Feasibility of antenatal ambulatory fetal electrocardiography: a systematic review.

BACKGROUND: Antenatal fetal heart rate (FHR) monitoring is currently limited by hospital-based accessibility as well as the availability of relevant equipment and expertise required to position device electrodes. Ambulatory FHR monitoring in the form of noninvasive fetal electrocardiography (NIFECG) is currently an area of research interest, particularly during the era of the COVID-19 pandemic, and the potential to improve maternity care and reduce hospital attendances need to be evaluated. OBJECTIVES: To assess the feasibility, acceptability, and signal success of ambulatory NIFECG monitoring and identify research areas required to facilitate clinical utilization of this method of monitoring. METHODS: Medline, EMBASE, and PubMed databases were searched from January 2005 to April 2021 using terms relevant to antenatal ambulatory or home NIFECG. The search was compliant with PRISMA guidelines, and was registered with the PROSPERO database (CRD42020195809). All studies reporting the clinical utilization of NIFECG inclusive of its use in the ambulatory setting performed in the antenatal period, human studies, and those in the English language were included. Those reporting novel technological methods and electrophysiological algorithms, satisfaction surveys, intrapartum studies, case reports and reviews, and animal studies were excluded. Study screening and data extraction were conducted in duplicate. Risk of bias was appraised using the Modified Downs and Black tool. Due to the heterogeneity of the reported findings, a meta-analysis was not feasible. RESULTS: The search identified 193 citations, where 11 studies were deemed eligible for inclusion. All studies used a single NIFECG system with a duration of monitoring ranging from 5.6 to 21.4 h. Predefined signal acceptance threshold ranged from 34.0-80.0%. Signal success in the study populations was 48.6-95.0% and was not affected by maternal BMI. Good signals were achieved in the 2nd trimester, but less so in the early 3rd trimester. NIFECG was a well-accepted method of FHR monitoring, with up to 90.0% of women's satisfaction levels when worn during outpatient induction of labor. Placement of the acquisition device needed input from healthcare staff in every report. CONCLUSIONS: Although there is evidence for the clinical feasibility of ambulatory NIFECG, the disparity in the literature limits the ability to draw firm conclusions. Further studies to establish repeatability and device validity, whilst developing standardized FHR parameters and set evidence-based standards for signal success for NIFECG are required to ascertain the clinical benefit and potential limitations of ambulatory outpatient FHR monitoring.

Clarifying the unmet clinical need during medical device innovation in women's health - A narrative review.

Medical technologies are pervasive across women's health, spanning across obstetric and gynecological care. FemTech, the sector responsible for developing these technologies, is growing at 15.6% per annum. However, there are concerns of disconnects between new product development (NPD) and the care afforded to women in consequence of implementing these innovations. The most crucial stage of NPD involves understanding the clinical need. Without a clear need and clinical use case, innovators risk developing solutions which do not address the issues women and caregivers experience. Thus, the product will miss the market and experience limited uptake. Tools for performing clinical needs assessments and defining the use case are being developed. This review provides an analysis of their strengths and weaknesses to inform FemTech innovators of the available resources. We further discuss concepts for creating a unified approach to assessing unmet needs such that technologies have a higher chance of improving women's healthcare.

Virtual reality and its use in post-operative pain following laparoscopy: a feasibility study.

Pain following laparoscopic surgery remains a neglected healthcare issue. Virtual reality-mediated therapy's (VRT) analgesic potential could address this. However, its effect in this setting remains unexplored. We aimed to establish the feasibility and safety of VRT as an adjunct analgesic following gynaecological laparoscopy and explore differences between active distraction and passive meditation content. 35 women were enrolled into an open crossover pilot and randomised to either intervention group 1 (active then passive content) or intervention group 2 (passive then active content) following surgery. VRT was administered in two 10-min segments with a 10-min washout period in between. Pain scores, opioid requirements and side effects were recorded before and after each segment whilst questionnaires evaluated acceptability. We observed a significant reduction in pain over time for the entire study population (F = 8.63, p < 0.0005) but no differences between intervention groups, in contrast to many studies demonstrating an increase in pain during this time. During segment one, intervention group 1 (n = 18) were administered significantly less opioid than intervention group 2 (n = 17) [0.0 (0.0-7.5) vs. 3.0(0.0-10.0), p = 0.04]. Intervention group 1 rated the VRT experience significantly higher than intervention group 2 (7.97 vs. 6.62. p = 0.017). 97.1% (n = 34) would recommend VRT to a friend and use it as the standard-of-care in future procedures. These results demonstrate that post-operative VRT is feasible and safe. However, adequately powered studies are needed to appropriately determine its efficacy.

