Implementation of intrapartum non-invasive electrophysiological monitoring: a pilot study.

Completed

Conditions: monitoring during labor
10010273

Registration Number: NL-OMON55415

Lead Sponsor: Maxima Medisch Centrum

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 50

Inclusion Criteria

In order to be eligible to participate in this study, a subject must meet all
of the following criteria:
- Pregnant women with a gestational age between 36 and 42 weeks.
- Admission to the labor ward because of labor and indication for fetal
monitoring during labor.
- Singleton fetus in cephalic presentation.
- Oral and written informed consent is obtained.

Exclusion Criteria

A potential subject who meets any of the following criteria will be excluded
from participation in this study:
- Women under the age of 18 years.
- Language barrier (other language than Dutch or English)
- Women with a multiple pregnancy.
- Fetal cardiac arrhythmias (detected and confirmed during pregnancy by
ultrasound).
- Contraindications to abdominal patch placement (dermatologic diseases of the
abdomen precluding preparation of the abdomen with abrasive paper).
- Women in labor taking a bath (because the Bluetooth signal is disturbed and
monitoring is impossible). It is possible to take a shower.
- Women connected to external or implanted electrical stimulators, such as
Transcutaneous Electro Neuro Stimulation (TENS) and pacemaker (because of
disturbance of the electrophysiological signal we want to measure, not because
of danger for mother or child).
- Contraindications for monitoring using a FSE (coagulation disorders and
maternal infections like HIV or hepatitis)

Study & Design

Study Type: Observational non invasive

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Primary outcomes: Percentage of switch to FSE and tocodynamography during labor<br /><br>and the reason of switch. </p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Secondary outcomes:<br /><br>Percentage and result of fetal blood sampling (FBS) in the primary and<br /><br>secondary stage of labor.<br /><br>Association of EHG pattern and the amount of blood loss within the first one<br /><br>and a half hour postpartum.<br /><br>Assocation of EHG pattern within the first one and a half hour postpartum and<br /><br>medication use and placental expulsion.<br /><br>Association of EHG pattern and initiation of labor analgesia.<br /><br>Other outcomes: This sample of patients will be a part of a greater study<br /><br>population to evaluate the effects of clinical implementation of NI-fECG and<br /><br>EHG monitoring on neonatal and maternal outcome. Retrospectively we will<br /><br>correlate fECG waveform details to clinical parameters and outcomes. </p><br>