23-16.40], P-value<.01; confidence score mean difference 13.64 [95% CI 6.79-20.48], P-value<.01), which were maintained 3-months post-training. Within the train-the-trainer group, knowledge and confidence scores immediate post-intervention were not significantly different compared with pre-course or 3-month post-course scores. Mean knowledge scores were significantly greater for the direct simulation group compared to the train-the-trainer group immediately post-training (89%+/-7 versus 74%+/-8, P-value<.01) and at 3-months (88%+/-7 versus 76%+/-12, P-value<.01). Comparisons between groups showed no difference in confidence and attitude scores at these timepoints. Both direct simulation participants and train-the-trainer instructors preferred virtual education, or a hybrid structure, over in-person education. Conclusion: Virtual education for obstetric simulation training is feasible, acceptable, and effective. Utilizing a direct simulation model for postpartum hemorrhage management resulted in enhanced knowledge acquisition and retention compared to a train-the-trainer model.

Clinical and Physician Factors Associated With Failed Operative Vaginal Delivery.

OBJECTIVE: To examine clinical and physician factors associated with failed operative vaginal delivery among individuals with nulliparous, term, singleton, vertex (NTSV) births. METHODS: This was a retrospective cohort study of individuals with NTSV live births with an attempted operative vaginal delivery by a physician between 2016 and 2020 in California. The primary outcome was cesarean birth after failed operative vaginal delivery, identified using linked diagnosis codes, birth certificates, and physician licensing board data stratified by device type (vacuum or forceps). Clinical and physician-level exposures were selected a priori, defined using validated indices, and compared between successful and failed operative vaginal delivery attempts. Physician experience with operative vaginal delivery was estimated by calculating the number of operative vaginal delivery attempts made per physician during the study period. Multivariable mixed effects Poisson regression models with robust standard errors were used to estimate risk ratios of failed operative vaginal delivery for each exposure, adjusted for potential confounders. RESULTS: Of 47,973 eligible operative vaginal delivery attempts, 93.2% used vacuum and 6.8% used forceps. Of all operative vaginal delivery attempts, 1,820 (3.8%) failed; the success rate was 97.3% for vacuum attempts and 82.4% for forceps attempts. Failed operative vaginal deliveries were more likely with older patient age, higher body mass index, obstructed labor, and neonatal birth weight more than 4,000 g. Between 2016 and 2020, physicians who attempted more operative vaginal deliveries were less likely to fail. When vacuum attempts were successful, physicians who conducted them had a median of 45 vacuum attempts during the study period, compared with 27 attempts when vacuum attempts were unsuccessful (adjusted risk ratio [aRR] 0.95, 95% CI 0.93-0.96). When forceps attempts were successful, physicians who conducted them had a median of 19 forceps attempts, compared with 11 attempts when forceps attempts were unsuccessful (aRR 0.76, 95% CI 0.64-0.91). CONCLUSION: In this large, contemporary cohort with NTSV births, several clinical factors were associated with operative vaginal delivery failure. Physician experience was associated with operative vaginal delivery success, more notably for forceps attempts. These results may provide guidance for physician training in maintenance of operative vaginal delivery skills.

Ampicillin Pharmacokinetics in Peripartum and Laboring Women.

OBJECTIVE: Ampicillin is used for multiple peripartum indications including prevention of neonatal group B streptococcus (GBS) and treatment of chorioamnionitis. Despite its widespread use in obstetrics, existing pharmacokinetic data for ampicillin do not address contemporary indications or dosing paradigms for this population. We sought to characterize the pharmacokinetic profile of ampicillin administered to laboring women. STUDY DESIGN: Using whole blood dried blood spot sampling technique, maternal blood samples were collected at specified times from 31 women receiving intravenous (IV) ampicillin for peripartum indications. Women received either a 2-g loading dose with 1-g administered every 4 hours (GBS) or 2-g every 6 hours (chorioamnionitis). Pharmacokinetics were analyzed via a population approach with nonlinear mixed-effect modeling. RESULTS: The data were best described by a two-compartment model with first-order elimination, with the following whole blood parameters: central volume of distribution (V1), 75.2 L (95% confidence interval [CI]: 56.3-93.6); clearance (CL), 82.4 L/h (95% CI: 59.7-95.7); intercompartmental clearance (Q), 20.9 L/h (95% CI: 16.2-38.2); and peripheral volume of distribution (V2), 61.1 L (95% CI: 26.1-310.5). Interpatient variation in CL and V1 was large (42.0 and 56.7%, respectively). Simulations of standard dosing strategies demonstrated over 98% of women are predicted to achieve an estimated free plasma concentration above mean inhibitory concentration (MIC) of 0.5 µg/mL for more than 50% of the dosing interval. CONCLUSION: Although large variation in the pharmacokinetics of ampicillin in pregnant women exists, as predicted by our model, current standard dosing strategies achieve adequate exposure for GBS in nearly all patients. KEY POINTS: · IV ampicillin is widely used in obstetrics.. · Pharmacokinetic studies are lacking.. · Ampicillin pharmacokinetics were established.. · Ampicillin clearance and volume of distribution are high.. · Current ampicillin dosing strategies are sufficient..

Severe maternal and neonatal morbidity after attempted operative vaginal delivery.

BACKGROUND: Operative vaginal delivery is a critical tool in reducing primary cesarean delivery, but declining operative vaginal delivery rates and concerns about provider skill necessitate a clear understanding of risks. These risks are ambiguous because most studies compare outcomes of operative vaginal delivery with that of spontaneous vaginal delivery rather than outcomes of cesarean delivery in the second stage of labor, which is usually the realistic alternative. OBJECTIVE: This study aimed to compare severe maternal and neonatal morbidity by mode of delivery of patients with a prolonged second stage of labor who had a successful operative vaginal delivery, a cesarean delivery after failed operative vaginal delivery, or a cesarean delivery without an operative vaginal delivery attempt. STUDY DESIGN: We used a population-based database to evaluate nulliparous, term, singleton, vertex live births in California between 2007 and 2012 of patients with prolonged second stage of labor. Birth certificates and the International Classification of Diseases, Ninth Revision, Clinical Modification coded diagnoses and procedures were used for ascertainment of exposure, outcome, and demographics. Exposure was mode of delivery of patients who had any operative vaginal delivery attempt vs cesarean delivery without operative vaginal delivery attempt. The outcomes were severe maternal morbidity and severe unexpected newborn morbidity, defined using established indices. Anticipating that the code for prolonged second stage of labor would represent only a fraction of true operative vaginal delivery candidates, a secondary analysis was conducted removing this restriction to explore granular outcomes in a larger cohort with unsuccessful labor. Multivariable logistic regression was used to compare outcomes by mode of delivery adjusted for measured confounders. Sensitivity analyses were done excluding patients with combined vacuum-forceps-assisted delivery and birthweight of >4000 g. RESULTS: A total of 9239 births after prolonged second stage of labor were included, where 6851 (74.1%) were successful operative vaginal deliveries, 301 (3.3%) were failed operative vaginal deliveries, and 2087 (22.6%) were cesarean deliveries without operative vaginal delivery attempts. Of successful operative vaginal deliveries, 6195 (90.4%) were vacuum assisted and 656 (10.6%) were forceps-assisted. Of failed operative vaginal deliveries where operative vaginal delivery type was specified, 83 (47.4%) were vacuum assisted, 38 (21.7%) were forceps-assisted, and 54 (30.9%) were combined vacuum-forceps-assisted. Of note, all 54 combined vacuum-forceps-assisted operative vaginal delivery attempts that we identified failed. The outcomes of patients with failed operative vaginal delivery differed from those with successful operative vaginal delivery, such as higher rates of comorbidities, use of combined operative vaginal delivery, and birthweight of >4000 g. Successful operative vaginal delivery was associated with reduced severe maternal morbidity (adjusted odds ratio, 0.55; 95% confidence interval, 0.39-0.78) without a difference in severe unexpected neonatal morbidity (adjusted odds ratio, 0.99; 95% confidence interval, 0.78-1.26). In contrast, failed operative vaginal delivery was associated with increased severe maternal morbidity (adjusted odds ratio, 2.14; 95% confidence interval, 1.20-3.82) and severe unexpected neonatal morbidity (adjusted odds ratio, 1.78; 95% confidence interval, 1.09-2.86). In addition, findings were similar in the secondary analysis of 260,585 patients with unsuccessful labor. CONCLUSION: In this large cohort of nulliparous, term, singleton, vertex births, successful operative vaginal delivery was associated with a 45% reduction in severe maternal morbidity without differences in severe unexpected neonatal morbidity compared with cesarean delivery after prolonged second stage of labor. Operative vaginal delivery infrequently failed and was associated with a 214% increase in severe maternal morbidity and a 78% increase in severe unexpected neonatal morbidity; furthermore, combined operative vaginal deliveries were major contributors to this, as all combined operative vaginal deliveries failed. Optimization of operative vaginal delivery success rates through means such as improved patient selection, enhanced provider skill, and discussions against combined operative vaginal delivery could reduce maternal and neonatal complications.

Differential Dynamics of the Maternal Immune System in Healthy Pregnancy and Preeclampsia.

