Unsupervised denoising of the non-invasive fetal electrocardiogram with sparse domain Kalman filtering and vectorcardiographic loop alignment.

Objective.Even though the electrocardiogram (ECG) has potential to be used as a monitoring or diagnostic tool for fetuses, the use of non-invasive fetal ECG is complicated by relatively high amounts of noise and fetal movement during the measurement. Moreover, machine learning-based solutions to this problem struggle with the lack of clean reference data, which is difficult to obtain. To solve these problems, this work aims to incorporate fetal rotation correction with ECG denoising into a single unsupervised end-to-end trainable method.Approach.This method uses the vectorcardiogram (VCG), a three-dimensional representation of the ECG, as an input and extends the previously introduced Kalman-LISTA method with a Kalman filter for the estimation of fetal rotation, applying denoising to the rotation-corrected VCG.Main results.The resulting method was shown to outperform denoising auto-encoders by more than 3 dB while achieving a rotation tracking error of less than 33∘. Furthermore, the method was shown to be robust to a difference in signal to noise ratio between electrocardiographic leads and different rotational velocities.Significance.This work presents a novel method for the denoising of non-invasive abdominal fetal ECG, which may be trained unsupervised and simultaneously incorporates fetal rotation correction. This method might prove clinically valuable due the denoised fetal ECG, but also due to the method's objective measure for fetal rotation, which in turn might have potential for early detection of fetal complications.

Early prediction of gestational diabetes mellitus using maternal demographic and clinical risk factors.

OBJECTIVE: To build and validate an early risk prediction model for gestational diabetes mellitus (GDM) based on first-trimester electronic medical records including maternal demographic and clinical risk factors. METHODS: To develop and validate a GDM prediction model, two datasets were used in this retrospective study. One included data of 14,015 pregnant women from Máxima Medical Center (MMC) in the Netherlands. The other was from an open-source database nuMoM2b including data of 10,038 nulliparous pregnant women, collected in the USA. Widely used maternal demographic and clinical risk factors were considered for modeling. A GDM prediction model based on elastic net logistic regression was trained from a subset of the MMC data. Internal validation was performed on the remaining MMC data to evaluate the model performance. For external validation, the prediction model was tested on an external test set from the nuMoM2b dataset. RESULTS: An area under the receiver-operating-characteristic curve (AUC) of 0.81 was achieved for early prediction of GDM on the MMC test data, comparable to the performance reported in previous studies. While the performance markedly decreased to an AUC of 0.69 when testing the MMC-based model on the external nuMoM2b test data, close to the performance trained and tested on the nuMoM2b dataset only (AUC = 0.70).

Transferring an extremely premature infant to an extra-uterine life support system: a prospective view on the obstetric procedure.

To improve care for extremely premature infants, the development of an extrauterine environment for newborn development is being researched, known as Artificial Placenta and Artificial Womb (APAW) technology. APAW facilitates extended development in a liquid-filled incubator with oxygen and nutrient supply through an oxygenator connected to the umbilical vessels. This setup is intended to provide the optimal environment for further development, allowing further lung maturation by delaying gas exposure to oxygen. This innovative treatment necessitates interventions in obstetric procedures to transfer an infant from the native to an artificial womb, while preventing fetal-to-neonatal transition. In this narrative review we analyze relevant fetal physiology literature, provide an overview of insights from APAW studies, and identify considerations for the obstetric procedure from the native uterus to an APAW system. Lastly, this review provides suggestions to improve sterility, fetal and maternal well-being, and the prevention of neonatal transition.

Voice outcome in medialisation thyroplasty with and without arytenoid adduction: a prospective comparison using intraoperative voice measurements.

