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Continuous non-invasive electrophysiological monitoring in high-risk pregnancies: study protocol of a cohort intervention random sampling study in a tertiary obstetrical care centre in the Netherlands (NIEM-O study)

Por: de Klerk · N. D. · Berben · P. B. Q. · de Vries · I. R. · Niemarkt · H. · Vullings · R. · van den Heuvel · E. R. · van der Ven · M. · Fransen · A. F. · Oei · S. G. · van Laar · J. O. E. H.
Introduction

Women with high-risk pregnancies (eg, pre-eclampsia, imminent preterm birth) are often hospitalised due to the need for foetal and maternal monitoring. They are monitored for 30–45 min up to three times a day with conventional cardiotocography (CTG). In the meantime, they reside at the hospital, but the foetal status is not monitored. Continuous foetal monitoring is currently not recommended using CTG, due to the potential temperature rise from consistent exposure to ultrasound waves. For safe 24/7 monitoring, newly developed devices using non-invasive electrophysiological cardiotocography (eCTG) instead of conventional CTG offer a promising alternative. Previous research into eCTG has shown favourable results in monitoring foetal heart rate throughout both pregnancy and labour. This study aims to investigate the effect of implementing continuous antepartum eCTG monitoring in hospitalised high-risk pregnancies on perinatal and maternal outcome.

Methods and analysis

In this single centre prospective cohort intervention random sampling study, eligible women will be included on the Obstetric High Care of Máxima MC Veldhoven, the Netherlands. In total, 511 pregnant women with a singleton pregnancy between 23+0 and 32+0 weeks of gestation requiring hospitalisation will be recruited. Eligible women will be prospectively included in the cohort receiving standard treatment: intermittent CTG monitoring. From these women, a random sample of the prospective cohort will be offered a new monitoring method: 24/7 eCTG monitoring. For the eCTG monitoring, a wireless abdominal electrode patch, the Nemo Foetal Monitoring System will be used. Additional data from a historical cohort (2014–2019) of 1400 women receiving standard treatment will be included. Perinatal and maternal outcome, along with satisfaction levels of both patient and caregivers, will be compared between groups.

Ethics and dissemination

The study is registered on 18 October 2022 to the Central Committee on Research Involving Human Subjects (NL82869.015.22) via https://www.toetsingonline.nl/to/ccmo_monitor.nsf/conceptabr?OpenForm and approved by the Medical Ethics Committee of Máxima MC (W22.070) on 7 November 2023. Results of the study will be disseminated in peer-reviewed scientific journals and conference presentations.

Trial registration number

NCT06151613.

Do self-reported and objective hearing measures similarly relate to general and domain-specific cognition? Observational cohort study of older adults in England

Por: OShea · B. Q. · Milan · R. A. · Gross · A. L. · Powell · D. S. · Kobayashi · L. C. · Steptoe · A.
Objectives

We compared associations between self-reported and HearCheck screening device measures of hearing difficulty with subsequent general and domain-specific cognitive function in a population-based sample of older English adults.

Design

Observational cohort study.

Setting

Population-based sample of older adults in wave 7 of the English Longitudinal Study of Ageing (ELSA) in 2014/15 and its Healthy Cognitive Ageing Project (HCAP) in 2018.

Participants

N=1119 adults aged ≥62 years.

Primary outcome measures

Factor scores for general cognitive function and domains of memory, language, orientation and executive function were derived from the HCAP neuropsychological test battery (mean of 0 and SD of 1 for each). Hearing difficulty was assessed using a self-reported 5-point Likert-type scale and the HearCheck screening device, which administered a series of six tones in each ear.

Results

According to the HearCheck device, 48% of participants had a mild or moderate-to-severe hearing difficulty, while 25% self-reported fair or poor hearing. In multivariable-adjusted, population-weighted linear regression models, hearing difficulty identified via HearCheck was associated with worse general cognitive function (β=–0.34 SD units; 95% CI –0.60 to –0.07 for moderate-to-severe hearing difficulty vs good hearing) as well as worse function in domains of memory, language and executive function, each with a dose-response relationship. Self-reported hearing difficulty was not associated with general or domain-specific cognitive function.

Conclusions

Peripheral hearing ability, as captured by the HearCheck screening device, may have stronger relevance for later-life cognitive outcomes than the broader construct of perceived hearing difficulty in one’s daily environment that is captured by a self-reported measure.

Non-invasive electrophysiological monitoring vs conventional monitoring during labour in a tertiary obstetric care centre in the Netherlands: study protocol of a cohort intervention random sampling study (NIEM-II study)

Introduction

Conventional cardiotocography (CTG) has been used extensively to monitor the fetal condition during labour. However, conventional non-invasive monitoring is limited by the difficulty of obtaining an adequate signal quality, particularly in the case of obese parturients. Furthermore, the rate of operative deliveries keeps rising despite the ability for conventional intrapartum monitoring. Electrophysiological monitoring is an alternative technique that has been developed over the past decades to improve signal quality. This non-invasive, transabdominal and wireless alternative measures fetal heart rate by fetal electrocardiography (NI-fECG), and uterine activity by electrohysterography (EHG). Both NI-fECG and EHG have been proven to be more accurate and reliable than conventional non-invasive methods and are less affected by maternal Body Mass Index. Nevertheless, it is still unknown whether electrophysiological intrapartum monitoring leads to better obstetric and neonatal outcomes. This study aims to investigate whether electrophysiological monitoring during labour affects the number of operative interventions compared with conventional monitoring during labour.

Methods and analysis

This is a single-centre cohort intervention random sampling study which will be performed in a tertiary obstetric care centre. In total, 3471 term pregnant women with a singleton fetus in cephalic position and indication for continuous fetal monitoring during labour will be included. Eligible women will be prospectively included in the cohort for conventional monitoring. From these women, 90.9% of women will be randomly sampled and will be offered electrophysiological monitoring. A historical cohort of an additional 2100 women who received conventional monitoring will be added to the conventional group. This historical cohort was collected between April 2019 and February 2023. The primary outcome will be the number of operative interventions during labour. Secondary outcome measures include maternal and neonatal outcomes, patient and healthcare professional perspectives and costs.

Ethics and dissemination

This study received approval from the Medical Ethics Committee of Máxima Medical Centre (W22.071) on 1 November 2023. All participants will provide informed consent prior to data collection. Results of the study will be disseminated in peer-reviewed scientific journals and conference presentations.

Trial registration number

NCT06135961.

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