Continuous Non-invasive Electrophysiological Monitoring in High Risk Pregnancies

NARecruitingINTERVENTIONAL
Enrollment

1,911

Participants

Timeline

Start Date

November 22, 2023

Primary Completion Date

November 20, 2025

Study Completion Date

November 20, 2025

Conditions
Perinatal OutcomesPreterm BirthHigh Risk Pregnancy
Interventions
DEVICE

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.

Trial Locations (1)

5504DB

RECRUITING

Maxima Medical Centre, Veldhoven

Sponsors
All Listed Sponsors
collaborator

ZonMw: The Netherlands Organisation for Health Research and Development

OTHER

lead

Maxima Medical Center

OTHER