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

Completed

Conditions: non-invasive fetal electrocardiogram
10016849

Registration Number: NL-OMON45988

Lead Sponsor: Maxima Medisch Centrum

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 150

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

< 18years 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 is qualitative and descriptive of nature, based on a<br /><br>collection of practical and/or technical problems within the 50 NI-fECG<br /><br>monitorings.</p><br>

Secondary Outcome Measures

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