PURPOSE: Arytenoid adduction as an addition to medialisation thyroplasty is highly advocated by some surgeons in selected cases but deemed less necessary by others in patients with unilateral vocal fold paralysis. This study aims to evaluate the additional benefits on voice outcome of arytenoid adduction in patients with unilateral vocal fold paralysis undergoing medialisation thyroplasty using intra-operative voice measurements. DESIGN/METHODS: A prospective study was conducted. Voice audio recordings were obtained at 4 moments; 1. direct prior to the start of surgery, 2. during surgery after medialisation thyroplasty, 3. during surgery after medialisation and arytenoid adduction, 3 months postoperative. At these same timepoints patients rated their own voice on a numeric rating scale between 0 and 10. The blinded recordings were rated by consensus in a team of experienced listeners, using the Grade of the GRBAS scale. Furthermore, the Voice Handicap Index was administered before and at 3 months after surgery. RESULTS: Ten patients who underwent medialisation and arytenoid adduction at our tertiary referral hospital between 2021 and 2022, were included. One patient was excluded after surgery. The intraoperative measurements showed a Grade score of 1.4 preoperatively, improving to 1.2 after medialisation, 1.2 after medialisation and arytenoid adduction, and further improving to 0.4 at 3 months postoperative, which was a not statistically significant improvement (p = 0.2). The intraoperative subjective numeric rating scale showed a statistically significant improvement from 3.9 preoperatively, to 6.1 after medialisation, 7.1 after medialisation and arytenoid adduction and a 7.6 at 3 months postoperative (p = 0.001). The Voice Handicap Index total score showed a statistically significant improvement from 71 points before surgery to 13 at 3 months after surgery (p = 0.008). CONCLUSIONS: Our study using intraoperative voice measurements indicate that the addition of arytenoid adduction to medialisation thyroplasty is a benefit in selected patients although more studies are needed due to the many limitations inherent to this field of investigation.

Deep Learing for Sparse Domain Kalman Filtering With Applications on ECG Denoising and Motility Estimation.

OBJECTIVE: The reconstruction of an input based on a sparse combination of signals, known as sparse coding, has found widespread use in signal processing. In this work, the combination of sparse coding with Kalman filtering is explored and its potential is shown on two use-cases. METHODS: This work extends the Iterative Shrinkage and Thresholding Algorithm with a Kalman filter in the sparse domain. The resulting method may be implemented as a deep unfolded neural network and may be applied to any signal which has a sparse representation and a known or assumed relation between consecutive measurements. This method is evaluated on the use cases of noise reduction in the electrocardiogram (ECG) and the estimation of object motility. RESULTS: For ECG denoising, the proposed method achieved an improvement in Signal-to-Noise ratio of 18.6 dB, which is comparable to state-of-the-art. In motility estimation, a correlation of 0.84 with ground truth simulations was found. CONCLUSION: The proposed method was shown to have advantages over sparse coding and Kalman filtering alone. Due to the low complexity and high generalizability of the proposed method, the implementation of context-specific knowledge or an extension to other applications can be readily made. SIGNIFICANCE: The presented Kalman-ISTA algorithm is a resource-efficient method combining the promise of both sparse coding and Kalman filtering, making it well-suited for various applications.

Using Artificial Intelligence to Predict Intracranial Hypertension in Patients After Traumatic Brain Injury: A Systematic Review.

Intracranial hypertension (IH) is a key driver of secondary brain injury in patients with traumatic brain injury. Lowering intracranial pressure (ICP) as soon as IH occurs is important, but a preemptive approach would be more beneficial. We systematically reviewed the artificial intelligence (AI) models, variables, performances, risks of bias, and clinical machine learning (ML) readiness levels of IH prediction models using AI. We conducted a systematic search until 12-03-2023 in three databases. Only studies predicting IH or ICP in patients with traumatic brain injury with a validation of the AI model were included. We extracted type of AI model, prediction variables, model performance, validation type, and prediction window length. Risk of bias was assessed with the Prediction Model Risk of Bias Assessment Tool, and we determined the clinical ML readiness level. Eleven out of 399 nonduplicate publications were included. A gaussian processes model using ICP and mean arterial pressure was most common. The maximum reported area under the receiver operating characteristic curve was 0.94. Four studies conducted external validation, and one study a prospective clinical validation. The prediction window length preceding IH varied between 30 and 60 min. Most studies (73%) had high risk of bias. The highest clinical ML readiness level was 6 of 9, indicating "real-time model testing" stage in one study. Several IH prediction models using AI performed well, were externally validated, and appeared ready to be tested in the clinical workflow (clinical ML readiness level 5 of 9). A Gaussian processes model was most used, and ICP and mean arterial pressure were frequently used variables. However, most studies showed a high risk of bias. Our findings may help position AI for IH prediction on the path to ultimate clinical integration and thereby guide researchers plan and design future studies.

