Intrapartum non-invasive electrophysiological monitoring: F2 study

Intrapartum non-invasive electrophysiological monitoring: F2 study - F2

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

NL-OMON

Registry ID

NL-OMON46764

Enrollment

120

Registered

2017-12-22

Start date

2018-02-20

Completion date

Unknown

Last updated

2024-06-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

non-invasive fetal electrocardiogram

Interventions

None listed

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria: Pregnant women who are in labour, carrying a healthy, singleton fetus in cephalic presentation, with a gestational age between 36 and 42 weeks

Exclusion criteria

Exclusion criteria: -

Design outcomes

Primary

Measure	Time frame
The main endpoint of this study is to assess the accuracy of the NI-fECG monitorings. This will be compared to the accuracy of the gold standard FSE monitoring.	—

Secondary

Measure	Time frame
To validate the monitoring of maternal heart rate measured by the Atlantis/Parides system as compared to standard methods of monitoring maternal heart rate during labour (for instance pulse oximetry or the pulse Doppler signal provided by the TOCO button). To compare the EHG (electrohysterogram) signals retrieved by the Parides patch with the tocodynamometer (TOCO) or intra-uterine pressure catheter (IUPC).	—

Measure

Time frame

To validate the monitoring of maternal heart rate measured by the Atlantis/Parides system as compared to standard methods of monitoring maternal heart rate during labour (for instance pulse oximetry or the pulse Doppler signal provided by the TOCO button). To compare the EHG (electrohysterogram) signals retrieved by the Parides patch with the tocodynamometer (TOCO) or intra-uterine pressure catheter (IUPC).

—

Countries

Netherlands

Outcome results