Continuous Non-invasive Electrophysiological Monitoring in High Risk Pregnancies

NCT06151613 | Unknown

• 1 other identifier: NL82869.015.22
• Study Type: interventional
• Target: 1,911
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this single centre cohort intervention study with historical controls, is to investigate the effect of implementing continuous antepartum electrophysiological CTG (eCTG) monitoring at the Obstetric High Care (OHC), on perinatal and maternal outcomes and obstetric care. 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.

Conditions

Perinatal Outcomes; Preterm Birth; High Risk Pregnancy

Keywords

Electrophysiological monitoring; Cardiotocography; Antepartum monitoring; continuous monitoring; Non-invasive fetal monitoring

Outcome Measures

Primary Outcomes (1)

• Incidence of perinatal mortality and major neonatal morbidity

  A composite outcome consisting of: 1. Incidence of perinatal mortality and/or 2.Incidence of a major neonatal morbidity (defined as either: Intraventricular hemorrhage (IVH) grade three or more, Periventricular leukomalacia (PVL) grade two or more, Moderate or severe bronchopulmonary dysplasia (BPD), Necrotizing enterocolitis (NEC) grade two or more, or Retinopathy of prematurity (ROP) necessitating laser therapy).

  during admission (immediately after birth until hospital discharge) or until at least 4 weeks after birth

Secondary Outcomes (12)

• Incidence of maternal mortality

  From moment of inclusion until six weeks after giving birth

• Incidence of neonatal morbidity

  From inclusion assessed up to 6 months after inclusion

• Assesment using a surveys (D-QUEST) to measure patient satisfaction

  At discharge, assessed up to 1 month.

• Assesment using a survey (EQ5D5L) to measure patient satisfaction

  EQ5D5L questionnaire is given on day 1 of the admission (day 1 after inclusion). and assessed up to 1 month.

• Assesment using one survey (Browns survey) to measure caregiver satisfaction

  Caregivers are invited to fill in the questionnaire at baseline and at 1 year

Study Arms (2)

Continuous eCTG monitoring

ACTIVE COMPARATOR

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

Device: continuous eCTG monitoring using the NFMS

Conventional intermittent CTG monitoring

NO INTERVENTION

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.

Interventions

continuous eCTG monitoring using the NFMS DEVICE

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.

Continuous eCTG monitoring

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• ≥18 years old
• 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

You may not qualify if:

• Multiple pregnancy
• 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)
• Fetal and/or maternal cardiac disease (i.e. arrhythmia, congenital defect)
• Women admitted with a clinical diagnosis of sepsis with hypotension (i.e. septic shock).

Sponsors & Collaborators

• Maxima Medical Center: lead
• ZonMw: The Netherlands Organisation for Health Research and Development: collaborator

Study Sites (1)

Maxima Medical Centre

Veldhoven, North Brabant, 5504DB, Netherlands

RECRUITING

Related Publications (1)

• de Klerk ND, Berben PBQ, de Vries IR, Niemarkt H, Vullings R, van den Heuvel ER, van der Ven M, Fransen AF, Oei SG, van Laar JOEH. 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). BMJ Open. 2025 Nov 12;15(11):e102732. doi: 10.1136/bmjopen-2025-102732.

  PMID: 41224309 DERIVED

MeSH Terms

Conditions

Premature Birth

Condition Hierarchy (Ancestors)

Obstetric Labor, Premature; Obstetric Labor Complications; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases

Study Officials

• SG Oei, Prof.dr.

  Maxima Medical Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

ND de Klerk, MD

CONTACT

+40 8888384; nadine.de.klerk@mmc.nl

M. van der Ven, MD

CONTACT

+31408888384; myrthe.van.der.ven@mmc.nl

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, researcher, PhD candidate

Model Details: A single center prospective cohort intervention study with historical controls.

Study Record Dates

• First Submitted: November 1, 2023
• First Posted: November 30, 2023
• Study Start: November 22, 2023
• Primary Completion: November 20, 2025
• Study Completion: November 20, 2025
• Last Updated: December 7, 2023

Record last verified: 2023-12

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, CSR
• Time Frame: Start when IPD is requested
• Access Criteria: Anonymous data will be shared to those requesting data published open access, meeting data sharing regulations.

Locations

NL (1)