Simulation-based development: shaping clinical procedures for extra-uterine life support technology.

BACKGROUND: Research into Artificial Placenta and Artificial Womb (APAW) technology for extremely premature infants (born < 28 weeks of gestation) is currently being conducted in animal studies and shows promising results. Because of the unprecedented nature of a potential treatment and the high-risk and low incidence of occurrence, translation to the human condition is a complex task. Consequently, the obstetric procedure, the act of transferring the infant from the pregnant woman to the APAW system, has not yet been established for human patients. The use of simulation-based user-centered development allows for a safe environment in which protocols and devices can be conceptualized and tested. Our aim is to use participatory design principles in a simulation context, to gain and integrate the user perspectives in the early design phase of a protocol for this novel procedure. METHODS: Simulation protocols and prototypes were developed using an iterative participatory design approach; usability testing, including general and task-specific feedback, was obtained from participants with clinical expertise from a range of disciplines. The procedure made use of fetal and maternal manikins and included animations and protocol task cards. RESULTS: Physical simulation with the active participation of clinicians led to the diffusion of tacit knowledge and an iteratively formed shared understanding of the requirements and values that needed to be implemented in the procedure. At each sequel, participant input was translated into simulation protocols and design adjustments. CONCLUSION: This work demonstrates that simulation-based participatory design can aid in shaping the future of clinical procedure and product development and rehearsing future implementation with healthcare professionals.

Clinical aspects of umbilical cord cannulation during transfer from the uterus to a liquid-based perinatal life support system for extremely premature infants a qualitative generic study.

A liquid-based perinatal life support system (PLS) for extremely premature infants (born before 28 week of gestational age) envisions a connection between the infant's native umbilical cord and an artificial placenta system through cannulation. This system mimics a natural mothers' womb to achieve better organ maturations. The objective of this study is to gain insight into the clinical focus points of umbilical cord cannulation and how cannulation should be addressed in extremely premature infants during the transfer from the uterus to an in-utero simulating liquid-based PLS system. We performed an explorative qualitative study. Twelve medical specialists with knowledge of vessel cannulation participated. We collected data through twelve interviews and two focus group discussions. Data were analyzed using inductive content and constant comparison analysis via open and axial coding. Results were derived on the following topics: (1) cannulation technique, (2) cannula fixation, (3) local and systemic anticoagulation, and (4) vasospasm. A side-entry technique is preferred as this may decrease wall damage, stabilizes the vessel better and ensures continuous blood flow. Sutures, especially via an automatic microsurgery instrument, are favored above glue, stents, or balloons as these may be firmer and faster. Medication possibilities for both vasospasm and anticoagulation should function locally since there were uncertainties regarding the systemic effects. According to the findings of this research, the needed umbilical cord cannulation method should include minimal wall damage, improved vascular stability, blood flow maintenance, a strong fixation connection, and local anticoagulation effect.

Simulation-Based Training in Emergency Obstetric Care in Sub-Saharan and Central Africa: A Scoping Review.

