Continuous Non-invasive Electrophysiological Monitoring in High Risk Pregnancies
NCT ID: NCT06151613
Last Updated: 2023-12-07
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
1911 participants
INTERVENTIONAL
2023-11-22
2025-11-20
Brief Summary
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The main aim is to investigate the effect of both monitoring methods on:
* primary outcome: perinatal outcomes (a composite of perinatal mortality or major neonatal morbidity) until hospital discharge
* secondary outcomes: Maternal mortality, neonatal morbidity, satisfaction for both patient and caregiver, duration of pregnancy, switch of monitoring method, duration of admission to the OHC, timing (planned or emergency) and number of obstetric interventions (such as caesarean section), and admission and duration of admission to the NICU (neonatal intensive care unit).
Eligible women will be prospectively included in the cohort receiving standard treatment: CTG monitoring intermittent up to three times a day. From these eligible women, a random sample (464) of the prospective cohort (511) will be offered to receive a new monitoring method: 24/7 eCTG monitoring. In order to strengthen the comparison between the two groups (eCTG and standard treatment), additional data from 1400 women who received standard treatment in 2014-2019 will be collected retrospectively.
Detailed Description
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The investigators aim to include 1911 pregnant women ≥18 years old with a singleton pregnancy between 23+0 and 32+0 weeks of gestation requiring hospitalization on the OHC for maternal or fetal surveillance (including 1400 historical controls).
Additional objectives: The collected NFMS and demographic data will be used to develop and verify a mathematical model for the prediction of time until (preterm) birth, which may be used in clinical practice to reduce unnecessary OHC admissions and facilitate a better timing of interventions. Furthermore, data collected in this study (NFMS, accelerometric, annotated ultrasound) will be used for the development and verification of a mathematical model for the automated detection of fetal movements in NFMS data. This latter model might provide new opportunities in non-invasive monitoring of fetal health.
Conditions
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Keywords
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Study Design
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NON_RANDOMIZED
PARALLEL
DIAGNOSTIC
NONE
Study Groups
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Continuous eCTG monitoring
For the continuous eCTG monitoring, a wireless abdominal electrode patch (measuring fetal heart rate (FHR) and uterine activity (UA)) is used, developed by Nemo Healthcare: The Nemo Fetal Monitoring System (NFMS).
The advantage of the NFMS is that is a safe method for continuous (24/7) fetal monitoring. Furthermore, the patch does not have to be repetitively repositioned during registration, it can be used under the shower and it is wireless giving women more freedom to move around freely. Another benefit of eCTG monitoring is that it is especially suited for women with obesity, where conventional CTG monitoring often fails
continuous eCTG monitoring using the NFMS
Eligible women will be prospectively included in the cohort receiving standard treatment: CTG monitoring intermittent up to three times a day. From these eligible women, a random sample (464) of the prospective cohort (511) will be offered to receive a new monitoring method: 24/7 eCTG monitoring with NFMS. In order to strengthen the comparison between the two groups (eCTG and standard treatment), additional data from 1400 women who received standard treatment in 2014-2019 will be collected retrospectively.
Conventional intermittent CTG monitoring
Conventional intermittent CTG monitoring is performed in Maxima Medical Centre by the use of Philips Avalon FM 30 (Philips Healthcare, Eindhoven, The Netherlands).
This is a combined external measurement method using two transducers placed on the maternal abdomen: one to measure fetal heart rate (FHR) by the use of Doppler ultrasound (DU) and the other at the fundus of the uterus to measure uterine activity (UA) pattern (TOCO), keeping them in place with elastic banding.
No interventions assigned to this group
Interventions
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continuous eCTG monitoring using the NFMS
Eligible women will be prospectively included in the cohort receiving standard treatment: CTG monitoring intermittent up to three times a day. From these eligible women, a random sample (464) of the prospective cohort (511) will be offered to receive a new monitoring method: 24/7 eCTG monitoring with NFMS. In order to strengthen the comparison between the two groups (eCTG and standard treatment), additional data from 1400 women who received standard treatment in 2014-2019 will be collected retrospectively.
Eligibility Criteria
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Inclusion Criteria
* Singleton pregnancy ≥23+0 weeks of gestation
* Requiring hospitalization to the OHC for maternal or fetal surveillance (i.e. imminent preterm delivery(PPI), PE, HELLP, pregnancy induced hypertension (PIH), FGR, fetal distress, vaginal blood loss, fetal congenital anomalies)
* Parents wishing for fetal monitoring
Exclusion Criteria
* Insufficient knowledge of Dutch or English language
* Contraindications to abdominal patch placement (dermatologic diseases of the abdomen precluding preparation of the abdomen with abrasive paper)
* Women connected to an external or implanted electrical stimulator (e.g. a pacemaker - exclusion due to possible signal interference)
* Fetal and/or maternal cardiac disease (i.e. arrhythmia, congenital defect)
* Treatment plan (with intervention planned within 24 hours after admission) already made before inclusion is completed
* Women admitted with a clinical diagnosis of sepsis with hypotension (i.e. septic shock).
18 Years
FEMALE
No
Sponsors
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ZonMw: The Netherlands Organisation for Health Research and Development
OTHER
Maxima Medical Center
OTHER
Responsible Party
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Nadine de Klerk
MD, researcher, PhD candidate
Principal Investigators
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SG Oei, Prof.dr.
Role: PRINCIPAL_INVESTIGATOR
Maxima Medical Center
Locations
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Maxima Medical Centre
Veldhoven, North Brabant, Netherlands
Countries
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Central Contacts
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Facility Contacts
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ND de Klerk, MD
Role: primary
Other Identifiers
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NL82869.015.22
Identifier Type: -
Identifier Source: org_study_id