Continuous Non-invasive Electrophysiological Monitoring in High Risk Pregnancies

Launched by MAXIMA MEDICAL CENTER · Nov 22, 2023

Keywords

ClinConnect Summary

This clinical trial is studying the effects of a new way to monitor pregnant women who are at high risk for complications. The researchers want to see if continuous monitoring using a special device called eCTG (electrophysiological cardiotocography) can improve outcomes for both mothers and their babies compared to the usual method, which involves checking the baby's heart rate a few times a day. The main goal is to find out if continuous monitoring can help reduce serious problems for babies after birth, such as death or severe health issues.

To participate in the trial, women need to be at least 18 years old, pregnant with a single baby, and hospitalized for monitoring due to potential complications like preterm labor or high blood pressure during pregnancy. Participants can expect to be monitored continuously with the new device if they are selected, while others will continue with the standard monitoring. This study will not only track how these monitoring methods affect health outcomes but also gather information on things like the length of the hospital stay and any procedures needed during delivery. Overall, this trial aims to improve care for high-risk pregnancies and ensure better health for both mothers and babies.

Gender

FEMALE

Eligibility criteria

• Inclusion Criteria:
• • ≥18 years old
• • Singleton pregnancy ≥23+0 weeks of gestation
• • Requiring hospitalization to the OHC for maternal or fetal surveillance (i.e. imminent preterm delivery(PPI), PE, HELLP, pregnancy induced hypertension (PIH), FGR, fetal distress, vaginal blood loss, fetal congenital anomalies)
• • Parents wishing for fetal monitoring
• Exclusion Criteria:
• • Multiple pregnancy
• • Insufficient knowledge of Dutch or English language
• • 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 (e.g. a pacemaker - exclusion due to possible signal interference)
• • Fetal and/or maternal cardiac disease (i.e. arrhythmia, congenital defect)
• • Treatment plan (with intervention planned within 24 hours after admission) already made before inclusion is completed
• • Women admitted with a clinical diagnosis of sepsis with hypotension (i.e. septic shock).