Background: Every day approximately 810 women die from complications related to pregnancy and childbirth worldwide. Around two thirds of these deaths happen in sub-Saharan Africa. One of the strategies to decrease these numbers is improving the quality of care by emergency obstetric simulation-based training. The effectiveness of such training programs depends on the program's instructional design. Objective: This review gives an overview of studies about emergency obstetric simulation-based training and examines the applied instructional design of the training programs in sub-Saharan and Central Africa. Methods: We searched Medline, Embase and Cochrane Library from inception to May 2021. Peer-reviewed articles on emergency obstetric, postgraduate, simulation-based training in sub-Saharan and Central Africa were included. Outcome measures were categorized based on Kirkpatrick's levels of training evaluation. The instructional design was evaluated by using the ID-SIM questionnaire. Findings: In total, 47 studies met the inclusion criteria. Evaluation on Kirkpatrick level 1 showed positive reactions in 18 studies. Challenges and recommendations were considered. Results on knowledge, skills, and predictors for these results (Kirkpatrick level 2) were described in 29 studies. Retention as well as decay of knowledge and skills over time were presented. Results at Kirkpatrick level 3 were measured in 12 studies of which seven studies demonstrated improvements of skills on-the-job. Improvements of maternal and neonatal outcomes were described in fifteen studies and three studies reported on cost-estimations for training rollout (Kirkpatrick level 4). Instructional design items were heterogeneously applied and described. Conclusions: Results of 47 studies indicate evidence that simulation-based training in sub-Saharan and Central Africa can have a positive impact across all four levels of Kirkpatrick's training evaluation model. However, results were not consistent across all studies and the effects vary over time. A detailed description of instructional design features in future publications on simulation-based training will contribute to a deeper understanding of the underlying mechanisms that determine why certain training programs are more effective in improving maternal and neonatal healthcare outcomes than other.

Detection of postpartum uterine activity with electrohysterography.

OBJECTIVE: Uterine contractions are essential for childbirth, but also for expulsion of the placenta and for limiting postpartum blood loss. Postpartum hemorrhage is associated with almost 25% of the maternal deaths worldwide and the leading cause of maternal death in most low-income countries. Little is known about the physiology of the uterus postpartum, particularly due to the lack of an accurate measurement tool. The primary objective of this pilot study is to explore the potential of using electrohysterography to detect postpartum uterine contractions. If postpartum uterine activity can be objectified, this could contribute to understanding the physiology of the uterus and improve diagnosis and treatment of postpartum hemorrhage. STUDY DESIGN: In this observational study we included women aiming for a vaginal birth in two large maternity clinics in the Netherlands, Amphia Hospital Breda (group A, N2018-0161) and Máxima Medical Center Veldhoven (group B, N17.149). An electrode patch was placed on the maternal abdomen to record real-time electrical uterine activity until one hour postpartum continuously. In group A, the placement of the patch was lower than in group B. For analysis, tracings were divided into five different phases (1: dilatation until start pushing, 2: from start pushing until childbirth, 3: from childbirth until placental expulsion, 4: first hour after placental expulsion and 5: after one hour postpartum). Readability, signal quality and contraction frequency per hour were assessed. Additionally, patient satisfaction was evaluated through a survey. RESULTS: In total 91 pregnant women were included of whom 45 in group A and 46 women in group B. Complete registrations were obtained throughout the five labor phases with very little artefacts or signal loss. The readability of the tracings decreased after childbirth. A significantly better readability was found in tracings where the patch placement was lower on the abdomen for phases 4 and 5. Contraction frequency was highest during phase 2 and decreased towards phase 5. Women rated the satisfaction with electrohysterography as high and mostly did not notice the patch. CONCLUSION: It is possible to detect uterine activity postpartum with electrohysterography. Further investigation is recommended to improve diagnosis and treatment of postpartum hemorrhage.

Visualization of contractions: Evaluation of a new experience design concept to enhance the childbirth experience.

