Pilot study. Intrapartum non-invasive monitoring of the fetal electrocardiogram: PF2 study.

Pilot study. Intrapartum non-invasive monitoring of the fetal electrocardiogram: PF2 study. - Non-invasive monitoring of the fetal ECG: PF2 study.

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

NL-OMON

Registry ID

NL-OMON45988

Enrollment

150

Registered

2016-06-30

Start date

2016-09-21

Completion date

Unknown

Last updated

2024-04-23

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 is qualitative and descriptive of nature, based on a collection of practical and/or technical problems within the 50 NI-fECG monitorings.	—

Secondary

Measure	Time frame
Secondary study parameters are signal quality and signal loss. The two methods (FSE and NI-fECG) will be compared regarding signal quality and signal loss (FSE serves as gold standard). Also, fECG waveform details will be analysed and relevant information will be correlated to several clinical maternal and fetal parameters. furthermore, the EHG signals retrieved with the NI-fECG wil be analysed.	—

Countries

Netherlands

Outcome results