Continuous non-invasive monitoring for high-risk pregnancies
Non-invasive Electrophysiological Monitoring in High Risk Pregnancies at the Obstetric High Care: the NIEM-O Study
This study tests if continuous monitoring of high-risk pregnancies with a special device can improve outcomes for mothers and babies compared to regular check-ups.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 1911 (estimated) |
| Ages | 18 Years and up |
| Sex | Female |
| Sponsor | Maxima Medical Center Academic / other |
| Locations | 1 site (Veldhoven, Noord-Brabant) |
| Trial ID | NCT06151613 on ClinicalTrials.gov |
What this trial studies
This study investigates the impact of continuous antepartum electrophysiological monitoring using the Nemo Fetal Monitoring System (NFMS) on perinatal and maternal outcomes in high-risk pregnancies. Pregnant women requiring hospitalization for maternal or fetal surveillance will be monitored continuously, compared to standard intermittent cardiotocography (CTG). The study aims to include 1911 women and assess various outcomes, including perinatal mortality, maternal morbidity, and satisfaction levels. Additionally, data collected will help develop a predictive model for preterm birth.
Who should consider this trial
Good fit: Ideal candidates are pregnant women aged 18 and older with a singleton pregnancy between 23+0 and 32+0 weeks of gestation requiring hospitalization for monitoring.
Not a fit: Patients with multiple pregnancies, certain cardiac diseases, or those requiring immediate intervention may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly improve perinatal and maternal outcomes in high-risk pregnancies.
How similar studies have performed: Previous studies using non-invasive electrophysiological monitoring have shown promising results, indicating potential for success in this approach.
Eligibility criteria
Show full inclusion / exclusion 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).
Where this trial is running
Veldhoven, Noord-Brabant
- Maxima Medical Centre — Veldhoven, Noord-Brabant, Netherlands (Recruiting)
Study contacts
- Principal investigator: SG Oei, Prof.dr. — Maxima Medical Center
- Study coordinator: ND de Klerk, MD
- Email: nadine.de.klerk@mmc.nl
- Phone: +40 8888384
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.