BACKGROUND: The purpose of this study was to develop and evaluate an innovative design proposition intended to help enhance the childbirth experience. The innovation consists of a smartphone application for birth preparation during pregnancy with information and coaching, in addition to a wall projection at the labor ward that visualizes the progress of labor based on uterine monitoring data. METHODS: We conducted a randomized controlled clinical pilot study. Singleton pregnant people pursuing a vaginal birth were recruited between 28 and 32 weeks of gestation and allocated to the intervention group (mobile application during the third trimester and wall projection at the labor ward) or to care as usual. Childbirth expectations and experiences were measured with validated questionnaires, which were completed at 32 and 36 weeks of gestation, immediately after birth, and at 4 weeks postpartum. Quantitative outcomes were analyzed and feedback about the proposition was evaluated using qualitative methods. RESULTS: The qualitative feedback from patients was largely positive; however, we could not detect any significant differences between the intervention and control groups about fear of childbirth and other outcome measures. CONCLUSION: In this pilot study, we evaluated a new experience design proposition for pregnancy and childbirth. This study generated data that will help to further improve and evaluate similar innovations in the future. This application may facilitate participatory care, promoting active involvement of parents in the healthcare processes of pregnancy and childbirth.

A review study of fetal circulatory models to develop a digital twin of a fetus in a perinatal life support system.

Background: Preterm birth is the main cause of neonatal deaths with increasing mortality and morbidity rates with decreasing GA at time of birth. Currently, premature infants are treated in neonatal intensive care units to support further development. However, the organs of, especially, extremely premature infants (born before 28 weeks of GA) are not mature enough to function optimally outside the womb. This is seen as the main cause of the high morbidity and mortality rates in this group. A liquid-filled incubator, a so-called PLS system, could potentially improve these numbers for extremely premature infants, since this system is designed to mimic the environment of the natural womb. To support the development and implementation of such a complex system and to interpret vital signals of the fetus during a PLS system operation, a digital twin is proposed. This mathematical model is connected with a manikin representing the digital and physical twin of the real-life PLS system. Before developing a digital twin of a fetus in a PLS system, its functional and technical requirements are defined and existing mathematical models are evaluated. Method and results: This review summarizes existing 0D and 1D fetal circulatory models that potentially could be (partly) adopted for integration in a digital twin of a fetus in a PLS system based on predefined requirements. The 0D models typically describe hemodynamics and/or oxygen transport during specific events, such as the transition from fetus to neonate. Furthermore, these models can be used to find hemodynamic differences between healthy and pathological physiological states. Rather than giving a global description of an entire cardiovascular system, some studies focus on specific organs or vessels. In order to analyze pressure and flow wave profiles in the cardiovascular system, transmission line or 1D models are used. As for now, these models do not include oxygen transport. Conclusion: This study shows that none of the models identified in literature meet all the requirements relevant for a digital twin of a fetus in a PLS system. Nevertheless, it does show the potential to develop this digital twin by integrating (parts) of models into a single model.

Sleep assessment in critically ill adults: A systematic review and meta-analysis.

PURPOSE: To systematically review sleep evaluation, characterize sleep disruption, and explore effects of sleepdisruption on outcomes in adult ICU patients. MATERIALS AND METHODS: We systematically searched databases from May 1969 to June 2021 (PROSPERO protocol number: CRD42020175581). Prospective and retrospective studies were included studying sleep in critically ill adults, excluding patients with sleep or psychiatric disorders. Meta-regression methods were applied when feasible. RESULTS: 132 studies (8797 patients) were included. Fifteen sleep assessment methods were identified, with only two validated. Patients had significant sleep disruption, with low sleep time, and low proportion of restorative rapid eye movement (REM). Sedation was associated with higher sleep efficiency and sleep time. Surgical versus medical patients had lower sleep quality. Patients on ventilation had a higher amount of light sleep. Meta-regression only suggested an association between total sleep time and occurrence of delirium (p < 0.001, 15 studies, 519 patients). Scarce data precluded further analyses. Sleep characterized with polysomnography (PSG) correlated well with actigraphy and Richards Campbell Sleep Questionnaire (RCSQ). CONCLUSIONS: Sleep in critically ill patients is severely disturbed, and actigraphy and RCSQ seem reliable alternatives to PSG. Future studies should evaluate impact of sleep disruption on outcomes.

New possibilities for ST analysis - A post-hoc analysis on the Dutch STAN RCT.

