Feasibility and impact of a mental health chatbot on postpartum mental health: a randomized controlled trial.

BACKGROUND: Perinatal mood disorders are common yet underdiagnosed and un- or undertreated. Barriers exist to accessing perinatal mental health services, including limited availability, time, and cost. Automated conversational agents (chatbots) can deliver evidence-based cognitive behavioral therapy content through text message-based conversations and reduce depression and anxiety symptoms in select populations. Such digital mental health technologies are poised to overcome barriers to mental health care access but need to be evaluated for efficacy, as well as for preliminary feasibility and acceptability among perinatal populations. OBJECTIVE: To evaluate the acceptability and preliminary efficacy of a mental health chatbot for mood management in a general postpartum population. STUDY DESIGN: An unblinded randomized controlled trial was conducted at a tertiary academic center. English-speaking postpartum women aged 18 years or above with a live birth and access to a smartphone were eligible for enrollment prior to discharge from delivery hospitalization. Baseline surveys were administered to all participants prior to randomization to a mental health chatbot intervention or to usual care only. The intervention group downloaded the mental health chatbot smartphone application with perinatal-specific content, in addition to continuing usual care. Usual care consisted of routine postpartum follow up and mental health care as dictated by the patient's obstetric provider. Surveys were administered during delivery hospitalization (baseline) and at 2-, 4-, and 6-weeks postpartum to assess depression and anxiety symptoms. The primary outcome was a change in depression symptoms at 6-weeks as measured using two depression screening tools: Patient Health Questionnaire-9 and Edinburgh Postnatal Depression Scale. Secondary outcomes included anxiety symptoms measured using Generalized Anxiety Disorder-7, and satisfaction and acceptability using validated scales. Based on a prior study, we estimated a sample size of 130 would have sufficient (80%) power to detect a moderate effect size (d=.4) in between group difference on the Patient Health Questionnaire-9. RESULTS: A total of 192 women were randomized equally 1:1 to the chatbot or usual care; of these, 152 women completed the 6-week survey (n=68 chatbot, n=84 usual care) and were included in the final analysis. Mean baseline mental health assessment scores were below positive screening thresholds. At 6-weeks, there was a greater decrease in Patient Health Questionnaire-9 scores among the chatbot group compared to the usual care group (mean decrease=1.32, standard deviation=3.4 vs mean decrease=0.13, standard deviation=3.01, respectively). 6-week mean Edinburgh Postnatal Depression Scale and Generalized Anxiety Disorder-7 scores did not differ between groups and were similar to baseline. 91% (n=62) of the chatbot users were satisfied or highly satisfied with the chatbot, and 74% (n=50) of the intervention group reported use of the chatbot at least once in 2 weeks prior to the 6-week survey. 80% of study participants reported being comfortable with the use of a mobile smartphone application for mood management. CONCLUSION: Use of a chatbot was acceptable to women in the early postpartum period. The sample did not screen positive for depression at baseline and thus the potential of the chatbot to reduce depressive symptoms in this population was limited. This study was conducted in a general obstetric population. Future studies of longer duration in high-risk postpartum populations who screen positive for depression are needed to further understand the utility and efficacy of such digital therapeutics for that population.

Moms in the NICU: developing a pilot to engage and empower women who have delivered a prematurely born infant.

BACKGROUND: Mothers spend long hours at their preterm infant's bedside in the Neonatal Intensive Care Unit (NICU), giving clinicians the opportunity to engage mothers in caring for their own health. OBJECTIVE: To develop a NICU based intervention to reduce the risk of a future premature birth by engaging and empowering mothers to improve their own health and identify barriers to implementing their improvement. DESIGN: Development based on a framework of narrative discourse refined by the Quality Improvement Plan Do Study Act Approach. SETTING: Level II Stepdown Neonatal Intensive Care Unit. PARTICIPANTS: 14 mothers of preterm infants, ages 24-39 years. METHODS: A team of Maternal Fetal Medicine Physicians, obstetricians, neonatologists, neonatal nurses, and parents developed guidelines to elicit the mother's birth story, review the story with a clinical expert to fill in knowledge gaps, identify strategies to improve health to reduce the risk of future preterm birth, and facilitate mother developing an action plan with specific six week goals. A phone interview was designed to assess success and identify barriers to implementing their health plan. The protocol was modified as needed after each intervention to improve the interventions. RESULTS: "Moms in the NICU" toolkit is effective to guide any clinical facilitator to engage, identify health improvement strategies, and co-develop an individualized health plan and its take home summary reached stability after the 5th mother. Mothers reported experiencing reassurance, understanding, and in some cases, relief. Participants were enthusiastic to inform future quality improvement activities by sharing the six week barriers faced implementing their health plan. CONCLUSION: Engaging in the NICU provides an opportunity to improve mothers' understanding of potential factors that may be linked to preterm birth, and promote personally selected actions to improve their health and reduce the risk of a future preterm birth.

Automated Alert System of Second-Line Uterotonic Drug Administration.

Multidisciplinary team management of postpartum hemorrhage (PPH) is needed to optimize care and improve outcomes. Lucile Packard Children's Hospital, Stanford, is a tertiary referral center with 4600 deliveries/y (>70% high-risk deliveries), and there have been times when the obstetric anesthesia team was alerted late or not at all for PPHs. Introduction of an automated alert process to the obstetric anesthesia team when a second-line uterotonic drug was administered has ensured prompt evaluation. Utilization of this automated drug alert system has improved communication and reduced failure to inform the obstetric anesthesiology team of PPH after vaginal and cesarean deliveries.

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.