Clinical trial NCT06135961: Intrapartum Non-invasive Electrophysiological Monitoring
Official title: Implementation of Intrapartum Non-invasive Electrophysiological Monitoring
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Fetal Monitoring
Non-invasive
Cardiotocography
Electrocardiography
Caesarean Section
Lead sponsor: Maxima Medical Center
Sponsor class: OTHER
Collaborators: name: ZonMw: The Netherlands Organisation for Health Research and Development
First posted: 2023-11-18
Enrollment: 3471
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Eligible women will be prospectively included in the cohort receiving conventional CTG monitoring. From the eligible women in the prospective cohort a random sample (90.9%) will be offered eCTG monitoring via a computer generated random collection. Participants will receive eCTG monitoring from the start of fetal monitoring during labour until 1.5 hour after delivery. A retrospective cohort of 2100 women who received conventional CTG monitoring between April 2019 and February 2023 will be added to the prospective cohort for statistical analysis.
Primary purpose: DIAGNOSTIC

Brief summary: 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.


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).

Primary outcomes:
measure: The number of operative interventions during labor
timeFrame: During delivery
Secondary outcomes:
measure: Duration of the first stage of labor in minutes
timeFrame: 0-10 cm dilation during labor
measure: Duration of the second stage of labor in minutes
timeFrame: Start pushing until childbirth
measure: The timing and reason of operative interventions during labor
timeFrame: During delivery
measure: The number of participants with analgesia for pain reduction: epidural or/and remifentanil
timeFrame: During delivery
measure: Perineal laceration (grade 1, 2, 3a, 3b, 3c, 4)
timeFrame: Directly after childbirth
measure: The number of participants with a mediolateral episiotomy and reason for the episiotomy
timeFrame: Directly after childbirth
measure: Number (percentage) and result of fetal blood sampling during the primary and secondary stages of labour
timeFrame: During delivery
measure: Perinatal mortality
timeFrame: During pregnancy up to seven completed days of life
measure: Neonatal mortality
timeFrame: After the seventh day but before the 28th day of life
measure: The number of neonates with hypoxic ischemic encephalopathy
timeFrame: childbirth - 28th day postpartum
measure: The number of neonates with Neonatal Respiratory Distress Syndrome (RDS)
timeFrame: childbirth - 28th day postpartum
measure: The number of neonates with Meconium Aspiration Syndrome (MAS)
timeFrame: childbirth - 28th day postpartum
measure: The number of neonates with convulsions
timeFrame: childbirth - 28th day postpartum
measure: The number of neonates with Clinical early onset sepsis
timeFrame: childbirth - 28th day postpartum
measure: The number of neonates with Confirmed early onset sepsis
timeFrame: childbirth - 72 hours after childbirth
measure: The number of neonates with admission to Neonatal Intensive Care Unit
timeFrame: childbirth - 28th day postpartum
measure: Length of Admission to Neonatal Intensive Care Unit
timeFrame: childbirth - 28th day postpartum
measure: Reason for the admission to Neonatal Intensive Care Unit
timeFrame: childbirth - 28th day postpartum
measure: The number of neonates with the need for mechanical ventilation
timeFrame: childbirth - 72 hours after childbirth
measure: The number of neonates with a 5 minute Apgar score <7
timeFrame: 5 minutes after childbirth
measure: The number of neonates with a neonatal acidosis at birth
timeFrame: Directly after childbirth
measure: Maternal mortality
timeFrame: During pregnancy and childbirth or within 42 days of termination of pregnancy
measure: The number of mothers admitted to the Intensive Care Unit
timeFrame: childbirth until six weeks postpartum
measure: The number of mothers with a thromboembolic event
timeFrame: childbirth until six weeks postpartum
measure: The number of mothers with an uterine rupture
timeFrame: childbirth until six weeks postpartum
measure: The number of mothers with an obstetric haemorrhage
timeFrame: childbirth until 24 hours after childbirth
measure: The number of mothers with a postpartum anemia due to postpartum haemorrhage with requires red cell transfusion
timeFrame: childbirth until six weeks postpartum
measure: The number of mothers with a suspected or confirmed postpartum infection requiring antibiotics
timeFrame: childbirth until six weeks postpartum
measure: Patient satisfaction by questionnaires
timeFrame: 2-6 hours after childbirth
measure: Professional satisfaction by questionnaire
timeFrame: 1 year after the start of the study
measure: Costs as a business case model until six weeks postpartum
timeFrame: Delivery until six weeks postpartum
measure: For eCTG monitoring: amount of signal loss in percentage of total duration during labour
timeFrame: During delivery
measure: For eCTG monitoring: frequency of switch from Nemo Fetal Monitoring System to conventional CTG + reason, timing and success percentage of the switch
timeFrame: During delivery
measure: For eCTG monitoring: EHG pattern within the first 1.5 hours postpartum and the possible association with the amount of bloodloss, medication use and time to placental expulsion
timeFrame: First 1.5 hours postpartum
measure: For eCTG monitoring: EHG pattern before and after labour analgesia and the possible association of EHG pattern with labour analgesia
timeFrame: During delivery
Other outcomes:
Locations:
city: Veldhoven
country: Netherlands
facility: Maxima MC
state: Noord-Brabant
Study officials:
References: