Pregnant women during delivery
Conditions
Interventions
None
Sponsors
Máxima MC
Eligibility
Inclusion criteria
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
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 (Patient information folder is available in English and Dutch) - Women with a multiple pregnancy - Fetal cardiac arrhythmias (detected and confirmed during pregnancy by ultrasound) - Contraindications to abdominal patch placement (dermatological disease 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)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Percentage of switch to fetal scalp electrode and external tocodynamometry in the primary and secondary stage of labor and the reason of switch. Amount of signal loss during primary and secondary stage of labor | — |
Secondary
| Measure | Time frame |
|---|---|
| Percentage and result of fetal blood sampling in the primary and secondary stage of labor. EHG pattern and the possible association with amount of blood loss within the first one and a half hour postpartum. To assess EHG patern within the first one and a half hour postpartum in relation to medication use and placental expulsion. To assess EHG patterns before and after labor analgesia. Frequency of replacement of abdominal patch during labor. Other outcomes: This sample of patients will be a part of a greater study population to evaluate the effects of clinical implementation of NI-fECG and EHG monitoring on neonatal and maternal outcome. Retrospectively we will correlate fECG waveform details to clinical parameters and outcomes. | — |
Contacts
Public ContactMarion Frenken
Máxima Medisch Centrum, Veldhoven
Outcome results
None listed