Intrapartum Non-invasive Electrophysiological Monitoring

Maxima Medical Center3,471 enrolled

Overview

Conventional cardiotocography (CTG) has been used extensively for more than 50 years to monitor the fetal condition during labour, but since the rate of operative deliveries keeps rising, its ability to improve neonatal outcomes is unsatisfactory. A transabdominal non-invasive and wireless alternative which overcomes the shortcomings of conventional methods is electrophysiological CTG (eCTG) monitoring. In eCTG the fetal heart rate (FHR) is measured by fetal electrocardiography (NI-fECG) and uterine activity (UA) by electrohysterography (EHG). Both NI-fECG and EHG have been proven more accurate and reliable than conventional non-invasive methods and are less affected by maternal body mass index (BMI). This study aims to evaluate the mode of delivery, maternal and perinatal outcomes, costs and patient and healthcare professionals perspectives on eCTG monitoring versus the conventional CTG during labour at term with a singleton fetus in cephalic position. The eCTG provides a more accurate assessment of the fetus and the UA, compared to the conventional CTG. This allows for optimization of the contraction pattern during high-risk deliveries. We hypothesize that this will reduce the number of operative interventions and improves perinatal outcome. There are three reasons why an improvement in the contraction pattern by the eCTG can influence our outcomes: 1. EHG can detect excessive UA more accurately. Increased UA is a major risk for fetal distress. In this case, stimulation with oxytocin should be reduced or stopped. More adequate interpretation of FHR, reduced tachysystole and reduced hypertonia is expected to result in fewer instrumented vaginal deliveries and a reduction of caesarean sections due to fetal distress. 2. EHG can demonstrate unorganized UA that needs to be corrected with a higher dose of oxytocin to enhance contraction frequency and efficiency. This can result in a less exhausted uterine muscle, shorter time to delivery, less vacuum deliveries and caesarean sections due to failure of progress. A shorter time to delivery will also result in a reduction of infections and blood loss. 3. Accurate registration of the relation between the contraction and decelerations of FHR, is expected to result in more reliable assessment of the fetal condition. This can result in fewer unnecessary operative deliveries and less unpredictable poor perinatal outcomes.

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Eligibility

Sex: FEMALEMin age: 18 YearsHealthy volunteers:

Medical Language ↔ Plain English

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).

Outcomes

Primary Outcomes

The number of operative interventions during labor

cesarean section or instrumental vaginal delivery

Time frame: During delivery

Secondary Outcomes

Duration of the first stage of labor in minutes

Time frame: 0-10 cm dilation during labor

Duration of the second stage of labor in minutes

Time frame: Start pushing until childbirth

The timing and reason of operative interventions during labor

Timing is defined as: * The decision delivery interval for the intervention: emergency ('code red' or within \<30 minutes of the decision) or ≥ 1 hour * As the phase of delivery: first stage or second stage of labor

Time frame: During delivery

The number of participants with analgesia for pain reduction: epidural or/and remifentanil

Time frame: During delivery

Perineal laceration (grade 1, 2, 3a, 3b, 3c, 4)

Time frame: Directly after childbirth

The number of participants with a mediolateral episiotomy and reason for the episiotomy

Time frame: Directly after childbirth

Number (percentage) and result of fetal blood sampling during the primary and secondary stages of labour

Time frame: During delivery

Perinatal mortality

Perinatal mortality is defined as the number of fetal deaths past 22 completed weeks (154 days) of gestation plus the number of deaths among live-born children up to seven completed days of life

Time frame: During pregnancy up to seven completed days of life

Neonatal mortality

Neonatal mortality is defined as the number of neonatal deaths after the seventh day but before the 28th day of life

Time frame: After the seventh day but before the 28th day of life

The number of neonates with hypoxic ischemic encephalopathy