To investigate the effect of eCTG monitoring versus conventional CTG monitoring during labour on mode of delivery, maternal and perinatal outcomes, costs and patient and health professional perspectives.
ID
Source
Brief title
Condition
- Pregnancy, labour, delivery and postpartum conditions
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Number of operative interventions during labour; caesarean section or
instrumental vaginal deliveries.
Secondary outcome
Secondary objectives:
eCTG compared with conventional CTG monitoring:
- To assess the duration of the first stage of labour in minutes.
- To assess the duration of the second stage of labour in minutes.
- To assess the timing and reason of operative interventions during labour.
- To assess the need of analgesia for pain reduction.
- To assess perineal laceration and the use of episiotomy.
- To assess how often FBS is performed during labour and the result of the
FBS.
- To assess neonatal and maternal mortality and morbidity.
- To assess patient and health care professional satisfaction by
questionnaires.
- The total costs during labour until six weeks postpartum.
For eCTG monitoring:
- To assess the amount of signal loss.
- To assess the frequency (percentage) of switch from the abdominal electrode
patch to the conventional system (i.e. doppler ultrasound or fetal
scalp electrode with tocodynamometry) during labour, along with the
reason and timing of switches and the success rate before
and after the switch.
- To assess the EHG pattern and the amount of blood loss within the first 1.5
hour postpartum.
- To assess EHG pattern in relation to medication use and placental expulsion
(during 1.5 hour postpartum).
- To assess EHG pattern before and after labour analgesia and the possible
association of EHG pattern with labour analgesia.
Background 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). eCTG has the potential to reduce the number of interventions
during labour and thereby to improve clinical outcomes for both mother and
child.
Study objective
To investigate the effect of eCTG monitoring versus conventional CTG monitoring
during labour on mode of delivery, maternal and perinatal outcomes, costs and
patient and health professional perspectives.
Study design
A single centre cohort intervention study with historial controls.
Intervention
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 2019 and 2022 will be added to the prospective cohort for statistical
analysis.
Study burden and risks
Participation in this study is expected not to cause any risk for the women or
fetus. The NIEM pilot study has shown an overall success rate of eCTG
monitoring with the Nemo Fetal Monitoring System (NFMS) of 94.5% during labour.
In case eCTG registration is insufficient, a switch to the conventional CTG can
be made.
The benefits of eCTG monitoring with NFMS include the fact that it is wireless
(enabling women to move while giving birth), non-invasive, and has the
potential to reduce the number of instrumental deliveries without compromising
the maternal and neonatal outcomes. Women with the NFMS have a very small
probability of developing skin irritation or a minor (local) allergic reaction
to the skin electrodes from the abdominal patch. There is no need for treatment
if skin irritation happens.
De Run 4600
Veldhoven 5504 DB
NL
De Run 4600
Veldhoven 5504 DB
NL
Listed location countries
Age
Inclusion criteria
In order to be eligible to participate in this study, a subject must meet all
of the following 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
A potential subject who meets any of the following criteria will be excluded
from participation in this study:
- 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)
- 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)
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL82822.015.22 |