The Effectiveness of Virtual Reality in Managing Acute Pain and Anxiety for Medical Inpatients: Systematic Review.

BACKGROUND: Virtual reality is increasingly being utilized by clinicians to facilitate analgesia and anxiolysis within an inpatient setting. There is however, a lack of a clinically relevant review to guide its use for this purpose. OBJECTIVE: To systematically review the current evidence for the efficacy of virtual reality as an analgesic in the management of acute pain and anxiolysis in an inpatient setting. METHODS: A comprehensive search was conducted up to and including January 2019 on PubMed, Ovid Medline, EMBASE, and Cochrane Database of Systematic reviews according to PRISMA (Preferred Reporting Items for Systematic Reviews and Meta-Analyses) guidelines. Search terms included virtual reality, vr, and pain. Primary articles with a focus on acute pain in the clinical setting were considered for the review. Primary outcome measures included degree of analgesia afforded by virtual reality therapy, degree of anxiolysis afforded by virtual reality therapy, effect of virtual reality on physiological parameters, side effects precipitated by virtual reality, virtual reality content type, and type of equipment utilized. RESULTS: Eighteen studies were deemed eligible for inclusion in this systematic review; 67% (12/18) of studies demonstrated significant reductions in pain with the utilization of virtual reality; 44% (8/18) of studies assessed the effects of virtual reality on procedural anxiety, with 50% (4/8) of these demonstrating significant reductions; 28% (5/18) of studies screened for side effects with incidence rates of 0.5% to 8%; 39% (7/18) of studies evaluated the effects of virtual reality on autonomic arousal as a biomarker of pain, with 29% (2/7) demonstrating significant changes; 100% (18/18) of studies utilized a head mounted display to deliver virtual reality therapy, with 50% being in active form (participants interacting with the environment) and 50% being in passive form (participants observing the content only). CONCLUSIONS: Available evidence suggests that virtual reality therapy can be applied to facilitate analgesia for acute pain in a variety of inpatient settings. Its effects, however, are likely to vary by patient population and indication. This highlights the need for individualized pilot testing of virtual reality therapy's effects for each specific clinical use case rather than generalizing its use for the broad indication of facilitating analgesia. In addition, virtual reality therapy has the added potential of concurrently providing procedural anxiolysis, thereby improving patient experience and cooperation, while being associated with a low incidence of side effects (nausea, vomiting, eye strain, and dizziness). Furthermore, findings indicated a head mounted display should be utilized to deliver virtual reality therapy in a clinical setting with a slight preference for active over passive virtual reality for analgesia. There, however, appears to be insufficient evidence to substantiate the effect of virtual reality on autonomic arousal, and this should be considered at best to be for investigational uses, at present.

Maternal and neonatal outcomes associated with COVID-19 infection: A systematic review.