BACKGROUND: The diagnostic value of ST analysis of the fetal electrocardiogram (fECG) during labor is uncertain. False alarms (ST events) may be explained by physiological variation of the fetal electrical heart axis. Adjusted ST events, based on a relative rather than an absolute rise from baseline, correct for this variation and may improve the diagnostic accuracy of ST analysis. AIMS: Determine the optimal cut-off for relative ST events in fECG to detect fetal metabolic acidosis. STUDY DESIGN: Post-hoc analysis on fECG tracings from the Dutch STAN trial (STAN+CTG branch). SUBJECTS: 1328 term singleton fetuses with scalp ECG tracing during labor, including 10 cases of metabolic acidosis. OUTCOME MEASURES: Cut-off value for relative ST events at the point closest to (0,1) in the receiver operating characteristic (ROC) curve with corresponding sensitivity and specificity. RESULTS: Relative baseline ST events had an optimal cut-off at an increment of 85% from baseline. Relative ST events had a sensitivity of 90% and specificity of 80%. CONCLUSIONS: Adjusting the current definition of ST events may improve ST analysis, making it independent of CTG interpretation.

Delirium in neurosurgery: a systematic review and meta-analysis.

Delirium is a frequent occurring complication in surgical patients. Nevertheless, a scientific work-up of the clinical relevance of delirium after intracranial surgery is lacking. We conducted a systematic review (CRD42020166656) to evaluate the current diagnostic work-up, incidence, risk factors and health outcomes of delirium in this population. Five databases (Embase, Medline, Web of Science, PsycINFO, Cochrane Central) were searched from inception through March 31st, 2021. Twenty-four studies (5589 patients) were included for qualitative analysis and twenty-one studies for quantitative analysis (5083 patients). Validated delirium screening tools were used in 70% of the studies, consisting of the Confusion Assessment Method (intensive care unit) (45%), Delirium Observation Screening Scale (5%), Intensive Care Delirium Screening Checklist (10%), Neelon and Champagne Confusion Scale (5%) and Nursing Delirium Screening Scale (5%). Incidence of post-operative delirium after intracranial surgery was 19%, ranging from 12 to 26% caused by variation in clinical features and delirium assessment methods. Meta-regression for age and gender did not show a correlation with delirium. We present an overview of risk factors and health outcomes associated with the onset of delirium. Our review highlights the need of future research on delirium in neurosurgery, which should focus on optimizing diagnosis and assessing prognostic significance and management.

Ethical Development of Artificial Amniotic Sac and Placenta Technology: A Roadmap.

In this paper we present an initial roadmap for the ethical development and eventual implementation of artificial amniotic sac and placenta technology in clinical practice. We consider four elements of attention: (1) framing and societal dialogue; (2) value sensitive design, (3) research ethics and (4) ethical and legal research resulting in the development of an adequate moral and legal framework. Attention to all elements is a necessary requirement for ethically responsible development of this technology. The first element concerns the importance of framing and societal dialogue. This should involve all relevant stakeholders as well as the general public. We also identify the need to consider carefully the use of terminology and how this influences the understanding of the technology. Second, we elaborate on value sensitive design: the technology should be designed based upon the principles and values that emerge in the first step: societal dialogue. Third, research ethics deserves attention: for proceeding with first-in-human research with the technology, the process of recruiting and counseling eventual study participants and assuring their informed consent deserves careful attention. Fourth, ethical and legal research should concern the status of the subject in the AAPT. An eventual robust moral and legal framework for developing and implementing the technology in a research setting should combine all previous elements. With this roadmap, we emphasize the importance of stakeholder engagement throughout the process of developing and implementing the technology; this will contribute to ethically and responsibly innovating health care.

Evaluating the Instructional Design and Effect on Knowledge, Teamwork, and Skills of Technology-Enhanced Simulation-Based Training in Obstetrics in Uganda: Stepped-Wedge Cluster Randomized Trial.

