Clinical Trials Logo

Clinical Trial 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.


Clinical Trial Description

n/a


Study Design


Related Conditions & MeSH terms


NCT number NCT06135961
Study type Interventional
Source Maxima Medical Center
Contact
Status Recruiting
Phase N/A
Start date November 20, 2023
Completion date February 15, 2026

See also
  Status Clinical Trial Phase
Terminated NCT03638011 - A Comparison of the Post-C/S Analgesic Effects of Neuraxial Duramorph vs Bilateral TAP Block With Liposomal Bupivacaine Phase 4
Completed NCT04238741 - Audio-recording of Consent for Anaesthesia for Elective Caesarean Section N/A
Completed NCT01718236 - Modern Myorelaxation Procedure and Reversal of Neuromuscular Blockade With General Anesthesia for Caesarean Section Phase 4
Completed NCT03199170 - Effect of Bilateral Quadratus Lumborum Block for Pain Relief in Patients With Cesarean Section N/A
Completed NCT03309163 - Effect of Tramadol in Prevention of Postpartum Depression Phase 4
Completed NCT03711552 - Validation of an Obstetric QoR Score and to Establish Its MCID.
Not yet recruiting NCT05583214 - Evaluating the Effectiveness of Ondansetron Versus Dexamethasone Versus Placebo for the Control of Intraoperative Nausea and Vomiting in Patients Undergoing Lower-segment Caesarean Section Under Spinal Anesthesia Phase 4
Recruiting NCT06070792 - Neurolinguistic Programming, Progressive Muscle Relaxation Exercises, and Breastfeeding N/A
Recruiting NCT06070844 - Yoga Nidra and Pain After Caesarean Section N/A
Recruiting NCT04435496 - Study to Evaluate the Learning Curve to Anchor GYN-CS® Device N/A
Completed NCT00916812 - Sensitivity of Hyomental Distance Ratio as a Single Predictor of Difficult Intubation in Obstetrics
Completed NCT05520580 - Effect of Mother's Push at Cesarean Delivery Mother's PUSHING AT CS A RANDOMIZED CONTROLLED TRIAL N/A
Recruiting NCT02755168 - External Pop-Out Technique Versus Classic Head Extraction During Cesarean Section N/A
Completed NCT02285569 - The Pleth Variability Index and Hypotension at Caesarean Under Spinal. N/A
Completed NCT01210300 - Exploring Taiwanese Womens' Decision-making Regarding Vaginal Birth After Caesarean Section N/A
Completed NCT03653442 - Non Invasive Haemodynamics in Neuraxial Anaesthesia Hypotension
Completed NCT03134677 - The Effects of Different Anesthetic Techniques on QT, Corrected QT (QTc), and P Wave Dispersions in Cesarean Section Phase 4
Not yet recruiting NCT05446311 - Naldebain® Extended-release Injection After Cesarean Section in Pain Management
Completed NCT01278238 - Optimization of Hemodynamic Conditions During Caesarean Section Under Spinal Anaesthesia N/A
Completed NCT04172727 - Subarachnoid Block With Ultrasound-Guided Transversalis Fascia Plane Block for Cesarean Section Phase 4