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

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

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

NL-OMON

Registry ID

NL-OMON55415

Enrollment

Registered

2019-12-02

Start date

2021-01-07

Completion date

Unknown

Last updated

2025-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

monitoring during labor

Interventions

None listed

Eligibility

Age

18 Years to 99 Years

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 (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)

Design outcomes

Primary

Measure	Time frame
Primary outcomes: Percentage of switch to FSE and tocodynamography during labor and the reason of switch.	—

Secondary

Measure	Time frame
Secondary outcomes: Percentage and result of fetal blood sampling (FBS) in the primary and secondary stage of labor. Association of EHG pattern and the amount of blood loss within the first one and a half hour postpartum. Assocation of EHG pattern within the first one and a half hour postpartum and medication use and placental expulsion. Association of EHG pattern and initiation of labor analgesia. 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.	—

Measure

Time frame

Secondary outcomes: Percentage and result of fetal blood sampling (FBS) in the primary and secondary stage of labor. Association of EHG pattern and the amount of blood loss within the first one and a half hour postpartum. Assocation of EHG pattern within the first one and a half hour postpartum and medication use and placental expulsion. Association of EHG pattern and initiation of labor analgesia. 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.

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Countries

Netherlands

Outcome results