Evidence mapPaperPMID 41224309Full record

ArticleBMJ open2025

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).

Nadine D de Klerk, Phebe B Q Berben, Ivar R de Vries, Hendrik Niemarkt, Rik Vullings, Edwin R van den Heuvel, Myrthe van der Ven, Annemarie F Fransen, S Guid Oei, Judith O E H van Laar

Registry-linked trialAbstract readClinical Trial Protocol
In one paragraph

Article in BMJ open, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT06151613 (Non-invasive Electrophysiological Monitoring in High Risk Pregnancies at the Obstetric High Care), which is not on this map. Cited by 1 paper.

0numbers the graph read from it
0cells of the map it votes in
1citing papers in PubMed
field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT06151613 naunknown statusnot on this map

Non-invasive Electrophysiological Monitoring in High Risk Pregnancies at the Obstetric High Care: the NIEM-O Study

TypeinterventionalSponsorMaxima Medical CenterRan2023 to 2025Enrolled1,911ConditionsPerinatal Outcomes, Preterm Birth, High Risk PregnancyArmscontinuous eCTG monitoring using the NFMS
3 · Its place in the literature

Who cites it

1 citing paper in PubMed.

  1. Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

10 authors.

Nadine D de KlerkGynaecology and Obstetrics, Maxima Medical Centre, Veldhoven, Netherlands nadine.de.klerk@mmc.nl.ORCID http://orcid.org/0009-0001-3861-9330
Phebe B Q BerbenGynaecology and Obstetrics, Maxima Medical Centre, Veldhoven, Netherlands.ORCID http://orcid.org/0009-0004-7909-3795
Ivar R de VriesGynaecology and Obstetrics, Maxima Medical Centre, Veldhoven, Netherlands.
Hendrik NiemarktPediatrics, Maxima Medical Centre, Veldhoven, Netherlands.
Rik VullingsElectrical Engineering, Eindhoven University of Technology, Eindhoven, Netherlands.
Edwin R van den HeuvelMathematics & Computer Science, Technische Universiteit Eindhoven, Eindhoven, Netherlands.
Myrthe van der VenGynaecology and Obstetrics, Maxima Medical Centre, Veldhoven, Netherlands.
Annemarie F FransenGynaecology and Obstetrics, Maxima Medical Centre, Veldhoven, Netherlands.
S Guid OeiGynaecology and Obstetrics, Maxima Medical Centre, Veldhoven, Netherlands.
Judith O E H van LaarGynaecology and Obstetrics, Maxima Medical Centre, Veldhoven, Netherlands.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

introductionWomen 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.

Indexed as

CardiotocographyPregnancy, High-RiskAdultFemaleHeart Rate, FetalHumansNetherlandsPregnancyPregnancy OutcomeProspective StudiesTertiary Care CentersFetal medicineOBSTETRICSPERINATOLOGYPregnancyPregnant Women

Identifiers

PMID41224309
PMCPMC12612757

What Socratic holds

Textmetadata
LicenceCC BY
Read underepoch 390

Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the Socratic graph.