BACKGROUND: COVID-19 has created an extraordinary global health crisis. However, with limited understanding of the effects of COVID-19 during pregnancy, clinicians and patients are forced to make uninformed decisions. OBJECTIVES: To systematically evaluate the literature and report the maternal and neonatal outcomes associated with COVID-19. SEARCH STRATEGY: PubMed, MEDLINE, and EMBASE were searched from November 1st, 2019 and March 28th, 2020. SELECTION CRITERIA: Primary studies, reported in English, investigating COVID-19-positive pregnant women and reporting their pregnancy and neonatal outcomes. DATA COLLECTION AND ANALYSIS: Data in relation to clinical presentation, investigation were maternal and neonatal outcomes were extracted and analysed using summary statistics. Hypothesis testing was performed to examine differences in time-to-delivery. Study quality was assessed using the ICROMS tool. MAIN RESULTS: Of 73 identified articles, nine were eligible for inclusion (n = 92). 67.4% (62/92) of women were symptomatic at presentation. RT-PCR was inferior to CT-based diagnosis in 31.7% (26/79) of cases. Maternal mortality rate was 0% and only one patient required intensive care and ventilation. 63.8% (30/47) had preterm births, 61.1% (11/18) fetal distress and 80% (40/50) a Caesarean section. 76.92% (11/13) of neonates required NICU admission and 42.8% (40/50) had a low birth weight. There was one indeterminate case of potential vertical transmission. Mean time-to-delivery was 4.3±3.08 days (n = 12) with no difference in outcomes (p>0.05). CONCLUSIONS: COVID-19-positive pregnant women present with fewer symptoms than the general population and may be RT-PCR negative despite having signs of viral pneumonia. The incidence of preterm births, low birth weight, C-section, NICU admission appear higher than the general population.

A randomised controlled trial to assess the feasibility of utilising virtual reality to facilitate analgesia during external cephalic version.

External cephalic version (ECV) is associated with a moderate degree of pain. Virtual reality (VR) is a technology that has shown promise in offering procedural analgesia. We undertook a clinical pilot to assess the viability of VR to reduce pain during ECV. In an open randomised controlled trial (RCT), we randomised 50 women to either VR or standard care each (25 per group). Women receiving VR were administered VR content (Skylights) via a headset. Pre- and post-procedural measures of pain, anxiety, device experience and vital signs were measured. There were no significant differences between groups (VR/no VR) in pain scores (60.68 vs 49.76; p = 0.2), ECV success rates (80% vs 76%; p = 0.7) or anxiety levels. The women receiving VR had a significantly higher anticipation of pain pre-procedurally (70.0 vs 50.0; p = 0.03). 20 (80%) of the VR women indicated that they would use VR again and 22 (88%) indicated they would recommend it to a friend having ECV. There were no significant differences between groups for side effects encountered or changes in vital signs. We have shown that using VR during ECV is feasible and appears safe. Our results inform the design of future RCTs.

Defining the clinician's role in early health technology assessment during medical device innovation - a systematic review.

BACKGROUND: Early Health Technology Assessment (EHTA) is an evolving field in health policy which aims to provide decision support and mitigate risk during early medical device innovation. The clinician is a key stakeholder in this process and their role has traditionally been confined to assessing device efficacy and safety alone. There is however, no data exploring their role in this process and how they can contribute towards it. This motivated us to carry out a systematic review to delineate the role of the clinician in EHTA as per the PRISMA guidelines. METHODS: A systematic search of peer reviewed literature was undertaken across PUBMED, OVID Medline and Web of science up till June 2018. Studies that were suitable for inclusion focused on clinician input in health technology assessment or early medical device innovation. A qualitative approach was utilised to generate themes on how clinicians could contribute in general and specific areas of EHTA. Data was manually extracted by the authors and themes were agreed in consensus using a grounded theory framework. The specific stages included: All stages of EHTA, Basic research on mechanisms, Targeting for specific product, Proof of principle and Prototype and product development. Bias was assessed utilising the NICE Qualitative checklist. RESULTS: A total of 33 articles met the inclusion criteria for the review. Areas identified in which the clinicians could contribute to EHTA included: i) needs driven problem solving, ii) conformity assessment of MDs, iii) economic evaluation of MDs and iv) addressing the conflicts in interest. For clinicians' input across the various specific areas of EHTA, an innovation framework was generated based on the subthemes extracted. CONCLUSIONS: The following review has identified the various segments in which clinicians can contribute to EHTA to inform stakeholders and has also proposed an innovation framework.

A systematic review on the utility of non-invasive electrophysiological assessment in evaluating for intra uterine growth restriction.