Preeclampsia is one of the most severe pregnancy complications and a leading cause of maternal death. However, early diagnosis of preeclampsia remains a clinical challenge. Alterations in the normal immune adaptations necessary for the maintenance of a healthy pregnancy are central features of preeclampsia. However, prior analyses primarily focused on the static assessment of select immune cell subsets have provided limited information for the prediction of preeclampsia. Here, we used a high-dimensional mass cytometry immunoassay to characterize the dynamic changes of over 370 immune cell features (including cell distribution and functional responses) in maternal blood during healthy and preeclamptic pregnancies. We found a set of eight cell-specific immune features that accurately identified patients well before the clinical diagnosis of preeclampsia (median area under the curve (AUC) 0.91, interquartile range [0.82-0.92]). Several features recapitulated previously known immune dysfunctions in preeclampsia, such as elevated pro-inflammatory innate immune responses early in pregnancy and impaired regulatory T (Treg) cell signaling. The analysis revealed additional novel immune responses that were strongly associated with, and preceded the onset of preeclampsia, notably abnormal STAT5ab signaling dynamics in CD4+T cell subsets (AUC 0.92, p = 8.0E-5). These results provide a global readout of the dynamics of the maternal immune system early in pregnancy and lay the groundwork for identifying clinically-relevant immune dysfunctions for the prediction and prevention of preeclampsia.

Systolic Hypertension, Preeclampsia-Related Mortality, and Stroke in California.

OBJECTIVE: To describe the clinical characteristics of stroke and opportunities to improve care in a cohort of preeclampsia-related maternal mortalities in California. METHODS: The California Pregnancy-Associated Mortality Review retrospectively examined a cohort of preeclampsia pregnancy-related deaths in California from 2002 to 2007. Stroke cases were identified among preeclampsia deaths, and case summaries were reviewed with attention to clinical variables, particularly hypertension. Health care provider- and patient-related contributing factors were also examined. RESULTS: Among 54 preeclampsia pregnancy-related deaths that occurred in California from 2002 to 2007, 33 were attributed to stroke. Systolic blood pressure exceeded 160 mm Hg in 96% of cases, and diastolic blood pressure was 110 or higher in 65% of cases. Hemolysis, elevated liver enzymes, and low platelet count syndrome was present in 38% (9/24) of cases with available laboratory data; eclampsia occurred in 36% of cases. Headache was the most frequent symptom (87%) preceding stroke. Elevated liver transaminases were the most common laboratory abnormality (71%). Only 48% of women received antihypertensive treatment. A good-to-strong chance to alter outcome was identified in stroke cases 66% (21/32), with delayed response to clinical warning signs in 91% (30/33) of cases and ineffective treatment in 76% (25/33) cases being the most common areas for improvement. CONCLUSION: Stroke is the major cause of maternal mortality associated with preeclampsia or eclampsia. All but one patient in this series of strokes demonstrated severe elevation of systolic blood pressure, whereas other variables were less consistently observed. Antihypertensive treatment was not implemented in the majority of cases. Opportunities for care improvement exist and may significantly affect maternal mortality.

Development of the TeamOBS-PPH - targeting clinical performance in postpartum hemorrhage.

INTRODUCTION: This study aimed to develop a valid and reliable TeamOBS-PPH tool for assessing clinical performance in the management of postpartum hemorrhage (PPH). The tool was evaluated using video-recordings of teams managing PPH in both real-life and simulated settings. MATERIAL AND METHODS: A Delphi panel consisting of 12 obstetricians from the UK, Norway, Sweden, Iceland, and Denmark achieved consensus on (i) the elements to include in the assessment tool, (ii) the weighting of each element, and (iii) the final tool. The validity and reliability were evaluated according to Cook and Beckman. (Level 1) Four raters scored four video-recordings of in situ simulations of PPH. (Level 2) Two raters scored 85 video-recordings of real-life teams managing patients with PPH ≥1000 mL in two Danish hospitals. (Level 3) Two raters scored 15 video-recordings of in situ simulations of PPH from a US hospital. RESULTS: The tool was designed with scores from 0 to 100. (Level 1) Teams of novices had a median score of 54 (95% CI 48-60), whereas experienced teams had a median score of 75 (95% CI 71-79; p < 0.001). (Level 2) The intra-rater [intra-class correlation (ICC) = 0.96] and inter-rater (ICC = 0.83) agreements for real-life PPH were strong. The tool was applicable in all cases: atony, retained placenta, and lacerations. (Level 3) The tool was easily adapted to in situ simulation settings in the USA (ICC = 0.86). CONCLUSION: The TeamOBS-PPH tool appears to be valid and reliable for assessing clinical performance in real-life and simulated settings. The tool will be shared as the free TeamOBS App.

Disseminated Intravascular Coagulation Complicating the Conservative Management of Placenta Percreta.

BACKGROUND: Retention of the placenta is an option in the management of placenta percreta; however, it may be associated with significant morbidity. CASE: We present a case of conservative management of placenta percreta. Disseminated intravascular coagulation (DIC) developed 49 days after delivery. An urgent hysterectomy was performed, followed by rapid normalization of coagulation parameters. CONCLUSION: Disseminated intravascular coagulation may complicate the conservative management of placenta percreta and can manifest weeks after delivery in the absence of antecedent hemorrhage or infection. The time course and presentation of this case are similar to the development of DIC after prolonged retention of a fetal demise with a probable shared pathophysiology. Close follow-up may facilitate prompt diagnosis of DIC, thereby minimizing associated morbidity.