Intrapartum Non-invasive Electrophysiological Monitoring

Launched by MAXIMA MEDICAL CENTER · Nov 13, 2023

Keywords

ClinConnect Summary

This clinical trial is studying a new way to monitor the health of a baby during labor using a method called electrophysiological cardiotocography (eCTG). This non-invasive and wireless approach aims to provide better information about both the baby's heart rate and the mother's contractions compared to the traditional method, which has been used for many years. The researchers hope that by using eCTG, they can reduce the need for cesarean sections and improve outcomes for both mothers and babies during labor.

To participate in this trial, women need to be at least 18 years old, pregnant with a single baby in a head-down position, and between 37 and 42 weeks of pregnancy. They must also need fetal monitoring during labor and be able to give their written consent. Participants can expect to have their baby's heart rate and the mother’s contractions monitored with the new eCTG method, rather than the usual method, throughout their labor. It’s important to know that certain conditions, like having a multiple pregnancy or specific heart issues, may prevent someone from joining the trial. Overall, the goal is to provide safer and more efficient care during labor.

Gender

FEMALE

Eligibility criteria

• Inclusion Criteria:
• • Minimal age of 18 years old
• • Pregnant women with a gestational age between 37+0 and 42+0 weeks and days
• • Indication for fetal monitoring during labour
• • Singleton fetus in cephalic position
• • Oral and written informed consent is obtained
• Exclusion Criteria:
• • Insufficient knowledge of Dutch or English language
• • Women with a multiple pregnancy
• • Fetal and/or maternal cardiac arrhythmias
• • Contraindications to abdominal patch placement (dermatologic diseases of the abdomen precluding preparation of the abdomen with abrasive paper)
• • Women connected to an external or implanted electrical stimulator, such as Transcutaneous Electro Neuro Stimulation (TENS) and pacemaker (because of disturbance of the electrophysiological signal)
• • Women who take a bath for multiple times during delivery and/or who take a bath for \> 1 hour during the first stage of labour and/or who take a bath in the second stage of labour. eCTG monitoring is impossible in bath because the Bluetooth signal is disturbed. In bath, monitoring will be performed by conventional CTG monitoring. However, it is possible to take a shower with eCTG monitoring
• • Treatment plan (with intervention plan) already made before inclusion is completed.
• • Women who were included in the study, but when circumstances before labour call for delivery of the baby by unplanned caesarean section.
• • There is insufficient time for proper counselling
• • Women admitted with a clinical diagnosis of sepsis with hypotension (i.e. septic shock).