BACKGROUND: Non-invasive electrophysiological assessment (NIEA) is an evolving area in fetal surveillance and is attracting increasing research interest. There is however, limited data outlining its utility in evaluating intra uterine growth restriction (IUGR). The objective of this study was to carry out a systematic review to outline the utility of NIEA parameters in evaluating IUGR. METHODS: A systematic review of peer reviewed literature was performed, searching PUBMED, Ovid MEDLINE and EMBASE. The outcomes of interest included NIEA parameters [P wave duration, PR interval, QRS duration, QT interval, T/QRS ratio, short term variability (STV) and long term variability (LTV)] and a descriptive summary of relevant studies as well. RESULTS: Sixteen studies were identified as suitable for inclusion. The utility of NIEA parameters were investigated in tabular form. In particular, QRS and QT duration, T/QRS ratio, STV and PRSA analysis displayed utility and merit further consideration in evaluating for IUGR. Issues identified in the review were in relation to variances in definition of IUGR, small sample sizes and the lack of technological consistency across studies. CONCLUSION: NIEA shows promise as an adjunct surveillance tool in fetal diagnostics for IUGR. Larger prospective studies should be directed towards establishing reliable parameters with a focus on uniformity of IUGR definition, technological consistency and the individualisation of NIEA parameters.

An Unexpected Case of Intrapartum Pneumomediastinum.

The dyad of spontaneous pneumomediastinum and subcutaneous emphysema is collectively known as Hamman's syndrome. This rare complication is known to occur during the intrapartum period and its aetiology has been linked to the Valsalva maneuver in the second stage of labour. Nitrous oxide inhalation increases the risk. We present the case of a 21-year-old healthy woman who experienced these symptoms after nitrous oxide inhalation during the second stage of labour.

A systematic review of cardiac time intervals utilising non-invasive fetal electrocardiogram in normal fetuses.

BACKGROUND: Non-invasive fetal electrocardiogram (NIFECG) is an evolving technology in fetal surveillance which is attracting increasing research interest. There is however, only limited data outlining the reference ranges for normal cardiac time intervals (CTIs). The objective of our group was to carry out a systematic review to outline normal fetal CTIs using NIFECG. METHODS: A systematic review of peer reviewed literature was performed, searching PUBMED,Ovid MEDLINE and EMBASE. The outcomes of interest included fetal CTIs (P wave duration, PR interval, QRS duration and QT interval) and a descriptive summary of relevant studies as well. The outcomes were grouped as early pre-term (≤ 32 weeks), moderate to late pre-term (32-37 weeks) and term (37-41 weeks). RESULTS: 8 studies were identified as suitable for inclusion. Reference ranges of CTIs were generated. Both PR interval and QRS duration demonstrated a linear correlation with advancing gestation. Several studies also demonstrated a reduction in signal acquisition between 27 and 32 weeks due to the attenuation by vernix caseosa. In this group, both the P wave and T waves were difficult to detect due to signal strength and interference. CONCLUSION: NIFECG demonstrates utility to quantify CTIs in the fetus, particularly at advanced gestations. Larger prospective studies should be directed towards establishing reliable CTIs across various gestations.

Prevention of Ovarian Hyperstimulation Syndrome: A Review.

The following review aims to examine the available evidence to guide best practice in preventing ovarian hyperstimulation syndrome (OHSS). As it stands, there is no single method to completely prevent OHSS. There seems to be a benefit, however, in categorizing women based on their risk of OHSS and individualizing treatments to curtail their chances of developing the syndrome. At present, both Anti-Müllerian Hormone and the antral follicle count seem to be promising in this regard. Both available and upcoming therapies are also reviewed to give a broad perspective to clinicians with regard to management options. At present, we recommend the use of a "step-up" regimen for ovulation induction, adjunct metformin utilization, utilizing a GnRH agonist as an ovulation trigger, and cabergoline usage. A summary of recommendations is also made available for ease of clinical application. In addition, areas for potential research are also identified where relevant.