Maternal and perinatal outcomes Outcomes mother and child
Conditions
Interventions
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 moni
Sponsors
Máxima MC
Eligibility
Age
18 Years to 64 Years
Inclusion criteria
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
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 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 outcomes
Primary
| Measure | Time frame |
|---|---|
| Number of operative interventions during labour; caesarean section or instrumental vaginal deliveries. | — |
Secondary
| Measure | Time frame |
|---|---|
| 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. | — |
Countries
Netherlands
Contacts
Public ContactA Barschot
Máxima MC
Outcome results
None listed