Status:
UNKNOWN
Continuous Non-invasive Electrophysiological Monitoring in High Risk Pregnancies
Lead Sponsor:
Maxima Medical Center
Collaborating Sponsors:
ZonMw: The Netherlands Organisation for Health Research and Development
Conditions:
Perinatal Outcomes
Preterm Birth
Eligibility:
FEMALE
18+ years
Phase:
NA
Brief Summary
The goal of this single centre cohort intervention study with historical controls, is to investigate the effect of implementing continuous antepartum electrophysiological CTG (eCTG) monitoring at the ...
Detailed Description
Pregnant women in need for maternal and/or fetal monitoring are hospitalized at the obstetric high care (OHC) of Máxima Medical Center (MMC). They are monitored for up to three times a day with conven...
Eligibility Criteria
Inclusion
- ≥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
- 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).
Key Trial Info
Start Date :
November 22 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
November 20 2025
Estimated Enrollment :
1911 Patients enrolled
Trial Details
Trial ID
NCT06151613
Start Date
November 22 2023
End Date
November 20 2025
Last Update
December 7 2023
Active Locations (1)
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1
Maxima Medical Centre
Veldhoven, North Brabant, Netherlands, 5504DB