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Cardiotocography clinical trials

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NCT ID: NCT06135961 Recruiting - Caesarean Section Clinical Trials

Intrapartum Non-invasive Electrophysiological Monitoring

NIEM-II
Start date: November 20, 2023
Phase: N/A
Study type: Interventional

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.

NCT ID: NCT05904314 Recruiting - Clinical trials for High Fidelity Simulation Training

Evaluation of the Effectiveness of Teaching Method With Simulation in Electronic Fetal Monitoring Management

EFM
Start date: December 15, 2022
Phase: N/A
Study type: Interventional

Electro fetal monitor monitoring in the antepartum and intrapartum periods is one of the most important responsibilities of midwives, who have important roles and responsibilities in maintaining and managing the health of women and newborns before, during and after delivery. Although midwives receive training on EFM monitoring with classical methods before graduation, they may experience problems in EFM monitoring in the clinical field after graduation. For this reason, midwife students should have the knowledge, skills and self-efficacy about a good level of EFM monitoring during their undergraduate education. In recent years, simulation-based education in the field of health has increased rapidly. This method creates an opportunity for health professionals, students, patient assessment, interaction and holistic care without compromising patient safety, and develops participants' critical thinking, clinical decision making and problem solving skills. In this context, it is very important to evaluate the EFM trace in the antepartum and intrapartum periods, to determine the possible risks, to plan, implement and evaluate the interventions, to provide the emergency crisis management in a short time without affecting the fetal health, and to increase the self-confidence of the midwives. The research was planned quantitatively in the form of randomized control-intervention of the scenario-based realistic simulation method, to increase the satisfaction and self-confidence levels of midwifery students in learning, to evaluate the simulation design and educational effectiveness, in EFM management. The research will facilitate midwifery students to intervene with the patient in a shorter time, with confidence and with sufficient clinical skills, and patient safety will be increased. It will also allow for the reduction of erroneous clinical practices and malpractices. This research aims to evaluate the effect of high-fidelity simulation teaching method on knowledge, satisfaction and self-efficacy of midwifery students in EFM follow-up.

NCT ID: NCT04632017 Recruiting - Sepsis Clinical Trials

Computerized Cardiotocography Monitoring of Fetuses With pPROM

COCA-PROM
Start date: June 15, 2020
Phase:
Study type: Observational

Preterm premature rupture of membranes (PPROM) is associated with neonatal complications leading to a high rate of cerebral palsy, sepsis, and death. Choosing the best time of delivery is crucial to improve fetal outcome. The balance is between a premature delivery exposing the infant to all the risk of prematurity, and keeping the baby in utero, prolonging the exposure to an adverse intrauterine milieu. There are no objective and reproducible tools to help in this decision-making process. Techniques most frequently used for fetal surveillance are biased by high inter- and intra-observer variability. Computerized cardiotocography (cCTG) identifies several objective parameters related to fetal heart rate (FHR) to determine fetal well-being. cCTG has been successfully used in fetuses with intrauterine growth restriction, but it has never been used in prospective studies to assess its role in the management of fetuses with PPROM. The investigators designed a case control study to highlight cCTG differences in PPROM pregnancies versus physiological pregnancies, to establish the effectiveness in predicting adverse outcome, and to develop a score to predict neonatal outcome.