Intrapartum non-invasive electrophysiological monitoring: F2 study

Completed

Conditions: non-invasive fetal electrocardiogram
10016849

Registration Number: NL-OMON46764

Lead Sponsor: Maxima Medisch Centrum

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 120

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

- < 18 years of age
- Multiple pregnancy
- Fetus in breech position
- Women with signs of fetal distress (abnormal CTG requiring immediate intervention)
- Women with a positive hepatitis B/C or HIV serology
- Women with idiopathic thrombocytopenia or other inheritable hematologic diseases
- Dermatologic disease of the abdomen precluding preparation of the abdomen with abrasive paper - Women in labour taking a shower or bath and women connected to external or implanted electrical stimulators

Study & Design

Study Type: Observational non invasive

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>The main endpoint of this study is to assess the accuracy of the NI-fECG<br /><br>monitorings. This will be compared to the accuracy of the gold standard FSE<br /><br>monitoring. </p><br>

Secondary Outcome Measures

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