BACKGROUND: Simulation-based training is a common strategy for improving the quality of facility-based maternity services and is often evaluated using Kirkpatrick's theoretical model. The results on the Kirkpatrick levels are closely related to the quality of the instructional design of a training program. The instructional design is generally defined as the "set of prescriptions for teaching methods to improve the quality of instruction with a goal of optimizing learning outcomes." OBJECTIVE: The aim of this study is to evaluate the instructional design of a technology-enhanced simulation-based training in obstetrics, the reaction of participants, and the effect on knowledge, teamwork, and skills in a low-income country. METHODS: A stepped-wedge cluster randomized trial was performed in a university hospital in Kampala, Uganda, with an annual delivery volume of over 31,000. In November 2014, a medical simulation center was installed with a full-body birthing simulator (Noelle S550, Gaumard Scientific), an interactive neonate (Simon S102 Newborn CPR Simulator, Gaumard Scientific), and an audio and video recording system. Twelve local obstetricians were trained and certified as medical simulation trainers. From 2014 to 2016, training was provided to 57 residents in groups of 6 to 9 students. Descriptive statistics were calculated for ten instructional design features of the training course measured by the 42-item ID-SIM (Instructional Design of a Simulation Improved by Monitoring). The Wilcoxon signed rank test was conducted to investigate the differences in scores on knowledge, the Clinical Teamwork Scale, and medical technical skills. RESULTS: The mean scores on the ten instructional design features ranged from 54.9 (95% CI 48.5-61.3) to 84.3 (95% CI 80.9-87.6) out of 100. The highest mean score was given on the feature feedback and the lowest scores on repetitive practice and controlled environment. The overall score for the training day was 92.8 out of 100 (95% CI 89.5-96.1). Knowledge improved significantly, with a test score of 63.4% (95% CI 60.7-66.1) before and 78.9% (95% CI 76.8-81.1) after the training (P<.001). The overall score on the 10-point Clinical Teamwork Scale was 6.0 (95% CI 4.4-7.6) before and 5.9 (95% CI 4.5-7.2) after the training (P=.78). Medical technical skills were scored at 55.5% (95% CI 47.2-63.8) before and 65.6% (95% CI 56.5-74.7) after training (P=.08). CONCLUSIONS: Most instructional design features of a technology-enhanced simulation-based training in obstetrics in a low-income country were scored high, although intervals were large. The overall score for the training day was high, and knowledge did improve after the training program, but no changes in teamwork and (most) medical technical skills were found. The lowest-scored instructional design features may be improved to achieve further learning aims. TRIAL REGISTRATION: ISRCTN Registry ISRCTN98617255; http://www.isrctn.com/ISRCTN98617255. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): RR2-10.1186/s12884-020-03050-3.

Changes in Maternal Heart Rate Variability in Response to the Administration of Routine Obstetric Medication in Hospitalized Patients: Study Protocol for a Cohort Study (MAMA-Heart Study).

Pregnancy is a period of continuous change in the maternal cardiovascular system, partly mediated by the autonomic nervous system. Insufficient autonomic adaptation to increasing gestation is associated with pregnancy complications, such as hypertensive disorders of pregnancy and preterm birth (both major causes of perinatal morbidity and mortality). Consequently, maternal heart rate variability (mHRV), which is a proxy measure for autonomic activity, is increasingly assessed in these cohorts to investigate the pathophysiology of their complications. A better pathophysiological understanding could facilitate the early detection of these complications, which remains challenging. However, such studies (typically performed in pregnancies leading to hospitalization) have generated conflicting findings. A probable reason for these conflicting findings is that these study cohorts were likely administered routine obstetric medications during the study period of which the effects on mHRV are largely unknown. Subsequently, we design a longitudinal, observational study to quantifying the effect of these medications-particularly corticosteroids, which are known to affect fetal HRV-on mHRV to improve the interpretation of past and future studies. We will enroll 61 women admitted to a tertiary obstetric unit with an indication to receive corticosteroids antenatally. Participants' mHRV will be continuously acquired throughout their hospitalization with wrist-worn photoplethysmography to facilitate a within-patient comparison of the effect of corticosteroids on mHRV.